By Mary Welch
Connetics Corp. filed a new drug application (NDA) for Olux (clobetasol propionate) Foam 0.05 percent for the treatment of moderate to severe scalp dermatoses.
¿It is good news but certainly not unexpected,¿ said Mary Ann Gray, senior vice president of Raymond James & Associates Inc. in New York. ¿It¿s shaping up that Connetics is introducing a new product every year or two, which was their goal. Again, that¿s good news. It¿ll take about a year for approval and we expect Olux to be available in the fourth quarter of 2000.¿
Connetics ¿focuses on late-stage product development and commercialization and this is our second NDA filing,¿ said John Higgins, the company¿s chief financial officer. ¿For us, it¿s a significant milestone. It will also allow our 45-person sales staff to leverage sales for both products.¿
In Phase III trials with 188 patients, it was shown that patients given Olux, administered twice daily for 14 days, improved over the placebo group in the endpoints of erythema, plaque thickness and scaling.
In addition, a physicians¿ global assessment showed that, overall, 63 percent of patients treated with Olux had complete or almost complete clearance of disease compared with 57 percent for a currently approved clobetasol solution and 0 percent and 3 percent for the two placebo groups. (See BioWorld Today, Nov. 11, 1998, p. 1.)
Gray said Connetics¿ two steroid foams for psoriasis may eventually capture the $200 million market.
Although Olux is for psoriasis patients with moderate to severe disease, Olux¿s degree of steroid potency is in the high or super-high category.
¿The entire topical steroid market is about $400 million to $500 million and the moderate to severe psoriasis is about $200 million,¿ Gray said. ¿The foam is just so much easier than the other products so I clearly believe that Olux and Luxiq, which is its mid-potency steroid, has the potential to capture the entire market. It could take four to five years, but each could become a $100 million drug.¿
Higgins said the market for the high- and super-high potency foam is about $300 million. ¿We feel we have developed real bookends to a very large market,¿ he said. ¿Depending on if you need a mid-potency up to a very high potency, our foam has shown its efficacy as well as patient preference from a cosmetic point of view.¿
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 cortico steroids in cream, gel or liquid formulations.
Connetics licensed the FDA-approved clobetasol from Soltec Research Pty Ltd., of Melbourne, Australia, and then formulated it into a foam-mousse delivery version. Later called Olux, the super-high-potency corticosteroid liquifies when applied to the scalp and is designed to achieve rapid and targeted delivery of the active drug to the disease site.
Connetics¿ first drug for scalp psoriasis, Luxiq (beta methasone valerate foam 0.1 percent) is a mid-potency steroid designed for moderate cases of psoriasis ¿ a market of about $200 million. Luxiq was approved by the FDA earlier this year. (See BioWorld Today, March 3, 1999, p. 1.)
Post-marketing trials are being conducted to further evaluate the foam¿s safety. ¿These foams have been for psoriasis of the scalp,¿ Higgins said. ¿We want to find out how it relates to other parts of the body. It¿s uncertain if we will submit data for an expanded label, but we are looking at adding proof of principle. Our main goal is to continue focusing on developing a whole family of dermatology products.¿
¿It would be interesting to see if they try to get approval for indications for throughout the body ¿ except the face,¿ said Gray. ¿Again, that would expand the market and sales potential dramatically.¿
Connetics¿ stock (NASDAQ:CNCT) closed Thursday at $6.375, down 18.75 cents per share.