"Of course, it's always interesting when a company takes more time to get to market," Allergan chief commercial officer William Meury said at the Bank of America healthcare conference in Las Vegas on Thursday, May 17. "It doesn't hurt our business, but to be fair we have to be focused on something bigger, which is market expansion."
Meury's appearance at the conference came a day after competitor Evolus Inc. (EOLS) - Get Evolus, Inc. Report said it had received a complete response letter from the U.S. Food and Drug Administration regarding its application for DWP-450 to treat glabellar, or frown, lines. A CRL indicates that a company's application is not ready to be approved.
Evolus, which earlier this month tapped former Allergan executive David Moatazedi as president and CEO, said Wednesday that the CRL cited deficiencies related to chemistry, manufacturing and controls processes, adding that the company expected to respond to the FDA within 90 days. Moatazedi said in the statement the company remained "committed to bringing DWP-450 to market by spring 2019."
On Thursday, Meury noted that the aesthetics business is large, lucrative and growing . "It's going to attract other companies," he said.
But Allergan has advantages including Botox's brand equity, Meury said. Botox is "in many respects equivalent" to Coke, Nike and Rolex in aesthetics, he said.
Besides DWP-450, an upcoming rival to Botox is Revance Therapeutics Inc.'s (RVNC) - Get Revance Therapeutics, Inc. Report RT002. Newark, Calif.-based Revance in December unveiled positive top-line results from a couple of Phase 3 studies evaluating RT002 for the treatment of frown lines. In the announcement, Revance said it believed that RT002, if approved, would be the first neuromodulator to work for as long as six months.
Separately, Revance and Mylan NV (MYL) - Get Viatris, Inc. Report in February said they had teamed up to create a proposed biosimilar, or copy, of Botox with both cosmetic and therapeutic indications.
At present, Botox Cosmetic competes with Galderma SA's Dysport and Merz Pharma GmbH & Co. KGaA's Xeomin. Galderma is a unit of Nestlé SA.
Botox Cosmetic had net revenue of $196.7 million in the U.S. in the first quarter, up 7% from the year-ago period. International net revenue was $148.6 million, representing a 15.3% rise from the first quarter of 2017, excluding the impact of foreign exchange.
Meanwhile, Allergan is in the process of evaluating options to create shareholder value. At the Deutsche Bank healthcare conference on May 8, Allergan CFO Matthew Walsh said the Dublin company expected to wrap up the strategic review shortly.
Allergan announced on Wednesday that CEO Brent Saunders is scheduled to speak at the Bernstein Strategic Decisions Conference on May 30.
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