Galena Biopharma Acquires Mills Pharmaceuticals, LLC

• Acquisition adds GALE-401 (Anagrelide CR) to expand Galena's product pipeline.
• Phase 2 clinical trial expected to begin in mid-2014 with GALE-401 to treat Essential Thrombocythemia (ET), an orphan myeloproliferative disorder.

Galena Biopharma (GALE), a biopharmaceutical company developing and commercializing innovative, targeted oncology treatments that address major unmet medical needs to advance cancer care, today announced it has acquired Mills Pharmaceuticals, which has the worldwide rights to GALE-401 (Anagrelide CR), a patented, controlled release formulation of anagrelide. Galena expects to pursue the expedited 505(b)(2) regulatory pathway to seek approval of GALE-401 for the treatment of Essential Thrombocythemia (ET). The Company also believes GALE-401 meets the qualifications for orphan drug status. GALE-401 has an estimated peak market size of approximately $200 million in the U.S.

Catalyst Pharmaceutical Partners Reports Positive Cardiac Safety Results of Its Phase 3 Product, Firdapse Tablets

Catalyst Pharmaceutical Partners, Inc. (CPRX), a specialty pharmaceutical company focused on developing safe and effective, approved medicines targeting orphan neuromuscular and neurological diseases, today announced positive results from a study jointly funded with, and conducted by BioMarin Pharmaceuticals (BMRN) to assess the cardiac safety of Firdapse(TM) tablets (amifampridine also known as 3,4-DAP). Firdapse is approved in the E.U., where it is marketed by BioMarin. Firdapse is also currently in Phase 3 development in the U.S. for Lambert-Eaton Myasthenic Syndrome (LEMS) by Catalyst.

Neurocrine Announces Positive Results of VMAT2 Inhibitor NBI-98854 in Kinect 2 Study

Plans to submit end of phase II meeting request to FDA

Neurocrine Biosciences, Inc. (NBIX) announced today that NBI-98854, a small molecule VMAT2 inhibitor, showed a statistically significant and clinically meaningful reduction in tardive dyskinesia symptoms in the Phase IIb Kinect 2 study. The pre-specified primary endpoint was the change-from-baseline in the Abnormal Involuntary Movement Scale (AIMS) at Week 6 as assessed by central blinded video raters.

ANI Pharmaceuticals Acquires 31 Generic Drug Products from Teva Pharmaceuticals

ANI Pharmaceuticals, Inc. (ANIP), an emerging generic pharmaceutical company, today announced that it has acquired 31 previously marketed generic drug products from Teva Pharmaceuticals for $12.5 million in cash and a percentage of future gross profits from product sales.  The acquisition includes 20 solid-oral immediate release products, 4 extended release products and 7 liquid products.  ANI will begin work immediately on transferring these products into its manufacturing facilities in anticipation of product launches beginning in the fourth quarter of 2014.  All of these products have been previously approved by FDA as abbreviated new drug applications (ANDAs).  The total current annual market for these products is $860 million per IMS Health.