Merrimack Pharmaceuticals, Inc. (MACK) announced that it has received fast track designation from the FDA for its oncology candidate, MM-398, for the treatment of metastatic adenocarcinoma of the pancreas in patients who have been previously treated with Eli Lilly’s (LLY) Gemzar.
We note that the FDA grants fast track designation to those candidates that are being developed for the treatment of serious conditions with unmet medical need. The overall goal of the process is to get new drugs to patients faster.
Meanwhile, Merrimack Pharma is presently working on submitting a new drug application (NDA) for MM-398 in the U.S. for this particular indication. Merrimack Pharma intends to complete the NDA submission late in the first quarter or early in the second quarter of 2015.
According to data provided by the American Cancer Society and the World Health Organization, pancreatic cancer is the fourth most common cause of cancer-related deaths in the U.S. affecting nearly 46,000 people, of which about 40,000 die annually.
We are encouraged by the FDA granting fast track designation to MM-398. The fast track status will expedite the development process of MM-398. We note that MM-398 also has orphan drug designation for the metastatic pancreatic cancer indication in the U.S. and EU.
We remind investors that in September this year, Merrimack Pharma entered into a license and collaboration agreement with Baxter (BAX) for the development and commercialization of MM-398 outside the U.S. and Taiwan. Baxter plans to submit regulatory applications for MM-398 outside the U.S. beginning next year.
We expect investor focus to remain on pipeline updates pertaining to MM-398.
Merrimack Pharma currently carries a Zacks Rank #2 (Buy). A better-ranked stock in the health care sector is AMAG Pharmaceuticals, Inc. (AMAG) carrying a Zacks Rank #1 (Strong Buy).
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