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News Breaks
April 26, 2010
10:54 EDTWPI, PFE, MYL, FRX, TEVAPfizer may obtain compensation from Teva following court verdict
A federal court jury found on Friday that Pfizer's (PFE) patent for a drug known as Protonix is valid. Generic versions of Protonix, which are currently made by Israel's Teva (TEVA), India's Sun Pharma, and a company called Prasco, are used to treat ulcers. Most of the worldwide revenue from the generic version of the drug is currently obtained by Teva. In a note to investors, Cowen analysts predicted that Teva would have to pay compensation of about $400M to Pfizer. Teva was not willfully infringing the patent, since it had received a favorable preliminary injunction on the matter, and consequently would not be liable for triple damages, Cowen contends. The firm recommends that investors buy Teva on weakness today. Meanwhile, Citigroup analysts predict that the court would force Teva to pay about $652M in damages to Pfizer, but the firm predicts that such a verdict would reduce the Israeli company's 2010 profits by only $350M. However, the firm, which reiterates a Buy rating on Teva and a Hold rating on Pfizer, expects the companies to settle the matter out of court. On the other hand, Teva added that the judge could overturn the jury's verdict and invalidate Pfizer's patent. In mid-morning trading, Teva lost 1.10, or 1.78%, to $60.44, while Pfizer inched up 2c to $16.93.
News For PFE;TEVA;MYL;WPI;FRX 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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15:24 EDTTEVATeva confirms U.S. approval of AstraZeneca's Nexium generic
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14:15 EDTTEVATeva unit wins FDA approval for Nexium generic
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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 EDTPFE, TEVATeva 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 EDTTEVA, PFETeva 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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08:38 EDTTEVAMomenta announces Supreme Court decision to remand generic Copaxone back to CAFC
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January 20, 2015
14:37 EDTMYL, TEVATeva generic competition to Copaxone pushed out by ruling, says BMO Capital
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12:56 EDTMYL, TEVAMylan says continues to believe '808 patent is 'invalid'
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11:29 EDTTEVATeva says Supreme Court reverses circuit court judgment on Copaxone 20 mg/mL
Teva Pharmaceutical announced the U.S. Supreme Court’s decision in Teva Pharmaceuticals USA, Inc. et al. Petitioners v. Sandoz Inc. et al. that reversed the Federal Circuit Court’s judgment of invalidity of Teva’s ‘808 patent for COPAXONE 20 mg/mL. The Supreme Court remanded the case to the Federal Circuit for further review in light of the applicable standard the Supreme Court laid out for appellate review of claim construction. A ruling last year by the U.S. Court of Appeals for the Federal Circuit upheld four Teva patents that expired in May 2014, while invalidating the ‘808 patent that is set to expire on September 1, 2015. “We are encouraged by the U.S. Supreme Court’s Decision and look forward to the Federal Circuit’s review. We will continue to explore all available avenues to protect our intellectual property for COPAXONE 20mg/mL,” said Erez Vigodman, President and CEO of Teva. “There is currently no FDA-approved follow-on version of Teva’s COPAXONE. We are encouraged by the FDA’s willingness to date to have dialogue regarding the complexities of COPAXONE 20 mg/mL and the potential limitations and other unknowns of purported follow-on versions,” added Rob Koremans, MD, President and CEO of Global Specialty Medicines at Teva.
10:45 EDTTEVATeva spikes, retraces, after win in Copaxone patent case
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10:40 EDTTEVA, MYLMomenta Pharma sinks after Supreme Court rules on Copaxone
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10:35 EDTTEVATeva rises after patent ruling upheld by Supreme Court
The Supreme Court upheld a lower court ruling related to generic versions of Teva's Copaxone drug. In the ruling, the court wrote that "When reviewing a district court’s resolution of subsidiary factual matters made in the course of its construction of a patent claim, the Federal Circuit must apply a “clear error,” not a de novo, standard of review." Teva shares are up 1.5% to $58.58 in early trading after the ruling. Reference Link
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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