ExtinaTreatment for Seborrheic Dermatitis
Update: Extina (ketoconazole) Foam Now FDA Approved - June 12, 2007
Connetics Receives FDA Non-Approvable Letter for Extina
PALO ALTO, Calif., November 23, 2004 - Connetics Corporation (Nasdaq:CNCT), a specialty pharmaceutical company focused on dermatology, today announced that the U.S. Food and Drug Administration (FDA) has issued a non-approvable letter (dated November 23, 2004) for Extina, an investigational new drug formulation of 2% ketoconazole for the treatment of seborrheic dermatitis. The FDA concluded that Extina was not effective for the treatment of seborrheic dermatitis because it was not superior to placebo foam.
Connetics announced in April 2003 that results from its Phase III clinical trial with Extina demonstrated non-inferiority to Nizoral (ketoconazole) 2% Cream as measured by the endpoint of the Investigator's Static Global Assessment. Connetics also announced the results did not achieve statistical superiority versus placebo foam.
"The FDA's decision is disappointing and surprising. Based on discussions with the FDA regarding the requirements for the Phase III trial, we believe Extina met the study endpoints and that the NDA was approvable," said Thomas G. Wiggans, Connetics' Chief Executive Officer. "We believe that Extina demonstrated efficacy and warranted approval. However, under the circumstances, we will evaluate all options for Extina."
Commenting on the company's near-term commercial prospects, Mr. Wiggans added, "With our recently expanded and highly experienced sales force, we project continued growth from our core brands in 2005, and we are prepared for the commercial launch of Evoclin, our new acne foam product, early next month. In addition, we have submitted an NDA for Velac and have a robust pipeline of clinical and formulation-stage product candidates. We believe that any potential lost revenue for Extina in 2005 will be offset by expense savings as we will not be incurring the planned commercialization costs for Extina."
As a result of today's announcement, Connetics now expects product revenues and earnings per diluted share for the 2004 fourth quarter will come in at the low end of previous guidance ranges of $43 million to $46 million and $0.16 to $0.18, respectively.
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. The Company's marketed products are OLUX (clobetasol propionate) Foam, 0.05%, Luxiq (betamethasone valerate) Foam, 0.12%, Soriatane (acitretin) capsules and Evoclin (clindamycin) Foam, 1%. Connetics is developing Velac (a combination of 1% clindamycin and 0.025% tretinoin) Gel, for treating acne, and Desilux (desonide) Foam, 0.05% a low-potency topical steroid formulated to treat atopic dermatitis. Our product formulations aim to improve the management of dermatological diseases and provide significant product differentiation. In our 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.
Posted: November 2004
- FDA Approves Extina for the Treatment of Seborrheic Dermatitis - June 13, 2007
- Connetics' New Drug Application for Extina Has Been Accepted for Filing by the FDA - April 8, 2004