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Monday, August 22, 2016 – Pfizer Inc. (NYSE:PFE) and Medivation, Inc. (NASDAQ:MDVN) today announced that they have entered into a definitive merger agreement under which Pfizer will acquire Medivation, a biopharmaceutical company focused on developing and commercializing small molecules for oncology, for $81.50 a share in cash for a total enterprise value of approximately $14 billion. The Boards of Directors of both companies have unanimously approved the merger, which is expected to be immediately accretive to Pfizer’s Adjusted Diluted EPS upon closing, approximately $0.05 accretive in the first full year after close with additional accretion and growth anticipated thereafter. Pfizer does not expect the transaction to impact its current 2016 financial guidance.

“The proposed acquisition of Medivation is expected to immediately accelerate revenue growth and drive overall earnings growth potential for Pfizer,” said Ian Read, chairman and chief executive officer, Pfizer. “The addition of Medivation will strengthen Pfizer’s Innovative Health business and accelerate its pathway to a leadership position in oncology, one of our key focus areas, which we believe will drive greater growth and scale of that business over the long-term. This transaction is another example of how we are effectively deploying our capital to generate attractive returns and create shareholder value.”

Medivation’s portfolio includes XTANDI® (enzalutamide), an androgen receptor inhibitor that blocks multiple steps in the androgen receptor signaling pathway within the tumor cell. XTANDI is the leading novel hormone therapy in the United States today and generated approximately $2.2 billion in worldwide net sales over the past four quarters, as recorded by Astellas Pharma Inc., with whom Medivation entered an agreement in 2009 to develop XTANDI globally and commercialize jointly in the U.S. Since its approval for advanced metastatic prostate cancer by the U.S. Food and Drug Administration in 2012, XTANDI has treated 64,000 men to date in the U.S. alone. Medivation and Astellas have built a robust development program for XTANDI, including two Phase 3 studies in non-metastatic prostate cancer and another Phase 3 study in hormone-sensitive prostate cancer. It is also being further developed in Phase 2 studies for the potential treatment of advanced breast cancer and hepatocellular carcinoma.

In addition, Medivation has a promising, wholly-owned, late-stage oncology pipeline, which includes two development-stage oncology assets, talazoparib and pidilizumab. Talazoparib, currently in a Phase 3 study for the treatment of BRCA-mutated breast cancer, has the potential to be a highly potent PARP inhibitor and could be efficacious across several additional tumors. Pidilizumab is an immuno-oncology (IO) asset being developed for diffuse large B-cell lymphoma and other hematologic malignancies and has the potential to be combined with IO therapies in Pfizer’s portfolio.

“We believe the combination with Pfizer is the right next step in our growth trajectory and is a testament to the passion and dedication by which the Medivation team has delivered on our mission to profoundly transform patients’ lives through medically innovative therapies,” said David Hung, M.D., founder, president and CEO of Medivation. “This compelling transaction will deliver significant and immediate value to our stockholders and provides new opportunities for our employees as part of a larger company. We believe that Pfizer is the ideal partner to extend the reach of our blockbuster XTANDI franchise and take our promising, late-stage assets – talazoparib and pidiluzimab – to their next stages of development so that they can be made available to patients as quickly as possible.”

“The proposed acquisition of Medivation will build upon Pfizer’s success with our IBRANCE® (palbociclib) launch in HR+/HER2- metastatic breast cancer and with our strong immuno-oncology portfolio, and will transform Pfizer into a leading oncology company,” said Albert Bourla, group president, Pfizer Innovative Health. “IBRANCE and XTANDI are anchor brands in breast and prostate cancer respectively, giving Pfizer leadership in two hormone-driven cancers. Similar to IBRANCE in the breast cancer setting, XTANDI is being explored for its potential to move from metastatic prostate cancer to treat earlier stages of non-metastatic prostate cancer. In addition, Medivation’s portfolio within prostate cancer and across diverse tumors will complement Pfizer’s broad IO portfolio. Finally, Medivation adds commercial scale to better compete with other top tier oncology companies in advance of the potential emergence of Pfizer’s IO pipeline expected in the next few years. Together, we believe Pfizer and Medivation can bring the full force of our combined research and resources to combat two of the most common cancers, as well as speed cures and make accessible breakthrough medicines to patients, redefining life with cancer.”

Cancer remains the second leading cause of death in the U.S. and a “Top 10” killer worldwide. According to the American Cancer Society, breast cancer and prostate cancer are among the top three cancers by annual incidence in the U.S. There are several parallels between breast and prostate cancer, including the incidence of prostate cancer in the U.S., which is similar to that of breast cancer with approximately 280,000 cases per year.

Pfizer expects to finance the transaction with existing cash.
Under the terms of the merger agreement, a subsidiary of Pfizer will commence a cash tender offer to purchase all of the outstanding shares of Medivation common stock for $81.50 per share, net to the seller in cash, without interest, subject to any required withholding of taxes. The closing of the tender offer is subject to customary closing conditions, including U.S. antitrust clearance and the tender of a majority of the outstanding shares of Medivation common stock. The merger agreement contemplates that Pfizer will acquire any shares of Medivation that are not tendered into the offer through a second-step merger, which will be completed promptly following the closing of the tender offer. Pfizer expects to complete the acquisition in the Third- or Fourth-Quarter 2016.

Pfizer’s financial advisors for the transaction were Guggenheim Securities and Centerview Partners, with Ropes & Gray LLP acting as its legal advisor. J.P. Morgan Securities and Evercore served as Medivation’s financial advisors, while Cooley LLP and Wachtell, Lipton, Rosen & Katz served as its legal advisors.

To view and listen to the webcast visit our web site at www.pfizer.com and click on the “Pfizer Analyst and Investor Call to Discuss Proposed Acquisition of Medivation” link in the For Investors section located on the lower right-hand corner of that page, or directly at https://www.webcaster4.com/Webcast/Page/748/16852 (link is external). Information on accessing and pre-registering for the webcast will be available at www.pfizer.com beginning today. Participants are advised to pre-register in advance of the conference call.

You can also listen to the conference call by dialing either (866) 662-3198 in the United States and Canada or (503) 343-6044 outside of the United States and Canada. The password is “Pfizer Analyst Call”. Please join the call five minutes prior to the start time to avoid operator hold times.

About Pfizer:
At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products. Our global portfolio includes medicines and vaccines as well as many of the world’s best-known consumer health care products. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world’s premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, Pfizer has worked to make a difference for all who rely on us. For more information, please visit us at www.pfizer.com. In addition, to learn more, follow us on Twitter at @Pfizer and @Pfizer_News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer.

About Medivation:
Medivation, Inc. is a biopharmaceutical company focused on the development and commercialization of medically innovative therapies to treat serious diseases for which there are limited treatment options. Medivation aims to transform the treatment of these diseases and offer hope to critically ill patients and their families. For more information, please visit us athttp://www.medivation.com

JERUSALEM- Aug. 3, 2016– Teva Pharmaceutical Industries Ltd., (NYSE and TASE: TEVA) today announced that it has entered into a definitive agreement to purchase Allergan’s Anda Inc., the 4th largest distributor of generic pharmaceuticals in the U.S. for $500 million.

“Anda is a natural fit into our business in general and our extensive supply chain network in particular,” stated Siggi Olafsson, President & CEO of Global Generic Medicines. “We believe Anda is truly a unique company which further enhances the offerings that Teva can provide. This strategic move enables us and our customers to improve capabilities and flexibility given the changes the pharmaceutical industry is currently undergoing, in order to provide access to more patients throughout the country. Additionally, both Teva and Anda’s customers will benefit from our ability as the largest producer of medicines in the world to leverage our size and scale.”

“Joining Teva opens a new world of possibilities for Anda, especially as the appropriate utilization of generic medicines remains the most effective means by which to ensure broad patient access,” stated Charles D. Phillips, President & CEO of Anda. “We look forward to the opportunity to utilize the Teva network to the advantage of our customers and patients across the country.”

Anda distributes generic, brand, specialty and over-the-counter pharmaceutical products from more than 300 manufacturers to retail independent and chain pharmacies, nursing homes, mail order pharmacies, hospitals, clinics and physician offices across the United States.

For the full year 2016, Anda is expected to generate more than $1 billion in third-party net revenue.
As part of the deal, Teva will acquire three distribution centers in Olive Branch, MS; Weston, FL; and Groveport, OH, with a total of over 650 employees.

Olafsson continued, “Anda will continue to operate as a stand-alone business and report directly to me. The addition of Anda and their ability to service over half of their 60,000 customers within 24 hours, combined with our existing offerings, will allow us to provide even better service to our customers.”

The closing of this transaction is subject to antitrust clearance and satisfaction of other conditions. The transaction is expected to close in the second half of 2016.

About Teva
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a leading global pharmaceutical company that delivers high-quality, patient-centric healthcare solutions used by millions of patients every day. Headquartered in Israel, Teva is the world’s largest generic medicines producer, leveraging its portfolio of more than 1,800 molecules to produce a wide range of generic products in nearly every therapeutic area. In specialty medicines, Teva has a world-leading position in innovative treatments for disorders of the central nervous system, including pain, as well as a strong portfolio of respiratory products. Teva integrates its generics and specialty capabilities in its global research and development division to create new ways of addressing unmet patient needs by combining drug development capabilities with devices, services and technologies. Teva’s net revenues in 2015 amounted to $19.7 billion. For more information, visit www.tevapharm.com.

GSK (LSE/NYSE: GSK) today announced an agreement with Verily Life Sciences LLC (formerly Google Life Sciences), an Alphabet company, to form Galvani Bioelectronics to enable the research, development and commercialisation of bioelectronic medicines. GSK will hold a 55% equity interest in the new jointly owned company and Verily will hold 45%.

Galvani Bioelectronics will be headquartered in the UK, with the parent companies contributing existing intellectual property rights[1] and an investment of up to £540 million over seven years, subject to successful completion of various discovery and development milestones.

Bioelectronic medicine is a relatively new scientific field that aims to tackle a wide range of chronic diseases using miniaturised, implantable devices that can modify electrical signals that pass along nerves in the body, including irregular or altered impulses that occur in many illnesses. GSK has been active in this field since 2012 and believes certain chronic conditions such as arthritis, diabetes and asthma could potentially be treated using these devices.

The agreement to establish Galvani Bioelectronics represents an important next step in GSK’s bioelectronics research. The new company will bring together GSK’s world class drug discovery and development expertise and deep understanding of disease biology with Verily’s world leading technical expertise in the miniaturisation of low power electronics, device development, data analytics and software development for clinical applications. Initial work will centre on establishing clinical proofs of principle in inflammatory, metabolic and endocrine disorders, including type 2 diabetes, where substantial evidence already exists in animal models; and developing associated miniaturised, precision devices.

Moncef Slaoui, GSK’s Chairman of Global Vaccines, who was instrumental in establishing GSK’s investments in the field of bioelectronics, will chair the board of the new company. He said:

“Many of the processes of the human body are controlled by electrical signals firing between the nervous system and the body’s organs, which may become distorted in many chronic diseases. Bioelectronic medicine’s vision is to employ the latest advances in biology and technology to interpret this electrical conversation and to correct the irregular patterns found in disease states, using miniaturised devices attached to individual nerves. If successful, this approach offers the potential for a new therapeutic modality alongside traditional medicines and vaccines.

“This agreement with Verily to establish Galvani Bioelectronics signals a crucial step forward in GSK’s bioelectronics journey, bringing together health and tech to realise a shared vision of miniaturised, precision electrical therapies. Together, we can rapidly accelerate the pace of progress in this exciting field, to develop innovative medicines that truly speak the electrical language of the body.”

Brian Otis, Verily’s Chief Technology Officer, said: “This is an ambitious collaboration allowing GSK and Verily to combine forces and have a huge impact on an emerging field. Bioelectronic medicine is a new area of therapeutic exploration, and we know that success will require the confluence of deep disease biology expertise and new highly miniaturised technologies.

“This partnership provides an opportunity to further Verily’s mission by deploying our focused expertise in low power, miniaturised therapeutics and our data analytics engine to potentially address many disease areas with greater precision with the goal of improving outcomes.”

Galvani Bioelectronics will be headquartered within GSK’s global R&D centre at Stevenage in the UK, with a second research hub at Verily’s facilities in South San Francisco. It will initially employ around 30 expert scientists, engineers and clinicians, and will fund and integrate a broad range of collaborations with both parent companies, academia and other R&D companies. GSK and Verily believe this collaborative way of working will rapidly accelerate the development of bioelectronic medicines.

Kris Famm, GSK’s Vice President of Bioelectronics R&D, has been appointed President of the new company. Famm has pioneered work in both large and small molecule drug discovery and worked for a decade developing and delivering R&D strategy with a recurring focus on emerging technologies. He has co-designed and led GSK’s exploration of bioelectronics. A seven-member board, chaired by Moncef Slaoui, will also be appointed and will include Andrew Conrad, CEO of Verily. The new company will be fully consolidated in GSK’s financial statements.

This agreement is subject to customary closing conditions (including requisite antitrust approvals) and is expected to close before the end of 2016.

GSK and bioelectronics
Since 2012, a dedicated team of scientists at GSK has been researching the potential of bioelectronic medicines. In that time, the company has established a leadership position in the field, including creating a global network of around 50 research collaborations and investing $50m in a dedicated bioelectronics venture capital fund. Through these collaborations and investments, GSK has seen encouraging proof of principles in animal models in a range of diseases. It believes the first bioelectronic medicines could be ready for approval within the next decade.

For further information visit GSK’s bioelectronics media resource centre http://www.gsk.com/en-gb/media/resource-centre/bioelectronics/

The history of Galvani
Galvani Bioelectronics is named after Luigi Aloisio Galvani, an 18th century Italian scientist, physician and philosopher, who was one of the first to explore the field of bioelectricity. In 1780, he made the pivotal discovery that the muscles of a frog’s legs twitched when he touched the sciatic nerve with two pieces of metal, leading him to propose the theory of bioelectricity. Galvani’s discovery, while disputed by many of his peers, paved the way for the modern study of electrophysiology and neuroscience – two fields that are key to the development of bioelectronic medicines.

GSK – one of the world’s leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For further information please visit www.gsk.com.

The United Nations health agency today issued a revised strategic response plan for the next one and a half years to combat the transmission of the Zika virus, which has now spread to 60 countries.

The Zika Strategic Response Plan from July 2016 to December 2017 would place a greater focus on preventing and managing medical complications caused by Zika virus infection, requiring $121.9 million for its effective implementation, according to the World Health Organization (WHO).

“Much has been learned about Zika virus infection […] This Zika virus strain and its complications represent a new type of public health threat which requires a unique and integrated strategy that places support for women and girls of child-bearing age at its core,” said WHO Director-General Dr. Margaret Chan in a news release on the strategy.

In an interconnected world characterized by profound mobility, Zika has spread dramatically across central and southern America and more recently to other regions, including Asia and Africa, she said.

“Its risk profile has changed from a mild threat to one with serious consequences,” Dr. Chan stressed, noting that there is now scientific consensus that Zika virus is a cause of microcephaly and Guillain-Barré syndrome.

Its risk profile has changed from a mild threat to one with serious consequences
The previous response plan was put in place in February, but at the time there had not been as much knowledge about Zika as there was now. The link between Zika and neurological disorders had not yet been established then.

“Knowing now that Zika could have long-term consequences, it was necessary to work with countries to have enough capacities to counsel couples before the pregnancy, to monitor and follow pregnancies, and to provide medical support if needed to babies,” WHO spokesperson Tarik Jasarevic told reporters in Geneva.

Risk communications targeting pregnant women, their partners, households and communities will be central to prevention efforts to ensure they have the information they need to protect themselves.

Other elements include integrated vector management, sexual and reproductive health counselling as well as health education and care within the social and legal contexts of each country where Zika virus is being transmitted.

The plan highlights several specific characteristics of the Zika outbreak that require a collaborative, global response and support. These include:

the potential for further international spread of Zika virus given the wide distribution of Aedes mosquitoes that are capable of transmitting Zika virus;
the lack of population immunity in areas where Zika virus is circulating for the first time and which allows the disease to spread quickly;
the absence of vaccines, specific treatments and rapid diagnostic tests; and
inequalities in access to sanitation, information and health services in affected areas.
Significant funding gaps existed for the full implementation of the previous plan, and coherent funding mechanisms are essential for successful implementation of the revised plan.

In May, Secretary-General Ban Ki-moon established a UN Zika response multi-partner trust fund, to generate and ensure the effective use of the resources necessary to implement this revised Zika strategic response plan.

NEW YORK, N.Y., April 6 – Pfizer Inc. (NYSE: PFE) today announced that the merger agreement between Pfizer and Allergan plc (NYSE: AGN) has been terminated by mutual agreement of the companies. The decision was driven by the actions announced by the U.S. Department of Treasury on April 4, 2016, which the companies concluded qualified as an “Adverse Tax Law Change” under the merger agreement.

“Pfizer approached this transaction from a position of strength and viewed the potential combination as an accelerator of existing strategies,” stated Ian Read, Chairman and Chief Executive Officer, Pfizer. “We remain focused on continuing to enhance the value of our innovative and established businesses. Our most recent product launches, including Prevnar 13 in Adults, Ibrance, Eliquis and Xeljanz, have been well-received in the market, and we believe our late stage pipeline has several attractive commercial opportunities with high potential across several therapeutic areas. We also maintain the financial strength and flexibility to pursue attractive business development and other shareholder friendly capital allocation opportunities.”

“We plan to make a decision about whether to pursue a potential separation of our innovative and established businesses by no later than the end of 2016, consistent with our original timeframe for the decision prior to the announcement of the potential Allergan transaction,” continued Read. “As always, we remain committed to enhancing shareholder value.”

In connection with the termination of the merger agreement, Pfizer has agreed to pay Allergan $150 million for reimbursement of expenses associated with the transaction.

As previously announced, Pfizer plans to report its First-Quarter 2016 financial results on May 3, 2016.

About Pfizer
At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products. Our global portfolio includes medicines and vaccines as well as many of the world’s best-known consumer health care products. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world’s premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, Pfizer has worked to make a difference for all who rely on us. For more information, please visit us at www.pfizer.com. In addition, to learn more, follow us on Twitter at @Pfizer and @Pfizer_News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer.

In a continuing effort to educate prescribers and patients about the potential risks related to opioid use, the U.S. Food and Drug Administration today announced required class-wide safety labeling changes for immediate-release (IR) opioid pain medications. Among the changes, the FDA is requiring a new boxed warning about the serious risks of misuse, abuse, addiction, overdose and death. Today’s actions are among a number of steps the agency recently outlined in a plan to reassess its approach to opioid medications. The plan is focused on policies aimed at reversing the epidemic, while still providing patients in pain access to effective relief.

The FDA is also requiring several additional safety labeling changes across all prescription opioid products to include additional information on the risk of these medications. This is part of the agency’s overall effort to help inform prescribers about the importance of balancing the serious risks of opioids with their role in managing pain.

“Opioid addiction and overdose have reached epidemic levels over the past decade, and the FDA remains steadfast in our commitment to do our part to help reverse the devastating impact of the misuse and abuse of prescription opioids,” said Robert Califf, M.D., FDA commissioner. “Today’s actions are one of the largest undertakings for informing prescribers of risks across opioid products, and one of many steps the FDA intends to take this year as part of our comprehensive action plan to reverse this epidemic.”

Opioid analgesics are powerful pain-reducing medications that include prescription oxycodone, hydrocodone and morphine, among others. Prescription opioids are divided into two main categories – IR products, usually intended for use every four to six hours; and extended-release/long-acting (ER/LA) products, which are primarily intended to be taken once or twice a day, depending on the individual product and patient. Certain opioids, such as methadone and buprenorphine, are also used as a form of treatment for opioid addiction, and in combination with behavioral therapy and counseling, are known as medication-assisted treatment, or MAT.

The updated indication clarifies that because of these risks, IR opioids should be reserved for pain severe enough to require opioid treatment and for which alternative treatment options (e.g., non-opioid analgesics or opioid combination products, as appropriate) are inadequate or not tolerated. The dosing information also provides clearer instructions regarding patient monitoring and drug administration, including initial dosage, dosage changes during therapy and a warning not to abruptly stop treatment in a physically dependent patient.

As part of the boxed warning on IR opioid analgesics, the FDA now requires a precaution that chronic maternal use of opioids during pregnancy can result in neonatal opioid withdrawal syndrome (NOWS), which may be life-threatening if not recognized and treated using protocols developed by neonatology experts. NOWS may occur in a newborn exposed to opioid drugs for a prolonged period while in utero.

In 2013, the FDA required class-wide labeling changes for ER/LA opioid analgesics that included modifications to the products’ indications, limitations of use, and warnings, including boxed warnings to more effectively communicate to prescribers the serious risks associated with these drugs. Today, the FDA is requiring similar changes to the labeling of IR opioid analgesics.

“We know that there is persistent abuse, addiction, overdose mortality and risk of NOWS associated with IR opioid products,” said Douglas Throckmorton, M.D., deputy center director of regulatory programs, FDA’s Center for Drug Evaluation and Research. “Today, we have taken an important next step in clarifying and making more prominent the known risks of IR opioid medications.”

Additionally, the FDA is requiring updated labeling for all opioids (both ER/LA and IR products) to include safety information about potentially harmful drug interactions with other medicines that can result in a serious central nervous system condition called serotonin syndrome. Updated labeling will also include information about opioid effects on the endocrine system, including a rare but serious disorder of the adrenal glands (called adrenal insufficiency) and decreased sex hormone levels (androgen deficiency). These labeling changes will also make it clear that these negative outcomes can occur whether a patient is taking an opioid to treat pain or if the product is being used for MAT. Today, the FDA issued a Drug Safety Communication outlining these risks.

“The broad set of actions announced today is reflective of the FDA’s efforts to improve informed prescribing of opioids across the board,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “We have been and will continue to evaluate all new data to ensure that labels of opioid drugs contain appropriate prescribing information about the benefits and risks of prescription opioids.”

The FDA is also aware of, and carefully reviewing, available scientific information about potentially serious outcomes related to interactions between benzodiazepines and opioids. Once a review of all available scientific information is completed, the FDA will take necessary actions to ensure prescribers and the public are informed of the risks involved with the use of these medications.

These actions are the latest examples of the agency’s commitment to combat this public health crisis and its profound impact on individuals, families and communities across our country. Health and Human Services Secretary Sylvia M. Burwell has made addressing opioid misuse, addiction and overdose a priority. Other work on this important issue is underway within HHS. The evidence-based HHS-wide opioid initiative focuses on three priority areas: informing opioid prescribing practices, increasing the use of naloxone (a rescue medication that can prevent death from overdose) and expanding access to and the use of MAT to treat opioid use disorder.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

SAN FRANCISCO and TORONTO – McKesson Corporation (NYSE: MCK), a leading international healthcare services and information technology company, and Katz Group, one of Canada’s largest privately-owned enterprises, today announced a definitive agreement to acquire Rexall Health from Katz Group for $3 billion CAD ($2.2 billion USD*, or approximately $1.9 billion USD* net of the present value of incremental cash tax benefits). The acquisition strengthens McKesson’s position in Canada’s pharmaceutical supply chain, and is a natural next step for two companies that have worked together for over 20 years delivering care to Canadians.

“The acquisition of Rexall Health supports McKesson’s commitment to drive value in the industry by improving healthcare solutions delivered in the pharmacy; it enhances our ability to provide best-in-class pharmacy care through an expanded retail footprint for patients across Canada,” said John H. Hammergren, chairman and chief executive officer, McKesson Corporation. “Canada’s healthcare environment is rapidly evolving; it is marked by a move of primary care into pharmacy and increasingly complex patient demand. With today’s announcement, McKesson will bring together the strengths and expertise of our diverse portfolio to address challenges and opportunities in delivering the very best patient care,” concluded Hammergren.

Daryl Katz, Founder and Chairman of Katz Group said, “I have the utmost confidence that Rexall Health will continue to flourish under McKesson’s ownership and Jürgen Schreiber’s continued leadership. I want to thank everyone who has helped to make Rexall Health a success over the past two decades, including all of our current and former employees, our partners, and above all our customers for their loyalty and dedication. Going forward, Katz Group will continue to invest in the growth of our three other lines of business: real estate, sports & entertainment, and private and public investments‎.”

“Today is an exciting day for Rexall Health and its employees,” said Jürgen Schreiber, CEO, Rexall Health. “With McKesson, we will ensure Rexall Health continues to deliver the highest quality care to its patients and service to its customers.”

Like McKesson Canada, the operations of Rexall Health will be part of McKesson’s Distribution Solutions segment, reporting to Paul C. Julian, executive vice president and group president, who commented: “We are looking forward to welcoming Rexall Health, its leadership team and employees to McKesson. We share a culture of respect for patients and the employees who serve them every day.”

Rexall Health will continue to have a dedicated management team in Canada led by Jürgen Schreiber, while retaining the existing brand Canadians have come to know and trust.

“For over one hundred years in Canada, McKesson has helped build a strong network of independent pharmacies,” said Alain Champagne, president, McKesson Canada. “With the acquisition of Rexall Health, McKesson will continue to deliver value-added pharmacy solutions through an expanded portfolio, while providing operational excellence to small business owners, independent pharmacists and our pharmaceutical distribution customers.”

Once completed, the acquisition of Rexall Health will enhance McKesson’s retail pharmacy capabilities and procurement scale. McKesson Canada’s diverse customer base, including its independent pharmacists, is expected to benefit from competitive pharmacy solutions and industry leading service levels.

As part of the transaction, McKesson intends to acquire Rexall Health’s business, including approximately 470 retail pharmacies. This will bring McKesson Canada’s combined pool of talent to 13,000 employees, serving customers and patients throughout the country. Rexall Health will help McKesson leverage its existing portfolio of assets to drive growth along the entire value chain, particularly in two of Canada’s fastest growing regions, Ontario and Western Canada.

The acquisition, which will be funded by a mix of cash and debt, is expected to close late in calendar year 2016. McKesson expects the acquisition to be modestly accretive to adjusted earnings per diluted share for Fiscal 2017 as earnings attributable to Rexall Health will be partially offset by an anticipated charge related to the reversal of a step-up to fair value of acquired inventory at the date of the acquisition. McKesson expects the acquisition to drive meaningful accretion, on a constant currency basis, to Fiscal 2018 adjusted earnings per diluted share.

The transaction is subject to review under the Investment Canada Act and by the Competition Bureau of Canada.

* $1 CAD = $0.74 USD

About McKesson Corporation
McKesson Corporation, currently ranked 11th on the FORTUNE 500, is a healthcare services and information technology company dedicated to making the business of healthcare run better. McKesson partners with payers, hospitals, physician offices, pharmacies, pharmaceutical companies and others across the spectrum of care to build healthier organizations that deliver better care to patients in every setting. McKesson helps its customers improve their financial, operational, and clinical performance with solutions that include pharmaceutical and medical-surgical supply management, healthcare information technology, and business and clinical services. For more information, visit www.mckesson.com.

About McKesson Canada
Founded more than 100 years ago, McKesson Canada is dedicated to delivering vital medicines, supplies and information technologies that enable the healthcare industry to provide patients better, safer care. Our solutions empower pharmacies, manufacturers, hospitals and other healthcare institutions by enabling them to get closer to the millions of patients they serve every single day, while contributing to the quality and safety of care in Canada.

About Rexall Health
With a heritage dating back to 1904, Rexall Health and Rexall Health Pharma Plus pharmacies are among the most trusted names in retail pharmacy. Rexall Health is focused on helping Canadians feel good about their health through easy access to a wide assortment of health and wellness services and products. Supported by our team of over 8,600 employees in over 470 pharmacies across the country, Rexall Health is continually evolving to enhance the customer experience. Rexall Health also includes Medicentres Canada, a group of family healthcare clinics in Edmonton, Calgary, London and Windsor where family physicians and specialists provide high-quality and accessible healthcare services to individuals and families, and ClaimSecure, Inc. an industry-leading healthcare management and technology firm that has been providing customized, value added health benefit claims management and plan administrative services to Canadian corporations and other health benefit plan sponsors for over 30 years. For more information, visit www.rexall.ca.

About Katz Group
Katz Group is one of Canada’s largest privately-owned enterprises, with operations in pharmacy, sports & entertainment and real estate development. Oilers Entertainment Group (OEG) delivers leading sports, entertainment and other special event programming to fans and patrons in Canada and the United States. OEG owns the 5-time Stanley Cup Champion Edmonton Oilers, the WHL’s Edmonton Oil Kings, the AHL’s Bakersfield Condors, and will operate Rogers Place, the new home of the Oilers and Oil Kings in downtown Edmonton. Through Katz Group Properties, Katz Group is also involved in land assembly, site, and building development in Canada and the United States, including the design and development of ICE District, North America’s leading sports & entertainment district, anchored by Rogers Place (www.rogersplace.com) and encompassing more than 25 acres in downtown Edmonton. Katz Group is based in Edmonton, Alberta. For more information, visit www.katzgroup.ca.

In response to a request by Massachusetts State Representative Bradley H. Jones, the Federal Trade Commission and the Department of Justice’s Antitrust Division have submitted a statement encouraging the Massachusetts legislature to consider expanding the services that optometrists can provide to glaucoma patients. Specifically, Representative Jones asked the agencies for views on the possible competitive impact of Massachusetts House Bill 1973 (HB 1973), which would expand the scope of practice for optometrists in Massachusetts by permitting them to treat glaucoma and other optical diseases.

Glaucoma affects 2.7 million Americans, and early diagnosis and managed treatment offer protection against the risk of vision loss or blindness. With respect to glaucoma care, HB 1973 would allow optometrists to treat glaucoma patients using medications, subject to certain training and referral requirements, as optometrists do in other states.

The statement, which is limited to the bill’s effect on glaucoma care, describes the potential benefits to patients of enhanced competition among glaucoma care providers, including greater access to timely and cost-competitive care, noting that unnecessarily broad scope of practice restrictions “can impose significant competitive costs on health care consumers and other payors.” It recommends that the legislature restrict optometrists’ ability to treat glaucoma only to the extent necessary to ensure patient health and safety.

WHO Director-General, Margaret Chan, will convene an International Health Regulations Emergency Committee on Zika virus and observed increase in neurological disorders and neonatal malformations.

The Committee will meet on Monday 1 February in Geneva to ascertain whether the outbreak constitutes a Public Health Emergency of International Concern.

Decisions concerning the Committee’s membership and advice will be made public on WHO’s website.

Outbreak in the Americas
In May 2015, Brazil reported its first case of Zika virus disease. Since then, the disease has spread within Brazil and to 22 other countries and territories in the region.

Arrival of the virus in some countries of the Americas, notably Brazil, has been associated with a steep increase in the birth of babies with abnormally small heads and in cases of Guillain-Barré syndrome, a poorly understood condition in which the immune system attacks the nervous system, sometimes resulting in paralysis.

A causal relationship between Zika virus infection and birth defects and neurological syndromes has not been established, but is strongly suspected.

WHO action
WHO’s Regional Office for the Americas (PAHO) has been working closely with affected countries since May 2015. PAHO has mobilized staff and members of the Global Outbreak and Response Network (GOARN) to assist ministries of health in strengthening their abilities to detect the arrival and circulation of Zika virus through laboratory testing and rapid reporting. The aim has been to ensure accurate clinical diagnosis and treatment for patients, to track the spread of the virus and the mosquito that carries it, and to promote prevention, especially through mosquito control.

The Organization is supporting the scaling up and strengthening of surveillance systems in countries that have reported cases of Zika and of microcephaly and other neurological conditions that may be associated with the virus. Surveillance is also being heightened in countries to which the virus may spread. In the coming weeks, the Organization will convene experts to address critical gaps in scientific knowledge about the virus and its potential effects on fetuses, children and adults.

WHO will also prioritize the development of vaccines and new tools to control mosquito populations, as well as improving diagnostic tests.

WASHINGTON, – Secretary of Health and Human Services Sylvia M. Burwell and Secretary of Agriculture Tom Vilsack today released updated nutritional guidelines that encourage Americans to adopt a series of science-based recommendations to improve how they eat to reduce obesity and prevent chronic diseases like Type 2 diabetes, hypertension, and heart disease. The 2015-2020 Dietary Guidelines for Americans is the nation’s trusted resource for evidence-based nutrition recommendations and serves to provide the general public, as well as policy makers and health professionals with the information they need to help the public make informed choices about their diets at home, school, work and in their communities.

“Protecting the health of the American public includes empowering them with the tools they need to make healthy choices in their daily lives,” said Secretary Burwell. “By focusing on small shifts in what we eat and drink, eating healthy becomes more manageable. The Dietary Guidelines provide science-based recommendations on food and nutrition so people can make decisions that may help keep their weight under control, and prevent chronic conditions, like Type 2 diabetes, hypertension, and heart disease.”

The newly released 8th edition of the Dietary Guidelines reflects advancements in scientific understanding about healthy eating choices and health outcomes over a lifetime. This edition recognizes the importance of focusing not on individual nutrients or foods in isolation, but on the variety of what people eat and drink—healthy eating patterns as a whole—to bring about lasting improvements in individual and population health.

“The Dietary Guidelines for Americans is one of many important tools that help to support a healthier next generation of Americans,” said Secretary Vilsack. “The latest edition of the Dietary Guidelines provides individuals with the flexibility to make healthy food choices that are right for them and their families and take advantage of the diversity of products available, thanks to America’s farmers and ranchers.”

The specific recommendations fit into five overarching guidelines in the new edition:
Follow a healthy eating pattern across the lifespan. Eating patterns are the combination of foods and drinks that a person eats over time.
Focus on variety, nutrient-dense foods, and amount
Limit calories from added sugars and saturated fats, and reduce sodium intake
Shift to healthier food and beverage choices
Support healthy eating patterns for all

Healthy eating patterns include a variety of nutritious foods like vegetables, fruits, grains, low-fat and fat-free dairy, lean meats and other protein foods and oils, while limiting saturated fats, trans fats, added sugars and sodium. A healthy eating pattern is adaptable to a person’s taste preferences, traditions, culture and budget.

Importantly, the guidelines suggest Americans should consume:
A variety of vegetables, including dark green, red and orange, legumes (beans and peas), starchy and other vegetables
Fruits, especially whole fruits
Grains, at least half of which are whole grains
Fat-free or low-fat dairy, including milk, yogurt, cheese, and/or fortified soy beverages
A variety of protein foods, including seafood, lean meats and poultry, eggs, legumes (beans and peas), soy products, and nuts and seeds
Oils, including those from plants: canola, corn, olive, peanut, safflower, soybean, and sunflower. Oils also are naturally present in nuts, seeds, seafood, olives, and avocados.

Further, Americans should be encouraged to consume:
Less than 10 percent of calories per day from added sugars. ChooseMyPlate.gov provides more information about added sugars, which are sugars and syrups that are added to foods or beverages when they are processed or prepared. This does not include naturally occurring sugars such as those consumed as part of milk and fruits.
Less than 10 percent of calories per day from saturated fats. The Nutrition Facts label can be used to check for saturated fats. Foods that are high in saturated fat include butter, whole milk, meats that are not labeled as lean, and tropical oils such as coconut and palm oil.
Less than 2,300 milligrams (mg) per day of sodium for people over the age of 14 years and less for those younger. The Nutrition Facts label is a helpful tool to check for sodium, especially in processed foods like pizza, pasta dishes, sauces, and soups.

Based on a review of current scientific evidence on nutrition, the 2015 edition includes updated guidance on topics such as added sugars, sodium, and cholesterol and new information on caffeine. For example, the 2015-2020 Dietary Guidelines is the first edition to recommend a quantitative limit to consume less than 10 percent of calories from added sugars. This edition also reaffirms guidance about the core building blocks of a healthy lifestyle that have remained consistent over the past several editions, and suggests there is still work to be done to encourage more Americans to follow the recommendations outlined in the Dietary Guidelines.

The 2015-2020 Dietary Guidelines was informed by the recommendations of the 2015 Dietary Guidelines Advisory Committee, which was composed of prestigious researchers in the fields of nutrition, health, and medicine, and by consideration of public and federal agency comments.

Since 1980, HHS and USDA have shared a responsibility to the American public to ensure that advancements in scientific understanding about the role of nutrition in health are incorporated into the Dietary Guidelines, which is updated every five years. USDA has also released updates for consumers on ChooseMyPlate.gov, and new resources will soon be available on Health.gov from HHS that will help health professionals support their clients and patients in making healthy choices.

The 2015-2020 Dietary Guidelines for Americans is available at dietaryguidelines.gov.

CDC, the U.S. Food and Drug Administration, the U.S. Department of Agriculture Food Safety and Inspection Service, and public health officials in several states are investigating an outbreak of Shiga toxin-producing Escherichia coli O157:H7 (STEC O157:H7) infections.

Public health investigators are using the PulseNet system to identify illnesses that may be part of this outbreak. PulseNet, the national subtyping network of public health and food regulatory agency laboratories, is coordinated by CDC. DNA “fingerprinting” is performed on E. coli bacteria isolated from ill people by using a technique called pulsed-field gel electrophoresis, or PFGE. PulseNet manages a national database of these DNA fingerprints to identify possible outbreaks.

One DNA fingerprint (outbreak strain) is included in this investigation. A total of 19 people infected with the outbreak strain of Shiga toxin-producing STEC O157:H7 have been reported from 7 states. The majority of illnesses have been reported from states in the western United States. The number of ill people reported from each state is as follows: California (1), Colorado (4), Missouri (1), Montana (6), Utah (5), Virginia (1), and Washington (1).

Among people for whom information is available, illnesses started on dates ranging from October 6, 2015 to November 3, 2015. Ill people range in age from 5 years to 84, with a median age of 18. Fifty-seven percent of ill people are female. Five (29%) people reported being hospitalized, and two people developed hemolytic uremic syndrome (HUS), a type of kidney failure. No deaths have been reported.

This outbreak can be illustrated with a chart showing the number of people who became ill each day. This chart is called an epidemic curve or epi curve. Illnesses that occurred after November 10, 2015, might not be reported yet due to the time it takes between when a person becomes ill and when the illness is reported. This takes an average of 2 to 3 weeks. Please see the Timeline for Reporting Cases of E. coli Infection for more details.

CDC and state and local public health partners are continuing laboratory surveillance through PulseNet to identify additional ill persons and to interview them.

Investigation of the Outbreak
The epidemiologic evidence available to investigators at this time suggests that rotisserie chicken salad made and sold in Costco stores is a likely source of this outbreak. The ongoing investigation has not identified what specific ingredient in the chicken salad is linked to illness.

State and local public health officials are interviewing ill people to obtain information about foods they might have eaten and other exposures in the week before their illness started. Fourteen (88%) of 16 people purchased or ate rotisserie chicken salad from Costco.

On November 20, 2015, Costco reported to public health officials that the company had removed all remaining rotisserie chicken salad from all stores in the United States and stopped further production of the product until further notice.

Updates will be provided when more information is available.

New York and Dublin: Pfizer Inc. (NYSE: PFE) and Allergan plc (NYSE: AGN) today announced that their boards of directors have unanimously approved, and the companies have entered into, a definitive merger agreement under which Pfizer, a global innovative biopharmaceutical company, will combine with Allergan, a global pharmaceutical company and a leader in a new industry model – Growth Pharma, in a stock transaction currently valued at $363.63 per Allergan share, for a total enterprise value of approximately $160 billion, based on the closing price of Pfizer common stock of $32.18 on November 20, 2015. The transaction represents more than a 30 percent premium based on Pfizer’s and Allergan’s unaffected share prices as of October 28, 2015. Allergan shareholders will receive 11.3 shares of the combined company for each of their Allergan shares, and Pfizer stockholders will receive one share of the combined company for each of their Pfizer shares.

“The proposed combination of Pfizer and Allergan will create a leading global pharmaceutical company with the strength to research, discover and deliver more medicines and therapies to more people around the world,” stated Ian Read, Chairman and Chief Executive Officer, Pfizer. “Allergan’s businesses align with and enhance Pfizer’s businesses, creating best-in-class, sustainable, innovative and established businesses that are poised for growth. Through this combination, Pfizer will have greater financial flexibility that will facilitate our continued discovery and development of new innovative medicines for patients, direct return of capital to shareholders, and continued investment in the United States, while also enabling our pursuit of business development opportunities on a more competitive footing within our industry.”

“The combination of Allergan and Pfizer is a highly strategic, value-enhancing transaction that brings together two biopharma powerhouses to change lives for the better,” said Brent Saunders, Chief Executive Officer, Allergan. “This bold action is the next chapter in the successful transformation of Allergan allowing us to operate with greater resources at a much bigger scale. Joining forces with Pfizer matches our leading products in seven high growth therapeutic areas and our robust R&D pipeline with Pfizer’s leading innovative and established businesses, vast global footprint and strength in discovery and development research to create a new biopharma leader.”

Under the terms of the proposed transaction, the businesses of Pfizer and Allergan will be combined under Allergan plc, which will be renamed “Pfizer plc.” The companies expect that shares of the combined company will be listed on the New York Stock Exchange and trade under the “PFE” ticker. Upon the closing of the transaction, the combined company is expected to maintain Allergan’s Irish legal domicile. Pfizer plc will have its global operational headquarters in New York and its principal executive offices in Ireland.

Pfizer’s innovative businesses will be significantly enhanced by the addition of a growing revenue stream from Allergan’s durable and innovative flagship brands in desirable therapeutic areas such as Aesthetics and Dermatology, Eye Care, Gastrointestinal, Neuroscience and Urology. The combined company will benefit from a broader innovative portfolio of leading medicines in key categories and a platform for sustainable growth with diversified payer groups. With the addition of Allergan, Pfizer will enhance its R&D capabilities in both new molecular entities and product line extensions. A combined pipeline of more than 100 mid-to-late stage programs in development and greater resources to invest in R&D and manufacturing is expected to sustain the growth of the innovative business over the long term. Through product approvals, launches and inline performance the combined company aspires to be a leader in growth.

The combination of Pfizer and Allergan will significantly increase the scale of Pfizer’s established business, and their complementary capabilities will maximize the combined established portfolio. The addition of Allergan’s Women’s Health and Anti-Infectives portfolio will add depth to Pfizer’s established business, and Pfizer will expand the reach of Allergan’s established portfolio using its existing commercial capabilities, infrastructure and global scale. In addition, Allergan brings topical formulation, manufacturing and its Anda distribution capabilities to the combined company.

As a result of the combination with Allergan and subsequent integration of the two companies, Pfizer now expects to make a decision about a potential separation of the combined company’s innovative and established businesses by no later than the end of 2018.

Financial Highlights
Pfizer anticipates the transaction will deliver more than $2 billion in operational synergies over the first three years after closing. Pfizer anticipates that the combined company will have a pro forma Adjusted Effective Tax Rate1 of approximately 17%-18% by the first full year after the closing of the transaction. The transaction is expected to be neutral to Pfizer’s Adjusted Diluted EPS1 in 2017, modestly accretive beginning in calendar year 2018, more than 10% accretive in 2019 with high-teens percentage accretion in 2020. These expectations include the impact of expected share repurchases following the transaction. The combined company is expected to generate annual operating cash flow in excess of $25 billion beginning in 2018.

The transaction is not expected to have an impact on Pfizer’s existing dividend level on a per share basis. It is expected that the combined company will use its combined cash flow to continue to support an attractive dividend policy, targeting a payout ratio of approximately 50% of Adjusted Diluted EPS.1

Independent of the transaction and consistent with 2015, Pfizer anticipates executing an approximately $5 billion accelerated share repurchase program in the first half of 2016. Pfizer has approximately $5.4 billion remaining under its previously announced repurchase authorization.

Transaction Details
The completion of the transaction, which is expected in the second half of 2016, is subject to certain conditions, including receipt of regulatory approval in certain jurisdictions, including the United States and European Union, the receipt of necessary approvals from both Pfizer and Allergan shareholders, and the completion of Allergan’s pending divestiture of its generics business to Teva Pharmaceuticals Ltd., which Allergan expects will close in the first quarter of 2016.

Pursuant to the terms of the merger agreement, the Allergan parent company will be the parent company of the combined group. A wholly owned subsidiary of Allergan will be merged with and into Pfizer, and subject to receipt of shareholder approval, the Allergan parent company will be renamed “Pfizer plc” after the closing of the transaction. Immediately prior to themerger, Allergan will effect an 11.3-for-one share split so that each Allergan shareholder willreceive 11.3 shares of the combined company for each of their Allergan shares, and the Pfizerstockholders will receive one share of the combined company for each of their Pfizer shares. Pfizer’s U.S. stockholders will recognize a taxable gain, but not a loss, for U.S. federal income tax purposes. The transaction is expected to be tax-free forU.S. federal income tax purposes to Allergan shareholders.

Pfizer stockholders will have the opportunity to elect to receive cash instead of stock of the combined company for some or all of their Pfizer shares, provided that the aggregate amount of cash to be paid in the merger will not be less than $6 billion or greater than $12 billion. In the event that the aggregate cash to be paid out in the merger would otherwise be less than $6 billion or greater than $12 billion, then the stock and cash elections will be subject to proration.

Following the transaction, and assuming that all $12 billion of cash is paid in the merger, it is expected that former Pfizer stockholders will hold approximately 56% of the combined company and Allergan shareholders will own approximately 44% of the combined company on a fully diluted basis.

Governance and Leadership
Pfizer plc’s board is expected to have 15 directors, consisting of all of Pfizer’s 11 current directors and 4 current directors of Allergan. The directors from Allergan will be Paul Bisaro, Allergan’s current Executive Chairman, Brent Saunders, Allergan’s current Chief Executive Officer (CEO), and two other directors from Allergan to be selected at a later date. Ian Read, Pfizer’s Chairman and CEO, will serve as Chairman and CEO of the combined company. Brent Saunders will serve as President and Chief Operating Officer of the combined company. He will be responsible for the oversight of all Pfizer and Allergan’s combined commercial businesses, manufacturing and strategy functions.

Guggenheim Securities, Goldman, Sachs & Co., Centerview Partners and Moelis & Company are serving as Pfizer’s financial advisors for the transaction, with Wachtell, Lipton, Rosen & Katz, Skadden, Arps, Slate, Meagher & Flom LLP and A & L Goodbody acting as its legal advisors.

J.P. Morgan and Morgan Stanley are serving as Allergan’s financial advisors for the transaction with Cleary Gottlieb Steen & Hamilton LLP, Latham & Watkins LLP and Arthur Cox acting as its legal advisors.

About Pfizer
At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products. Our global portfolio includes medicines and vaccines as well as many of the world’s best-known consumer health care products. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world’s premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, Pfizer has worked to make a difference for all who rely on us. To learn more, please visit us at www.pfizer.com.

About Allergan
Allergan plc (NYSE: AGN), headquartered in Dublin, Ireland, is a unique, global pharmaceutical company and a leader in a new industry model – Growth Pharma. Allergan is focused on developing, manufacturing and commercializing innovative branded pharmaceuticals, high-quality generic and over-the-counter medicines and biologic products for patients around the world.

Allergan markets a portfolio of best-in-class products that provide valuable treatments for the central nervous system, eye care, medical aesthetics, gastroenterology, women’s health, urology, cardiovascular and anti-infective therapeutic categories, and operates the world’s third-largest global generics business, providing patients around the globe with increased access to affordable, high-quality medicines. Allergan is an industry leader in research and development, with one of the broadest development pipelines in the pharmaceutical industry and a leading position in the submission of generic product applications globally.

Pfizer Inc. (NYSE:PFE) announced today a multi-year collaboration with GSK on the development of a next-generation equipment design, building upon Pfizer’s existing portable, continuous, miniature and modular (PCMM) prototype for oral solid dose (OSD) pharmaceutical development and manufacturing.

Pfizer’s current PCMM prototype is an autonomous and transportable pod that may be quickly shipped from location to location and readily brought online to create a fully functional module that is compliant with industry-standard good manufacturing practice (GMP) guidelines.

Together with GSK, which has notable technical and regulatory experience in continuous processing, Pfizer will conduct coordinated experiments to create the next-generation design of Pfizer’s current PCMM prototype. This collaboration expands upon Pfizer’s existing collaboration with GEA and G-CON Manufacturing, which resulted in the design of the current prototype unit presently implemented at Pfizer’s labs in Groton, Conn.

“Pfizer’s success in building a first-of-a-kind, transportable, modular prototype for oral solid dose pharmaceutical development and manufacturing holds promise to help transform industry practices, and we invite other organizations to join us in this effort,” said Rod MacKenzie, senior vice president, PharmaTherapeutics Research & Development at Pfizer. “We believe coupling Pfizer’s industry-leading development and manufacturing capabilities with GSK’s experience and expertise in continuous processing has the potential to lead to a superior technology, thereby allowing us to more quickly and efficiently bring therapies to patients.”

“GSK is pursuing a strategy to enhance our manufacturing supply chains and drive access to medicines for patients. Continuous manufacturing is a key part of that strategy,” said Mark Buswell, Vice President and Head of Advanced Manufacturing Technologies at GSK. “This strategic collaboration allows Pfizer and GSK to align on a vision for PCMM-OSD equipment designs and enables us to deploy flexible, agile and reliable manufacturing solutions to benefit patients.”

About Pfizer’s PCMM Technology

Pfizer’s PCMM technology is a first-of-a-kind manufacturing system that accelerates the speed of tablet production. The pharmaceutical industry has been trending toward lower-volume products, driven by an increased focus on precision medicine approaches to develop and commercialize new therapies. This creates a need for smaller, more flexible continuous processing technologies.

By miniaturizing the equipment, the continuous process can be enclosed in a portable, autonomous space called a POD, which can be transported to any location in the world and quickly assembled.

The PCMM technology has the potential to transform the current biopharmaceutical industry standard of using batch processing to manufacture tablets and capsules from powders—an oftentimes complex process that requires large, dedicated manufacturing facilities. The PCMM continuous process takes only minutes from the addition of raw materials to the completion of finished tablets or capsules.

Highlights of PCMM’s potential for smaller, more flexible, continuous processing technologies include:

A PCMM facility has a 60 to 70% smaller footprint than a conventional production facility.
PCMM enables use of the same equipment for development, clinical trials and commercial manufacturing.
A PCMM facility takes about one year to set up and start running, compared to two to three years for standard processes.
Pfizer Inc.: Working together for a healthier world®

At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products. Our global portfolio includes medicines and vaccines as well as many of the world’s best-known consumer health care products. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world’s premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, Pfizer has worked to make a difference for all who rely on us. To learn more, please visit us at www.pfizer.com

DUBLIN, – Allergan plc today confirmed that it has been approached by Pfizer Inc. and is in preliminary friendly discussions regarding a potential business combination transaction. Allergan stated that no agreement has been reached and there can be no certainty that these discussions will lead to a transaction, or as to the terms on which a transaction, if any, might be agreed. The company will not comment on speculation regarding the terms of a potential transaction.

Under any potential scenario with Pfizer, Allergan remains strongly committed to complete the proposed divestment of its global generics business to Teva Pharmaceutical Industries Ltd and expects the generics divestiture transaction to close in the first quarter of 2016.

A further announcement will be made when appropriate.

About Allergan plc
Allergan plc (NYSE: AGN), headquartered in Dublin, Ireland, is a unique, global pharmaceutical company and a leader in a new industry model – Growth Pharma. Allergan is focused on developing, manufacturing and commercializing innovative branded pharmaceuticals, high-quality generic and over-the-counter medicines and biologic products for patients around the world.

Allergan markets a portfolio of best-in-class products that provide valuable treatments for the central nervous system, eye care, medical aesthetics, gastroenterology, women’s health, urology, cardiovascular and anti-infective therapeutic categories, and operates the world’s third-largest global generics business, providing patients around the globe with increased access to affordable, high-quality medicines. Allergan is an industry leader in research and development, with one of the broadest development pipelines in the pharmaceutical industry and a leading position in the submission of generic product applications globally.

Deerfield, Ill. and Camp Hill, Pa., – Walgreens Boots Alliance, Inc. (Nasdaq: WBA) and Rite Aid Corporation (NYSE: RAD) today announced that they have entered into a definitive agreement under which Walgreens Boots Alliance will acquire all outstanding shares of Rite Aid, a U.S. retail pharmacy chain, for $9.00 per share in cash, for a total enterprise value of approximately $17.2 billion, including acquired net debt. The purchase price represents a premium of 48 percent to the closing price per share on 26 October 2015, the day before the agreement was signed. The combination of Walgreens Boots Alliance and Rite Aid creates a further opportunity to deliver a high-quality retail pharmacy choice for U.S. consumers in an evolving and increasingly personalized healthcare environment.

Walgreens Boots Alliance is highly focused on building a differentiated in-store experience for health, wellness and beauty, and this combination will help accelerate Rite Aid’s own efforts toward that end. Once the acquisition closes, Walgreens Boots Alliance plans to further transform Rite Aid’s stores to better meet consumer needs.

“Today’s announcement is another step in Walgreens Boots Alliance’s global development and continues our profitable growth strategy. In both mature and newer markets across the world, our approach is to advance and broaden the delivery of retail health, wellbeing and beauty products and services,” said Walgreens Boots Alliance Executive Vice Chairman and CEO Stefano Pessina. “This combination will further strengthen our commitment to making quality healthcare accessible to more customers and patients. Our complementary retail pharmacy footprints in the U.S. will create an even better network, with more health and wellness solutions available in stores and online. Walgreens Boots Alliance will provide to Rite Aid its global expertise and resources to accelerate the delivery of integrated frontline care, and to offer innovative solutions for providers, payers and other entities in the U.S. healthcare system. Finally, this combination will generate a stronger base for sustainable growth and investment into Rite Aid stores, while realizing synergies over time.”

“Joining together with Walgreens Boots Alliance will enhance our ability to meet the health and wellness needs of Rite Aid’s customers while also delivering significant value to our shareholders,” said Rite Aid Chairman and CEO John Standley. “This transaction is a testament to the hard work of all our associates to deliver a higher level of care to the patients and communities we serve. Together with Walgreens Boots Alliance, the Rite Aid team can continue to build upon this great work through access to increased capital that will enhance our store base and expand opportunities as part of the first global pharmacy-led, health and wellbeing enterprise.”

The boards of directors of both companies have approved the transaction, which is subject to approval by the holders of Rite Aid’s common stock, the expiration or termination of applicable waiting periods under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended, and other customary closing conditions. The transaction is expected to close in the second half of calendar 2016.

The transaction is expected to be accretive to Walgreens Boots Alliance’s adjusted earnings per share in its first full year after completion. Additionally, Walgreens Boots Alliance expects to realize synergies in excess of $1 billion.

Upon completion of the merger, Rite Aid will be a wholly owned subsidiary of Walgreens Boots Alliance, and is expected to initially operate under its existing brand name. Working together, decisions will be made over time regarding the integration of the two companies, ultimately creating a fully harmonized portfolio of stores and infrastructure.

Walgreens Boots Alliance expects to finance the transaction through a combination of existing cash, assumption of existing Rite Aid debt and issuance of new debt.

Citi acted as Rite Aid’s exclusive financial adviser, with Skadden, Arps, Slate, Meagher & Flom LLP acting as its legal counsel on transaction legal matters and Jones Day acting as its legal counsel on antitrust regulatory matters.

UBS Investment Bank acted as Walgreens Boots Alliance’s financial adviser and provided a fairness opinion to the board of directors of Walgreens Boots Alliance, with Simpson Thacher & Bartlett LLP acting as its legal counsel on transaction legal matters and Weil, Gotshal & Manges LLP acting as its legal counsel on antitrust regulatory matters. UBS Investment Bank will be the sole arranger on the bridge financing to Walgreens Boots Alliance.

Walgreens Boots Alliance will hold a one-hour conference call to discuss its fourth quarter results and today’s acquisition announcement beginning at 8:30 a.m. Eastern time tomorrow, 28 October 2015. The conference call will be simulcast through the Walgreens Boots Alliance investor relations website at: http://investor.walgreensbootsalliance.com. A replay of the conference call will be archived on the website for 12 months after the call.

The replay also will be available from 11:30 a.m. Eastern time, 28 October 2015 through 4 November 2015, by calling 855-859-2056 FREE within the USA and Canada, or 404-537-3406 outside the USA and Canada, using replay code 42212047.

About Walgreens Boots Alliance
Walgreens Boots Alliance (Nasdaq: WBA) is the first global pharmacy-led, health and wellbeing enterprise.

The company was created through the combination of Walgreens and Alliance Boots in December 2014, bringing together two leading companies with iconic brands, complementary geographic footprints, shared values and a heritage of trusted health care services through pharmaceutical wholesaling and community pharmacy care, dating back more than 100 years.

The company employs more than 370,000* people and has a presence in more than 25* countries; it is the largest retail pharmacy, health and daily living destination in the USA and Europe. Including its equity method investments, Walgreens Boots Alliance is a global leader in pharmacy-led, health and wellbeing retail with over 13,100* stores in 11* countries. The company includes one of the largest global pharmaceutical wholesale and distribution networks with over 350* distribution centers delivering to more than 200,000** pharmacies, doctors, health centers and hospitals each year in 19* countries. In addition, Walgreens Boots Alliance is one of the world’s largest purchasers of prescription drugs and many other health and wellbeing products.

Its portfolio of retail and business brands includes Walgreens, Duane Reade, Boots and Alliance Healthcare, as well as increasingly global health and beauty product brands, such as No7, Botanics, Liz Earle and Soap & Glory. More company information is available at www.walgreensbootsalliance.com.

In October, 2015, 22 scientists from ten countries met at the International Agency for Research on Cancer (IARC) in Lyon, France, to evaluate the carcinogenicity of the consumption of red meat and processed meat.

Red meat refers to unprocessed mammalian muscle meat—for example, beef, veal, pork, lamb, mutton, horse, or goat meat—including minced or frozen meat; it is usually consumed cooked. Processed meat refers to meat that has been transformed through salting, curing, fermentation, smoking, or other processes to enhance flavour or improve preservation. Most processed meats contain pork or beef, but might also contain other red meats, poultry, offal (eg, liver), or meat byproducts such as blood.

Red meat contains high biological-value proteins and important micronutrients such as B vitamins, iron (both free iron and haem iron), and zinc. The fat content of red meat varies depending on animal species, age, sex, breed, and feed, and the cut of the meat. Meat processing, such as curing and smoking, can result in formation of carcinogenic chemicals, including N-nitroso-compounds (NOC) and polycyclic aromatic hydrocarbons (PAH). Cooking improves the digestibility and palatability of meat, but can also produce known or suspected carcinogens, including heterocyclic aromatic amines (HAA) and PAH. High-temperature cooking by pan-frying, grilling, or barbecuing generally produces the highest amounts of these chemicals.

Depending on the country, the proportion of the population that consumes red meat varies worldwide from less than 5% to up to 100%, and from less than 2% to 65% for processed meat. The mean intake of red meat by those who consume it is about 50–100 g per person per day, with high consumption equalling more than 200 g per person per day.4 Less information is available on the consumption of processed meat.

The Working Group assessed more than 800 epidemiological studies that investigated the association of cancer with consumption of red meat or processed meat in many countries, from several continents, with diverse ethnicities and diets. For the evaluation, the greatest weight was given to prospective cohort studies done in the general population. High quality population-based case-control studies provided additional evidence. For both designs, the studies judged to be most informative were those that considered red meat and processed meat separately, had quantitative dietary data obtained from validated questionnaires, a large sample size, and controlled for the major potential confounders for the cancer sites concerned.

The largest body of epidemiological data concerned colorectal cancer. Data on the association of red meat consumption with colorectal cancer were available from 14 cohort studies. Positive associations were seen with high versus low consumption of red meat in half of those studies, including a cohort from ten European countries spanning a wide range of meat consumption and other large cohorts in Sweden and Australia.5, 6, 7 Of the 15 informative case-control studies considered, seven reported positive associations of colorectal cancer with high versus low consumption of red meat. Positive associations of colorectal cancer with consumption of processed meat were reported in 12 of the 18 cohort studies that provided relevant data, including studies in Europe, Japan, and the USA.5, 8, 9, 10, 11 Supporting evidence came from six of nine informative case-control studies. A meta-analysis of colorectal cancer in ten cohort studies reported a statistically significant dose–response relationship, with a 17% increased risk (95% CI 1·05–1·31) per 100 g per day of red meat and an 18% increase (95% CI 1·10–1·28) per 50 g per day of processed meat.12
Data were also available for more than 15 other types of cancer. Positive associations were seen in cohort studies and population-based case-control studies between consumption of red meat and cancers of the pancreas and the prostate (mainly advanced prostate cancer), and between consumption of processed meat and cancer of the stomach.

On the basis of the large amount of data and the consistent associations of colorectal cancer with consumption of processed meat across studies in different populations, which make chance, bias, and confounding unlikely as explanations, a majority of the Working Group concluded that there is sufficient evidence in human beings for the carcinogenicity of the consumption of processed meat. Chance, bias, and confounding could not be ruled out with the same degree of confidence for the data on red meat consumption, since no clear association was seen in several of the high quality studies and residual confounding from other diet and lifestyle risk is difficult to exclude. The Working Group concluded that there is limited evidence in human beings for the carcinogenicity of the consumption of red meat.

There is inadequate evidence in experimental animals for the carcinogenicity of consumption of red meat and of processed meat. In rats treated with colon cancer initiators and promoted with low calcium diets containing either red meat or processed meat, an increase in the occurrence of colonic preneoplastic lesions was reported in three and four studies, respectively.13, 14, 15

The mechanistic evidence for carcinogenicity was assessed as strong for red meat and moderate for processed meat. Mechanistic evidence is mainly available for the digestive tract. A meta-analysis published in 2013 reported a modest but statistically significant association between consumption of red or processed meat and adenomas (preneoplastic lesions) of the colorectum that was consistent across studies.16 For genotoxicity and oxidative stress, evidence was moderate for the consumption of red or processed meat. In human beings, observational data showed slight but statistically significant associations with APC gene mutation or promoter methylation that were identified in 75 (43%) and 41 (23%) of 185 archival colorectal cancer samples, respectively.17 Consuming well done cooked red meat increases the bacterial mutagenicity of human urine. In three intervention studies in human beings, changes in oxidative stress markers (either in urine, faeces, or blood) were associated with consumption of red meat or processed meat.18 Red and processed meat intake increased lipid oxidation products in rodent faeces.13
Substantial supporting mechanistic evidence was available for multiple meat components (NOC, haem iron, and HAA). Consumption of red meat and processed meat by man induces NOC formation in the colon. High red meat consumption (300 or 420 g/day) increased levels of DNA adducts putatively derived from NOC in exfoliated colonocytes or rectal biopsies in two intervention studies.19, 20 Few human data, especially from intervention studies, were available for processed meat. Haem iron mediates formation of NOC, and of lipid oxidation products in the digestive tract of human beings and rodents. Haem iron effects can be experimentally suppressed by calcium, supporting its contribution to carcinogenic mechanisms. Meat heated at a high temperature contains HAA. HAA are genotoxic, and the extent of conversion of HAA to genotoxic metabolites is greater in man than in rodents. Meat smoked or cooked over a heated surface or open flame contains PAH. These chemicals cause DNA damage, but little direct evidence exists that this occurs following meat consumption.

Overall, the Working Group classified consumption of processed meat as “carcinogenic to humans” (Group 1) on the basis of sufficient evidence for colorectal cancer. Additionally, a positive association with the consumption of processed meat was found for stomach cancer.

The Working Group classified consumption of red meat as “probably carcinogenic to humans” (Group 2A). In making this evaluation, the Working Group took into consideration all the relevant data, including the substantial epidemiological data showing a positive association between consumption of red meat and colorectal cancer and the strong mechanistic evidence. Consumption of red meat was also positively associated with pancreatic and with prostate cancer.

PHILADELPHIA, PA – Academic medical centers across the U.S. are experiencing increasing pressure to enhance value – deliver higher quality at lower cost – as they continue to face challenges related to outcomes, cost control, market competition, and other dynamics. Initiatives to promote value typically involve reimbursement arrangements between health insurers and providers that align financial, efficiency and quality incentives.

Today, Temple University Health System (TUHS) and GE Healthcare announced a pioneering, first-of-its-kind risk collaboration between a health care technology company and an academic medical center that aligns incentives to promote value by providing higher-quality radiologic imaging services more efficiently at a lower cost.

The new arrangement targets improvements in specific operational, clinical and financial outcomes, putting TUHS on the cutting edge of delivering high-value imaging services across a health system and making GE Healthcare a pioneer in what could become a preferred business model over the next few years.

Under the seven-year agreement, TUHS and GE Healthcare will work together to achieve performance goals enabled by new technology and industry best practices. TUHS will modernize its radiological imaging equipment with state-of-the art technology from GE, while also benefitting from enhancements, including data storage and retrieval, service contract consolidation and consultation to optimize scheduling and workflow efficiency. The arrangement includes financial incentives aligning the parties toward realizing shared objectives, including a targeted $39 million in operational savings over the life of the contract.

“Like many health systems throughout the country, Temple University Health System faces clinical, operational and financial demands. GE Healthcare understands these market challenges, and we are dedicated to helping customers deliver the best outcomes in today’s environment,” said Jeffrey Immelt, Chairman and CEO of GE. “GE is honored to work with Temple University Health System in this strategic alliance designed to improve operational and clinical outcomes while reducing costs by $39 million.”

“This collaboration represents a new chapter in value-based healthcare contracting strategies,” said Larry R. Kaiser, MD, FACS, President/CEO and Dean of Temple’s healthcare enterprise. “Our collaboration with GE Healthcare provides Temple physicians and patients with access to the latest imaging technology while reducing its costs by millions of dollars, improving patient convenience and safety, enhancing clinical quality, increasing hospital efficiency, and promoting the Triple Aim of better care and better health at lower cost,” Kaiser added.

The strategic arrangement between TUHS and GE Healthcare applies to the radiology departments at Temple University Hospital’s Main, Episcopal and Northeastern campuses; Fox Chase Cancer Center and Jeanes Hospital.

About Temple Health
Temple University Health System (TUHS) is a $1.6 billion academic health system dedicated to providing access to quality patient care and supporting excellence in medical education and research. The Health System consists of Temple University Hospital (TUH), ranked among the “Best Hospitals” in the region by U.S. News & World Report; TUH-Episcopal Campus; TUH-Northeastern Campus; Fox Chase Cancer Center, an NCI-designated comprehensive cancer center; Jeanes Hospital, a community-based hospital offering medical, surgical and emergency services; Temple Transport Team, a ground and air-ambulance company; and Temple Physicians, Inc., a network of community-based specialty and primary-care physician practices. TUHS is affiliated with Temple University School of Medicine.

Temple University School of Medicine (TUSM), established in 1901, is one of the nation’s leading medical schools. Each year, the School of Medicine educates approximately 840 medical students and 140 graduate students. Based on its level of funding from the National Institutes of Health, Temple University School of Medicine is the second-highest ranked medical school in Philadelphia and the third-highest in the Commonwealth of Pennsylvania. According to U.S. News & World Report, TUSM is among the top 10 most applied-to medical schools in the nation.

Temple Health refers to the health, education and research activities carried out by the affiliates of Temple University Health System (TUHS) and by Temple University School of Medicine. TUHS neither provides nor controls the provision of health care. All health care is provided by its member organizations or independent health care providers affiliated with TUHS member organizations. Each TUHS member organization is owned and operated pursuant to its governing documents.

About GE Healthcare
GE Healthcare provides transformational medical technologies and services to meet the demand for increased access, enhanced quality and more affordable healthcare around the world. GE (NYSE: GE) works on things that matter – great people and technologies taking on tough challenges. From medical imaging, software & IT, patient monitoring and diagnostics to drug discovery, biopharmaceutical manufacturing technologies and performance improvement solutions, GE Healthcare helps medical professionals deliver great healthcare to their patients. For more information visit our website www.gehealthcare.com.

SAN ANTONIO– Celebrating its 25th Annual Conference this week in San Antonio, Texas, the Hispanic Dental Association (HDA) is renewing its commitment with trusted partners Crest® and Oral-B® to together improve the oral health of the growing U.S. Hispanic population. Details of the exclusive partnership will be revealed during a reception on Aug. 14 honoring the winners of the HDA’s Orgullo Program, an annual competition sponsored by Procter and Gamble (P&G) oral care brands.

“Our collaborative work with the Hispanic Dental Association has helped shed light on many of the challenges1 faced by U.S. Hispanics when it comes to their oral health,” said Iván Lugo, DMD, MBA and P&G spokesperson. “We are proud to continue to support the work of Hispanic oral health professionals across the nation to turn awareness into action with an emphasis on prevention to help close the oral health gap that prevails in the community.”

The Friday evening reception, which brings together Hispanic oral health professionals and students to celebrate the next generation of dental professionals, will also mark the official unveiling of a new HDA/Crest stamp to be used exclusively by Crest and Oral-B in materials developed in conjunction with the HDA over the next two years to promote good oral health habits.

“Our collaboration with Crest and Oral-B has helped debunk top misperceptions about Hispanic oral care and educate the community through the distribution of oral health materials in Spanish to dental offices, professional schools and associations, ” said David Peña, Jr., executive director/CEO, Hispanic Dental Association. “We are thrilled to expand our partnership to further improve the state of oral health in the Hispanic community.”

About the Hispanic Dental Association (HDA)
The Hispanic Dental Association is a national, non-profit organization comprised of oral health professionals and students dedicated to promoting and improving the oral health of the Hispanic community and providing advocacy for Hispanic oral health professionals across the U.S. The Association works with a wide spectrum of individuals and organizations to communicate to Hispanic and non-Hispanic dental professionals, students and the public.

About Crest
A trusted leader in oral health, Crest was the first oral care brand to secure the ADA Seal of Acceptance for a clinically proven fluoride toothpaste. Since first introducing fluoride toothpaste 54 years ago, it is estimated that Crest has helped prevent more than half a billion cavities in the United States. Headquartered in Cincinnati, OH, Crest is owned and distributed by The Procter & Gamble Company.

About Oral-B
Oral-B is the worldwide leader in the over $5 billion brushing market. Part of Procter & Gamble, the brand includes manual and power toothbrushes for children and adults, oral irrigators and interdental products, such as dental floss. Oral-B toothbrushes are used by more dentists in the world than any other brand.

About Procter & Gamble
P&G serves consumers around the world with one of the strongest portfolios of trusted, quality, leadership brands, including Always®, Ambi Pur®, Ariel®, Bounty®, Charmin®, Crest®, Dawn®, Downy®, Fairy®, Febreze®, Gain®, Gillette®, Head & Shoulders®, Lenor®, Olay®, Oral-B®, Pampers®, Pantene®, SK-II®, Tide®, Vicks®, and Whisper®. The P&G community includes operations in approximately 70 countries worldwide. Please visit http://www.pg.com for the latest news and information about P&G and its brands.

The CMA has today issued a statement of objections to the pharmaceutical suppliers Pfizer and Flynn Pharma alleging that they have breached competition law.

Pill bottle with capsules
The Competition and Markets Authority’s (CMA) provisional view is that Pfizer and Flynn Pharma each abused a dominant position by charging excessive and unfair prices in the UK for phenytoin sodium capsules, an anti-epilepsy drug, in breach of UK and EU competition law.

Phenytoin sodium capsules are used in the treatment of epilepsy in order to prevent and control seizures and are an important drug for over 50,000 patients in the UK. Pfizer manufactures phenytoin sodium capsules and supplies them to Flynn Pharma, which then distributes them to UK wholesalers and pharmacies. The statement of objections concerns both the prices that Pfizer has charged to Flynn Pharma and the prices that Flynn Pharma has charged to its customers, since September 2012.

Prior to September 2012, Pfizer manufactured and sold phenytoin sodium capsules to UK wholesalers and pharmacies under the brand name Epanutin®. Pfizer sold the UK distribution rights for Epanutin® to Flynn Pharma, which de-branded (or genericised) the drug and started selling its version in September 2012. Pfizer continued to manufacture the drug, which it sold to Flynn at prices that were significantly higher than those at which it had previously sold Epanutin® in the UK – between 8 and 17 times Pfizer’s historic prices. Flynn then sold the drug on to customers at prices which were between 25 and 27 times higher than those historically charged by Pfizer.

Prior to September 2012, the NHS spent approximately £2.3 million on phenytoin sodium capsules annually. This spend (paid to Flynn and other suppliers of phenytoin sodium capsules) was just over £50 million in 2013 and over £40 million in 2014.

Ann Pope, CMA Senior Director of Antitrust Enforcement, said:

While businesses are generally free to set prices as they see fit, those that hold a dominant position have a special responsibility to ensure that their conduct does not impair genuine competition and that their prices are not excessive and unfair. The prices that the CMA is concerned about in this case are very high compared to those prices previously charged and have led to a big increase in the total NHS drug bill for what is a very important drug for tens of thousands of patients.

The CMA’s findings on dominance and abuse are provisional and no conclusion can be drawn at this stage that there has, in fact, been any breach of competition law. We will carefully consider any representations from Pfizer and Flynn Pharma before deciding whether the law has been infringed.

The CMA is the UK’s primary competition and consumer authority. It is an independent non-ministerial government department with responsibility for carrying out investigations into mergers, markets and the regulated industries and enforcing competition and certain consumer law. From 1 April 2014 it took over the functions of the Competition Commission and the competition and certain consumer functions of the Office of Fair Trading.
The Chapter II prohibition of the Competition Act 1998 prohibits the abuse of a dominant position by one or more undertakings which may affect trade within the UK or a part of it. Similarly, Article 102 of the Treaty on the Functioning of the European Union prohibits the abuse of a dominant position which may affect trade between EU Member States.

The CMA may impose a financial penalty on any business found to have infringed the Chapter II prohibition or Article 102 (or both) of up to 10% of its annual worldwide group turnover. In calculating financial penalties, the CMA takes into account a number of factors including seriousness of the infringement(s), turnover in the relevant market and any mitigating and/or aggravating factors.
Phenytoin sodium capsules are sold in 4 different strengths in the UK; 25mg, 50mg, 100mg and 300mg capsules. The statement of objections concerns the price that each of Pfizer and Flynn Pharma charged for each of those capsule strengths.
The statement of objections is addressed to the following companies, which the CMA provisionally considers were directly involved in the alleged infringements since September 2012:

Pfizer Limited
Flynn Pharma Limited
The statement of objections is also addressed to the following companies, which the CMA provisionally considers are jointly and severally liable as parent companies of the companies directly involved:
Pfizer Inc
Flynn Pharma (Holdings) Limited

A statement of objections gives parties notice of a proposed infringement decision under the competition law prohibitions in the Competition Act 1998 or the Treaty on the Functioning of the European Union. It is a provisional decision only and does not necessarily lead to an infringement decision. Parties have the opportunity to make written and oral representations on the matters set out in the statement of objections. Any such representations will be considered by the CMA before any final decision is made. The final decision is taken by a three-member case decision group, which is separate from the case investigation team and was not involved in the decision to issue the statement of objections.
The statement of objections will not be published. However, any person who wishes to comment on the CMA’s provisional findings, and who is in a position materially to assist the CMA in testing its factual, legal or economic arguments, may request a non-confidential version of the statement of objections by contacting the CMA no later than 31 August 2015.

GENEVA ¦ 31 JULY 2015 – Results from an interim analysis of the Guinea Phase III efficacy vaccine trial show that VSV-EBOV (Merck, Sharp & Dohme) is highly effective against Ebola. The independent body of international experts – the Data and Safety Monitoring Board – that conducted the review, advised that the trial should continue. Preliminary results from analyses of these interim data are published today in the British journal The Lancet.

“This is an extremely promising development,” said Dr Margaret Chan, Director-General of the World Health Organization. “The credit goes to the Guinean Government, the people living in the communities and our partners in this project. An effective vaccine will be another very important tool for both current and future Ebola outbreaks.”

While the vaccine up to now shows 100% efficacy in individuals, more conclusive evidence is needed on its capacity to protect populations through what is called “herd immunity”. To that end, the Guinean national regulatory authority and ethics review committee have approved continuation of the trial.

A line of defence against a terrible disease

“This is Guinea’s gift to West Africa and the world,” said Dr Sakoba Keita, Guinea’s national coordinator for the Ebola response. “The thousands of volunteers from Conakry and other areas of Lower Guinea, but also the many Guinean doctors, data managers and community mobilisers have contributed to finding a line of defence against a terrible disease.”

“The ‘ring’ vaccination method adopted for the vaccine trial is based on the smallpox eradication strategy,” said John-Arne Røttingen, Director of the Division of Infectious Disease Control at the Norwegian Institute of Public Health and Chair of the Study Steering Group. “The premise is that by vaccinating all people who have come into contact with an infected person you create a protective ‘ring’ and stop the virus from spreading further. This strategy has helped us to follow the dispersed epidemic in Guinea, and will provide a way to continue this as a public health intervention in trial mode.”

The Guinea vaccination trial began in affected communities on 23 March 2015 to evaluate the efficacy, effectiveness and safety of a single dose of the vaccine VSV-EBOV by using a ring vaccination strategy. To date, over 4 000 close contacts of almost 100 Ebola patients, including family members, neighbours, and co-workers, have voluntarily participated in the trial.

The trial stopped randomisation on 26 July to allow for all people at risk to receive the vaccine immediately, and to minimize the time necessary to gather more conclusive evidence needed for eventual licensure of the product. Until now, 50% of the rings were vaccinated 3 weeks after the identification of an infected patient to provide a term of comparison with rings that were vaccinated immediately. This now stops. In addition, the trial will now include 13 to 17-year-old and possibly 6 to 12-year-old children on the basis of new evidence of the vaccine’s safety.

If the vaccine is effective, then we are protecting frontline workers from the virus

“In parallel with the ring vaccination, we are also conducting a trial of the same vaccine on frontline workers,” said Bertrand Draguez, Medical Director at Médecins sans Frontières. “These people have worked tirelessly and put their lives at risk every day to take care of sick people. If the vaccine is effective, then we are already protecting them from the virus. With such high efficacy, all affected countries should immediately start and multiply ring vaccinations to break chains of transmission and vaccinate all frontline workers to protect them.”

The trial is being implemented by the Guinean authorities, WHO, Médecins sans Frontières (MSF) and the Norwegian Institute of Public Health, with support from a broad partnership of international and national organizations.

“This is a remarkable result which shows the power of equitable international partnerships and flexibility,” said Jeremy Farrar, Director of the Wellcome Trust, one of the funders of the trial. “This partnership also shows that such critical work is possible in the midst of a terrible epidemic. It should change how the world responds to such emerging infectious disease threats. We, and all our partners, remain fully committed to giving the world a safe and effective vaccine.”

“This record-breaking work marks a turning point in the history of health R&D,” said Assistant Director-General Marie-Paule Kieny, who leads the Ebola Research and Development effort at WHO. “We now know that the urgency of saving lives can accelerate R&D. We will harness this positive experience to develop a global R&D preparedness framework so that if another major disease outbreak ever happens again, for any disease, the world can act quickly and efficiently to develop and use medical tools and prevent a large-scale tragedy.”

The vaccine
VSV-EBOV was developed by the Public Health Agency of Canada. The vaccine was licensed to NewLink Genetics, and on 24 November 2014, Merck & Co., Inc and NewLink Genetics Corp. entered into an exclusive worldwide licensing agreement wherein Merck assumed responsibility to research, develop, manufacture, and distribute the investigational vaccine. Financial support was provided by the Canadian and US Governments, among others.

A ring vaccination protocol was chosen for the trial, where some of the rings are vaccinated shortly after a case is detected, and other rings are vaccinated after a delay of 3 weeks. This is an alternative to using a placebo by providing a randomized control group for comparison but at the same time ensures that all contacts are vaccinated within the trial.

The trial design was developed by a group of experts from Canada, France, Guinea, Norway, Switzerland, United Kingdom, United States, and WHO. The group included Professor Donald A. Henderson of John Hopkins University, who led the WHO smallpox eradication effort by using the ring vaccination strategy.

The partners
The Guinea Ebola vaccine trial is the coordinated effort of many international agencies. WHO is the regulatory sponsor of the study, which is implemented by the Ministry of Health of Guinea, WHO, Médecins sans Frontières (MSF), EPICENTRE and the Norwegian Institute of Public Health.

The trial is funded by WHO, with support from the Wellcome Trust, the United Kingdom Department for International Development, the Norwegian Ministry of Foreign Affairs to the Norwegian Institute of Public Health through the Research Council of Norway, the Canadian Government through the Public Health Agency of Canada, Canadian Institutes of Health Research, International Development Research Centre and Department of Foreign Affairs, Trade and Development and MSF.

The trial team includes experts from The University of Bern, the University of Florida, the London School of Hygiene and Tropical Medicine, Public Health England, the European Mobile Laboratories among others.