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News Breaks
June 2, 2014
07:03 EDTPFE, MYLMylan settles patent litigation related to Celebrex capsules with Pfizer
Mylan (MYL) announced that it has entered into a settlement and license agreement with Pfizer (PFE) relating to Mylan's Abbreviated New Drug Application filed with the FDA for Celecoxib Capsules, 50 mg, 100 mg, 200 mg and 400 mg. This product is the generic version of Celebrex, which is 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. Under the terms of the agreement, Mylan will begin selling product at the earliest market formation, however in any case not later than December. 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. Additionally, Mylan has appealed the decision by the United States District Court for the Northern District of West Virginia denying Mylan's request for an injunction in its suit against the FDA. Mylan continues to believe that FDA seriously erred in its decision awarding one party eligibility for 180 days of exclusivity on Celecoxib, and will continue with this suit independent of the aforementioned settlement.
News For MYL;PFE From The Last 14 Days
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January 30, 2015
06:30 EDTPFEEli Lilly FY15 EPS guidance does not include 12c potential charge
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January 29, 2015
11:19 EDTMYLMylan shareholders approve acquisition of Abbott's generics business
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09:13 EDTMYLAbbott sees 6% negative impact to FY sales from forex
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08:15 EDTPFEOPKO Health, Pfizer receive regulatory clearance for global agreement
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January 28, 2015
11:34 EDTMYLEC clears Abbott sale of non-U.S. EPD-DM business to Mylan, with conditions
The European Commission has cleared under the EU Merger Regulation the proposed acquisition of Abbott Laboratories' (ABT) Non-U.S. Developed Markets Specialty and Branded Generics Business, or EPD-DM, by Mylan (MYL). The decision is conditional upon the divestment of a number of Mylan's businesses in Germany, the United Kingdom, France, Ireland and Italy. The Commission had concerns that the transaction, as initially notified, would have reduced competition on the market for several medicines. The commitments offered by Mylan address these concerns, the EC said.
07:39 EDTPFEPfizer CEO says company not in need of big M&A deal, FT reports
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January 27, 2015
07:16 EDTPFEPfizer drops 2.7% after FY15 outlook miss expectations
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07:07 EDTPFEPfizer sees FY15 adjusted EPS $2.00-$2.10, consensus $2.18
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07:01 EDTPFEPfizer reports Q4 adjusted EPS 54c, consensus 53c
Reports Q4 revenue $13.1B, consensus $12.9B.
January 26, 2015
16:15 EDTPFEPfizer commits to lower price for Prevenar 13 in developing countries
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15:40 EDTPFENotable companies reporting before tomorrow's open
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13:29 EDTPFEEarnings Preview: Pfizer set to report Q4 results as generics impact Celebrex
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11:00 EDTMYLMylan expands Hepatitis C licensing agreement with Gilead
Mylan (MYL) announced that its subsidiary Mylan Laboratories Limited is expanding its hepatitis C licensing agreement with Gilead Sciences (GILD) to include the non-exclusive rights to manufacture and distribute the investigational NS5A inhibitor GS-5816 and single tablet regimen of sofosbuvir/GS-5816, once approved, in 91 developing countries. The single tablet regimen is being evaluated in Phase 3 clinical studies for the treatment of all six genotypes of hepatitis C. If approved by regulatory authorities, the sofosbuvir/GS-5816 regimen would become the first all-oral single tablet regimen for all hepatitis C genotypes. A pan-genotypic therapeutic option is particularly important for developing countries, where genotype testing is often unreliable or not readily available. This agreement is in addition to the licensing and technology transfer agreement that Mylan entered into with Gilead in September 2014, which grants Mylan the non-exclusive rights to manufacture and distribute sofosbuvir and ledipasvir/sofosbuvir in 91 developing countries. Mylan also partners with Gilead on expanding access to high quality, affordable antiretrovirals for the treatment of HIV/AIDS in India and other developing countries.
January 23, 2015
16:08 EDTPFETeva volatility elevated, Pfizer approached late last year, Bloomberg says
Teva (TEVA) overall option implied volatility of 25 compares to its 26-week average of 23 according to Track Data, suggesting large price movement into Pfizer (PFE) approach late last year, Bloomberg says.
16:04 EDTPFETeva rebuffed Pfizer approach late last year, Bloomberg says
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January 22, 2015
11:23 EDTPFEPfizer says CHMP adopted positive opinion on Prevenar 13 expansion
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January 21, 2015
12:30 EDTPFEGlaxoSmithKline 'admired' by Pfizer CEO, FT reports
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January 20, 2015
14:37 EDTMYLTeva generic competition to Copaxone pushed out by ruling, says BMO Capital
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12:56 EDTMYLMylan says continues to believe '808 patent is 'invalid'
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10:40 EDTMYLMomenta Pharma sinks after Supreme Court rules on Copaxone
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