By Kim Coghill
Atrix Laboratories Inc. submitted to the FDA a new drug application for Leuprogel 1-month, 7.5 mg (leuprolide acetate for subcutaneous depot injection) for the treatment of advanced prostate cancer.
Richard Jackson, senior vice president for research and development at Fort Collins, Colo.-based Atrix, said the company expects approval and drug launch within a year.
"We like to say that we are a drug delivery company, but we are also a product development company and I think this first product really exemplifies that," Jackson said. "We completed these studies in record time and submitted the NDA, and with our key alliances with Pfizer, Elan and Novartis, we think that we are really on the move here and will continue to grow."
Atrix has five patented drug delivery technologies and is developing a portfolio of proprietary products in the areas of oncology, pain management and dermatology. The Leuprogel prostate cancer products are being tested for one-, three- and four-month applications.
The company in December released positive data on the Phase III trial of Leuprogel 1-month. "We found two very exciting things in the one-month indication," Jackson said. "The first was that we had very low testosterone - the point of this therapy is to reduce testosterone since these cancer cells require testosterone for growth - and the second point, we found no breakthroughs. In other words, if you get this product again and again and again, you don't find that patients actually increase their testosterone, which the other products on the market do." (See BioWorld Today, Dec. 6, 2000.)
Jackson said Leuprogel also is a unique product because it is being delivered through Atrix's proprietary Atrigel delivery system. Leuprogel is injected into the body subcutaneously, as a liquid, where it solidifies and releases a predetermined dose of leuprolide acetate continuously for one, three or four months as the implant bioabsorbs. Sustained levels of leuprolide, a luteinizing hormone-releasing agonist, decrease testosterone to suppress tumor growth in patients with hormone-responsive prostate cancer.
Leuprogel 3-month currently is in Phase III studies with an anticipated NDA filing by the end of the year, and the four-month indication last week completed Phase III enrollment with an NDA expected to be filed in early 2002.
Leuprogel products will be marketed in North America by Paris-based Sanofi-Synthelabo. Atrix will receive milestone payments in addition to royalties on sales and will manufacture the product at its facility in Fort Collins. (See BioWorld Today, Jan. 10, 2001.)
Atrix has a collaborative agreement with Novartis AG company Geneva Pharmaceuticals Inc., of Denver, to develop and manufacture prescription generic dermatology products over the next 10 years. Also, Atrix has an agreement with Pfizer Inc., of New York, granting Pfizer worldwide licensing and research rights to newly developed products using Atrix's proprietary parenteral, transmucosal and topical drug delivery systems. Under the agreement with Elan Pharmaceuticals, of San Francisco, Atrix will develop fentanyl using Atrix's bioerodible mucoadhesive system for breakthrough cancer pain and management of chronic pain.
Atrix's stock (NASDAQ:ATRX) closed Tuesday at $15.375, up 25 cents. n