By Kim Coghill
Vivus Inc. withdrew its new drug application for Alibra, a second-generation product used to treat erectile dysfunction.
Richard Walliser, chief financial officer of the Mountain View, Calif., company, said the FDA had some questions concerning the product, which is a urethral microsuppository of alprostadil and prazosin hydrochloride. "If we didn't withdraw the application, they would publish a non-approval letter," he said.
Vivus' next step is scheduling a meeting with the FDA to address the concerns. "They'll tell us why they didn't approve," Walliser said. "It may be very minor. We've been talking with the FDA all along. That's why this is such a surprise to us."
Bonnie Feldman, an analyst with Lippert/Heilshorn & Associates Inc. in Los Angeles, said it is not uncommon to withdraw an application and doing so should not affect Vivus' stock. The stock (NASDAQ:VVUS), in fact, closed unchanged Monday at $3.
The company last December filed the application for Alibra. It's the second generation of Muse, a non-injectable delivery system for alprostadil, which is chemically identical to the naturally occurring eicosanoid, prostaglandin E1 (PGE1). (See BioWorld Today, Sept. 7, 1999.)
The products are different in that Alibra will be given in a smaller dose and likely will cause fewer side effects, Walliser said. In addition, Alibra's applicator is a smaller, redesigned version.
"We felt Alibra would give us a drug to more aggressively compete with Viagra," Walliser said.
Until New York-based Pfizer Inc.'s Viagra entered the market, Muse was a leading treatment for erectile dysfunction. Muse had a successful launch in 1997, generating sales of $130 million. Since Viagra's introduction, Muse's United States sales have dropped annually, to $25 million in 1998 and $45 million in 1999.
Alibra and Muse are delivered locally, thus circumventing systemic effects sometimes associated with Viagra.
Vivus in June entered a distribution and marketing agreement with Abbott Laboratories, of Abbott Park, Ill., giving Abbott exclusive rights for Muse and Alibra in Europe, Japan, Australia, New Zealand, South America and Central America.
Walliser said there's a growing market for products that address sexual dysfunction in both men and women.
In late September, Vivus filed an investigational new drug application with the FDA for its female sexual dysfunction product Alista. The company plans to initiate human clinical testing soon after the FDA's 30-day waiting period. Alista is a proprietary topical formulation of alprostadil applied locally to the female genitalia. According to a statement released by the company, Alista is believed to increase blood flow to the female genitalia, thereby promoting engorgement and other natural processes that occur during sexual stimulation.