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News Breaks
March 13, 2014
11:59 EDTMYL, PFEMylan to launch generic Celebrex after Pfizer patent ruling
Earlier today, Mylan (MYL) confirmed that the United States District Court for the Eastern District of Virginia has ruled invalid a patent, United States Patent No. RE44,048, related to Pfizer's (PFE) Celebrex 50 mg, 100 mg, 200 mg and 400 mg capsules. Mylan was sued by G.D. Searle and Pfizer Asia Pacific for alleged infringement of this patent in connection with Mylan's Abbreviated New Drug Application, ANDA, for its generic version of Celebrex. Mylan expects to launch its generic version of Celebrex in May 2014, pending final approval of its ANDA by the U.S. Food and Drug Administration, FDA. Based on available information, Mylan believes it may be entitled to 180 days of shared generic market exclusivity on the 100 mg, 200 mg and 400 mg strengths, subject to the FDA's determination that the product qualifies for an award of exclusivity under the provisions of the Hatch-Waxman Act. Mylan shares are fractionally higher in mid day trading.
News For MYL;PFE From The Last 14 Days
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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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January 15, 2015
14:31 EDTMYLMylan launches generic Epivir-HBV tablets
Mylan (MYL) announced the U.S. launch of its Lamivudine Tablets, 100 mg, which is the generic version of GlaxoSmithKline's (GSK) Epivir-HBV. Mylan received final approval from the U.S. FDA for its Abbreviated New Drug Application for this product, which is indicated for the treatment of chronic hepatitis B virus infection associated with evidence of hepatitis B viral replication and active liver inflammation. Lamivudine Tablets, 100 mg, had U.S. sales of approximately $18.1M for the 12 months ending September 30, 2014, according to IMS Health. Currently, Mylan has 284 ANDAs pending FDA approval representing $109.1B in annual brand sales, according to IMS Health. Forty-four of these pending ANDAs are potential first-to-file opportunities, representing $29.3B in annual brand sales, for the 12 months ending June 30, 2014, according to IMS Health.
11:20 EDTPFEGoldman cuts J&J to sell citing competitive pressures
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07:59 EDTPFEAmerican Society of Clinical Oncology to hold a symposium
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January 12, 2015
12:45 EDTPFEActavis CEO says 'can't speculate on what Pfizer is going to do'
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09:22 EDTPFE23andMe announces collaboration with Pfizer
Google (GOOG)-backed 23andMe announced an agreement with Pfizer (PFE) that will provide Pfizer with access to 23andMe’s research platform, including services and Research Portal analysis of 23andMe’s genotyped population of over 800,000 individuals, of which more than 80 percent have consented to participate in research. 23andMe’s Research Portal enables qualified and approved scientists outside of 23andMe the opportunity to leverage the company’s unique research model while still protecting the privacy and security of 23andMe’s customers. As a part of the agreement, the companies will collaborate on certain genome-wide association studies, surveys, and clinical trial recruitment. One of these collaborations will be a longitudinal study to better understand the genetics of lupus. This study will entail enrollment and genotyping of 5,000 people into a new lupus research community, and include the integration of medical records, targeted bio-sampling along with genetic information for all participants. This announcement follows a collaboration between 23andMe and Pfizer to enroll 10,000 people with Inflammatory Bowel Disease in a research initiative designed to explore the genetic factors associated with the onset, progression, severity and response to treatments for IBD. Nearly 4,000 patients have been enrolled in the community since August 2014.
08:37 EDTPFEShire deal suggests most biotech companies in play, says JMP Securities
After Shire (SHPG) agreed to buy NPS Pharmaceuticals (NPSP), JMP Securities says the deal indicates that most biotech companies are in play, particularly those with worldwide rights to their products for well-defined patient populations. The firm expects investors to speculate all week about potential new targets in the space. Publicly traded companies in the space include AstraZeneca (AZN), Bristol-Myers (BMY), Eli Lilly (LLY), GlaxoSmithKline (GSK), Johnson & Johnson (JNJ), Merck (MRK), Novartis (NVS), Pfizer (PFE), Roche (RHHBY) and Sanofi (SNY).
07:17 EDTMYLJPMorgan to hold a conference
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