Merrimack Pharmaceuticals (MACK) reported news today that the company had received FDA Fast Track Status for its its investigational drug for Pancreatic cancer which it calls MM-398. When the FDA grants Fast Track Status it allows the company to submit parts of the NDA (New Drug Application) for approval in stages. This allows more frequent discussions with the FDA and may even allow priority review over other drug compounds in current clinical testing. The reason the FDA gave Fast Track approval is because there are no current therapies for pancreatic cancer — the drug meets an unmet medical need.
MM-398 has already proven to be effective in a phase 3 trial in patients that had already attempted therapy with Gemcitabine (a Lilly chemotherapy agent for several cancers that has shown some promise for pancreatic cancer). Gemcitabine proved not to be effective with these patients. The patients were enrolled in MACK’s phase 3 trial, NAPOLI-1, which used the MM-398 compound against the cancerous cells. The phase 3 trial tested MM-398 in combination with 5-FU and Leucovorin vs. 5-FU and Leucovorin alone. The control arm — 5-FU and Leucovorin — only achieved an overall survival of 4.2 months. The combination of Merrimack’s drug MM-398 together with the other two drugs produced an overall survival of 6.1 months. This is an improvement of 2 months which seems very little to some but pancreatic cancer is a very difficult form of cancer to treat and the life expectancy from diagnosis is short. Pancreatic cancer is a difficult cancer to detect and even when it is detected early, there are no good treatments.
MM-398 is a nanotherapeutic drug that consists of a chemotherapeutic irinotecan enclosed in a liposmal barrier that only releases upon contact with the cancerous cells. This targeted approach increases efficacy and somewhat reduces some toxic side effects.
Merrimack has established a partnership with Baxter (BAX) to sell the drug in other territories besides the United States. In the deal with BAX, Merrimack obtained an upfront payment of $100 million. Merrimack expects to complete the full submission of the NDA for MM-398 by late first quarter 2015 or early 2nd quarter 2015. We think that shares of Merrimack are attractive at the current price.
