Baxter and Merrimack Pharma have filed for approval of their pancreatic cancer therapy MM-398 in the EU, a few days after the FDA started a priority review of the drug.
The two companies are developing MM-398 as a second-line therapy for patients with advanced pancreatic cancer who have failed first-line treatment with gemcitabine, a group with very few treatment options available.
The drug is a liposomal formulation of the established cancer chemotherapy irinotecan that is thought to help direct the active drug into tumours, improving its anticancer effects whilst also sparing healthy tissues from the toxic effects of the drug.
The FDA has already given the drug priority review status and Merrimack and Baxter, raising the possibility of approval before the end of the year. Analysts have suggested MM-398 could become a $500m-a-year product at peak.
Both the US and EU applications are based on the results of the phase III NAPOLI-1 study, which showed that the combination of MM-398, 5-fluorouracil (5-FU) and leucovorin (LV) was more effective that 5-FU and LV alone at extending survival in patients who had progressed despite gemcitabine therapy.
Baxter and Merrimack’s drug improved overall survival (OS) by 43%, with patients on the combination achieving an OS of 8.9 months compared to just over five months for 5-FU and LV. The median survival times in the open-label trial were similar to those previously reported for FOLFIRI (fluorouracil, leucovorin, irinotecan) in second-line pancreatic cancer.
NAPOLI-1 “was the first global phase III study in a post-gemcitabine setting to show a survival benefit in this aggressive disease,” according to the two companies.
Merrimack licensed rights to MM-398 to Baxter last September in a $970m deal that excluded the US – where Merrimack retains ownership – as well as Taiwan where rights to the drug are held by local company PharmaEngine. If approved it will be Merrimack’s first commercial product.
The global pancreatic cancer market is experiencing rapid expansion and is set to hit $1.6bn by 2017, largely driven by strong performance from Celgene’s Abraxane (paclitaxel albumin), according to GlobalData.
Abraxane is expected to lead the market with close to $1bn in sales in this indication – thanks to first-line use in combination with gemcitabine – but MM-398 and Threshold Pharmaceuticals/Merck’s TH-302 are also tipped as having significant sales potential.