Recro Pharma to Acquire IV/IM Meloxicam and Gainesville, GA GMP Manufacturing Facility and Business Unit From Alkermes

- Transformative Acquisition Diversifies Recro Pharma's Development Risk with Second, Complementary Acute Pain Product
- Phase III-Ready, Long-Acting Injectable Meloxicam Has Demonstrated Robust Efficacy, Good Tolerability in Multiple Phase II Trials
- Transaction Includes Cash Flow Positive Manufacturing, Royalty and Formulation Business
- Alkermes to Receive Up-front Cash, Warrant, Milestone Payments and Royalties on Meloxicam Net Sales
- Up-front Payment Funded Via Secured Loan from an affiliate of OrbiMed

MALVERN, Pa., March 9, 2015 -- Recro Pharma, Inc. (REPH) today announced a definitive agreement under which Recro Pharma will acquire assets from Alkermes plc including worldwide rights to IV/IM meloxicam, a proprietary, Phase III-ready, long-acting COX-2 NSAID for moderate to severe acute pain, as well as a contract manufacturing facility, royalty and formulation business in Gainesville, GA.

Heat Biologics, Inc. Receives US FDA Fast Track Designation for HS-410 (Vesigenurtacel L) in Combination With BCG for the Treatment of Non-Muscle Invasive Bladder Cancer

-- Designation Expected to Expedite Development of Cutting-Edge Cancer Immunotherapy --

DURHAM, N.C., March 9, 2015 - Heat Biologics, Inc. ("Heat") (HTBX), a clinical stage biopharmaceutical company focused on the development of cancer immunotherapies, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for HS-410 (vesigenurtacel-L) for the treatment of non-muscle invasive bladder cancer (NMIBC). HS-410 is Heat's NMIBC product candidate and is based on its cutting-edge Immune Pan Antigen Cytotoxic Therapy ("ImPACT") platform that is designed to generate killer T cells to attack cancers. HS-410 is currently being evaluated in a randomized Phase 2 trial in combination with BCG and as monotherapy for the treatment of NMIBC.

Retrophin Reports Fourth Quarter and Full Year 2014 Financial Results

FY 2014 revenues of $28.2 million
Development efforts focused on Phase II DUET trial and preparation of RE-024 IND

SAN DIEGO--- Retrophin, Inc. (RTRX) today reported fourth quarter and full year 2014 financial results.

• Net product sales for the fourth quarter 2014 were $14.1 million
• Net product sales for the full year 2014 were $28.2 million
• Non-GAAP operating loss for the fourth quarter 2014 was $8.6 million, compared to a non-GAAP operating loss of $8.9 million for the same period in 2013

  Published: 06 March 2015

  Written by Editor

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Calithera Biosciences Gains Exclusive, Worldwide License to TransTech Pharma's Hexokinase II Inhibitor Program

SOUTH SAN FRANCISCO, Calif., March 5, 2015 -- Calithera Biosciences, Inc. (CALA), a clinical-stage pharmaceutical company focused on discovering and developing novel small molecule drugs directed against tumor metabolism and tumor immunology targets for the treatment of cancer, announced today an exclusive global license agreement with TransTech Pharma, a clinical stage pharmaceutical company, granting Calithera exclusive world-wide rights to research, develop and commercialize TransTech's portfolio of hexokinase II inhibitors. Hexokinase II is the first and rate-limiting enzyme in the pathway that enables cancer cells to convert glucose to energy and building blocks that feed cancer cell growth. Under the terms of the agreement, Calithera will obtain exclusive, worldwide rights to TransTech's hexokinase II inhibitors for research, development and commercialization. TransTech will receive an upfront payment and will be eligible to receive future development and commercialization milestones as well as royalties on sales of approved products.