By Kim Coghill
Atrix Laboratories Inc. this week submitted a new drug application (NDA) for its subcutaneous prostate cancer drug that is expected to win FDA approval next year and generate millions of dollars for the small company based in Fort Collins, Colo.
By next fall, the company believes it will be selling Leuprogel Depot (leuprolide acetate) in a three-month dose, said David Bethune, Atrix¿s president and CEO. In clinical trials, Leuprogel met its primary endpoint of testosterone suppression.
Bethune said Atrix has submitted two NDAs already this year, and anticipates submitting a third in early 2002. The first NDA, for Leuprogel in a one-month dose, was submitted in March and the final in this series of products, Leuprogel in a four-month dose, will be filed next year. (See BioWorld Today, March 28, 2001.)
¿How many companies that are our size [130 employees] have two NDAs in to the FDA?¿ Bethune said. ¿Not many.¿
Richard Stover, a senior analyst with Arnhold and S. Bleichroeder Inc. in New York, said at the five-year peak, the Leuprogel products should generate over $500 million worldwide for Atrix. ¿I would say that estimate is probably conservative,¿ Stover told BioWorld Today.
According to Atrix, the U.S. market is about $1 billion annually. Stover and Bethune said they expect Atrix will make more money from the three-month and four-month products.
Bethune expects approval to come fairly easily. Leuprogel¿s active ingredient is contained in a similar product, Lupron Depot, Abbott Park, Ill.-based Abbott Laboratories Inc.¿s product for prostate cancer.
¿We like to say Leuprogel is new and improved,¿ Bethune said. ¿What we¿ve done is provided a new delivery mechanism for the same active ingredient.¿
Leuprogel will be administered through Atrix¿s Atrigel drug delivery system, which is patented until 2017. Injected subcutaneously as a liquid, Leuprogel solidifies and releases a dose continuously for one, three or four months as the implant bioabsorbs.
Sanofi-Synthelabo, of Paris, has U.S. rights to Leuprogel; MediGene AG, of Martinsried, Germany, has European rights; and Faulding Pharmaceutical Inc., a division of Melbourne, Australia-based F.H. Faulding & Co. Ltd., has rights in Australia and New Zealand.
In other news Wednesday, Atrix said it rescinded its notice of intent to redeem the remainder of its 7 percent convertible subordinate notes due 2004. In a prepared statement, Brian Richmond, Atrix¿s chief financial officer, said the company decided to redeem the remaining $7.3 million before the terrorist attacks in Washington and New York.
¿As a result of the tragedy and its impact on the financial markets, the company has decided not to proceed with the redemption at this time,¿ he said.
In August, Atrix raised about $69 million in a public offering of 3 million shares at $23 per share. (See BioWorld Today, Aug. 10, 2001.)
Atrix¿s shares (NASDAQ:ATRX) closed Wednesday at $21.42, down four cents.