Portland Business Journal article: January 13, 2104

By Elizabeth Hayes, staff reporter

Lake Oswego-based Galena Biopharma has acquired Mills Pharmaceuticals, which has the worldwide rights to a drug with an estimated market size of up to $200 million in the U.S.

The drug is GALE-401, a patented, controlled release formulation of anagrelide, which is used to treat Essential Thrombocythemia (ET), an acquired disease of the bone marrow. ET is characterized by highly elevated platelet counts and is associated with vascular complications, including increased risk of thrombosis, bleeding, and heart attack and stroke.

“This acquisition is an excellent fit for Galena’s focused business strategy, adding another novel product to our pipeline that strengthens the breadth and depth of our hematology-oncology portfolio,” Mark Ahn, president and CEO of Galena Biopharma said in a statement.

Galena made an upfront cash payment of $1.6 million to Mills Pharmaceuticals’ owners. Additionally, Mills Pharmaceuticals owners are eligible to receive one-time payments of up to 4 million shares with the achievement of specified regulatory milestones and $3 million upon FDA approval of a new drug application in respect to GALE-401.

Anagrelide immediate release is currently one of two generic drugs approved to treat ET. But current treatments often have very debilitating side effects, Ahn said. GALE-401 can reduce the side effects of anagrelide while maintaining efficacy, he said.

“With established guidance from the FDA on the development process, we are excited to initiate a Phase 2 study in mid-2014,” he said.

GALE-401 contains an active ingredient anagrelide that has been in use since the late 1990s. GALE-401 is a reformulated, controlled release version that is currently only given as an immediate release.

Galena in October began selling an analgesic for cancer pain, tapping into a $400 million market in the U.S. Abstral Sublingual Tablets are administered to manage “breakthrough” pain in cancer patients who are already receiving, and are tolerant to, opioid therapy for persistent pain.

Galena also is in a Phase 3 study for another cancer drug, a vaccine called NeuVax.