Connetics Reports Positive Results From Second Phase III Clinical Trial of Extina(R) (Ketoconazole) Foam, 2%; NDA Resubmission Anticipated by Year-End 2006.PALO ALTO, Calif. -- Connetics Corporation (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on :CNCT CNCT Connect CNCT Certified Network Computer Technician ), a specialty pharmaceutical company that develops and commercializes dermatology products, today announced a positive outcome in a 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 Extina(R) (ketoconazole ketoconazole /ke·to·co·na·zole/ (ke?to-kon´ah-zol) a derivative of imidazole used as an antifungal agent. ke·to·co·na·zole n. ) Foam, 2%, formulated in VersaFoam-HF(TM), for the treatment of seborrheic dermatitis Seborrheic Dermatitis Definition Seborrheic dermatitis is a common inflammatory disease of the skin characterized by scaly lesions usually on the scalp, hairline, and face. . The Extina Phase III clinical study was a four-week, double-blinded, active- and placebo-controlled trial that included 1,162 patients at 24 centers in the United States. The trial was designed to demonstrate that Extina is superior to placebo foam as measured by the primary endpoint of Investigator's Static Global Assessment (ISGA ISGA Interim Self Governing Authority ). The ISGA for this trial was an overall assessment of the severity of seborrheic dermatitis with respect to the clinically relevant signs of the disease. The treatment success based on ISGA showed a 56% response for Extina and a 42% response for placebo foam, a statistically significant difference (p=0.0001). The trial also demonstrated non-inferiority versus an active comparator comparator Instrument for comparing something with a similar thing or with a standard measure, in particular to measure small displacements in mechanical devices. In astronomy, the blink comparator is used to examine photographic plates for signs of moving bodies. arm of ketoconazole cream. The treatment success based on the ISGA showed a 56% response for Extina and a 56% response for the reference ketoconazole product. Adverse events with Extina were mild to moderate in nature and were related primarily to burning and stinging at the application site. "We are enthusiastic about the strength of the Extina pivotal data," said Lincoln Krochmal, M.D., Executive Vice President of Research and Product Development for Connetics. "Seborrheic dermatitis most often affects the scalp and face, and is a common condition, with more than one million patients seeking physician treatment for the disease in 2005. We believe our quick-drying foam application offers significant convenience and ease of application, particularly on the scalp, compared to currently available topical antifungal shampoos, gels and creams. We look forward to the prospect of submitting a Class 2 Resubmission to 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. by the end of the year and obtaining approval to market Extina in the United States six months after submission." In April 2003, Connetics announced results from the initial Phase III clinical trial of Extina in seborrheic dermatitis. The trial enrolled a total of 619 patients at 25 centers in the United Sates. Results demonstrated Extina was not inferior to Nizoral(R) (ketoconazole), 2%, cream as measured by the ISGA. The trial was also designed to compare Extina Foam to placebo foam. That result, although in favor of Extina per the ISGA, did not achieve statistical significance versus placebo foam. On all other endpoints, statistical significance was achieved, and Connetics submitted an 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 the FDA in July 2003. In November 2004, Connetics received a non-approvable letter for Extina Foam based primarily on the FDA's conclusion that it did not demonstrate statistically significant superiority to placebo foam. As a result of meetings between Connetics and FDA officials regarding requirements for the Extina NDA, Connetics announced that it would recommence Re`com`mence´ v. i. 1. To commence or begin again. 2. To begin anew to be; to act again as. He seems desirous enough of recommencing courtier. - Johnson. v. t. 1. To commence again or anew. development by conducting a Phase III trial intended to demonstrate that Extina Foam is superior to placebo foam and not inferior to a reference ketoconazole product. The second Phase III study was initiated in September 2005. About Ketoconazole Ketoconazole is used to treat a variety of fungal infections, including seborrheic dermatitis. Seborrheic dermatitis is a chronic, recurrent skin condition that affects three to five percent of the U.S. population. It usually involves the scalp, but also can affect skin on other parts of the body, including the face and chest. Symptoms include itching, redness and scaling. In 2005, the total U.S. market for topical antifungal products was approximately $735 million. About Connetics Connetics Corporation is a specialty pharmaceutical company focused on the development and commercialization of innovative therapeutics for the dermatology market. Connetics has branded its proprietary foam drug delivery vehicle VersaFoam(R). The Company's marketed products are OLUX(R) (clobetasol propionate clobetasol propionate (klōbā´t Eczema is a general term used to describe a variety of conditions that cause an itchy, inflamed skin rash. Atopic dermatitis, a form of eczema, is a non-contagious disorder characterized by chronically inflamed skin and ; Primolux(TM) (clobetasol propionate) Foam, 0.05%, a super high-potency topical steroid formulation to treat atopic dermatitis and plaque psoriasis; Extina(R) (ketoconazole) Foam, 2%, to treat seborrheic dermatitis; and Velac(R) (a combination of 1% clindamycin and 0.025% tretinoin tretinoin /tret·i·noin/ (tret´i-noin?) the all-trans stereoisomer of retinoic acid, used as a topical keratolytic in the treatment of acne vulgaris and disorders of keratinization and administered orally in the treatment of acute ) Gel, to treat acne. Connetics' product formulations are designed to improve the management of dermatological diseases and provide significant product differentiation Product Differentiation A source of competitive advantage that depends on producing some item that is regarded to have unique and valuable characteristics. . In Connetics' marketed products, these formulations have earned wide acceptance by both physicians and patients due to their clinical effectiveness, high quality and cosmetic elegance. For more information about Connetics and its products, please visit www.connetics.com. Forward-Looking Statements Except for historical information, this press release includes "forward-looking statements" within the meaning of the Securities Litigation An action brought in court to enforce a particular right. The act or process of bringing a lawsuit in and of itself; a judicial contest; any dispute. When a person begins a civil lawsuit, the person enters into a process called litigation. Reform Act. All statements included in this press release that address activities, events or developments that Connetics expects, believes or anticipates will or may occur in the future, including, particularly, statements about the timing and outcome of submissions to the FDA, and the market potential of Extina Foam relative to currently available treatments are forward-looking statements. All forward-looking statements are based on assumptions made by Connetics' management based on its experience and perception of historical trends, current conditions, expected future developments and other factors it believes are appropriate under the circumstances. Such statements are subject to a number of assumptions, risks and uncertainties, many of which are beyond Connetics' control, and which could cause actual results or events to differ materially from those expressed in such forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, risks and other factors that are discussed in documents filed by Connetics with the Securities and Exchange Commission from time to time, including Connetics' Annual Report on Form 10-K/A for the year ended December 31, 2005 and the Form 10-Q for the quarter ended June 30, 2006. Forward-looking statements represent the judgment of the Company's management as of the date of this release, and Connetics disclaims any intent or obligation to update any forward-looking statements. Press Release Code: CNCT-G |
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