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May 23, 2014
09:15 EDTPFEPfizer says tofacitinib met two primary efficacy endpoints in Phase 3 study
Pfizer announced detailed results from the Oral treatment Psoriasis Trial Retreatment study, a Phase 3 study investigating tofacitinib for the treatment of adult patients with moderate-to-severe chronic plaque psoriasis. This three-period study showed that tofacitinib, as a 5 mg or 10 mg pill taken twice daily, met its two primary efficacy endpoints. The safety profile of tofacitinib in OPT Retreatment was consistent with previous studies and there were no new safety findings in this trial. The first primary endpoint of OPT Retreatment evaluated the maintenance of clinical response in patients who remained on tofacitinib after an initial treatment phase compared to patients who were switched to placebo. The second primary endpoint examined patients who lost half of their original clinical response during the withdrawal phase, and measured the proportion of these patients who regained their original clinical response after restarting treatment with tofacitinib. Throughout the study, the efficacy response was measured by the proportion of subjects achieving a Physician’s Global Assessment response of “clear” or “almost clear” skin and the proportion of subjects achieving at least a 75% reduction in the Psoriasis Area and Severity Index, two commonly used measures of efficacy in psoriasis.
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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