Yesterday Merrimack (MACK) announced that it had received FDA approval for its pancreatic cancer drug, known as ONIVYDE. ONIVYDE treats patients with an advanced form of pancreatic cancer where patients had already failed gemcitabine based therapy — chemotherapy drug. One item to note is that ONIVYDE is not approved as a single use injection therapy for these patients.
Instead ONIVYDE is combined with other drugs F-5U and leucovorin which is the FDA approved use combination to treat these patients with metastatic pancreatic cancer. This is a huge win for Merrimack because this is the first and only drug approved by the FDA for this indication. The phase 3 trial used to test for the efficacy of the company’s combo therapy was known as the NAPOLI-1 trial.
This is a good therapy because patients with metastatic pancreatic cancer typically have a one year survival time. Many previous therapies have failed to produce any significant results in the post gemcitabine therapy over the years which makes this a huge milestone achieved for the company. The company responsible for the development and commercialization of this therapy outside the United states and Taiwan is Baxalta (BXLT).
Baxalta has already submitted a marketing authorization application — MAA — for European Approval of this combo therapy. Possible approval in Europe is expected sometime in the 4th quarter of 2015. While the FDA approval of ONIVYDE was good news the share price saw a huge decline today. The possible reason for the decline is because of the black box label warning placed on the product by the FDA.
Because ONIVYDE causes severe diarrhea and low white blood cell count in the body. While these are serious adverse events we believe this to be a non-issue. We are talking about patients who live less than one year with no standard of care treatment options. Patients will probably want to take this therapy regardless of the black box label warning. Analysts predict that this drug combo could generate peak sales in the U.S. and Europe of $1.5 billion annually.
