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Allergan Receives Written Requests from Pershing Square; Cubist Announces EMA Acceptance of Ceftolozane/Tazobactam Marketing(BioMed Reports Via Acquire Media NewsEdge) Below is a look at some of the headlines for companies that made news in the healthcare sector on August 22, 2014. {nfg}Allergan, Inc. (NYSE: AGN)confirmed that Pershing Square Capital Management, L.P. (“Pershing Square”) has delivered written requests from Allergan stockholders in connection with Pershing Square’s request to call a Special Meeting of Stockholders (the “Special Meeting”). At the Special Meeting, Allergan stockholders would be asked, among other things, to remove a majority of the Company’s existing directors in connection with Valeant Pharmaceuticals International, Inc.’s (“Valeant”) unsolicited exchange offer to acquire all outstanding common shares of Allergan for 0.83 shares of Valeant common stock and $72.00 in cash, or subject to proration, an amount of cash or a number of Valeant common shares with the implied value set forth in the exchange offer (the “Exchange Offer”). Allergan and an independent inspector will review the written requests submitted by Pershing Square, and the Company expects to report the results promptly following this review.The Allergan Board of Directors continues to believe that Valeant’s unsolicited exchange offer is grossly inadequate and substantially undervalues Allergan. In considering whether to submit written requests, stockholders were asked to evaluate if they wanted the opportunity to vote on the offer at a later date; not to evaluate the merits of the offer itself. In fact, many stockholders have explicitly conveyed their view that the requests are not an endorsement of Valeant’s offer.Allergan recognizes that this is all about stockholder value, and the Board remains confident in the Company's ability to create significantly more value than Valeant's offer. While Allergan does not believe that Valeant’s offer provides compelling value relative to the alternatives available to the Company, the Allergan Board of Directors fully supports the right of stockholders to vote on the value proposition offered by Valeant at the appropriate time.Delivering value to stockholders remains Allergan’s priority, and, in this regard, the Company recently recorded the strongest increase in absolute dollar sales in any quarter in the Company’s history, and again delivered sales and earnings per share growth above the high end of expectations. Allergan’s value creation plan for its stockholders will significantly reduce costs in 2015 by approximately $475 million annually relative to its prior strategic plan, while preserving the Company’s ability to deliver double digit sales growth across the next five years. Over the same five year period, Allergan expects to generate compounded annual adjusted EPS growth of more than 20 percent.The Company also noted that Valeant’s request for declaratory judgment from the Delaware Court of Chancery is premature as Allergan has yet to review the submitted written requests nor has the Allergan Board of Directors yet made any determination as to such requests.Allergan will announce additional detail regarding a Special Meeting following its review. Allergan stockholders are not required to take any action at this time.Goldman, Sachs & Co. and BofA Merrill Lynch are serving as financial advisors to the Company and Latham & Watkins, Richards, Layton & Finger, P.A. and Wachtell, Lipton, Rosen & Katz are serving as legal counsel to the Company. ====================================Cubist Pharmaceuticals, Inc. (NASDAQ:CBST)announced the European Medicines Agency (EMA) has accepted for review the Company’s Marketing Authorization Application (MAA) for its investigational antibiotic ceftolozane/tazobactam. Cubist is seeking approval of ceftolozane/tazobactam for the treatment of complicated urinary tract Infections and complicated intra-abdominal infections, with a decision from the European Commission (EC) expected during the second half of 2015.The MAA submission is based on positive data from two pivotal Phase 3 clinical trials of ceftolozane/tazobactam in complicated urinary tract infections and complicated intra-abdominal infections. These studies met both the EMA and U.S. Food and Drug Administration (FDA) specified primary endpoints. Results of the secondary analyses were consistent with and supportive of the primary outcomes. In the clinical trials, ceftolozane/tazobactam demonstrated activity against problematic Gram-negative bacteria, including Pseudomonas aeruginosa and extended-spectrum beta-lactamase (ESBL)-producing Escherichia coli (E. coli) and Klebsiella pneumoniae in patients with complicated infections.“We are pleased to receive MAA acceptance for ceftolozane/tazobactam and look forward to working with the EMA on this important review,” said Steven Gilman, Ph.D., Executive Vice President of Research and Development and Chief Scientific Officer of Cubist. “As we continue to expand globally, this advancement further positions Cubist to respond to growing health threats and reinforces our commitment to bring new antibiotics to patients worldwide facing serious infections, including those caused by Gram-negative bacteria.”Prior to the EMA acceptance of the MAA, the FDA accepted the Company’s New Drug Application (NDA) for ceftolozane/tazobactam with Priority Review and assigned an action date of December 21, 2014. Also Friday:Aastrom Biosciences, Inc. (Nasdaq:ASTM), the leading developer of patient-specific expanded cellular therapies for the treatment of severe diseases and conditions, today announced that results from the company's Phase 2a clinical studies of ixmyelocel-T for the treatment of advanced heart failure due to ischemic dilated cardiomyopathy (DCM) were published in the peer-reviewed journal Circulation Research. Agritek Holdings, Inc. (OTCQB: AGTK), a fully reporting company on the OTCQB and leader in Compassionate Care Technology and indoor/outdoor agricultural solutions for the medicinal marijuana industry, today announced that the Company has moved forward with the first of several multi-year lease agreements for its Colorado Cannabis Agricultural facility located in Pueblo county. Easton Pharmaceuticals Inc. (OTC: EAPH) a specialty pharmaceutical company that owns, designs, develops, and markets an array of topically-delivered drugs and therapeutic / cosmetic healthcare products, today announces financing update, provides due diligence documents towards financing from a Toronto, Canada, based brokerage firm.Mallinckrodt plc (NYSE: MNK), a leading global specialty pharmaceutical company, announced today that Gary Phillips, MD, current Senior Vice President and Chief Strategy Officer, has been appointed to serve as Senior Vice President and President of the Company’s Autoimmune and Rare Disease business, which includes the commercial organization supporting H.P. Acthar® Gel. Masimo (NASDAQ: MASI)announced today that a new study published in the journal Anesthesia & Analgesia demonstrates that Masimo's rainbow® Acoustic Monitoring (RAM™) technology for Acoustic Respiration Rate (RRa®) rapidly detects changes in respiration rate during general anesthesia with a laryngeal mask airway and spontaneous ventilation, and is helpful in the early identification of patients at risk for adverse outcomes.1MIT Holding, Inc. (OTCQB: MITD) announces the hiring of New York City-based ProActive Capital Group, LLC (PCG), a leading capital markets advisory and communication strategies firm, to assist with achieving investor and corporate awareness.MTBC (Nasdaq:MTBC), a leading provider of proprietary, web-based electronic health records, practice management and mHealth solutions will visit the NASDAQ MarketSite in Times Square. PLC Systems Inc. (PINKSHEETS: PLCSF), a medical device company focused on innovative technologies for the cardiac and vascular markets, today announced that the date has been established for its 2014 annual and special meeting of shareholders. PositiveID Corporation (OTCQB:PSID), a developer of biological detection and diagnostics solutions, today announced that its Firefly Dx system, designed to deliver molecular diagnostic results rapidly at the point-of-need, which could be used to detect Ebola and other biological threats, was recently featured in Computerworld. Quidel Corporation (NASDAQ: QDEL), a provider of rapid diagnostic testing solutions, cell-based virology assays and molecular diagnostic systems, announced today that it will present at the Baird 2014 Health Care Conference to be held at the New York Palace hotel in New York, NY on Wednesday, September 3, 2014.Spine Pain Management, Inc. (OTCQB:SPIN), a technology-driven, financial services, medical device, and healthcare solution company servicing the multi-billion dollar spine injury sector, today announced the addition of Michael K. Smith as its VP of Sales and Marketing. Smith, who recently joined the company as VP of Sales and Marketing of its Quad Video HALO™ (QVH) subsidiary, will maintain that position, but has now additionally been elevated to the similar position at SPIN, the parent company. ZELTIQ® (NASDAQ: ZLTQ), a medical technology company focused on developing and commercializing products utilizing its proprietary controlled-cooling technology platform, today announced that Mark Foley, President and Chief Executive Officer and Patrick F. Williams, Senior Vice President and Chief Financial Officer, will host an investor and analyst day at the Park Hyatt New York in New York, NY on September 18th, 2014 from 10:00 a.m. ET to 12:00 p.m. ET. 2014 BioMed Reports All rights reserved. |