October 01, 2014
NEWARK, Calif., Oct. 1, 2014 (GLOBE NEWSWIRE) -- Revance Therapeutics, Inc. (Nasdaq:RVNC), a biopharmaceutical company developing botulinum toxin products for use in aesthetic and therapeutic indications, today announced that the company has initiated a study to confirm this quarter the successful transfer of production of the topical RT001 drug product to Revance's U.S. commercial manufacturing facility. Following successful confirmation of this transfer, Revance plans to initiate its first U.S. Phase 3 RT001 pivotal study for the treatment of lateral canthal (crow's feet) lines, with results now anticipated during the first quarter of 2015. Previously, Revance expected to report results from the first U.S. Phase 3 pivotal study by the end of 2014.
"To confirm success of the production transfer, we decided to initiate an open-label clinical study using RT001 drug product made in our commercial manufacturing facility," said Dan Browne, Revance's President & CEO. "We believe taking the extra time to complete this short duration clinical study to confirm successful manufacturing transfer of RT001 prior to enrolling patients in our Phase 3 pivotal studies has the potential to benefit our pipeline of RT001 product candidates."
"The recently initiated open-label study is a four-week, multi-center study of up to 60 patients. We plan to provide a clinical program update on both of our product candidates, topical RT001 and injectable RT002, during our third quarter earnings conference call in November," added Browne.
About Revance Therapeutics, Inc.
Revance is a specialty biopharmaceutical company focused on the development, manufacturing and commercialization of novel botulinum toxin products for multiple aesthetic and therapeutic applications. Revance is leveraging its proprietary portfolio of botulinum toxin compounds combined with its patented TransMTS® peptide delivery system to address unmet needs in the large and growing aesthetic and therapeutic botulinum toxin market. Revance's proprietary TransMTS® technology enables transcutaneous delivery of botulinum toxin A, eliminating the need for injections. Revance's lead product candidate, RT001, is a topical formulation of botulinum toxin type A, which has the potential to be the first commercially-available non-injectable dose form. RT001 is being evaluated in a broad clinical program that includes aesthetic indications such as crow's feet lines (wrinkles around the eyes) and therapeutic indications such as hyperhidrosis (excessive sweating) and migraine headache. Revance's second product candidate is RT002, a novel injectable formulation of botulinum toxin type A designed to be more targeted and longer lasting than currently available botulinum toxin injectable products.
"Revance Therapeutics", TransMTS® and the Revance logo are registered trademarks of Revance Therapeutics, Inc.
For more information, please visit: www.revance.com.
This press release contains forward-looking statements, including statements related to the process, results and timing of, and ability of Revance to complete ongoing and anticipated clinical development of our product candidates, including but not limited to successful manufacturing transfer of RT001 and results from our clinical development programs, reporting of such results; statements about our business strategy and goals, plans and prospects; and the potential benefits and pipeline of our product candidates and our technologies.
Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from our expectations. These risks and uncertainties include, but are not limited to: the outcome, cost and timing of our product development activities and clinical trials; the uncertain clinical development process, including the risk that clinical trials may not have an effective design or expected results; our ability to obtain and maintain regulatory approval of our product candidates; our ability to obtain funding for our operations; our plans to research, develop and commercialize our product candidates; our ability to achieve market acceptance of our product candidates; unanticipated costs or delays in research, development and commercialization efforts; the applicability of clinical study results to actual outcomes; the size and growth potential of the markets for our product candidates; our ability to successfully commercialize our product candidates and the timing of commercialization activities; the rate and degree of market acceptance of our product candidates; our ability to develop sales and marketing capabilities; the accuracy of our estimates regarding expenses, future revenues, capital requirements and needs for financing; our ability to continue obtaining and maintaining intellectual property protection for our product candidates; and other risks. Detailed information regarding factors that may cause actual results to differ materially from the results expressed or implied by statements in this press release may be found in Revance's periodic filings with the Securities and Exchange Commission (the "SEC"), including factors described in the "Risk Factors" section of our Form 10-Q filed August 13, 2014. These forward-looking statements speak only as of the date hereof. Revance Therapeutics disclaims any obligation to update these forward-looking statements.
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