August 8, 2016
By Mark Terry, BioSpace.com Breaking News Staff
Lugano, Switzerland-based Helsinn Group and San Diego, California-based MEI Pharma , announced that they had inked an exclusive licensing, development and commercialization deal. The two companies will develop and market Pracinostat, a drug ready for Phase III trials to treat acute myeloid leukemia (AML) and other possible indications.
Helsinn will receive exclusive worldwide rights, including manufacturing and commercialization, and will fund the global development of the drug. Helsinn will pay MEI $15 million upfront and $5 million upon dosing the first patient. MEI will be eligible for up to $444 million in possible development, regulatory and sales-based milestone payments. In addition, MEI is eligible for tiered royalty payments in specific territories.
The two companies will also work together on an optimal dosing regimen of Pracinostat in combination with azacitidine to treat high-risk myelodysplastic syndrome (MDS). This trial is projected to start in the first half of next year. In relation to this deal, Helsinn will make a $5 million equity investment in MEI.
“Helsinn is delighted to be entering into this agreement with MEI Pharma for the exclusive rights on Pracinostat, a promising late-stage novel asset,” said Riccardo Braglia, Helsin’s vice chairman and chief executive officer, in a statement. “In the first instance we will target acute myeloid leukemia (AML), an area of huge unmet medical need. As part of the development, we will also target additional indications. Helsinn is committed to helping people to survive cancer and offer a better quality of living with cancer.”
Pracinostat is an oral histone deacetylase (HDAC) inhibitor. The U.S. Food and Drug Administration (FDA) gave the drug Breakthrough Therapy Designation last week in combination with azacitidine in patients with newly diagnosed AML in patients who are older than 75 years or otherwise unable to receive intensive chemotherapy.
Helsinn is a privately owned cancer-focused pharmaceutical group with a broad pipeline and large portfolio of marketed products. Its products are available in 90 countries. One of its top products is Aloxi, an anti-nausea drug often given to patients being treated with azacitidine.
“Helsinn is an ideal strategic partner to entrust the development of Pracinostat,” said Daniel Gold, president and chief executive officer of MEI in a statement. “Helsinn has a strong commercial presence in the United States and, globally, has been able to create and skillfully coordinate a solid and significant network of 70 commercial partners in 90 countries. Helsinn’s antiemetic, Aloxi, is a market leader and is often used by patients receiving azacitidine, so their commercial organization is well positioned to market Pracinostat for the treatment of AML and MDS. Helsinn shares our enthusiasm for bringing Pracinostat to patients in need, and we look forward to a successful partnership for the development of the program.”
On April 20, MEI announced new clinical data from a Phase I study of ME-401, a next generation oral P13K delta inhibitor. “P13K delta is a class of drugs that has shown great promise in the treatment of B-cell malignancies, but with certain toxicities,” said Gold in a statement at the time. “We believe this provides an opportunity for a next-generation drug that can produce therapeutic responses at a safe, effective dose. Thus far, ME-401 has demonstrated all of the attributes we had hoped to see, including linear PK and on-target activity at very low concentrations. Now the goal of our upcoming Phase Ib study will be to show a large therapeutic window in cancer patients.”
