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News Breaks
July 17, 2014
07:18 EDTMYL, GSKMylan wins motion to enjoin GlaxoSmithKline from production of generic product
Mylan's (MYL) motion for a permanent injunction against GlaxoSmithKline (GSK) in relation to Paroxetine CR, the generic version of GSK's Paxil CR, has been granted by the U.S. District Court for the District of New Jersey. GSK is now precluded from supplying product to Apotex, which marketed the product as an authorized generic. Mylan had previously been awarded damages in the amount of $106.7M by the District Court after a favorable jury verdict in March. In addition, the District Court awarded Mylan prejudgment interest and permitted it to take an accounting so that Mylan can determine the amount of additional damages it has suffered since Sept. 30, 2013 as a result of GSK's ongoing breach. All of GSK's post-trial motions were denied.
News For MYL;GSK From The Last 14 Days
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April 17, 2015
15:05 EDTMYLTeva weighing potential bid for Mylan, WSJ reports
Teva Pharmaceutical (TEVA) is weighing a takeover bid for Mylan (MYL), according to the Wall Street Journal, citing people familiar with the matter. This comes one week after Mylan made a $28.9B acquisition offer for Perrigo (PRGO), the Journal added. Reference Link
14:54 EDTMYLPerrigo trims losses after Mylan says committed to acquisition proposal
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14:51 EDTMYLMylan says fully committed to Perrigo bid after speculation on Teva interest
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14:48 EDTMYLMylan says tie-up with Teva 'without sound industrial logic or cultural fit'
14:47 EDTMYLMylan says fully committed to stand-alone strategy, proposal to buy Perrigo
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14:32 EDTMYLMylan spikes higher, levels to watch
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14:31 EDTMYLMylan jumps after reports of potential bid from Teva
Shares of Mylan (MYL) jumped in afternoon trading after The Wall Street Journal and Bloomberg separately reported that Teva (TEVA) is exploring a takeover offer for the company. Both reports, which each cited sources, said Teva is evaluating a bid internally, but that the company has not made any formal offer as of yet. WHAT'S NOTABLE: In a note to investors this morning, analysts at Cowen said the approval of a generic version of Teva's 20mg Copaxone should spur management to make a value-creating decision to acquire Mylan. The firm also believes in Teva's skill in protecting its Copaxone asset and said now is the time to pursue aggressive strategic actions. Cowen reiterated its Outperform rating and $100 price target on Teva shares. ANOTHER TO WATCH: On April 8, Mylan announced that it delivered to Perrigo's Chairman on April 6 a non-binding proposal to buy the company for $205 per share in a combination of cash and Mylan stock. RBC Capital analyst Randall Stanicky said earlier this week he believed Perrigo may be engaging other companies in talks after Mylan made its offer public. Stanicky sees no clear competing bidder for Perrigo, however, and used a $230 per share takeover while analyzing possible deals. PRICE ACTION: In afternoon trading, Mylan shares rose 5.6% to $70.58, Teva added 3.7% to $65.53 and Perrigo fell 2.5% to $193.99.
14:23 EDTMYLMylan jumps after Dow Jones says Teva considering bid
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14:21 EDTMYLTeva weighing potential bid for Mylan, Dow Jones says
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12:56 EDTMYLFederal Circuit upholds Mylan's patents on Perforomist inhalation solution
Mylan (MYL) announced the United States Court of Appeals for the Federal Circuit upheld the validity and infringement of all four patents asserted by Mylan Specialty, L.P. protecting its Perforomist Inhalation Solution. The Court summarily affirmed the previous decision by the district court against Teva (TEVA). Today's decision prevents Teva from receiving final approval of its ANDA from the FDA prior to expiration of U.S. Patent Nos. 6,667,344; 6,814,953; 7,348,362; and 7,462,645. Those patents cover Perforomist until they expire in June 2021.
08:00 EDTMYLTeva patent loss should move management to acquire Mylan, says Cowen
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05:53 EDTMYLStocks with implied volatility movement; XLNX MYL
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April 16, 2015
15:40 EDTMYLGeneric Copaxone approval a bit early but expected, says BMO Capital
BMO Capital believes FDA approval for Sandoz (NVS) and Momenta's (MNTA) generic 20mg Copaxone came slightly earlier than the market expected, but the firm added that the generic threat has been well expected. The firm added that it appears Mylanís (MYL) generic Copaxone hasn't been approved yet, leaving a "legitimate question" about why the FDA approved one generic and not the other. BMO thinks Teva's rate of conversion to the 40mg dose will help retain patients on the Copaxone franchise and it keeps an Outperform rating on Teva shares.
09:14 EDTGSKAdamis says albuterol HFA product study met clinical FEV1 primary endpoint
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08:15 EDTGSKGlaxoSmithKline and Theravance announce launch of Anoro in Spain
In a regulatory filing, GlaxoSmithKline (GSK) and Theravance (THRX) announced the launch of Anoro in Spain following the approval in Europe in May 2014. Anoro Ellipta is indicated as a once-daily maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease. Anoro Ellipta is a combination of two bronchodilators, umeclidinium, a long-acting muscarinic antagonist and vilanterol, a long-acting beta2 agonist, in a single dry powder inhaler, the Ellipta. The approved dose of UMEC/VI is 55/22mcg. UMEC/VI has been developed under the 2002 LABA collaboration agreement between Glaxo Group Limited and Theravance.
April 15, 2015
11:53 EDTGSKGlaxoSmithKline initiated with a Sell at Societe Generale
09:02 EDTMYLRBC sees Akorn as possible play on Perrigo takeover interest
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April 13, 2015
15:12 EDTMYLMylan enters settlement, license agreement with Pfizer regarding Viagra
Mylan (MYL) announced that its subsidiaries Mylan Inc. and Mylan Pharmaceuticals have entered into a settlement and license agreement with Pfizer (PFE), Pfizer Limited and Pfizer Ireland Pharmaceuticals to settle patent litigation relating to Mylan's Abbreviated New Drug Application filed with the U.S. FDA for Sildenafil Citrate Tablets 25 mg, 50 mg, and 100 mg. This product is the generic version of Viagra, which is indicated to treat erectile dysfunction. Under the terms of the agreement, Mylan will be able to launch its ANDA products pursuant to a royalty-bearing license as early as December 11, 2017, or sooner under certain conditions, subject to FDA approval. 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. For the 12 months ending Dec. 31, 2014, Viagra had U.S. sales of approximately $1.3B, according to IMS Health.
07:56 EDTMYLMylan, Teva, Perrigo price targets raised at JPMorgan
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06:49 EDTMYLMylan notifies Perrigo of HSR filing regarding proposed acquisition
Mylan N.V. (MYL) announced that it has provided Perrigo (PRGO) with notice of its filing of the premerger notification under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 with the U.S. Federal Trade Commission and the U.S. Department of Justice Antitrust Division regarding its proposed acquisition of Perrigo, as required by the HSR Act. Mylan proposed to acquire Perrigo for $205 per share in a cash-and-stock transaction on April 6.
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