By Kim Coghill
Atrix Laboratories Inc. has licensed North American rights of its topical acne treatment, Atrisone, to Fujisawa Healthcare Inc., of Deerfield, Ill.
The deal calls for Fujisawa to pay Atrix, of Fort Collins, Colo., up to $25 million in licensing fees, research and development support and milestone payments. Atrix will manufacture Atrisone and will receive a manufacturing margin as well as royalties based on sales.
Fujisawa, which employs 65 sales people, is a subsidiary of Fujisawa Pharmaceutical Co. Ltd., of Osaka, Japan, a developer and marketer of dermatological and pharmaceutical products. Atrisone contains the oral antibiotic dapsone, and currently is in the first of two Phase III trials. The product is expected to enter the market in early 2004.
David Bethune, Atrix¿s chairman and CEO, said he sought the agreement with Fujisawa because of the company¿s history.
¿You look for power and people who have knowledge,¿ Bethune told BioWorld Today. ¿They are a quality group, they have money and they have expertise in dermatology.¿
Bethune also has personal experience with Fujisawa. When he was heading up Lederle, a division of American Cyanamid (now part of Madison, N.J.-based American Home Products), Bethune licensed Aristrocort and Cyclocort, dermatosis treatments, to Fujisawa.
¿It helps to know who you are working with,¿ Bethune said. Atrix is seeking a partner in Europe, he added.
When Atrisone enters the market, it will offer people who suffer from acne a more potent treatment option, Peter Ginsberg, a biotechnology analyst with US Bancorp Piper Jaffray in Minneapolis, told BioWorld Today.
¿Dapsone not only has an antibiotic effect, but it also has an anti-inflammatory effect so you are attacking the acne with two different mechanisms,¿ Ginsberg said.
Bethune said dapsone reduces inflammation on the skin independently of its antibacterial activity. ¿Dapsone has existed as a systemic treatment for other diseases but it has never been used topically,¿ he said. ¿And our drug delivery system [solvent microparticle system, or SMP] for topical use makes it soluble and usable on the surface of the skin. SMP makes it possible for dapsone to penetrate the epidermal layers of the skin and get down into the skin where the acne lesion is existing. Then, it acts as an anti-inflammatory to reduce the acne lesion, and reduces the bacterial count by killing the bacteria in the lesion.¿
Ginsberg said the U.S. market for acne topical treatments is about $600 million annually. ¿That¿s the market as it currently stands, but with new products, the overall market size could increase,¿ he said.
Atrix has completed enrollment of the 500-patient Phase III study of Atrisone, Bethune said. Following discussions with the FDA, the company has decided to conduct a second Phase III study, possibly with 700 patients. ¿We want to make sure we have all the statistical data needed to get Atrisone to market,¿ Bethune said.
Atrisone also is being studied in the treatment of atopic dermatitis and itching associated with severe burn wounds. As part of the deal with the licensing agreement, Bethune said Fujisawa will review data from additional studies and decide whether to pursue further trials in other indications.
Last month, Atrix submitted an NDA for its subcutaneous prostate cancer drug, Leuprogel Depot (leuprolide acetate) in a three-month dose. And in March, the company submitted an NDA for the one-month dose of the product. The 120-day dose will be submitted next year. (See BioWorld Today, March 28, 2001, and Sept. 27, 2001.)
Using Atrigel, Atrix¿s drug delivery system, Leuprogel is injected subcutaneously as a liquid. Leuprogel solidifies and releases a dose continuously for one, three or four months, as the implant bioabsorbs.
Fujisawa also is the developer and marketer of Protopic, a steroid-free prescription treatment for eczema.
Atrix¿s stock (NASDAQ:ATRX) closed Wednesday at $25.68, up 13 cents.