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April 22, 2014
08:03 EDTPFEPfizer says OPT Pivotal #1 and #2 programs meet primary endpoints in study
Pfizer announced results from two pivotal Phase 3 trials from the Oral treatment Psoriasis Trials Program, OPT Pivotal #1 and OPT Pivotal #2, evaluating the efficacy and safety of tofacitinib, an oral Janus kinase inhibitor, the first in a new class of medicines being investigated for the treatment of moderate-to-severe plaque psoriasis. The OPT Pivotal #1 and OPT Pivotal #2 studies showed that tofacitinib, as a 5 mg or a 10 mg dose taken as a pill twice-daily, met the primary efficacy endpoints of statistically significant superiority over placebo at Week 16 in the proportion of subjects achieving a Physician’s Global Assessment response of “clear” or “almost clear,” and the proportion of subjects achieving at least a 75% reduction in Psoriasis Area and Severity Index, two commonly used measures of efficacy in psoriasis. No new safety signals for tofacitinib were observed in the OPT Pivotal #1 or OPT Pivotal #2 studies. Detailed analyses of these studies, including additional efficacy and safety data, will be submitted for presentation at a future scientific meeting. Top-line results from the first two studies from the OPT Program, OPT Compare and OPT Retreatment, were previously announced in October 2013, and these four studies, in addition to a long-term extension study, will form the planned psoriasis submission package to regulatory authorities in various markets. Pfizer currently intends to submit a supplemental New Drug Application to the U.S. FDA for the approval of tofacitinib 5 mg and 10 mg twice-daily for the treatment of adults with moderate-to-severe chronic plaque psoriasis by early 2015.
News For PFE From The Last 14 Days
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April 20, 2015
08:02 EDTPFEMerck KGaA, Pfizer initiate Phase III study with Avelumab
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06:05 EDTPFEProvectus receives notice of allowance for PV-10 combined with other drugs
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April 15, 2015
08:04 EDTPFEPfizer: PALOMA-3 trial for IBRANCE met primary endpoint, trial stopped early
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April 13, 2015
15:12 EDTPFEMylan enters settlement, license agreement with Pfizer regarding Viagra
Mylan (MYL) announced that its subsidiaries Mylan Inc. and Mylan Pharmaceuticals have entered into a settlement and license agreement with Pfizer (PFE), Pfizer Limited and Pfizer Ireland Pharmaceuticals to settle patent litigation relating to Mylan's Abbreviated New Drug Application filed with the U.S. FDA for Sildenafil Citrate Tablets 25 mg, 50 mg, and 100 mg. This product is the generic version of Viagra, which is indicated to treat erectile dysfunction. Under the terms of the agreement, Mylan will be able to launch its ANDA products pursuant to a royalty-bearing license as early as December 11, 2017, or sooner under certain conditions, subject to FDA approval. All other terms and conditions of the settlement and license agreement are confidential, and the agreement itself is subject to review by the U.S. Department of Justice and the Federal Trade Commission. For the 12 months ending Dec. 31, 2014, Viagra had U.S. sales of approximately $1.3B, according to IMS Health.
April 9, 2015
09:51 EDTPFEPerrigo did not expect Mylan takeover letter, CNBC's Faber reports
Perrigo (PRGO) did not expect the takeover letter it received from Mylan (MYL), CNBC's David Faber reports, citing sources. Perrigo will take its time in deciding what its next steps are, Faber added. Shares of Mylan are up 3% in early trading, which is being attributed, at least in part, to speculation the company could be a takeover target itself. Analysts this morning mentioned Teva (TEVA) as a potential acquirer of Mylan. Chatter this morning has Pfizer (PFE) also potentially interested in the EpiPen maker
09:25 EDTPFEPiper Jaffray pharmaceuticals analysts hold an analyst/industry conference call
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08:04 EDTPFEPfizer launches PCSK9 competitive grants program
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April 7, 2015
08:09 EDTPFEPfizer, Merck KGaA finalize agreement to co-promote XALKORI
Merck KGaA (MKGAY) and Pfizer (PFE) announced the finalization of the co-promotion agreement allowing the companies to co-promote Pfizer’s anaplastic lymphoma kinase inhibitor XALKORI. Under the agreement, XALKORI will be co-promoted in two waves, the first of which will begin in the second and third quarters of 2015 in the United States, Canada, Japan and five European Union countries: France, Germany, Italy, Spain and the United Kingdom. In the U.S. and Canada, XALKORI will be co-promoted by EMD Serono, the U.S. and Canadian biopharmaceutical businesses of Merck KGaA. The second wave will begin in 2016 and includes China and Turkey. n 2015, Merck KGaA will receive a reimbursement associated with its promotion of XALKORI, followed by an 80% for Pfizer, 20% for Merck KGaA profit sharing on the product starting in 2016. The co-promotion term will last through December 31, 2020 for the U.S., Canada, Japan, France, Germany, Italy, Spain and the U.K. and from January 1, 2016 through December 31, 2021 in China and Turkey. Pfizer will report the sales of XALKORI in countries where it is co-promoted with Merck KGaA.
07:14 EDTPFEEyeforpharma to hold a summit
Philadelphia 2015 Commercial Pharma Summit is being held in Philadelphia on April 7-8.
07:02 EDTPFEGlycoMimetics updates on Pfizer's plans to initiate Phase 3 Rivipansel trial
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