By Mary Welch
Less than 10 months after filing its new drug application, Connetics Corp. received word that the FDA approved its application for Olux, a foam formulation for moderate to severe scalp dermatoses.
"We're very pleased to get the approval in under 10 months," said John Higgins, Connetics' chief financial officer. "It's always great to get a product approved."
Jeffrey Davis, president and director of research for Small Caps Online LLC in New York, said the news is positive, but not unexpected. "Given the company's experience with Luxiq, it wasn't a surprise. It's very good news and fills out Connetics' pipeline in dermatology. I just don't know why the stock is down."
Connetics' stock (NASDAQ:CNCT) closed Wednesday at $8.50, down 62.5 cents.
Olux (clobetasol propionate) foam, 0.05 percent, was approved for the short-term topical treatment of the inflammatory and pruritic manifestations of moderate to severe corticosteroid-responsive dermatoses of the scalp.
"What this approval does is expand our commercial business in dermatology," Higgins said. "It will join Luxiq, which was approved last year. Now we have a super-high- potency corticosteroid that complements Luxiq, which is a mid-potency corticosteroid."
Luxiq (betamethasone valerate) foam, 0.12 percent, was approved in February 1999 for the treatment of corticosteroid-responsive dermatoses of the scalp - moderate psoriasis. (See BioWorld Today, March 3, 1999, p. 1.)
"There's some overlap between the two products but I don't think there will be a lot of cannibalism," Davis said.
Olux should be available in the fourth quarter of this year, Higgins said.
"Obviously any sales figures for this year will be small," he said. "However, we expect it'll be around $10 million for the first year of sales."
The entire topical steroid market is about $400 million to $500 million, according to one analyst, and the moderate to severe psoriasis market is about $200 million.
Davis predicts both products could be in the $25 million to $40 million range. "It could be more," he said. "The acceptance of the foam in the dermatology community has been positive - even more than the company expected. Olux will give them good cash flow and will be like a backstop for the company as it waits for Relaxin to get going."
Olux's market will be the 3 million people in the U.S. who suffer from scalp psoriasis, a chronic, recurrent dermatologic disease. More than 1.2 million patients are in treatment at any one time. Patients suffer from various degrees of erythema, scaling, plaque and itching. Typically, the disease involves periods of remission followed by acute exacerbation. Current treatment consists of corticosteroids in cream, gel or liquid formulations
Olux's delivery technology was developed by Soltec Research Pty Ltd., a wholly owned subsidiary of F.H. Faulding & Co. Ltd., of Melbourne, Australia. Connetics licensed the FDA-approved clobetasol and then formulated it into a foam-mousse delivery version.
In its Phase III trial, patients treated with Olux twice a day for 14 days improved over the placebo group in the endpoints of erythema, plaque thickness and scaling. In addition, a physician's global assessment showed that, overall, 74 percent of the Olux patients had complete or almost complete clearance of disease compared with 63 percent for a currently approved clobetasol solution and 8 percent in the placebo arm. The Palo Alto, Calif.-based company filed for a new drug application last July. (See BioWorld Today, Nov. 12, 1998, p. 1; and July 30, 1999, p. 1.)
In other company news, Higgins said enrollment is completed in a Phase III trial of Relaxin (recombinant human relaxin-H2) for scleroderma, with results expected in November. The company anticipates filing an NDA in the third quarter of 2001, he said. In addition, it expects to start Phase II trials with Relaxin for infertility and peripheral arterial disease this summer.
"There's some excellent stuff happening with Relaxin," Davis said. "There's going to be a good pipeline of positive news coming out of this company for a while."