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News Breaks
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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September 16, 2014
11:51 EDTPFEOECD looks to close tax loopholes with new proposals
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07:19 EDTPFECompanies' share buybacks at fasttest clip since 2007, WSJ reports
Companies are buying back their own shares at its fastest pace since the financial crisis to fuel a stock rally, reports the Wall Street Journal. According to Birinyi Associates, companies have bought back $338.3B of stock in 1H14, the most since 2007. Citing an analysis by Barclays, companies with the largest buyback programs by dollar value have outperformed the broader market by 20% since 2008. Reference Link
September 15, 2014
09:25 EDTPFEJPMorgan biotech analysts hold an analyst/industry conference call
Analysts assess Pfizer's M&A options on an Analyst/Industry conference call to be held on September 15 at 10 am.
07:27 EDTPFEIBC Life Sciences to hold a conference
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07:27 EDTPFEPfizer acquisition could drive shares higher, says JPMorgan
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September 14, 2014
13:32 EDTPFEPfizer shares look cheap, Barron's says
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September 12, 2014
10:32 EDTPFEPfizer CEO says company still open to inversion deal, FT says
Pfizer (PFE) CEO Ian Read said U.S. rhetoric against tax inversions has been "political theater" ahead of midterm elections and made clear that his company is still open to a potential tax-saving acquisition, according to Financial Times, which added Read's comment about not being “held hostage” over price would likely be read as a signal the company might look elsewhere after being rebuffed by AstraZeneca (AZN). The Fly notes that Bloomberg previously reported, citing people familiar with the matter, that Pfizer is looking at targets other than AstraZeneca, including Actavis (ACT). Shares of Actavis trading in New York are up 2% this morning. Reference Link
September 8, 2014
07:15 EDTPFEIBC Life Sciences to hold a conference
10th Annual Cell Line Development & Engineering Conference to be held in Berkeley, California on September 8-10.
September 4, 2014
16:05 EDTPFEPfizer granted orphan status for sickle cell disease drug
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07:23 EDTPFEAstraZeneca called for inversion clamp down as part of defense, WSJ says
Amid its defense against an unsolicited takeover bid from rival Pfizer (PFE), AstraZeneca (AZN) hired advisers with close ties to the Obama administration, who made calls to senior administration officials urging a clamp down on tax inversions, said The Wall Street Journal, citing people familiar with the previously undisclosed calls. Reference Link
September 3, 2014
11:30 EDTPFEPfizer has conference call hosted by Bernstein
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