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News Breaks
June 2, 2014
07:03 EDTPFE, MYLMylan settles patent litigation related to Celebrex capsules with Pfizer
Mylan (MYL) announced that it has entered into a settlement and license agreement with Pfizer (PFE) relating to Mylan's Abbreviated New Drug Application filed with the FDA for Celecoxib Capsules, 50 mg, 100 mg, 200 mg and 400 mg. This product is the generic version of Celebrex, which is indicated for the relief of the signs and symptoms of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis, and for the management of acute pain in adults. Under the terms of the agreement, Mylan will begin selling product at the earliest market formation, however in any case not later than December. 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. Additionally, Mylan has appealed the decision by the United States District Court for the Northern District of West Virginia denying Mylan's request for an injunction in its suit against the FDA. Mylan continues to believe that FDA seriously erred in its decision awarding one party eligibility for 180 days of exclusivity on Celecoxib, and will continue with this suit independent of the aforementioned settlement.
News For MYL;PFE From The Last 14 Days
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May 29, 2015
16:00 EDTPFEOptions Update; May 29, 2015
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08:31 EDTPFEPfizer says FDA approves Rapamune for treatment of LAM
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May 28, 2015
16:34 EDTPFEFDA approves Pfizer's Rapamune to treat LAM
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15:30 EDTPFECellectis in takeover talks with Pfizer named as suitor, FT reports
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10:52 EDTPFEPfizer to host conference call
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09:24 EDTMYLJefferies sees Pharma M&A continuing, lists 22 possible targets
Jefferies analyst David Steinberg believes the M&A wave in the Pharmaceuticals space that began in 2005 can continue as the key drivers remain largely intact. In a note titled "Who is Next? The Feeding Frenzy in Specialty Pharmaceuticals," Steinberg sees deals continuing amid cheap debt, the push for lower corporate taxes and investors rewarding many acquirers for their transactions. He points out there are now around 100 publicly traded Specialty Pharmaceutical companies following the recent life sciences IPO boom. Potential takeover targets, according to Steinberg, include Valeant (VRX), Shire (SHPG), Perrigo (PRGO), Zoetis (ZTS), Mallinckrodt (MNK), Jazz Pharmaceuticals (JAZZ), United Therapeutics (UTHR), Pacira (PCRX), Indivior, Insys Therapeutics (INSY), The Medicines Co. (MDCO), Depomed (DEPO), Spectrum (SPPI), KYTHERA (KYTH), Revance (RVNC), XenoPort (XNPT), Mylan (MYL), Akorn (AKRX), Impax (IPXL), Amphastar Pharmaceuticals (AMPH), Anacor (ANAC) and BioDelivery Sciences (BDSI).
09:00 EDTPFEPfizer has 'significant capacity' for additional deals, says JPMorgan
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08:33 EDTPFEPfizer announces $3M grants program to further research in breast cancer
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06:11 EDTMYLTeva takes 1.35% stake in Mylan, says 'ready to meet' on deal
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May 27, 2015
12:10 EDTMYLTeva to sweeten offer for Mylan before July shareholder vote, NY Post says
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May 26, 2015
14:07 EDTPFEFDA approves request for updated package insert for Prevnar 13
The FDA approved a request from Pfizer's Wyeth Pharmaceuticals to supplement the biologics license application for Pneumococcal 13-valent Conjugate Vaccine, or Prevnar 13, to update the package insert to include data from the CAPiTA confirmatory efficacy study in adults. Reference Link
May 25, 2015
13:56 EDTMYLMylan responds to claims of EPS forecasting by Perrigo
Mylan (MYL) announced that it was asked by the Irish Takeover Panel to issue the following clarification and retraction in accordance with the Irish takeover rules, relating to its firm intention to make an offer to acquire Perrigo (PRGO). The clarification and retraction relates to certain forward-looking statements made by Mylan specifically during the "pendency of the offer" period concerning its long-stated target since 2012 of at least $6.00 in adjusted EPS by 2018. Subsequent to Mylan's May 5 earnings release, Perrigo submitted a complaint to the Irish Takeover Panel alleging that the reference to Mylan's $6.00 long-term target should be treated as a forward-looking profit forecast statement. Although Mylan's adjusted EPS goal has been a stated long-term target, and not a forecast of Mylan, at least during the offer period as it pertains to the Perrigo transaction, Mylan will no longer refer to that 2018 target or any other forward looking statements beyond 2015 that could constitute profit forecasts.
May 22, 2015
10:52 EDTPFEJPMorgan says Actavis shares cheap compared to peers
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May 21, 2015
07:37 EDTPFEPfizer replaces AbbVie as top global pharma pick at Jefferies
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May 20, 2015
07:46 EDTPFEDeutsche Bank positive on potential Pfizer, GSK merger
Deutsche Bank analyst Gregg Gilbert believes a large foreign deal for Pfizer (PFE) may make sense and says a buyout of GlaxoSmithKline (GSK) could be "materially" accretive to earnings while improving the company's tax situation over time. Gilbert assumes a $60 per share buyout price for GlaxoSmithKline in a research note this morning titled "Introducing 'PfizerKline'". The stock closed yesterday up 2c to $44.68. Gilbert reiterates a Buy rating on Pfizer with a $41 price target. Shares ended yesterday up 23c to $34.21.
May 19, 2015
06:55 EDTPFEGenocea could be takeover target after data, says Piper Jaffray
Piper Jaffray analyst Edward Tenthoff expects Genocea Biosciences (GNCA) will report positive Phase II GEN-003 post-immunization results late in Q2. GEN-003 is a therapeutic vaccine for genital herpes targeting Herpes Simplex Virus Type 2. Positive GEN-003 data could position Genocea as a potential acquisition target by a larger vaccine player, Tenthoff tells investors today in a research note. Large vaccine makers include Sanofi (SNY), Merck (MRK), GlaxoSmithKline (GSK), Pfizer (PFE) and Novartis (NVS). The analyst reiterates an Overweight rating on Genocea with a $14 price target. Shares of the clinical-stage vaccine developer with a $227M market capitalization closed yesterday up 83c to $10.22.
06:08 EDTMYLPerrigo CEO says would talk with Mylan, but at a higher price, Globes reports
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May 18, 2015
12:07 EDTMYLPerrigo: there is price point where would engage with Mylan, Bloomberg reports
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07:22 EDTMYLUBS to hold a conference
Global Healthcare Conference is being held in New York on May 18-20 with webcasted company presentations to begin on May 18 at 8 am; not all company presentations may be webcasted. Webcast Link
06:58 EDTPFEActavis CEO says chances of Pfizer offer are 'unlikely', Financial Times says
Actavis (ACT) CEO Brent Saunders said the chances of Pfizer (PFE) making an offer are "incredibly unlikely," reports the Financial Times. Saunders said he has heard the gossip that Actavis could become a takeover target for a larger group, but he spends "zero time thinking about it." Reference Link

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