Connetics Announces Positive Phase III Data for OLUX -- Clobetasol Foam.PALO ALTO, Calif.--(BW HealthWire)--Nov. 11, 1998--Connetics Corporation (Nasdaq:CNCT CNCT Connect CNCT Certified Network Computer Technician ) announced today that results from it's Phase III clinical trial Noun 1. phase III clinical trial - a large clinical trial of a treatment or drug that in phase I and phase II has been shown to be efficacious with tolerable side effects; after successful conclusion of these clinical trials it will receive formal approval from the of OLUX(TM) (a novel foam formulation of clobetasol propionate clobetasol propionate (klōbā´t  sol´ prō´pē , 0.05%) for the treatment of severe corticosteroid-responsive dermatoses of the scalp, demonstrated statistically significant improvement over placebo for the treatment of severe scalp psoriasis. The Company intends to file a New Drug Application (NDA (Non Disclosure Agreement) An agreement signed between two parties that have to disclose confidential information to each other in order to do business. In general, the NDA states why the information is being divulged and stipulates that it cannot be used for any ) to market the product with the FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. in 1999. The 188 patient, placebo-controlled, randomized ran·dom·ize tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es To make random in arrangement, especially in order to control the variables in an experiment. , double-blind, multi-center Phase III study demonstrated that patients treated with OLUX, administered twice-daily for 14 days, experienced a statistically significant improvement over patients in the placebo group in all primary endpoints, including erythema erythema (ĕr'əthē`mə), more or less diffuse redness of the skin due to concentration of an abnormally large amount of blood within the small vessels of the skin (hyperemia), as in burns. (p equals .0001), plaque thickness (p equals .0001), and scaling (p equals .0001). In addition, study investigators completed a physicians' global assessment which showed that overall 74% of patients treated with OLUX had complete or almost complete clearance of disease compared with 63% for a currently approved clobetasol solution and 8% for placebo. Both OLUX and the clobetasol solution were generally well tolerated. "OLUX represents our second successful clinical effort at developing a novel dermatology product," stated Scott Harkonen M.D., Senior Vice President Product Development and Operations. "Our other dermatology product, Luxiq (betamethasone betamethasone /be·ta·meth·a·sone/ (ba?tah-meth´ah-son) a synthetic glucocorticoid, the most active of the antiinflammatory steroids; used topically as the benzoate, dipropionate, or valerate salts as an antiinflammatory, topically or valerate foam 0.1%), is pending approval by the FDA. "We are pleased to have conducted a successful trial, beat our deadlines and come one major step closer to potentially bringing another innovative product to patients." Connetics' initial target indication for OLUX is severe psoriasis and other dermatoses of the scalp. Scalp psoriasis is a chronic, recurrent dermatologic disease that affects approximately three million people in the United States with over 1.2 million patients in treatment at any time. Patients with severe scalp psoriasis suffer from various degrees of erythema, scaling, plaque and itching associated with the disease. The disease course typically involves periods of remission followed by accute exacerbation. Current treatment consists of corticosteroids Corticosteroids Definition Corticosteroids are group of natural and synthetic analogues of the hormones secreted by the hypothalamic-anterior pituitary-adrenocortical (HPA) axis, more commonly referred to as the pituitary gland. in cream, gel or liquid formulations. OLUX is a stabilized foam formulation of clobetasol propionate, 0.05%, a super high-potency corticosteroid corticosteroid /cor·ti·co·ster·oid/ (-ster´oid) any of the steroids elaborated by the adrenal cortex (excluding the sex hormones) or any synthetic equivalents; divided into two major groups, the glucocorticoids and . OLUX foam liquefies when applied to the scalp and is designed to achieve rapid and targeted delivery of the active drug to the disease site. In addition, the foam formulation is designed to be easier-to-apply, less messy and cosmetically more acceptable than currently marketed dermatological solutions, creams, ointments and gels. The foam formulation is licensed from Soltec Research, Pty. Ltd, an Australian company. Connetics Corporation, headquartered in Palo Alto, is focused on the acquisition, development and commercialization of marketed and late-stage products. Connetics currently markets Ridaura(R) (auranofin), a treatment for rheumatoid arthritis rheumatoid arthritis Chronic, progressive autoimmune disease causing connective-tissue inflammation, mostly in synovial joints. It can occur at any age, is more common in women, and has an unpredictable course. . Several products are under development including Luxiq and OLUX, for the treatment of certain dermatological indications; ConXn(R) (recombinant human relaxin-H2), for the treatment of certain rheumatologic and fibrotic diseases; and gamma interferon (through its wholly-owned subsidiary, InterMune Pharmaceuticals Inc.) for the treatment of certain congenital, infectious and other diseases. For more information on Connetics, visit the Connetics Web Site at http://www.connetics.com. This news release contains forward-looking statements or predictions. These statements represent the Company's judgement as of this date and are subject to risks and uncertainties that could cause actual results or events to differ materially from those expressed in such forward-looking statements. Potential risks and uncertainties include, without limitation, those associated with product development, clinical trials, future revenues and profitablity, and obtaining marketing approval. These and other factors are discussed in more depth in Connetics' Form 10-K Form 10-K A report required by the SEC from exchange-listed companies that provides for annual disclosure of certain financial information. Form 10-K See 10-K. for the fiscal year ended December 31, 1997 under the heading "Additional Factors That May Affect Future Results" and the Company's other filings with the SEC. These documents contain and identify important factors that could cause the actual results to differ materially from those contained in the projections or forward-looking statements. |
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