Shares of Ariad Pharmaceuticals ($ARIA) got a boost this morning as its development partner Merck ($MRK) took one more big step forward in its quest for an approval of ridaforolimus. The Big Pharma company, which has tapped the cancer drug as one of its top prospects, says it has filed for EU approval with an FDA filing expected in short order.
Cambridge, MA-based Ariad has a lot riding on the success of these applications. Mere acceptance of the app in Europe will trigger a $25 million milestone for Ariad, with an approval worth another $10 million. U.S. approval is worth $25 million.
"We are delighted by the submission for regulatory review of ridaforolimus in the European Union," said Ariad CEO Dr. Harvey J. Berger. "We look forward to the submission of additional filings on ridaforolimus and to the review of ridaforolimus as a potential new treatment option for patients with metastatic soft-tissue and bone sarcomas."
A year ago Merck restructured its partnership with Ariad to acquire global control over the development and commercialization of the cancer therapy, an mTOR inhibitor which has potential to treat various cancers.
Investigators from Merck and Ariad reported at ASCO last June that the drug hit its primary endpoint in Phase III, improving progression-free survival in metastatic sarcoma patients compared to a placebo. Median PFS was 17.7 weeks for those treated with ridaforolimus compared to 14.6 weeks in the placebo group. Furthermore, based on the full analysis of PFS determined by investigator assessment, there was a statistically significant 31% reduction by ridaforolimus in the risk of progression or death compared to placebo.
- here's the Ariad release