Daiichi Sankyo to Acquire Ambit Biosciences

Lead Compound, Quizartinib, Will Further Build Daiichi Sankyo Oncology Pipeline

TOKYO and SAN DIEGO, Sept. 28, 2014 -- Daiichi Sankyo Company, Ltd. (hereinafter Daiichi Sankyo) (TSE:4568) and Ambit Biosciences (AMBI), jointly announced today that they have entered into a definitive merger agreement under which Daiichi Sankyo will acquire all of the outstanding common stock of Ambit Biosciences for $15 per share in cash through a tender offer followed by a merger with a subsidiary of Daiichi Sankyo, or approximately $315 million on a fully diluted basis.  In addition to the upfront cash payment, each Ambit Biosciences stockholder will receive one Contingent Value Right (CVR), entitling the holder to receive an additional cash payment of up to $4.50 for each share they own if certain commercialization related milestones are achieved. The total transaction is valued at up to $410 million on a fully diluted basis.

FDA Schedules Type B Pre-NDA Meeting With Repros

THE WOODLANDS, Texas, Sept. 26, 2014  -- Repros Therapeutics Inc.^(R) (RPRX) today reported it has been granted a Type B Pre-NDA meeting with the FDA in the first half of November. In this meeting the Company will seek guidance on its planned New Drug Application (NDA) for Androxal^(R) for the treatment of secondary hypogonadism with preservation of testicular function. Repros believes that the NDA for Androxal^(R) will be filed around the end of 2014.

Dr. Andre Guay, Clinical Professor of Medicine (Endocrinology), Tufts University School of Medicine, Boston, MA, commented, "This news is encouraging as Androxal^(R), in my mind, is a compound that is not another form of exogenous testosterone replacement, but rather stimulates the body to make its own testosterone in men with secondary hypogonadism, which is the most common type of hypogonadism (approximately 80%), by our research and that of the European Male Aging Study."

Agios Pharmaceuticals to Present Clinical Data from AG-120 Ongoing Phase 1 Study in Hematologic Malignancies at EORTC-NCI-AACR 2014

CAMBRIDGE, Mass.-- Agios Pharmaceuticals, Inc. (AGIO), a leader in the fields of cancer metabolism and rare genetic disorders of metabolism, today announced that clinical data from a Phase 1 study of AG-120, an orally available, selective, potent inhibitor of the mutated IDH1 protein, will be highlighted in a late breaking oral presentation at the 26th EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics taking place November 18 - 21, 2014, in Barcelona, Spain.

“We look forward to sharing the first clinical data from our AG-120 Phase 1 trial in patients with advanced hematologic malignancies during the late-breaker session at EORTC-NCI-AACR,” said David Schenkein, M.D., chief executive officer at Agios. “We believe IDH1 is an important target that has the potential to make a difference for patients with a broad range of hematologic and solid tumor cancers.”

IGI Laboratories, Inc. Acquires Eighteen Former Products From AstraZeneca

BUENA, N.J., Sept. 25, 2014  -- IGI Laboratories, Inc. (NYSE MKT: IG), a New Jersey based specialty generic pharmaceutical company, today announced it has acquired the regulatory rights and related documents and records for 18 drug products from AstraZeneca, 17 of which were marketed. The acquisition includes the regulatory rights and documents for 17 injectable products and 1 suppository product. All of these products had been previously approved by the US FDA as abbreviated new drug applications (ANDAs) or new drug applications (NDAs) prior to their discontinuation or withdrawal from the market. According to IMS Health, the current addressable market in the United States for the therapeutic areas that these products were previously indicated for is estimated at $200 million as of May 2014.