Lilly Forgoes FDA Filing, Sucampo Wins FDA sNDA Approval: Healthcare Business Recap
Eli Lilly and Company (NYSE:LLY) has elected to forgo filing for FDA approval for its closely monitored Alzheimer’s candidate solanezumab following discussions with regulators. Rather, the firm will go with a new Phase III evaluation to further investigate whether the antibody therapy slows cognitive declines in patients with disease. Lilly’s two late-stage trials of the treatment failed this summer on measures of cognitive and functional status in patients suffering from mild-to-moderate Alzheimer’s disease.
In a Wednesday release, The Medicines Company (NASDAQ:MDCO) and Bristol-Myers Squibb Company (NYSE:BMY) said today that they have signed a global license and two year collaboration for Recothrom, a recombinant thrombin approved by the FDA for use as a topical hemostat to control non-arterial bleeding during surgical procedures. Chairman and CEO of The Medicines Company, Clive Meanwell, M.D. Ph.D., commented that, “As a marketed, growing product to control blood loss in the hospital, we believe Recothrom is a strategic fit that enables operating leverage with The Medicines Company’s emerging perioperative care portfolio. The financial structures and net revenues fit well with our strategy for aggressive and sustainable growth in acute and intensive care medicine. Of course, thrombin is also a hemodynamic target we know well based on our experience with Angiomax (bivalirudin), a thrombin inhibitor.”
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ACADIA Pharmaceuticals (NASDAQ:ACAD) reported on Wednesday a private placement equity financing through which the company will receive gross proceeds of $86.4 million from the divestiture of its securities. Shares of its common stock will be sold at $4.43 which was the December 11th close. The placement should close on December 17th and is subject to the satisfaction of the usual closing conditions. ACADIA is a biopharmaceutical firm that concentrates upon innovative treatments that address unmet medical needs in neurological and related central nervous system disorders.
Sucampo Pharmaceuticals (NASDAQ:SCMP) said Wednesday that it has received FDA approval of an sNDA for Rescula (unoprostone isopropyl ophthalmic solution) 0.15 percent for the reduction of intraocular pressure (IOP) in patients suffering from open-angle glaucoma or ocular hypertension. Sucampo intends to commercialize Rescula in the first quarter of 2013.
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