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DUBLIN, Ireland, May 16, 2017 (GLOBE NEWSWIRE) -- Prothena Corporation plc (NASDAQ:PRTA), a late-stage clinical biotechnology company focused on the discovery, development and commercialization of novel protein immunotherapies, announced today the appointment of Sarah Noonberg, MD, PhD, as Chief Medical Officer. Dr. Noonberg will have key responsibilities to define and advance Prothena’s product pipeline and for leadership of Prothena’s clinical and medical organizations. She succeeds Martin Koller, MD, whose planned retirement from Prothena at the end of 2017 was previously announced. "Sarah is a talented and experienced physician-scientist with a successful track record of developing novel products across multiple therapeutic categories,” stated Gene Kinney, PhD, President and Chief Executive Officer of Prothena. “As we continue to advance our pipeline of innovative immunotherapies, Sarah’s capability in translating science into new medicines, experience leading large organizations across several areas of drug development and deep commitment to serving patients will further strengthen our management team. We also want to thank Marty, whose leadership has been instrumental to our success, and wish him the best in retirement.” Dr. Noonberg joins Prothena after serving as Group Vice President and Head of Global Clinical Development at BioMarin Pharmaceuticals where she was responsible for development strategy and execution across a diverse clinical portfolio. Before BioMarin, she held positions of increasing responsibility at Medivation, Inc., where as Senior Vice President of Early Development and Vice President of Clinical Development she led programs across all phases of development, including enzalutamide for the treatment of chemotherapy-naïve metastatic prostate cancer. She also held several positions of increasing seniority at Chiron Corporation, where she led the clinical development of compounds in infectious disease and pulmonary indications. Dr. Noonberg earned her MD at the University of California, San Francisco, her PhD in Bioengineering at the University of California, Berkeley, and her BS at Dartmouth College. Dr. Noonberg is a board-certified internist and completed her residency at Johns Hopkins Hospital. For the past 14 years, she has been an active part-time hospitalist, working as an attending physician treating a broad range of inpatient and critical care patients. Prothena Corporation plc is a global, late-stage clinical biotechnology company establishing fully-integrated research, development and commercial capabilities. Fueled by its deep scientific understanding built over decades of research in protein misfolding and cell adhesion — the root causes of many serious or currently untreatable amyloid and inflammatory diseases — Prothena seeks to fundamentally change the course of progressive diseases associated with this biology. The Company’s pipeline of antibody therapeutic candidates targets a number of indications including AL amyloidosis (NEOD001), Parkinson’s disease and other related synucleinopathies (PRX002/RG7935), inflammatory diseases, including psoriasis and psoriatic arthritis (PRX003), and ATTR amyloidosis (PRX004). The Company continues discovery of additional novel therapeutic candidates where its deep scientific understanding of disease pathology can be leveraged. For more information, please visit the Company’s website at www.prothena.com


DUBLIN, Ireland, May 16, 2017 (GLOBE NEWSWIRE) -- Prothena Corporation plc (NASDAQ:PRTA), a late-stage clinical biotechnology company focused on the discovery, development and commercialization of novel protein immunotherapies, announced today the appointment of Sarah Noonberg, MD, PhD, as Chief Medical Officer. Dr. Noonberg will have key responsibilities to define and advance Prothena’s product pipeline and for leadership of Prothena’s clinical and medical organizations. She succeeds Martin Koller, MD, whose planned retirement from Prothena at the end of 2017 was previously announced. "Sarah is a talented and experienced physician-scientist with a successful track record of developing novel products across multiple therapeutic categories,” stated Gene Kinney, PhD, President and Chief Executive Officer of Prothena. “As we continue to advance our pipeline of innovative immunotherapies, Sarah’s capability in translating science into new medicines, experience leading large organizations across several areas of drug development and deep commitment to serving patients will further strengthen our management team. We also want to thank Marty, whose leadership has been instrumental to our success, and wish him the best in retirement.” Dr. Noonberg joins Prothena after serving as Group Vice President and Head of Global Clinical Development at BioMarin Pharmaceuticals where she was responsible for development strategy and execution across a diverse clinical portfolio. Before BioMarin, she held positions of increasing responsibility at Medivation, Inc., where as Senior Vice President of Early Development and Vice President of Clinical Development she led programs across all phases of development, including enzalutamide for the treatment of chemotherapy-naïve metastatic prostate cancer. She also held several positions of increasing seniority at Chiron Corporation, where she led the clinical development of compounds in infectious disease and pulmonary indications. Dr. Noonberg earned her MD at the University of California, San Francisco, her PhD in Bioengineering at the University of California, Berkeley, and her BS at Dartmouth College. Dr. Noonberg is a board-certified internist and completed her residency at Johns Hopkins Hospital. For the past 14 years, she has been an active part-time hospitalist, working as an attending physician treating a broad range of inpatient and critical care patients. Prothena Corporation plc is a global, late-stage clinical biotechnology company establishing fully-integrated research, development and commercial capabilities. Fueled by its deep scientific understanding built over decades of research in protein misfolding and cell adhesion — the root causes of many serious or currently untreatable amyloid and inflammatory diseases — Prothena seeks to fundamentally change the course of progressive diseases associated with this biology. The Company’s pipeline of antibody therapeutic candidates targets a number of indications including AL amyloidosis (NEOD001), Parkinson’s disease and other related synucleinopathies (PRX002/RG7935), inflammatory diseases, including psoriasis and psoriatic arthritis (PRX003), and ATTR amyloidosis (PRX004). The Company continues discovery of additional novel therapeutic candidates where its deep scientific understanding of disease pathology can be leveraged. For more information, please visit the Company’s website at www.prothena.com


DUBLIN, Ireland, May 16, 2017 (GLOBE NEWSWIRE) -- Prothena Corporation plc (NASDAQ:PRTA), a late-stage clinical biotechnology company focused on the discovery, development and commercialization of novel protein immunotherapies, announced today the appointment of Sarah Noonberg, MD, PhD, as Chief Medical Officer. Dr. Noonberg will have key responsibilities to define and advance Prothena’s product pipeline and for leadership of Prothena’s clinical and medical organizations. She succeeds Martin Koller, MD, whose planned retirement from Prothena at the end of 2017 was previously announced. "Sarah is a talented and experienced physician-scientist with a successful track record of developing novel products across multiple therapeutic categories,” stated Gene Kinney, PhD, President and Chief Executive Officer of Prothena. “As we continue to advance our pipeline of innovative immunotherapies, Sarah’s capability in translating science into new medicines, experience leading large organizations across several areas of drug development and deep commitment to serving patients will further strengthen our management team. We also want to thank Marty, whose leadership has been instrumental to our success, and wish him the best in retirement.” Dr. Noonberg joins Prothena after serving as Group Vice President and Head of Global Clinical Development at BioMarin Pharmaceuticals where she was responsible for development strategy and execution across a diverse clinical portfolio. Before BioMarin, she held positions of increasing responsibility at Medivation, Inc., where as Senior Vice President of Early Development and Vice President of Clinical Development she led programs across all phases of development, including enzalutamide for the treatment of chemotherapy-naïve metastatic prostate cancer. She also held several positions of increasing seniority at Chiron Corporation, where she led the clinical development of compounds in infectious disease and pulmonary indications. Dr. Noonberg earned her MD at the University of California, San Francisco, her PhD in Bioengineering at the University of California, Berkeley, and her BS at Dartmouth College. Dr. Noonberg is a board-certified internist and completed her residency at Johns Hopkins Hospital. For the past 14 years, she has been an active part-time hospitalist, working as an attending physician treating a broad range of inpatient and critical care patients. Prothena Corporation plc is a global, late-stage clinical biotechnology company establishing fully-integrated research, development and commercial capabilities. Fueled by its deep scientific understanding built over decades of research in protein misfolding and cell adhesion — the root causes of many serious or currently untreatable amyloid and inflammatory diseases — Prothena seeks to fundamentally change the course of progressive diseases associated with this biology. The Company’s pipeline of antibody therapeutic candidates targets a number of indications including AL amyloidosis (NEOD001), Parkinson’s disease and other related synucleinopathies (PRX002/RG7935), inflammatory diseases, including psoriasis and psoriatic arthritis (PRX003), and ATTR amyloidosis (PRX004). The Company continues discovery of additional novel therapeutic candidates where its deep scientific understanding of disease pathology can be leveraged. For more information, please visit the Company’s website at www.prothena.com


News Article | May 17, 2017
Site: www.reuters.com

(Reuters) - A breast cancer drug that Pfizer Inc acquired with its $14 billion purchase of Medivation showed promising anti-tumor activity following prior treatments and a modest ability to hold the disease in check, according to data from a mid-stage study released on Wednesday.


DUBLIN, Ireland, May 16, 2017 (GLOBE NEWSWIRE) -- Prothena Corporation plc (NASDAQ:PRTA), a late-stage clinical biotechnology company focused on the discovery, development and commercialization of novel protein immunotherapies, announced today the appointment of Sarah Noonberg, MD, PhD, as Chief Medical Officer. Dr. Noonberg will have key responsibilities to define and advance Prothena’s product pipeline and for leadership of Prothena’s clinical and medical organizations. She succeeds Martin Koller, MD, whose planned retirement from Prothena at the end of 2017 was previously announced. "Sarah is a talented and experienced physician-scientist with a successful track record of developing novel products across multiple therapeutic categories,” stated Gene Kinney, PhD, President and Chief Executive Officer of Prothena. “As we continue to advance our pipeline of innovative immunotherapies, Sarah’s capability in translating science into new medicines, experience leading large organizations across several areas of drug development and deep commitment to serving patients will further strengthen our management team. We also want to thank Marty, whose leadership has been instrumental to our success, and wish him the best in retirement.” Dr. Noonberg joins Prothena after serving as Group Vice President and Head of Global Clinical Development at BioMarin Pharmaceuticals where she was responsible for development strategy and execution across a diverse clinical portfolio. Before BioMarin, she held positions of increasing responsibility at Medivation, Inc., where as Senior Vice President of Early Development and Vice President of Clinical Development she led programs across all phases of development, including enzalutamide for the treatment of chemotherapy-naïve metastatic prostate cancer. She also held several positions of increasing seniority at Chiron Corporation, where she led the clinical development of compounds in infectious disease and pulmonary indications. Dr. Noonberg earned her MD at the University of California, San Francisco, her PhD in Bioengineering at the University of California, Berkeley, and her BS at Dartmouth College. Dr. Noonberg is a board-certified internist and completed her residency at Johns Hopkins Hospital. For the past 14 years, she has been an active part-time hospitalist, working as an attending physician treating a broad range of inpatient and critical care patients. Prothena Corporation plc is a global, late-stage clinical biotechnology company establishing fully-integrated research, development and commercial capabilities. Fueled by its deep scientific understanding built over decades of research in protein misfolding and cell adhesion — the root causes of many serious or currently untreatable amyloid and inflammatory diseases — Prothena seeks to fundamentally change the course of progressive diseases associated with this biology. The Company’s pipeline of antibody therapeutic candidates targets a number of indications including AL amyloidosis (NEOD001), Parkinson’s disease and other related synucleinopathies (PRX002/RG7935), inflammatory diseases, including psoriasis and psoriatic arthritis (PRX003), and ATTR amyloidosis (PRX004). The Company continues discovery of additional novel therapeutic candidates where its deep scientific understanding of disease pathology can be leveraged. For more information, please visit the Company’s website at www.prothena.com


News Article | May 18, 2017
Site: www.prnewswire.com

"We are thrilled to announce our largest presence to date at this year's ASCO meeting," said Steven Benner, M.D., senior vice president and global therapeutic area head, oncology development, Astellas. "We believe these data reflect significant progress in our pursuit to create innovative treatment options for some of the most difficult-to-treat cancers and further underscore our ongoing commitment to becoming a world-class oncology company focusing on patients with cancer." Additionally, the Company announced today the joint decision with Pfizer to discontinue the planned ENDEAR trial (A Phase III, Randomized, International Study Comparing the Efficacy and Safety of Enzalutamide in Combination With Paclitaxel Chemotherapy or as Monotherapy Versus Placebo With Paclitaxel in Patients With Advanced, Diagnostic-Positive, Triple-Negative Breast Cancer); no patients were ever enrolled in the trial. The companies have also decided that based on the enzalutamide data from the Phase 2 HER2+ and ER/PR+ breast cancer studies, there will not be follow-on Phase 3 studies at this time. About XTANDI® (enzalutamide) capsules XTANDI (enzalutamide) is an androgen receptor inhibitor that blocks multiple steps in the androgen receptor signaling pathway within the tumor cell. In preclinical studies, enzalutamide has been shown to competitively inhibit androgen binding to androgen receptors, and inhibit androgen receptor nuclear translocation and interaction with DNA. The clinical significance of this mechanism of action (MOA) is unknown. XTANDI is approved by the U.S. Food and Drug Administration for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC). Enzalutamide is not approved for use in patients with breast cancer. Important Safety Information Contraindications XTANDI is not indicated for women. XTANDI can cause fetal harm and potential loss of pregnancy. Warnings and Precautions Seizure occurred in 0.5% of patients receiving XTANDI in clinical studies. In placebo-controlled studies, 8 of 1671 (0.5%) patients treated with XTANDI and 1 of 1243 (0.1%) patients treated with placebo experienced a seizure. In patients who previously received docetaxel, 7 of 800 (0.9%) patients treated with XTANDI experienced a seizure and no patients treated with placebo experienced a seizure. In a placebo-controlled study in chemotherapy-naïve patients, 1 of 871 (0.1%) treated with XTANDI and 1 of 844 (0.1%) patients treated with placebo experienced a seizure. In bicalutamide-controlled studies conducted in chemotherapy-naïve patients, 3 of 380 (0.8%) patients treated with XTANDI and 1 of 387 (0.3%) patients treated with bicalutamide experienced a seizure. Permanently discontinue XTANDI in patients who develop a seizure during treatment. Posterior Reversible Encephalopathy Syndrome (PRES)  In post approval use, there have been reports of PRES in patients receiving XTANDI. PRES is a neurological disorder which can present with rapidly evolving symptoms including seizure, headache, lethargy, confusion, blindness, and other visual and neurological disturbances, with or without associated hypertension. A diagnosis of PRES requires confirmation by brain imaging, preferably MRI. Discontinue XTANDI in patients who develop PRES. Adverse Reactions The most common adverse reactions (≥ 10%) that occurred more commonly (≥ 2% over placebo) in the XTANDI patients from the two placebo-controlled clinical trials were asthenia/fatigue, back pain, decreased appetite, constipation, arthralgia, diarrhea, hot flush, upper respiratory tract infection, peripheral edema, dyspnea, musculoskeletal pain, weight decreased, headache, hypertension, and dizziness/vertigo. In the bicalutamide-controlled study of chemotherapy naïve patients, the most common adverse reactions (≥ 10%) reported in XTANDI patients were asthenia/fatigue, back pain, musculoskeletal pain, hot flush, hypertension, nausea, constipation, upper respiratory tract infection, diarrhea, and weight loss. In the study of patients taking XTANDI who previously received docetaxel, Grade 3 and higher adverse reactions were reported among 47% of XTANDI patients and 53% of placebo patients. Discontinuations due to adverse events were reported for 16% of XTANDI patients and 18% of placebo patients. In the placebo-controlled study of chemotherapy-naïve patients, Grade 3-4 adverse reactions were reported in 44% of XTANDI patients and 37% of placebo patients. Discontinuations due to adverse events were reported for 6% of both study groups. In the bicalutamide-controlled study of chemotherapy naïve patients, Grade 3-4 adverse reactions were reported in 38.8% of XTANDI patients and 37.6% of bicalutamide patients. Discontinuations due to adverse events were reported for 7.6% of XTANDI patients and 6.3% of bicalutamide patients. Lab Abnormalities: In the two placebo-controlled trials Grade 1-4 neutropenia occurred in 15% of XTANDI patients (1% Grade 3-4) and 6% of placebo patients (0.5% Grade 3-4). Grade 1-4 thrombocytopenia occurred in 6% of XTANDI patients (0.3% Grade 3-4) and 5% of placebo patients (0.5% Grade 3-4). Grade 1-4 elevations in ALT occurred in 10% of XTANDI patients (0.2% Grade 3-4) and 16% of placebo patients (0.2% Grade 3-4). Grade 1-4 elevations in bilirubin occurred in 3% of XTANDI patients (0.1% Grade 3-4) and 2% of placebo patients (no Grade 3-4). Infections: In a study of patients taking XTANDI who previously received docetaxel, 1% of XTANDI patients compared to 0.3% of placebo patients died from infections or sepsis. In the placebo-controlled study of chemotherapy-naïve patients, 1 patient in each treatment group (0.1%) had an infection resulting in death. Falls (including fall-related injuries) occurred in 9% of XTANDI patients and 4% of placebo patients in the two placebo-controlled trials. Falls were not associated with loss of consciousness or seizure. Fall-related injuries were more severe in XTANDI patients, and included non-pathologic fractures, joint injuries, and hematomas. Hypertension occurred in 11% of XTANDI patients and 4% of placebo patients in the two placebo-controlled trials. No patients experienced hypertensive crisis. Medical history of hypertension was balanced between arms. Hypertension led to study discontinuation in < 1% of all patients in each arm. Drug Interactions Effect of Other Drugs on XTANDI  Avoid strong CYP2C8 inhibitors, as they can increase the plasma exposure to XTANDI. If co-administration is necessary, reduce the dose of XTANDI. Avoid strong CYP3A4 inducers as they can decrease the plasma exposure to XTANDI. If co-administration is necessary, increase the dose of XTANDI. Effect of XTANDI on Other Drugs  Avoid CYP3A4, CYP2C9, and CYP2C19 substrates with a narrow therapeutic index, as XTANDI may decrease the plasma exposures of these drugs. If XTANDI is co-administered with warfarin (CYP2C9 substrate), conduct additional INR monitoring. Please see Full Prescribing Information at for additional safety information. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. About Astellas Astellas Pharma Inc., based in Tokyo, Japan, is a company dedicated to improving the health of people around the world through the provision of innovative and reliable pharmaceutical products. We focus on Urology, Oncology, Immunology, Nephrology and Neuroscience as prioritized therapeutic areas while advancing new therapeutic areas and discovery research leveraging new technologies/modalities. We are also creating new value by combining internal capabilities and external expertise in the medical/healthcare business. Astellas is on the forefront of healthcare change to turn innovative science into value for patients. For more information, please visit our website at www.astellas.com/en. Cautionary Notes In this press release, statements made with respect to current plans, estimates, strategies and beliefs and other statements that are not historical facts are forward-looking statements about the future performance of Astellas. These statements are based on management's current assumptions and beliefs in light of the information currently available to it and involve known and unknown risks and uncertainties. A number of factors could cause actual results to differ materially from those discussed in the forward-looking statements. Such factors include, but are not limited to: (i) changes in general economic conditions and in laws and regulations, relating to pharmaceutical markets, (ii) currency exchange rate fluctuations, (iii) delays in new product launches, (iv) the inability of Astellas to market existing and new products effectively, (v) the inability of Astellas to continue to effectively research and develop products accepted by customers in highly competitive markets, and (vi) infringements of Astellas' intellectual property rights by third parties. Information about pharmaceutical products (including products currently in development) which is included in this press release is not intended to constitute an advertisement or medical advice. About the Pfizer/Astellas Collaboration In October 2009, Medivation, Inc., which is now part of Pfizer (NYSE: PFE), and Astellas (TSE: 4503) entered into a global agreement to jointly develop and commercialize enzalutamide. The companies are collaborating on a comprehensive development program that includes studies to develop enzalutamide across the full spectrum of advanced prostate cancer as well as other cancers. The companies jointly commercialize XTANDI in the United States and Astellas has responsibility for manufacturing and all additional regulatory filings globally, as well as commercializing XTANDI outside the United States. To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/astellas-announces-oncology-portfolio-updates-300459680.html


News Article | May 2, 2017
Site: www.businesswire.com

NEW YORK--(BUSINESS WIRE)--Pfizer Inc. (NYSE:PFE) reported financial results for first-quarter 2017 and reaffirmed its 2017 financial guidance. On June 24, 2016, Pfizer acquired Anacor Pharmaceuticals, Inc. (Anacor). Therefore, financial results for first-quarter 2017 reflect three months of legacy Anacor operations, which were immaterial. On September 28, 2016, Pfizer acquired Medivation, Inc. (Medivation). Therefore, financial results for first-quarter 2017 reflect three months of legacy Medivation operations. On February 3, 2017, Pfizer completed the sale of its global infusion therapy net assets, Hospira Infusion Systems (HIS). Therefore, financial results for first-quarter 2017 reflect approximately one month of legacy HIS domestic operations and approximately two months of legacy HIS international operations, while financial results for first-quarter 2016 reflect three months of legacy HIS global operations.(3) Some amounts in this press release may not add due to rounding. All percentages have been calculated using unrounded amounts. References to operational variances pertain to period-over-period growth rates that exclude the impact of foreign exchange.(4) Results for the first quarter of 2017 and 2016 are summarized below. Ian Read, Chairman and Chief Executive Officer, stated, “I was pleased with our first-quarter 2017 financial performance, which was in line with our expectations, and it reinforces our confidence in the business going forward. I believe each of our businesses is well positioned within their individual markets with strong portfolios, highly skilled and accomplished leadership and focused strategies. Innovative Health’s core franchises -- Prevnar 13, Lyrica, Ibrance, Eliquis, Xeljanz and Xtandi -- have strong leadership positions in their respective therapeutic categories and are complemented by new product launches, including Eucrisa and Bavencio, as well as meaningful pipeline progress. Essential Health’s growth opportunities -- Sterile Injectables, Biosimilars and Emerging Markets -- continue to perform in line with our expectations while we refine the business and position it for potential sustainable revenue growth. “Finally, we will continue to allocate our capital to initiatives that we believe will maximize value creation,” Mr. Read concluded. Frank D’Amelio, Executive Vice President, Business Operations and Chief Financial Officer, stated, “Today we are reaffirming our 2017 financial guidance, reflecting our performance to date as well as our confidence in the business going forward. Excluding the negative impacts of the divestiture of HIS and foreign exchange, the midpoints of our 2017 revenue and Adjusted diluted EPS(2) guidance ranges reflect 4% and 10% operational growth, respectively.” QUARTERLY FINANCIAL HIGHLIGHTS (First-Quarter 2017 vs. First-Quarter 2016) First-quarter 2017 revenues totaled $12.8 billion, a decline of $226 million, or 2% compared to the prior-year quarter, reflecting an operational decline of $110 million, or 1%, and the unfavorable impact of foreign exchange of $116 million, or 1%. Excluding the revenues for HIS in both periods and the unfavorable impact of foreign exchange, first-quarter 2017 revenues increased by $97 million, or 1%. First-quarter 2017 revenues excluding the net impact of acquisitions and divestitures completed in 2016 and 2017 were flat operationally compared to first-quarter 2016. Of note, there was one less selling day in the U.S. and two fewer selling days in international markets during first-quarter 2017 compared to first-quarter 2016, resulting in a negative impact on first-quarter 2017 revenues of approximately $300 million compared to the prior-year quarter. Full-year 2017 will have one less U.S. selling day and one less international selling day compared to full-year 2016. The diluted weighted-average shares outstanding used to calculate Reported(1) and Adjusted(2) diluted EPS declined by 133 million shares compared to the prior-year quarter due to Pfizer’s share repurchase program, reflecting the impact of a $5 billion accelerated share repurchase agreement executed in March 2016 and completed in June 2016 and another $5 billion accelerated share repurchase agreement executed in February 2017. A full reconciliation of Reported(1) to Adjusted(2) financial measures and associated footnotes can be found starting on page 18 of the press release located at the hyperlink below. A comprehensive update of Pfizer’s development pipeline was published today and is now available at http://www.pfizer.com/science/drug-product-pipeline. It includes an overview of Pfizer’s research and a list of compounds in development with targeted indication and phase of development, as well as mechanism of action for some candidates in Phase 1 and all candidates from Phase 2 through registration. Please find Pfizer’s press release and associated financial tables, including reconciliations of certain GAAP reported to non-GAAP adjusted information, at the following hyperlink: For additional details, see the associated financial schedules and product revenue tables attached to the press release located at the hyperlink referred to above and the attached disclosure notice. DISCLOSURE NOTICE: Except where otherwise noted, the information contained in this earnings release and the related attachments is as of May 2, 2017. We assume no obligation to update any forward-looking statements contained in this earnings release and the related attachments as a result of new information or future events or developments. This earnings release and the related attachments contain forward-looking statements about our anticipated future operating and financial performance, business plans and prospects, in-line products and product candidates, strategic reviews, capital allocation, business-development plans, the benefits expected from our acquisitions of Hospira, Inc. (Hospira), Anacor Pharmaceuticals, Inc. (Anacor), Medivation, Inc. (Medivation) and AstraZeneca's small molecule anti-infectives business and plans relating to share repurchases and dividends, among other things, that involve substantial risks and uncertainties. You can identify these statements by the fact that they use future dates or use words such as “will,” “may,” “could,” “likely,” “ongoing,” “anticipate,” “estimate,” “expect,” “project,” “intend,” “plan,” “believe,” “target,” “forecast,” “goal,” “objective,” “aim” and other words and terms of similar meaning. Among the factors that could cause actual results to differ materially from past results and future plans and projected future results are the following: We cannot guarantee that any forward-looking statement will be realized. Achievement of anticipated results is subject to substantial risks, uncertainties and inaccurate assumptions. Should known or unknown risks or uncertainties materialize or should underlying assumptions prove inaccurate, actual results could vary materially from past results and those anticipated, estimated or projected. Investors should bear this in mind as they consider forward-looking statements, and are cautioned not to put undue reliance on forward-looking statements. A further list and description of risks, uncertainties and other matters can be found in our Annual Report on Form 10-K for the fiscal year ended December 31, 2016 and in our subsequent reports on Form 10-Q, in each case including in the sections thereof captioned “Forward-Looking Information and Factors That May Affect Future Results” and “Item 1A. Risk Factors”, and in our subsequent reports on Form 8-K. The operating segment information provided in this earnings release and the related attachments does not purport to represent the revenues, costs and income from continuing operations before provision for taxes on income that each of our operating segments would have recorded had each segment operated as a standalone company during the periods presented. This earnings release may include discussion of certain clinical studies relating to various in-line products and/or product candidates. These studies typically are part of a larger body of clinical data relating to such products or product candidates, and the discussion herein should be considered in the context of the larger body of data. In addition, clinical trial data are subject to differing interpretations, and, even when we view data as sufficient to support the safety and/or effectiveness of a product candidate or a new indication for an in-line product, regulatory authorities may not share our views and may require additional data or may deny approval altogether.


News Article | August 22, 2016
Site: www.biosciencetechnology.com

Pfizer will pay about $14 billion in cash for the cancer drug company Medivation, a deal that will add the pricey late-stage prostate cancer treatment Xtandi to its oncology portfolio. The New York drugmaker said Monday that it will pay $81.50 per Medivation share. That's a 21 percent premium to the San Francisco biotech's Friday closing price of $67.19. Medivation Inc. and the Japanese drugmaker Astellas Pharma jointly market Xtandi, with Astellas selling the drug outside the U.S. Xtandi drew attention earlier this year from the public interest group Knowledge Economy International, which petitioned the National Institutes of Health to reduce the $129,000-a year list price for the advanced prostate cancer treatment. The government declined. Knowledge Ecology and the Union for Affordable Cancer Treatment said the price on Xtandi, which amounts to $88.48 per pill, is two to four times the price in other wealthy countries. The U.S. government covers much of the cost for Xtandi prescriptions filled under federal health programs such as Medicare, Medicaid and the Veterans Administration. Medivation is a specialty drugmaker, focused on developing medicines for cancer and serious diseases with few treatment options. The drugmaker brought in $943 million in revenue last year. Aside from Xtandi, Pfizer Inc. said Medivation also has a promising pipeline of cancer drugs in late-stage clinical development. That includes the potential breast cancer treatment talazoparib and a potential lymphoma drug. Researchers also are studying Xtandi as a possible treatment for earlier-stage prostate cancers. The boards of both companies have approved the deal, which is targeted to close in the third or fourth quarter. Pfizer, which makes the erectile dysfunction treatment Viagra and fibromyalgia and pain treatment Lyrica, expects to finance it with existing cash. The deal comes about three months after Medivation rejected a $9.3 billion takeover bid from the French drugmaker Sanofi, saying that offer, worth $52.50 per share, undervalued the company. The Pfizer-Medivation deal is the third-largest health care combination proposed so far this year, according to Dealogic. Abbott Laboratories' planned, $25 billion acquisition of St. Jude Medical is the largest. The Pfizer-Medivation deal also is much smaller than Pfizer's proposed, $160-billion combination with Ireland's Allergan, a plan the drugmakers scrapped after the Treasury Department issued new rules this spring aimed specially at blocking that deal. It was structured as a tax inversion, which means Pfizer's headquarters would move, on paper only, from New York to reduce the drugmaker's U.S. tax bill. Shares of Medivation Inc. soared nearly 20 percent, or $13.25, to $80.41 before the opening bell Monday, while Pfizer stock slipped 18 cents to $34.80.


News Article | September 23, 2016
Site: www.rdmag.com

Pfizer expects to complete its $14 billion buyout of cancer drug developer Medivation in the third quarter following the expiration of a regulatory waiting period. The New York drugmaker has agreed to pay $81.50 per Medivation share, which marked a 21 percent premium to San Francisco-based Medivation's closing price when it was announced in August. The acquisition will stock Pfizer's product portfolio with leading treatments for the most common cancers in men and women by adding Medivation's pricey prostate cancer treatment Xtandi to a lineup that already includes the breast cancer drug Ibrance. Medivation focuses on developing medicines for cancer and serious diseases with few treatment options. Pfizer is better known for mass market drugs, including the impotence pill Viagra and cholesterol drug Lipitor. Xtandi is Medivation's key revenue driver, bringing in $943 million in 2015. But, the drug has drawn attention for its $129,000-a-year list price. Pfizer Inc. says Medivation also has a promising pipeline of cancer drugs in late-stage clinical development. That includes the potential breast cancer treatment talazoparib and a potential lymphoma drug. Researchers also are studying Xtandi as a possible treatment for earlier-stage prostate cancers. Medivation Inc. shares rose 36 cents to $81.44 in morning trading Friday while Pfizer shares slipped 3 cents to $34.13.


News Article | August 22, 2016
Site: www.rdmag.com

Pfizer will pay about $14 billion to buy cancer drug developer Medivation in a cash deal aimed at fortifying its hold in one of the hottest and most lucrative areas of medicine. The New York drugmaker said Monday that the acquisition will stock its product portfolio with leading treatments for the most common cancers in men and women by adding Medivation's pricey prostate cancer treatment Xtandi to a lineup that already includes the breast cancer drug Ibrance. Pfizer CEO Ian Read called the acquisition a "rare opportunity" to add an established treatment and a pipeline of drugs under development. Medivation presents an attractive target as a specialty drugmaker focused on developing medicines for cancer and serious diseases with few treatment options. Earlier this year, it rejected a $9.3 billion offer from the French drugmaker Sanofi. Pfizer, best known for mass-market drugs such as impotence pill Viagra and cholesterol fighter Lipitor, began pursuing cancer drugs well after most industry leaders. It has been furiously playing catch up, mainly through partnerships with university researchers and other drugmakers. Last year, Medivation brought in $943 million in revenue, mainly through Xtandi, which it sells in partnership with the Japanese drugmaker Astellas Pharma. Xtandi has drawn attention from the public interest group Knowledge Economy International, which has protested the $129,000-a year list price for the treatment. The U.S. government covers much of the cost for Xtandi prescriptions filled under federal health programs such as Medicare, Medicaid and the Veterans Administration. Aside from Xtandi, Pfizer Inc. said Medivation also has a promising pipeline of cancer drugs in late-stage clinical development. That includes the potential breast cancer treatment talazoparib and a potential lymphoma drug. Researchers also are studying Xtandi as a possible treatment for earlier-stage prostate cancers. Pfizer said Monday that it will pay $81.50 per Medivation share. That's a 21 percent premium to the San Francisco biotech's Friday closing price of $67.19. The boards of both companies have approved the deal, which is targeted to close in the third or fourth quarter. The Pfizer-Medivation deal is much smaller than Pfizer's proposed, $160-billion combination with Ireland's Allergan, a plan the drugmakers scrapped after the Treasury Department issued new rules this spring aimed specially at blocking that deal. It was structured as a tax inversion, which means Pfizer's headquarters would move, on paper only, from New York to reduce the drugmaker's U.S. tax bill. There has been a push from Wall Street for the drugmaker to break itself up into smaller companies so that it can grow faster. While hesitant, Pfizer has promised to decide the issue by the end of this year. In the meantime, the company has focused on a series of partnerships and deals showing the company can grow as a whole. And company shares have begun to climb after years in the doldrums. Shares are up 8 percent this year, outpacing all major U.S. trading indexes. BernsteinResearch analyst Dr. Tim Anderson, who has pushed repeatedly for a breakup, wrote that paying more than $80 per share "for a stock that was trading in the $30s just a few months ago feels pricey" at first glance. Shares of Medivation Inc. soared nearly 20 percent, or $13.33, to $80.49 early Monday, while Pfizer climbed 22 cents to $35.20. Murphy reported from Indianapolis, and Johnson contributed from Trenton, N.J.

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