September 9, 2015
By Alex Keown, BioSpace.com Breaking News Staff
CAMBRIDGE, Mass. – Merrimack Pharmaceuticals Inc. chief Bob Mulroy is moving quickly to set a sales team in place in anticipation of federal regulatory approval for its cancer therapy MM-398, also known as nal-IRI.
Mulroy has hired approximately 50 new sales associates to be in place for expected approval of the drug, the Boston Business Journal reported this morning. In June the U.S. Food and Drug Administration (FDA) granted Merrimack priority review status for MM-398, which is being developed in partnership with Baxalta Incorporated, a subsidiary of Baxter International MM-398 was developed for the treatment of patients with metastatic adenocarcinoma of the pancreas. The FDA is set to review MM-398 on Oct. 24. If approved, the drug could generate nearly $1 billion for Merrimack when milestone payments from Baxalta are factored into the equation, the Journal said.
hit a morning high of $10.51 per share. Stock prices have steadily increased over the summer as MM-398 successfully completed a Phase III trial and has moved closer to regulatory approval
Merrimack’s drug generated a lot of buzz in the oncology community after a Phase III clinical trial of MM-398 in combination with 5-fluorouracil (5-FU) and leucovorin showed a statistically significant improvement in overall survival, progression free survival and overall response rate compared to the control group of patients who received a combination of 5-FU and leucovorin.
Pancreatic cancer accounts for approximately three percent of all cancer cases worldwide, but is the fourth leading cause of cancer death. There are an estimated 140,000 new cases diagnosed annually around the world, two-thirds of which are among people aged 65 or older. Mulroy told the Journal that MM-398 will likely benefit approximately 19,000 patients whose cancer has progressed after initial treatment withEli Lilly and Company ’s Gemvar. Celgene Corporation ’s Abraxane, which had first quarter sales of $223 million, was recently approved for the treatment of pancreatic cancer.
In addition to treatment of metastatic adenocarcinoma of the pancreas, MM-398 is also being studied for use in the treatment of other cancers, including ewing sarcoma, metastatic breast cancer and glioma. The company expanded a Phase I pilot study for breast cancer treatment in June and has enrolled patients who have metastatic breast cancer which is either hormone receptor-positive, triple-negative, or where active brain metastases are present.
MM-398 was granted orphan drug designation for patients with metastatic pancreatic cancer by both the FDA and the European Medicine’s Agency, the regulatory body in the European Union. In addition to FDA review, MM-398 is also under review in the European Union
Under terms of the collaborative agreement with Baxalta, Merrimack will market MM-398 in the United States and Baxalta will market the drug globally. PharmaEngine, Inc. holds the rights to commercialize MM-398 in Taiwan.
