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News Breaks
April 6, 2014
13:46 EDTPFEPfizer's palbociclib significantly prolonged PFS in metastatic breast cancer
Pfizer announced detailed results from the PALOMA-1 study, a randomized Phase 2 study of palbociclib, PD-0332991, in combination with letrozole. PALOMA-1 achieved its primary endpoint by significantly prolonging progression-free survival, PFS, compared with letrozole alone in post-menopausal women with estrogen receptor positive, ER+, human epidermal growth factor receptor 2 negative, HER2-, locally advanced or metastatic breast cancer. For women treated with the combination of palbociclib plus letrozole, the median PFS was 20.2 months, a statistically significant improvement compared to the 10.2 months of PFS in women who received letrozole alone. These data will be presented by Dr. Richard S. Finn, associate professor of medicine at University of California, Los Angeles at the American Association of Cancer Research (AACR) Annual Meeting 2014 in San Diego. "These data demonstrate the potential of palbociclib to be a major advance in the treatment of women with this type of advanced breast cancer," said Dr. Mace Rothenberg, senior vice president of Clinical Development and Medical Affairs and chief medical officer for Pfizer Oncology. "We are proud to be at the forefront of research and development with respect to this promising new class of investigational anticancer agents and have initiated a broad clinical development program for palbociclib that includes breast and non-breast cancers." Final results for the secondary efficacy endpoints of duration of treatment and clinical benefit rate demonstrated superiority in the palbociclib plus letrozole arm compared to the letrozole-only arm. Per the PALOMA-1 trial protocol, an initial assessment of overall survival, OS, a secondary endpoint, was also performed. Based on the events at the time of the assessment, a median OS of 37.5 months was observed in the combination arm versus 33.3 months for those who received letrozole alone, a difference of 4.2 months. This OS observation at the time of final PFS analysis was not statistically significant. A follow-up OS analysis will be conducted following the accrual of additional events.
News For PFE From The Last 14 Days
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March 26, 2015
07:30 EDTPFEDeutsche Bank to hold a conference
Pharma One-on-One Day is being held in Denver, Colorado on March 26.
March 24, 2015
07:45 EDTPFEFDA Pediatric Advisory Committee holds a meeting
The Committee discusses pediatric-focused safety reviews, as mandated by the FDA Safety and Innovation Act (FDASIA) for Eli Lilly's Cymbalta, Pfizer's Quillivant XR and Revatio, Johnson & Johnson's Risperdal, GlaxoSmithKline's Advair, HFA Altabax Ointment and Fluarix Quadrivalent, Supernus Pharmaceuticals' Oxtellar XR, Teva Pharmaceutical's Qnasl and Roche's Invirase. The Committee will also discuss the safety ongoing propriety of the humanitarian device exemption for the Medtronic Activa Dystonia Therapy and for the Liposorber LA-15 System in a meeting being held in Silver Spring, Maryland on March 24 at 8 am. Webcast Link
March 23, 2015
11:09 EDTPFEPfizer hits best level in over decade after Jefferies adds to list of best ideas
The shares of Pfizer (PFE) are rising after an analyst wrote that the company's shares are poised to rise significantly over the next one to two years. Additionally, the company announced that it would resume developing its painkiller, tanezumab, in partnership with Eli Lilly (LLY). ANALYST OUTLOOK: Pfizer's breast cancer drug for postmenopausal women, Ibrance, has had one of the best launches of any oncology drug ever, Jefferies analyst Jeffrey Holdford wrote in a note to investors today. A survey of U.S. oncologists conducted by the firm shows that the doctors expect the drug to be used on about 50% of patients needing first line hormonal therapy within one year, while the drug will be used as an off-label treatment in all lines of therapy, the analyst wrote. The drug will generate revenue of $5.5B in 2020, versus the consensus outlook of $3.3B, Holford estimated. Meanwhile, the drug maker's Global Established Pharmaceutical, or GEP, business' revenue and profits should top consensus estimates by14% by 2018, according to the analyst. Pfizer could generate value through accretive M&A activity and by separating the GEP unit by 2017, Holdford stated. He raised his price target on the name to $45 from $42, kept a buy rating on the shares, and added the stock to the firm's Franchise Picks list, which encompasses its best ideas. WHAT'S NOTABLE: Pfizer announced that, in partnership with Eli Lilly, it would resume its Phase 3 clinical program for tanezumab. The announcement was made after the FDA removed a partial clinical hold on the drug, Pfizer noted. As a result of its decision, Pfizer expects to receive a $200M payment, in accordance with the companies' agreement, Pfizer stated. PRICE ACTION: In mid-morning trading, Pfizer climbed 2.4% to $35.08. The stock has not traded at a price per share this high since 2004.
11:01 EDTPFEPfizer rallies to fresh 52-week high, levels to watch
Shares are up over 2.8% at time of writing to $35.14, just below the new 52-week high at $35.26 which is now initial resistance. Next resistance above is at $35.89 and then at $36.63. Support is at $34.89.
09:37 EDTPFEActive equity options trading on open
Active equity options trading on open according to Track Data: AAPL AUY SLB PFE MCP CELG VRTX SHPG GILD LOGI TSLA TASR NFLX SCTY WFM
08:06 EDTPFEPfizer, Eli Lilly to resume Phase 3 chronic pain program for Tanezumab
Pfizer (PFE) and Eli Lilly and Company (LLY) announced that they are preparing to resume the Phase 3 clinical program for tanezumab. As a result, Pfizer expects to receive a $200M upfront payment from Lilly in accordance with their collaboration agreement. This announcement follows a decision by the U.S. FDA to lift the partial clinical hold on the tanezumab development program after a review of a robust body of nonclinical data characterizing the sympathetic nervous system response to tanezumab. The data were submitted to the FDA in February. In the prior clinical studies of more than 11,000 patients, tanezumab demonstrated clinically meaningful efficacy vs. placebo and other select commonly used pain medicines. A partial clinical hold has been in place for tanezumab and all other anti-nerve growth factor antibodies since December 2012 due to adverse changes in the sympathetic nervous system of mature animals. Studies in terminal cancer pain were allowed to proceed.
08:05 EDTPFEPfizer, Eli Lilly to resume Phase 3 chronic pain program for Tanezumab
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07:36 EDTPFEPfizer should rise 'significantly' over next two years, says Jefferies
Jefferies analyst Jeffrey Holford told investors this morning that he expects shares of Pfizer (PFE) to appreciate "significantly" over the next two years. A survey of U.S. oncologists indicated the company's Ibrance drug will be used in 50% of first line hormonal therapy within one year, with off-label use in all lines of therapy including adjuvant, Holford noted. He thinks peak sales of the drug could top $13B, which is well above consensus. In addition, the analyst views Pfizer's Global Established Pharmaceutical business as being underappreciated by the market. Potential value creating options for the pharmaceutical giant include spinning off its GEP unit by 2017 and accretive acquisitions, with possible takeover targets being Shire (SHPG), Actavis (ACT), AstraZeneca (AZN) and GlaxoSmithKline (GSK), in the eyes of Holford. He added the stock to the firm's Franchise Picks list, which encompasses its best ideas. He also raised his price target for Pfizer to $45 from $42. The stock closed Friday up 10c to $34.25.
March 20, 2015
13:03 EDTPFEPfizer says oral tofacitinib meets primary endpoint in Phase 3 trials
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07:55 EDTPFEAstraZeneca seen as potential target again if oncology drugs lag, Bloomberg says
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07:41 EDTPFEAmerican Academy of Dermatology to hold annual meeting
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March 19, 2015
11:00 EDTPFEPfizer participates in a conference call with Bernstein
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March 18, 2015
17:09 EDTPFEPfizer CAPiTA published in New England Journal of Medicine
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March 16, 2015
06:40 EDTPFEPCSK9 studies show potential improvement in heart health, WSJ says
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