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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.
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December 15, 2014
18:32 EDTPFEPfizer announces Palbociclib PALOMA-1 data published in The Lancet Oncology
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12:09 EDTPFEPfizer increases dividend 8% to 28c per share
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10:40 EDTPFEOPKO Health deal with Pfizer removes financing overhang, says Ladenburg
Ladenburg views the agreement OPKO Health (OPK) signed with Pfizer (PFE) as a significant positive catalyst since the company is partnering with an established leader in short-acting hGH and because the large upfront payment removes near-term financing needs as an overhang on the stock. The firm reiterates its Buy rating and $14.50 price target on OPKO, but said it will re-examine its projections after the deal closes.
10:19 EDTPFEOPKO Health soars after entering hGP-CTP agreement with Pfizer
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09:03 EDTPFEBaxter to divest Vero cell vaccines platform to Nanotherapeutics
Baxter International (BAX) announced that it has entered into a definitive agreement to sell its proprietary Vero cell technology and related assets, including its production facility in Bohumil, Czech Republic, to Nanotherapeutics, Inc. Financial details were not disclosed. The agreement with Nanotherapeutics includes all assets related to the platform, including vaccines for H5N1, H1N1 and seasonal influenza. The agreement also includes investigational vaccine programs for Ross River virus, Chikungunya disease and West Nile virus. In recent weeks, the company has also completed the sale of its commercial vaccines business and related manufacturing facilities to Pfizer (PFE).
08:02 EDTPFEPfizer, OPKO Health enter into global agreement for hGH-CTP
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December 10, 2014
08:31 EDTPFETeva announces launch of first generic Celebrex capsules in the U.S.
Teva Pharmaceutical Industries (TEVA) announces the launch of the first FDA-approved generic equivalent to Celebrex Capsules in the United States. Teva is offering 50, 100, 200, and 400 mg strengths of Celecoxib Capsules. Celebrex Capsules, marketed by Pfizer (PFE) had annual sales of approximately $2.56B in the United States, according to IMS data as of October 2014.
07:38 EDTPFEMylan launches generic version of Pfizer's Celebrex capsules
Mylan (MYL) announced the U.S. launch of its Celecoxib Capsules, 50 mg, 100 mg, 200 mg, and 400 mg, one of the first available generic versions of Pfizer's (PFE) Celebrex Capsules, indicated for the relief of the signs and symptoms of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis, and for the management of acute pain in adults. Celecoxib Capsules had U.S. sales of approximately $2.5B for the 12 months ending September 30, 2014.
December 9, 2014
12:22 EDTPFEPiper Jaffray biopharm analyst holds an analyst/industry conference call
Senior Research Analyst Schimmer, along with Biopharmaceuticals Analyst Breazzano, discuss gene therapy for hemophilia on an Analyst/Industry conference call to be held on December 11 at 10 am.
10:32 EDTPFEPfizer says in talks with FDA on path forward for Mylotarg
Pfizer announced the presentation of encouraging early- and late-stage data from clinical studies across several hematologic malignancies, including acute myeloid leukemia, acute lymphoblastic leukemia and chronic myeloid leukemia. Among the highlights are results from several investigator-led, large, randomized studies evaluating the antibody-drug conjugate MYLOTARG in select adult AML populations. Research was presented at the 56th Annual Meeting of the American Society of Hematology in San Francisco, December 6-9. Mace Rothenberg, senior vice president of Clinical Development and Medical Affairs and chief medical officer for Pfizer Oncology, said “In particular, we are encouraged by the significant clinical evidence emerging from large randomized trials, such as AML-19 and ALFA-0701, demonstrating a positive impact of MYLOTARG when added to standard first-line treatment for patients with acute myeloid leukemia. We are engaging in discussions with the U.S. FDA and other health authorities to determine the best path forward for MYLOTARG. In addition, we plan to initiate an expanded access protocol for the therapy by the end of 2014 in the United States in patients with relapsed or refractory acute myeloid leukemia for whom there are no other treatment options.”
07:44 EDTPFEAmerican Association for Cancer Research to hold a symposium
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December 8, 2014
13:32 EDTPFEPfizer, Bristol-Myers announce results of human study on Eliquis
Bristol-Myers Squibb Company (BMY) and Pfizer (PFE) announced results of the first human study evaluating the reversal of the anticoagulant effect of Eliquis by 4-factor prothrombin complex concentrates in healthy subjects. The study results demonstrated that both PCCs, Sanquin’s Cofact and CSL Behring’s Beriplex P/N reversed the steady-state pharmacodynamic effects of Eliquis in several coagulation assessments, including endogenous thrombin potential. The full data will be presented today during the Antithrombotic Therapy: Anticoagulant Therapy session at the 56th annual meeting of the American Society of Hematology in San Francisco, CA. The study was an open label, randomized, placebo-controlled, three-period crossover study in 15 healthy, adult subjects. Within each period, subjects received Eliquis 10 mg twice daily. On day four, three hours after Eliquis administration, subjects received a 30-minute infusion of 4-factor PCCs, either 50 IU/kg Cofact or Beriplex P/N, or an equivalent volume of saline solution. The effect of Cofact and Beriplex P/N on the pharmacodynamics of Eliquis was based upon changes in endogenous thrombin potential, a measure of thrombin-mediated coagulation. Treatment periods were separated by an 11-day washout, after which the alternate treatment was administered. In this study, no serious adverse events, bleeding-related events or signs of thrombosis were reported with Eliquis administration with or without PCC treatment. Overall, these data demonstrate that Cofact and Beriplex P/N reversed the steady-state pharmacodynamic effects of Eliquis as measured by ETP and support further evaluation of PCCs in the management of patients treated with Eliquis who require reversal of its anticoagulant effect.
08:03 EDTPFEPfizer announces agreement with Spark Therapeutics to develop SPK-FIX
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December 5, 2014
10:22 EDTPFEBristol-Myers call activity attributed to takeover speculation
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10:05 EDTPFEBristol-Myers jumps 2% amid talk of potential Pfizer bid
Shares of Bristol-Myers (BMY) are up in early trading amid chatter of a potential takeover bid from Pfizer (PFE). The stock is up $1.26 to $60.15. Bristol's market capitalization stands around $99B, less than twice that of Pfizer's $200B. A Jefferies analyst last week called Mylan (MYL) the most likely takeover target for Pfizer. Pfizer is "highly motivated" to buy a foreign company using its overseas cash and Mylan looks like the most likely target, Jefferies analyst Jeffrey Holford wrote.
09:56 EDTPFERumor: Bristol-Myers strength attributed to takeover speculation
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December 4, 2014
08:45 EDTPFEAbbVie price target raised to $80 from $72 at Jefferies
Jefferies raised its price target for AbbVie shares to $80 while calling the company one of its top five global pharma picks for 2015. The firm's top U.S. pick is Pfizer (PFE) and its top Europe pick is Novartis (NVS). Bayer (BAYRY) and AstraZeneca (AZN) round out the top five. Jefferies thinks AbbVie's "strong momentum" will continue into the first half of 2015 and keeps a Buy rating on the name.
December 3, 2014
17:12 EDTPFEPfizer reports positive results from PROFILE 1014 study
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16:42 EDTPFEDiplomat chosen as limited-distribution pharmacy partner by Pfizer
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07:16 EDTPFEFood & Drug Law Institute to hold a conference
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