Galena Biopharma Acquires Mills Pharmaceuticals

(RTTNews) - Galena Biopharma, Inc. (GALE), a developer of oncology treatments, Monday said it acquired Mills Pharmaceuticals, which possesses the rights to GALE-401, a controlled-release formulation of anagrelide. Towards consideration, Galena said it made an upfront payment to Mills Pharmaceuticals' owners, but did not disclose the amount. Galena also said Mills' Pharmaceuticals owners are eligible to receive a milestone, one-time payment of up to 4,000,000 shares, and $3 million upon FDA approval of a new drug application with regard to GALE-401. Galena intends to pursue the expedited 505(b)(2) regulatory pathway to seek approval of Gale-401 for the treatment of Essential Thombocythemia. In addition, Galerna believes that GALE-401 meets the requirements for orphan drug status.

Currently, Anagrelide immediate release (IR) is one of two generic drugs approved to treat Essential Thrombocythemia, an acquired disease of the bone marrow characterized by highly elevated platelet counts. Galena claims that a significant number of patients cannot tolerate fully effective doses of anagrelide IR. GALE-401 (Anagrelide CR) is expected to greatly decrease the adverse effects associated with anagrelide IR. The adverse effects include nausea, diarrhea, abdominal pain, palpitations, tachycardia, headache.

The company said, "Many physicians are not satisfied with currently available treatments for ET due to the fact that they cannot effectively lower and maintain platelet levels in many of their patients without unmanageable side effects. GALE-401 (Anagrelide CR) is designed to deliver anagrelide with controlled release over a longer period of time to take advantage of the known benefits of the drug, while reducing the adverse events to offer a better treatment option for patients."

The company said the Phase 2 clinical trial is expected to begin in mid-2014. Galena also claimed that FDA had indicated that only a single Phase 3 trial is required for approval.