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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.


Tombal B.,Catholic University of Louvain | Borre M.,Aarhus University Hospital | Rathenborg P.,Herlev Hospital | Werbrouck P.,AZ Groeninge Kortrijk | And 11 more authors.
The Lancet Oncology | Year: 2014

Background: The androgen receptor inhibitor enzalutamide is approved for the treatment of metastatic castration-resistant prostate cancer that has progressed on docetaxel. Our aim was to assess the activity and safety of enzalutamide monotherapy in men with hormone-naive prostate cancer. Methods: This trial is an ongoing open-label, single-arm, phase 2 study, done across 12 European sites. Men aged over 18 years, with hormone-naive prostate cancer for whom hormone therapy was indicated, and who had non-castration levels of testosterone and prostate-specific antigen (PSA) of 2 ng/mL or greater at screening, and an Eastern Cooperative Oncology Group score of 0, received oral enzalutamide 160 mg/day. The primary outcome was the proportion of patients with an 80% or greater decline in PSA at week 25. All analyses included all patients who had received at least one dose of the study drug. This study is registered with ClinicalTrials.gov, number NCT01302041. Findings: 67 men were enrolled into the study. 62 patients (92·5%, 95% CI 86·2-98·8) had a decline in PSA of 80% or greater at week 25. The most commonly reported treatment-emergent adverse events up to week 25 were gynaecomastia (n=24), fatigue (n=23), nipple pain (n=13), and hot flush (n=12), all of which were of mild to moderate severity. Nine patients had a treatment-emergent adverse event of grade 3 or higher, most of which were reported in one patient each, except for pneumonia (grade 3, two patients) and hypertension (grade 3, four patients). Five patients reported serious adverse events, none of which were deemed to be treatment related. Interpretation: Our findings suggest that enzalutamide monotherapy in men with hormone-naive prostate cancer of varying severity provides a level of disease suppression, and was generally well tolerated. These findings provide a rationale for further investigation of clinical response and outcomes with enzalutamide in non-castrate men with prostate cancer. Funding: Astellas Pharma Inc, Medivation Inc. © 2014 Elsevier Ltd.


Sternberg C.N.,San Camillo and Forlanini Hospitals | de Bono J.S.,Institute of Cancer Research | Chi K.N.,BC Cancer Agency | Fizazi K.,University Paris - Sud | And 5 more authors.
Annals of Oncology | Year: 2014

Background: The randomized, double-blind phase III AFFIRM trial demonstrated that enzalutamide, an oral androgen receptor inhibitor, significantly prolonged overall survival (OS) [median 18.4 versus 13.6 months (hazard ratio, HR) 0.63 (95% confidence interval, CI, 0.53-0.75); P < 0.001] compared with placebo in patients with metastatic castration-resistant prostate cancer who received prior docetaxel chemotherapy. Patients and methods: A post hoc analysis was carried out to assess the efficacy and safety of enzalutamide on outcomes in younger (<75 years) and elderly (≥75 years) patients in the AFFIRM population. Statistics are presented by age group (<75 years, ≥75 years) for efficacy outcomes of OS, radiographic progression-free survival (rPFS), time to prostatespecific antigen (PSA) progression, PSA response, and safety. Results: OS was significantly improved with enzalutamide over placebo in patients <75 years [median not yet reached versus 13.6 months; HR 0.63 (95% CI 0.52-0.78), P < 0.001] and in patients ≥75 years [median 18.2 versus 13.3 months; HR 0.61 (95% CI 0.43-0.86), P ≥ 0.004], respectively. rPFS was similarly improved in both the younger [HR 0.45 (95% CI 0.38-0.53), P < 0.001] and elderly patient cohorts [HR 0.27 (95% CI 0.20-0.37), P < 0.001] relative to placebo, as were time to PSA progression and PSA response. Adverse events (AEs) were similar between the two enzalutamide age groups, with the exception of an increase in patients ≥75 years in the rates of all grade peripheral edema (22.1% versus 12.5%), fatigue (39.7% versus 31.6%), and diarrhea (26.6% versus 19.6%). The overall grade ≥3 AE rates were low with no major difference in frequency or severity between age groups or treatment arms. Five patients were reported with seizure events; three patients <75 years and two patients ≥75 years. Conclusions: Enzalutamide significantly improves outcomes in both younger (<75 years) and elderly patients (≥75 years), with comparable safety and tolerability. © The Author 2014. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved.


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.


Ardiani A.,U.S. National Cancer Institute | Farsaci B.,U.S. National Cancer Institute | Rogers C.J.,U.S. National Cancer Institute | Protter A.,Medivation Inc. | And 4 more authors.
Clinical Cancer Research | Year: 2013

Purpose: Enzalutamide, a second-generation androgen antagonist, was approved by the U.S. Food and Drug Administration (FDA) for castration-resistant prostate cancer (CRPC) treatment. Immunotherapy has been shown to be a promising strategy for prostate cancer. This study was performed to provide data to support the combination of enzalutamide and immunotherapy for CRPC treatment. Experimental Design: Male C57BL/6 or TRAMP (transgenic adenocarcinoma of the mouse prostate) prostate cancer model mice were exposed to enzalutamide and/or a therapeutic vaccine targeting Twist, an antigen involved in epithelial-to-mesenchymal transition and metastasis. The physiologic and immunologic effects of enzalutamide were characterized. The generation of Twist-specific immunity by Twist-vaccine was assessed. Finally, the combination of enzalutamide and Twist-vaccine to improve TRAMP mice overall survival was evaluated. Results: Enzalutamide mediated immunogenic modulation in TRAMP-C2 cells. In vivo, enzalutamide mediated reduced genitourinary tissue weight, enlargement of the thymus, and increased levels of T-cell excision circles. Because no changes were seen in T-cell function, as determined by CD4 + T-cell proliferation and regulatory T cell (Treg) functional assays, enzalutamide was determined to be immune inert. Enzalutamide did not diminish the ability of Twist-vaccine to generate Twist-specific immunity. Twist was confirmed as a valid tumor antigen in TRAMP mice by immunohistochemistry. The combination of enzalutamide and Twist-vaccine resulted in significantly increased overall survival of TRAMP mice compared with other treatment groups (27.5 vs. 10.3 weeks). Notably, the effectiveness of the combination therapy increased with disease stage, i.e., the greatest survival benefit was seen in mice with advanced-stage prostate tumors. Conclusions: These data support the combination of enzalutamide and immunotherapy as a promising treatment strategy for CRPC. © 2013 American Association for Cancer Research.


Guerrero J.,Fundacion Ciencia and Vida | Alfaro I.E.,Fundacion Ciencia and Vida | Gomez F.,Fundacion Ciencia and Vida | Protter A.A.,Medivation Inc. | And 2 more authors.
Prostate | Year: 2013

BACKGROUND Enzalutamide (formerly MDV3100 and available commercially as Xtandi®), a novel androgen receptor (AR) signaling inhibitor, blocks the growth of castration-resistant prostate cancer (CRPC) in cellular model systems and was shown in a clinical study to increase survival in patients with metastatic CRPC. Enzalutamide inhibits multiple steps of AR signaling: binding of androgens to AR, AR nuclear translocation, and association of AR with DNA. Here, we investigate the effects of enzalutamide on AR signaling, AR-dependent gene expression and cell apoptosis. METHODS The expression of AR target gene prostate-specific antigen (PSA) was measured in LnCaP and C4-2 cells. AR nuclear translocation was assessed in HEK-293 cells stably transfected with AR-yellow fluorescent protein. The in vivo effects of enzalutamide were determined in a mouse xenograft model of CRPC. Differential gene expression in LNCaP cells was measured using Affymetrix human genome microarray technology. RESULTS We found that unlike bicalutamide, enzalutamide lacked AR agonistic activity at effective doses and did not induce PSA expression or AR nuclear translocation. Additionally, it is more effective than bicalutamide at inhibiting agonist-induced AR nuclear translocation. Enzalutamide induced the regression of tumor volume in a CRPC xenograft model and apoptosis in AR-over-expressing prostate cancer cells. Finally, gene expression profiling in LNCaP cells indicated that enzalutamide opposes agonist-induced changes in genes involved in processes such as cell adhesion, angiogenesis, and apoptosis. CONCLUSIONS These results indicate that enzalutamide efficiently inhibits AR signaling, and we suggest that its lack of AR agonist activity may be important for these effects. Copyright © 2013 Wiley Periodicals, Inc.


Trademark
Medivation Inc. | Date: 2015-02-19

Pharmaceutical preparations for the treatment of cancer. research in the fields of chemicals and pharmaceuticals; scientific research services; research and testing services in the fields of chemicals and pharmaceuticals; research and development of new products for others in the fields of chemical and pharmaceuticals.


Trademark
Medivation Inc. | Date: 2015-02-18

Pharmaceutical preparations for the treatment of cancer. research in the fields of chemicals and pharmaceuticals; scientific research services; research and testing services in the fields of chemicals and pharmaceuticals; research and development of new products for others in the fields of chemical and pharmaceuticals.


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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