By Matthew Willett
Atrix Laboratories Inc. entered a $60 million exclusive North American marketing agreement with Sanofi-Synthelabo for Leuprogel one-, three- and four-month products, a leuprolide acetate for subcutaneous depot injection.
The company is preparing a new drug application for the one-month formulation of the advanced prostate cancer treatment.
The agreement, which includes a license fee, research and development support and payments for clinical, regulatory and sales milestones in addition to royalty payments based on sales for Fort Collins, Colo.-based Atrix, includes a $15 million equity investment in Atrix by Sanofi-Synthelabo, of Paris.
That investment gives Sanofi-Synthelabo about a 6 percent stake in Atrix. Atrix CEO David Bethune told BioWorld Today the deal is exciting for the company that he said is still a "fledgling."
"We're extremely excited by having such a great partner," Bethune said. "I think Sanofi-Sythelabo is a great and powerful company that has the human and financial resources. They've got a long-established record in Europe."
He said the deal for Leuprogel was right for the Parisian company.
"They've established themselves with a focus in urology, and Leuprogel fits the bill perfectly for them. It's a major product for urologists to use."
It's the market for Leuprogel that made the deal so rich, he said.
"This is a gigantic market, $1.3 billion annually in the U.S. alone," Bethune said. "It's fantastically large, and there are only a couple or three products that represent these sales. We're fast moving along, and I think we have a marketing advantage. I think this gives Atrix an opportunity to be well founded as a specialty pharma company."
He said the company is in discussions with potential European partners.
Bethune said the company plans to see Leuprogel on the market in the latter part of 2002.
"The NDA is under way," he said. "We're preparing the NDA for the 30-day product. We're just as busy as we can be developing and putting together the NDA and that will be submitted before the end of the first quarter, sometime in March. The 90-day product is being completed now, and we expect filing before the end of the second quarter, and the 120-day product is starting clinical study next month."
He said company officials will be especially excited to see the product attain regulatory approval, considering the "fine" royalty included in this agreement.
"We're moving very rapidly to get the clinical study completed, and then through the process of preparing these NDAs as rapidly as possible so that these products can be on the market, hopefully, depending on FDA approval, in the mid to later part of 2002," he said.
Atrix's stock (NASDAQ:ATRX) closed up 15 percent on the news Tuesday, or $2.75, at $20.875.