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News Breaks
May 30, 2014
09:17 EDTTEVA, MYL, PFETeva receives favorable court decision regarding generic Celebrex capsules
Teva Pharmaceutical Industries Ltd. (TEVA) announced that the U.S. District Court for the Northern District of West Virginia denied a motion filed by Mylan (MYL) and issued an opinion and order affirming a decision by the FDA under which Teva should receive sole 180-day “first-to-file” exclusivity for generic Celebrex 100, 200 and 400 mg capsules. On April 17, Teva entered into a settlement agreement 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. Sales of Celebrex were $2.2B in the U.S. according to IMS data as of December, 2013.
News For TEVA;MYL;PFE From The Last 14 Days
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August 14, 2014
12:58 EDTTEVAJANA Partners gives quarterly update on stakes
NEW STAKES: Apache (APA), FMC Corp (FMC), Civeo (CVEO), PetSmart (PETM), and Charter Communications (CHTR). INCREASED STAKES: Actavis (ACT), AIG (AIG), Mallinckrodt (MNK), HD Supply (HDS), and American Capital (ACAS). DECREASED STAKES: Liberty (LVNTA), Oil States International (OIS), eBay (EBAY), Liberty Media (LMCA), and Liberty Interactive (LINTA). LIQUIDATED STAKES: Sirius XM (SIRI), Juniper (JNPR), Golar LNG (GLNG), Outerwall (OUTR), and Teva (TEVA).
August 12, 2014
17:07 EDTPFEPfizer announces results from Lyrica studies conducted in China
Pfizer announced top-line results from two placebo-controlled studies conducted in China with Lyrica in patients with postherpetic neuralgia, pain after shingles or PHN, and painful diabetic peripheral neuropathy, pDPN, respectively.The PHN Phase 4 study, A0081276, met its primary endpoint by demonstrating a statistically significant reduction in pain when compared to placebo. Separately, the pDPN Phase 3 study, A0081265, did not meet its primary endpoint, a statistically significant change in endpoint mean pain score relative to placebo. The PHN study was an eight-week, randomized, double-blind, multi-center, placebo-controlled, post-marketing study evaluating the efficacy, safety and tolerability of pregabalin 300mg/day in the treatment of subjects with PHN. For the primary efficacy parameter, change from baseline in weekly mean pain scores, a significant treatment difference of -0.71 points for pregabalin relative to placebo was observed. The safety profile in this study was consistent with the known profile for Lyrica.
August 11, 2014
07:36 EDTMYLMylan launches generic Xeloda tablets
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August 8, 2014
17:10 EDTMYLMarket finishes week up slightly as earnings offset by political events
Stocks finished the week fractionally higher than where they started as strong corporate earnings reports and better than expected economic data was weighed against concerns about geopolitical issues and negative M&A news. MACRO NEWS: A few ongoing geopolitical conflicts worried investors and weighed on shares. Russia unveiled sanctions against Western countries, banning the import of a wide range of food items from the U.S, the EU and a few allied countries in response to sanctions recently enacted against it from G7 nations... President Obama authorized the bombing of rebels in Iraq and Hamas and Israel failed to reach a permanent truce... An ISM services index, the U.S. trade deficit for June, and weekly jobless claims were all better than expected. Meanwhile, the increase in unit labor costs last quarter came in below the consensus outlook, perhaps easing fears that the Fed will need to raise interest rates sooner than expected. COMPANY NEWS: On the M&A front, two huge potential deals fell through as 21st Century Fox (FOX, FOXA) withdrew its offer to acquire Time Warner (TWX) and Sprint (S) reportedly decided to end its pursuit of a merger with peer T-Mobile (TMUS)... President Obama indicated that his administration would take unilateral steps in an effort to prevent companies from carrying out tax inversion acquisitions. Among the deals or possible transactions that involve inversion are Medtronic's (MDT) acquisition of Covidien (COV), Valeant's (VRX) proposed takeover of Allergan (AGN) and Mylan's (MYL) acquisition of Abbott's (ABT) developed markets branded generics pharmaceuticals business. Meanwhile, Walgreen's (WAG) stock tumbled after the U.S. company said it would not structure its takeover of European drugstore chain Alliance Boots as a tax inversion deal... 21st Century Fox, 3D printer maker Stratasys (SSYS), chip maker NVIDIA (NVDA), brewer Molson Coors (TAP), and luxury accessories maker Coach (COH) all rose following their earnings reports. Conversely, Target (TGT), luxury accessories maker Michael Kors (KORS) and Internet coupon provider Groupon (GRPN) fell following their results or guidance... Gannett (GCI) struck a deal to acquire the remaining 73% interest in Classified Ventures, whose primary asset is the online car shopping website Cars.com, for $1.8B from the other partners in the venture, which include McClatchy (MNI), Tribune Media (TRBAA), Graham Holdings (GHC) and A. H. Belo (AHC). Gannett also announced plans to spin-off its Publishing business, which includes USA Today, through a tax-free distribution to shareholders... McDonald's (MCD) stock was little changed after the company reported that its comparable store sales fell 2.5% in July, which was significantly worse than expected. Food quality issues weighed on the fast food company's sales in Asia and as a result of the China supplier issue, the company warned its previously issued global comparable sales forecast for 2014 is now at risk. INDEXES: The Dow finished the week up 0.35% to 16,553.93, the S&P 500 rose 0.32% to 1,931.59, and the Nasdaq gained 0.41% to 4,370.90.
12:34 EDTMYLOn The Fly: Midday Wrap
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10:00 EDTMYLOn The Fly: Analyst Downgrade Summary
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07:01 EDTMYLHarvard professor says Treasury can reduce inversion incentives, NY Times says
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06:39 EDTPFEPfizer faces torrent of Lipitor suits, Reuters says
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06:30 EDTMYLMylan downgraded to Sector Perform from Outperform at RBC Capital
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August 7, 2014
13:55 EDTTEVATeva won't be meaningfully hurt soon by new Copaxone filing, says BMO Capital
After Teva (TEVA) confirmed that it received the first paragraph IV notice for the 3x per week version of its Copaxone drug from Dr. Reddy's (RDY), BMO Capital said it had expected companies to seek to market a generic version of the latest Copaxone formulation, but was surprised that Dr. Reddy's took this action. The firm notes that Teva's decision to file a lawsuit against Dr. Reddy over the application will trigger a 30 month stay of approval of the generic version,. BMIO Capital says that investors should keep this issue on their radar, but the firm does not expect Teva to be meaningfully hurt in the near-term by this development. It keeps an Outperform rating on Teva.
12:06 EDTTEVATeva will continue to defend COPAXONE intellectual property rights
Teva (TEVA) confirmed that it has received the first paragraph IV notice for its three-times-a-week COPAXONE 40 mg/mL product from Dr. Reddy’s Laboratories (RDY). Teva will continue to vigorously defend its COPAXONE intellectual property rights against infringement wherever they are challenged. Teva intends to file a lawsuit for patent infringement against Dr. Reddy’s within the 45 day period provided under the Hatch-Waxman Act. The filing of the lawsuit will trigger a 30 month stay of FDA approval of Dr. Reddy’s ANDA. COPAXONE 40 mg/mL is protected by two Orange Book patents that expire in 2030.
10:29 EDTMYLMylan: Noise about inversion is tremendous speculation and that's all it is
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10:23 EDTMYLMylan sees FY14 CapEx $350M-$400M
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10:20 EDTMYLMylan sees FY14 adjusted EBITDA $2.2B-$2.4B
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10:20 EDTTEVA, MYLMylan says litigation ins ongoing in India regarding Teva
Mylan (MYL) said that it expects Teva's (TEVA) efforts to seek an injunction will "as ineffective as it was in U.S. courts." The company said it will not provide further comment on the matter. Mylan said it will also postpone its 2014 Investor Day due to the ongoing nature of the Abbott (ABT) transaction. It expects its fully realized savings and profit from new products will not be realized till 2015. Comments taken from Q2 earnings conference call.
08:12 EDTPFEPfizer says EMA accpets application seeking new indication for Prevenar 13
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06:42 EDTMYLObama to look to limit inversion deals, Politico says
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06:37 EDTMYLMylan narrows FY14 adjusted EPS view to $3.25-$3.45 from $3.25-$3.60
Consensus $3.37. Narrows FY14 revenue guidance to $7.8B-$8B from $7.8B-$8.2B, consensus $7.77B.
06:36 EDTMYLMylan sees Q3 EPS 90c-95c, consensus $1.03
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06:34 EDTMYLMylan reports Q2 adjusted EPS 69c, consensus 70c
Reports Q2 revenue $1.84B, consensus $1.88B.
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