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Stock Market & Financial Investment News

News For JNJ;SNY;PFE;MRK;SHPG From The Last 14 Days
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October 17, 2014
16:41 EDTPFEPfizer confirms FDA labeling approval for EMBEDA capsules
Pfizer announced that the FDA has approved an updated label for EMBEDA extended-release capsules, for oral use to include abuse-deterrence studies. The updated label states that EMBEDA has properties that are expected to reduce abuse via the oral and intranasal routes when crushed. However, abuse of EMBEDA by these routes is still possible. The updated label also includes data from a human abuse potential study of intravenous, or IV, morphine and naltrexone to simulate crushed EMBEDA. However, it is unknown whether the results with simulated crushed EMBEDA predict a reduction in abuse by the IV route until additional postmarketing data are available. EMBEDA is indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Pfizer expects EMBEDA will be available in the U.S. in early 2015.
16:30 EDTPFEFDA approves new labeling from Embeda extended-release capsules
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10:37 EDTJNJOptions with decreasing implied volatility: ATLS JNJ XLNX JNK HYG
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09:06 EDTSNYAmgen files patent infringement lawsuit against Sanofi, Regeneron
Amgen (AMGN) announced that it filed a lawsuit in the United States District Court of Delaware against Sanofi (SNY), Aventisub, formerly doing business as Aventis Pharmaceuticals, and Regeneron Pharmaceuticals (REGN) for patent infringement of U.S. Patent Numbers 8,563,698, 8,829,165, and 8,859,741. These patents, which are owned by Amgen, describe and claim monoclonal antibodies to proprotein convertase subtilisin/kexin type 9, or PCSK9. By its complaint, Amgen seeks an injunction to prevent the infringing manufacture, use and sale of Sanofi and Regeneron's alirocumab, a monoclonal antibody targeting PCSK9. Sanofi and Regeneron recently announced that they have completed Phase 3 clinical trials on alirocumab and intend to pursue regulatory approval to market alirocumab in the U.S. Amgen previously announced submission of a Biologics License Application to the FDA for evolocumab, its own investigational human monoclonal antibody to PCSK9, for the treatment of high cholesterol, on Aug. 28.
08:57 EDTJNJPharmacyclics price target raised to $188 from $185 at Roth Capital
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08:51 EDTJNJPharmacyclics announces European approval for Imbruvica
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08:02 EDTJNJCovidien granted preliminary injunction against Ethicon's Harmonic ACE+7
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07:58 EDTMRKDeutsche Bank specialty pharma analyst holds analyst/industry conference call
Specialty Pharmaceuticals Analyst Gilbert provides of preview of The Improved Reduction of Outcomes: Vytorin Efficacy Internal Study (IMPROVE-IT) on an Analyst/Industry conference call to be held on October 17 at 10 am.
07:07 EDTSHPGShire may be buyer instead of target if AbbVie deal breaks, WSJ says
Assuming AbbVie's (ABBV) deal to buy Shire (SHPG) gets cancelled, which appears likely at this point, many analysts and investors believe Shire will become a buyer and Leerink Partners estimates the company could have $10B to use for a takeover deal, reported The Wall Street Journal. AbbVie will also be likely to look for other deals and could be forced to pay up for them, as its top seller, Humira, moves closer to losing patent exclusivity, the Journal said, citing analysts. Reference Link
October 16, 2014
16:29 EDTSHPGShire price target lowered to $198 from $278 at Leerink
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14:47 EDTJNJRoche in pact with Pharmacyclics to evaluate Imbruvica, Gazyva combo
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08:52 EDTSHPGAbbVie price target lowered to $59 from $71 at BMO Capital
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08:38 EDTPFEBaxter expects divestiture of vaccines business to Pfizer to close in Q4
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08:19 EDTSNYSanofi Pasteur, Immune Design enter collaboration HSV therapy
Immune Design (IMDZ) announced that it has entered into a broad collaboration for the development of a herpes simplex virus, or HSV, immune therapy with Sanofi Pasteur, the vaccines division of Sanofi (SNY). Sanofi Pasteur and Immune Design will each contribute product candidates to the collaboration: Sanofi Pasteur will contribute HSV-529, a clinical-stage replication-defective HSV vaccine product candidate, and Immune Design will contribute G103, its preclinical trivalent vaccine product candidate. The collaboration will explore the potential of various combinations of agents, including leveraging Immune Design's GLAASTM platform, with the goal to select the best potential immune therapy for patients. The two companies will develop the products jointly through Phase 2 clinical trials, at which point Sanofi Pasteur intends to continue development of the most promising candidate and be responsible for commercialization. Sanofi Pasteur will bear the costs of all preclinical and clinical development, with Immune Design providing a specific formulation of GLA from the GLAAS platform at its cost through Phase 2 studies. Immune Design will be eligible to receive future milestone and royalty payments on any product developed from the collaboration; other financial terms of the agreement have not been disclosed.
08:08 EDTPFEActavis confirms generic Quillivant XR patent challenge
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07:28 EDTPFEFDA to hold a joint advisory committee meeting on Chantix
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06:17 EDTSHPGJefferies says Medtronic 'needs to do' Covidien takeover
Jefferies says it "can't see how Medtronic walks" from the Covidien (COV) takeover given how compelling the merger is. The firm confirmed with Medtronic (MDT) that nothing has changed in the company's commitment to the deal since new financing terms were announced on October 3. In Jefferies view, "Medtronic needs to do this deal." It notes the spread on the acquisition widened significantly on the news that Abbvie (ABBV) is reconsidering its acquisition of Shire (SHPG).
05:50 EDTSHPGStocks with implied volatility movement; SHPG SIRI
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05:37 EDTSHPGShire releases statement regarding AbbVie withdrawal of recommendation
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05:21 EDTSHPGAbbVie recommends holders vote against Shire transaction
Following Shire's (SHPG) waiver of the three-day notice period, AbbVie (ABBV) announces its board withdraws its recommendation made on July 18 regarding the proposed Shire transaction and recommends that stockholders vote against the transaction. AbbVie and its board made this determination following a detailed consideration of the impact of the U.S. Department of Treasury's unilateral changes to the tax rules, as issued on September 22. The breadth and scope of the changes, including the unexpected nature of the exercise of administrative authority to impact longstanding tax principles, and to target specifically a subset of companies that would be treated differently than either other inverted companies or foreign domiciled entities, introduced an unacceptable level of uncertainty to the transaction. Additionally, the changes eliminated certain of the financial benefits of the transaction, most notably the ability to access current and future global cash flows in a tax efficient manner as originally contemplated in the transaction. This fundamentally changed the implied value of Shire to AbbVie in a significant manner. Under the conditions of AbbVie's offer and the terms of the Co-operation Agreement, the withdrawal of the recommendation alone will not cause a lapse of AbbVie's offer or terminate the Co-operation Agreement between AbbVie and Shire. Unless Shire and the U.K. Takeover Panel agree otherwise, AbbVie must convene an AbbVie stockholder meeting to consider the adoption of the U.S. merger agreement. AbbVie's offer will lapse if the company's stockholders do not adopt the agreement. Assuming Shire provides the requisite cooperation and consents, a pre-effective amendment to the registration statement filed by AbbVie Private Limited in connection with the combination is expected to be filed with the SEC as soon as practicable. Under the terms of the Co-operation Agreement, following the withdrawal of the AbbVie Board of Directors' recommendation, a break fee of approximately $1.64B will be payable to Shire if either: AbbVie stockholders do not approve the adoption of the U.S. merger agreement at an AbbVie stockholder meeting; or such a meeting does not occur by December 14.
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