By Matthew Willett
MGI Pharma Inc. and Helsinn Healthcare SA entered an $11 million agreement granting MGI exclusive North American license and distribution rights to palonosetron, a 5-HT3 antagonist.
Palonosetron is in Phase III testing for the prevention of chemotherapy-induced nausea and vomiting. The deal includes $11 million in up-front payments by MGI, including a $5 million payment made upon the signing of a letter of intent in February.
MGI officials said the Phase III trial, funded along with the remainder of development expenses by Lugano, Switzerland-based Helsinn, could be complete in the first half of 2002, and that a new drug application filing would come soon after.
"It adds greatly to our presence in oncology, which is our only focus today," MGI's president and CEO, Chuck Blitzer, told BioWorld Today. "This is a very late-stage drug, well advanced in a Phase III clinical trial, and it has the opportunity to be on the market, hopefully, in the near term. It allows us to enter a different market, the supportive care market."
Three 5-HT3 inhibitors are on the $1 billion North American market for chemotherapy-induced nausea and vomiting. Palonosetron, Blitzer said, has certain advantages over the others.
"One of the exciting things that attracted our attention is that this drug has an extended half-life," he said. "In Phase II trials what was observed was that when patients got the first-day injection, in Phase II the drug showed therapeutic effect continued through day five, and we believe that the Phase III trial should continue to bear that kind of data. Phase III will compare the effect of palonosetron against the effect of the other drugs in the marketplace already, and if palonosetron continues to bear out, I think we have an opportunity for differentiation when it enters the market."
MGI, of Minneapolis, has a pipeline of anticancer agents that includes the approved product Hexalen, a second-line chemotherapy drug for ovarian cancer patients who are refractory to existing cancer therapies.
Irofulven (hydroxymethylacylfulvene) is the first anticancer agent developed by MGI from a family of compounds called acylfulvenes.
MGI reported in November Phase II irofulven results that indicated 10 of the 53 patients with advanced pancreatic cancer who were refractory to gemcitabine achieved six-month survival, the trial's primary endpoint. One patient experienced tumor shrinkage of 100 percent and a second experienced 84 percent shrinkage.
MGI began dosing in a Phase III trial of irofulven in advanced-stage pancreatic cancer earlier this year. (See BioWorld Today, Feb. 8, 2001.)
MGI's stock (NASDAQ:MOGN) closed Tuesday at $11, up 28 cents.