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News Breaks
November 25, 2013
08:57 EDTTEVA, MYLTeva, Mylan settle Copaxone patent litigation in France, U.K. Netherlands
Teva (TEVA) and Mylan (MYL) announce that certain of their affiliates have agreed to settle and dismiss pending patent litigation involving Copaxone in the U.K., the Netherlands and France relating to non-infringement and the validity of European Patent 0,762,888, which expires in May 2015. The terms of the settlement are confidential.
News For TEVA;MYL From The Last 14 Days
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April 22, 2014
10:00 EDTTEVAOn The Fly: Analyst Initiation Summary
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07:42 EDTTEVATeva initiated with a Buy at Jefferies
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April 21, 2014
09:21 EDTTEVAOn The Fly: Pre-Market Movers
HIGHER: Sarepta (SRPT), up 54% after announcing plans to to submit NDA for Eteplirsen by year end 2014. Shares of Prosnesa (RNA), another drugmaker working on a competing DMD drug, are up more than 12%... AstraZeneca (AZN), up 6% after the Sunday Times says that Pfizer (PFE) is considering a takeover bid for the company. Pfizer is up 1.2% following the report... Newmont Mining (NEM), up 8% after WSJ says the company and Barrick Gold (ABX) could resume merger talks as soon as today... Cbeyond (CBEY), up 39% after agreeing to be acquired for about $323M by Birch Communications... Momenta Pharma (MNTA), up 10.5% after the Supreme Court rejected Teva's (TEVA) bid to delay generic Copaxone... Nu Skin (NUS), up 5% after saying its China division will resume corporate-hosted business meetings... Micron (MU), up 4% after price target raised at Drexel Hamilton... DOWN AFTER EARNINGS: Acacia Research (ACTG), down 6%... athenahealth (ATHN), down 5.6%.
08:18 EDTTEVA, MYLMomenta Pharma rises after high court rejects Copaxone delay bid
Shares of Momenta Pharmaceuticals (MNTA) are higher in pre-market trading after the Supreme Court denied Teva's (TEVA) request to delay the launch of generic forms of its relapsing-remitting multiple sclerosis product, Copaxone. WHAT'S NEW: Teva confirmed on April 19 that the Chief Justice of the United States denied the company's application for an injunction seeking to prevent the launch of a generic version of Copaxone. Teva will continue pursuing its appeal in the Supreme Court and defending its intellectual property for Copaxone, the company said. WHAT'S NOTABLE: Momenta has developed a generic version of Copaxone in partnership with Novartis' (NVS) Sandoz unit. Mylan, which is preparing to launch a generic version of Copaxone as well, said after the ruling: "We are pleased with the Chief Justice's decision, and we look forward to introducing the first generic Copaxone treatment for multiple sclerosis patients in the U.S. at market formation. Mylan remains eligible to receive approval from the U.S. FDA on May 25, 2014." PRICE ACTION: In pre-market trading, Momenta shares are up over 12% to $12.46, while Mylan shares are up more than 3% to $48.48. Teva shares trading in New York are down about 1.7% to $50 in pre-market trading.
April 19, 2014
18:50 EDTMYL, TEVAMylan says Teva denied injunction seeking to prevent launch of generic Copaxone
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18:32 EDTTEVASupreme Court denies Teva stay in generic Copaxone case
Teva Pharmaceutical Industries announced that while the Chief Justice of the United States found that Teva had demonstrated “a fair prospect of success on the merits” in its appeal of a decision from the United States Court of Appeals for the Federal Circuit that invalidated the claim of U.S. Patent 5,800,808, he denied the company’s application to stay the Federal Circuit's decision due to the potential for the company to recover patent infringement damages. The ‘808 patent expires on September 1, 2015 and claims a process for manufacturing the active ingredient of Teva’s relapsing-remitting multiple sclerosis, RRMS, product, Copaxone 20mg/mL. Teva will continue pursuing its appeal in the Supreme Court and defending its intellectual property for Copaxone. Teva previously prevailed in the District Court, which upheld the validity of nine Copaxone patents, including the ‘808 patent. A ruling last year by the Court of Appeals for the Federal Circuit upheld some of the COPAXONE patents that expire in May, while invalidating the ‘808 patent that is the subject of Teva’s now-granted certiorari petition. Any purported generic version of Copaxone would be required to obtain the approval of the FDA prior to being made available to the public. The inability to fully characterize the active ingredients of the product leads many experts to believe that the only way to ensure the safety, efficacy and immunogenicity of any purported generic version of Copaxone would be through full-scale, placebo-controlled clinical trials with measured clinical endpoints in RRMS patients. The company is confident Copaxone will remain a proprietary, global market leading product for the reduction in the frequency of relapses in RRMS patients over the product’s lifecycle, given the strength of its intellectual property rights.
April 17, 2014
08:38 EDTTEVATeva settles patent ligitigation with Pfizer on Celebrex
Teva (TEVA) announced that its subsidiary Teva Pharmaceuticals USA, Inc. has entered into a settlement with Pfizer (PFE) related to Teva’s generic version of Celebrex 50, 100, 200 and 400 mg capsules in the United States. Under the terms of the settlement, Teva may launch its generic versions in December 2014 or earlier under certain circumstances. Teva has received tentative approval from the U.S. Food and Drug Administration for all strengths and believes that it is first-to-file on at least the 100, 200 and 400 mg capsules. Sales of Celebrex were $2.2B in the U.S. according to IMS data as of December, 2013.
04:22 EDTMYLMylan (MYL) implied volatility of 45 at upper end of index mean range
April 16, 2014
16:16 EDTMYLMylan launches first generic Ortho Evra patch
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10:00 EDTTEVAOn The Fly: Analyst Initiation Summary
Today's noteworthy initiations include: A10 Networks (ATEN) initiated with a Buy at BofA/Merrill... Actavis (ACT) initiated with a Buy at Sterne Agee... Allergan (AGN) initiated with a Buy at Sterne Agee... Autohome (ATHM) initiated with a Neutral at Credit Suisse... BitAuto (BITA) initiated with an Outperform at Credit Suisse... Centene (CNC) initiated with a Neutral at UBS... Endo International (ENDP) initiated with a Buy at Sterne Agee... FS Investment (FSIC) initiated with an Overweight at Evercore... Hertz (HTZ) initiated with a Buy at Gabelli... Hilton (HLT) initiated with a Hold at Jefferies... Hospira (HSP) initiated with a Neutral at Sterne Agee... ImmunoGen (IMGN) initiated with a Buy at Canaccord... Impax (IPXL) initiated with a Neutral at Sterne Agee... Imperva (IMPV) assumed with a Neutral at Wedbush... Ingredion (INGR) initiated with an Outperform at Credit Suisse... Laredo Petroleum (LPI) initiated with an Outperform at RW Baird... Lpath (LPTN) initiated with a Buy at Canaccord... MediWound (MDWD) initiated with an Outperform at Oppenheimer... Medivation (MDVN) initiated with a Hold at Canaccord... NPS Pharmaceuticals (NPSP) assumed with a Buy at Canaccord... Nimble Storage (NMBL) initiated with a Market Perform at Raymond James... Regeneron (REGN) initiated with a Buy at Canaccord... Salix (SLXP) initiated with a Buy at Sterne Agee... Sibanye Gold (SBGL) initiated with an Outperform at Imperial Capital... Teva (TEVA) initiated with a Neutral at Sterne Agee... Wipro (WIT) assumed with a Hold at Jefferies.
07:00 EDTTEVATeva initiated with a Neutral at Sterne Agee
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April 15, 2014
12:26 EDTTEVATeva announces launch of generic Lunesta tablets in U.S.
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10:21 EDTMYLMylan announces settlement agreement for first-to-file Generess
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10:10 EDTMYLMylan launches generic Lunesta tablets
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08:07 EDTMYLActavis announces agreement related to Generess FE patent challenge litigation
Actavis (ACT) announced that it has entered into an agreement with Mylan (MYL) and Famy Care to settle all outstanding patent litigation related to Mylan's generic version of Generess. Under the terms of the agreement, Actavis will grant Mylan a license to market its generic version of Generess® FE under its pending Abbreviated New Drug Application beginning on April 1, 2015. Alternatively, Mylan will be permitted to launch an authorized generic version of Actavis' product beginning on October 1, 2015. Other terms of the settlement were not disclosed. Actavis remains in litigation with Lupin Ltd in connection with Lupin's pending ANDA for a generic version of Generess.
08:06 EDTMYLProsonix, Mylan enter licensing deal for generic version of Flixotide, Flovent
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April 11, 2014
11:50 EDTMYLStocks with call strike movement; TNA MYL
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10:30 EDTMYLActavis and Mylan shares recommended at Bernstein
07:31 EDTMYLMylan confirms judge enforces agreement with Endo regarding generic Frova
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April 9, 2014
05:57 EDTMYLMylan implied volatility of 47 at upper end of index mean range

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