Cancer therapeutics firm Galena Biopharma acquired Mills Pharmaceuticals and in the process added Mills' GALE-401 (anagrelide CR), a controlled-release formulation of anagrelide, to its pipeline. The company believes GALE-401 qualifies for orphan drug status and aims to seek approval of the candidate for the treatment of essential thrombocythemia (ET), a bone marrow disease.
Per the agreement, Galena paid an up-front payment to Mills Pharmaceuticals' owners, and the owners of Mills Pharmaceuticals are eligible to receive one-time payments of up to 4,000,000 shares once certain regulatory milestones are achieved. Mills' owners are also eligible to receive $3 million upon FDA approval of a new drug application in respect to GALE-401.
Currently, anagrelide immediate release (IR) is one of two generic drugs that have been approved to treat ET, but many patients can't tolerate the side effects—including nausea, diarrhea, abdominal pain, palpitations, and tachycardia—that come with the doses of anagrelide IR known to be fully effective. The firms believe GALE-401, which is said to have an estimated peak market size of approximately $200 million in the U.S., could decrease greatly the adverse event rate relative to the approved product. Several Phase I studies have reportedly shown a dose-dependent reduction in platelet count and a safety profile no different from placebo.
Galena hopes these advantages could allow the firm to expand the market to treat the currently undertreated younger and elderly patient populations with ET.
"This acquisition is an excellent fit for Galena's focused business strategy, adding another novel product to our pipeline which strengthens the depth and breadth of our hematology-oncology portfolio," said Galena's president and CEO Mark J. Ahn, Ph.D., in a statement. "We believe GALE-401 can enhance the therapeutic index for ET patients—reducing the side effects of anagrelide while maintaining efficacy for these patients. With established guidance from the FDA on the development process, we are excited to initiate a Phase II study in mid-2014."
Mills Pharmaceuticals is affiliated with Aceras Partners, and Roth Capital Partners acted as Galena's financial advisor in this transaction.