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January 27, 2014
07:07 EDTPFEPfizer announces results from two dacomitinib Phase 3 trials
Pfizer announced top-line results from two randomized Phase 3 studies of the irreversible pan-HER kinase inhibitor dacomitinib in patients with advanced non-small cell lung cancer. Both trials evaluated dacomitinib in populations of previously treated patients with advanced NSCLC. The ARCHER 1009 trial did not meet its objective of demonstrating statistically significant improvement in progression-free survival when compared with the EGFR inhibitor erlotinib. Separately, the NCIC CTG BR.26 trial did not meet its objective of prolonging overall survival versus placebo. An ongoing, third Phase 3 trial, ARCHER 1050, is evaluating PFS of dacomitinib in a different patient population than was studied in ARCHER 1009 and BR26. ARCHER 1050 compares dacomitinib versus gefitinib in treatment-na´ve patients with EGFR-mutant advanced NSCLC. The results are expected in 2015. In both studies, the adverse events observed for dacomitinib generally were consistent with its known adverse event profile. Full efficacy and safety data from ARCHER 1009 and BR.26 will be submitted for presentation at an upcoming medical meeting.
News For PFE From The Last 14 Days
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April 21, 2015
10:01 EDTPFEPfizer receives FDA breakthrough therapy designation for Xalkori
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08:18 EDTPFEPain Therapeutics resumes responsibility for Remoxy
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08:06 EDTPFEPfizer says Phase 3 inotuzumab ozogamicin study met first primary endpoint
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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.

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