By Mary Welch
Connetics Corp. received its first FDA product approval as the agency gave the nod to Luxiq (betamethasone valerate) Foam .12 percent, a foam formulation for the relief of moderate psoriasis.
¿We¿re excited,¿ said John Higgins, vice president of finance and administration and chief financial officer for the Palo Alto, Calif.-based company. ¿These approvals don¿t come too often.¿
Jim Reddoch, a research associate with Gerard Klauer Mattison & Co. Inc., of New York, believes that Luxiq will double Connetics¿ sales revenues next year.
¿Right now they are about $8 million from two products,¿ he said. ¿We expect Luxiq to do about $11 million this year and between $10 [million] to $17 million in 2000. That will essentially double their revenues.¿
The mid-potency steroid market is about $200 million in the U.S., and Reddoch believes that Luxiq¿s sales could reach as much as $40 million to $50 million.
Approval Should Pave Way For Olux, Says Analyst
The approval helps Connetics in several ways, he said.
¿It¿s the first approval for them where they went through all the regulatory processes themselves,¿ he said. ¿That should help develop meaningful investor interest and help them reach near-term profitability by 2000, which is what we¿re looking at. It also should pave the regulatory way for Olux, its foam product for severe psoriasis, which is a larger market. We expect them to file an NDA [new drug application] soon.¿
Licensed from Soltec Research Pty. Ltd., of Melbourne, Australia, Luxiq was formulated by Connetics. The foam is a stabilized formulation of betamethasone 17-alpha-valerate. When applied to the body, it liquefies and remains localized at the disease site.
The company filed the NDA in December 1997. Phase III trials showed when the mousse was administered twice a day for 28 days, patients experienced a statistically significant improvement in all primary endpoints. Those included erythema (redness of the skin), plaque thickness and scaling. (See BioWorld Today, Jan. 6, 1998, p. 1., and Aug. 6, 1997, p. 1.)
Connetics has 35 to 40 salespeople ready to market Luxiq to dermatologists, who would be asked to prescribe it to the 3.2 million Americans suffering from scalp psoriasis. The product will be launched at the mid-March meeting of the American Academy of Dermatology in New Orleans, with the mousse actually becoming available in early April.
Connetics¿ stock (NASDAQ:CNCT) closed Tuesday at $7.75, down $1.125. n