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Alkermes, Inc. (Nasdaq: ALKS) $14.22. Announced Thursday after market close that the U.S. Food and Drug Administration (FDA) Psychopharmacologic Drugs Advisory Committee voted 12 to 1 that VIVITROL (naltrexone for extended-release injectable suspension) should be approved for the treatment of opioid dependence.
“The Advisory Committee meeting outcome today underscores the strength of the clinical data for VIVITROL and the need for new treatment options,” said Richard Pops, Chief Executive Officer of Alkermes. “We believe that, if approved, VIVITROL would offer a new path to recovery as the first non-addictive, once-monthly medication for patients with opioid dependence.”
The Advisory Committee’s recommendation, while not binding, will be considered by the FDA in its review of the supplemental New Drug Application (sNDA) that Alkermes has submitted for VIVITROL. The current Prescription Drug User Fee Act (PDUFA) date for VIVITROL is October 12, 2010; the PDUFA date is the target date for the FDA to complete its review of the VIVITROL sNDA.
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What They Do: Alkermes, Inc. is a fully integrated biotechnology company committed to developing innovative medicines to improve patients' lives.
Ultralife Corporation (Nasdaq: ULBI) $4.20 Today announced it hasreceived an Indefinite Quantity Contract to source its BA 5390 batteries to the Defense Logistics Agency (DLA). The award consists of one base year, commencing on September 14, 2010, with four option years to be exercised in one-year increments at the discretion of the Government. DLA has estimated annual demand value for the base year at $5.3 million and has estimated the total award not to exceed $42.1 million.
“We are pleased to continue our partnership as the chosen supplier of our BA 5390 batteries to the US military. This award demonstrates the recognized quality of our products in mission critical applications. The BA 5390 is recognized for its long life, unsurpassed safety record and ability to lighten the load for the warfighter,” said John D. Kavazanjian, president and chief executive officer.
What They Do: Ultralife Corporation, which began as a battery company, serves its markets with products and services ranging from portable and standby power solutions to communications and electronics systems.
Johnson & Johnson (NYSE: JNJ) $61.29 and Crucell N.V. (Nasdaq: CRXL) $20.54. Today announced that they are in advanced negotiations for a potential public offer by Johnson & Johnson or an affiliate for all outstanding ordinary shares of Crucell not already held by Johnson & Johnson and its affiliates. Johnson & Johnson, through an affiliate, currently holds approximately 17.9 percent of the outstanding shares of Crucell and has submitted a statement on Schedule 13D to the U.S. Securities and Exchange Commission in connection with its change in investment intent with respect to Crucell.
Under the terms of the negotiations, which are at an advanced stage, Johnson & Johnson or an affiliate would acquire all outstanding equity of Crucell that it does not already own for approximately euro 1.75 billion, which represents a purchase price of euro 24.75 per share. The public offer would be an all cash transaction.
What They Do: Johnson & Johnson engages in the research and development, manufacture, and sale of various products in the health care field worldwide.
What They Do: Crucell N.V. is a global biopharmaceutical company focused on research development, production and marketing of vaccines, proteins and antibodies that prevent and/or treat infectious diseases.
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