Revance Therapeutics, Inc. (Revance) today announced a settlement and termination agreement for its contractual relationships with Medicis Pharmaceutical Corporation (MRX) concerning RT001 Botulinum Toxin Type A Topical Gel and RT002 Injectable Botulinum Toxin Type A. As part of the settlement, all worldwide rights to develop and commercialize both products across all indications will be returned to Revance. The agreement will also resolve the outstanding litigation between the companies.
Under the terms of the agreement, Revance will make an upfront payment to Medicis of $7 million and up to an additional $18 million based on certain events. In return, the RT001 Option Agreement and related agreements, and the 2009 RT002 License Agreement will be terminated in their entirety. Medicis will retain its current equity ownership in Revance. Additional terms of the agreement were not disclosed.
Following the effective date of the agreement, Revance will be moving forward with the Phase 3 program for RT001 in the lead aesthetic indication. RT001 has reached End of Phase 2 with the FDA after studying more than 550 patients in eleven clinical trials. Collectively, these trials showed that RT001 demonstrated statistically significant efficacy with a strong safety profile. Revance is also pursuing clinical development of RT001 for therapeutic indications.
In addition, Revance will be initiating the Phase 1/2 program for RT002. RT002 is a next generation injectable designed to provide greater safety and efficacy than currently available injectable botulinum toxin products.
“We are tremendously excited about recovering all global rights to our product portfolio. This independence and our entrepreneurial corporate culture will keep fueling scientific innovation and progress,” said Dan Browne, President and Chief Executive Officer of Revance. “Controlling the development and commercialization of these innovative compounds will allow us to leverage our groundbreaking neuromodulation platform and maximize the value of our botulinum toxin franchise.”
About RT001 and RT002
RT001 Botulinum Toxin Type A Topical Gel is an investigational product whose first aesthetic indication is designed to reduce crow’s feet wrinkles by temporarily relaxing the muscle around the eyes. Based on clinical results, Revance’s goal is to expand the market beyond injectable treatments which, despite their popularity, have only captured about 10% of the potential market. Revance believes that offering a safe, efficacious and painless procedure will appeal to many consumers who have considered treatment but are uncomfortable with the pain and bruising associated with injectables. RT001 is currently being studied for the treatment of lateral canthal lines (crow’s feet) and the therapeutic indications of hyperhidrosis (excessive sweating) and migraine headaches.
RT002 is an investigational, next-generation, injectable neurotoxin that integrates Revance’s proprietary, purified botulinum toxin type A molecule with the patented TransMTS® peptide technology. Pre-clinical data suggests the TransMTS technology may enhance delivery of the drug to the target which may positively affect duration of effect and safety profile.
About Revance Therapeutics, Inc.
Revance Therapeutics, Inc. (Revance) is a privately held specialty biopharmaceutical company which develops next generation products in dermatology and therapeutic medicine. Revance has developed a platform technology, TransMTS® that enables local, targeted delivery of botulinum toxin and other potent macromolecules across skin without patches, needles or other invasive procedures.
Revance is backed by a blue chip roster of healthcare venture capital investors, including Essex Woodlands Health Ventures, Vivo Ventures, Technology Partners, NovaQuest Capital Management, Shepherd Ventures, Palo Alto Investors, Bio*One Capital and Pac-Link Ventures. For more information, see the company website at www.revance.com
About Revance's Litigation Team at Keker & Van Nest
Stuart Gasner centers his practice in the areas of white collar criminal and securities defense, intellectual property litigation and complex corporate disputes. A federal prosecutor before joining Keker & Van Nest, Mr. Gasner has tried more than 20 cases to verdict before juries across the United States.
Laurie Mims has extensive experience litigating complex civil and white collar criminal matters. She has tried a variety of cases, including several as first chair. Ms. Mims has represented institutional and individual clients in a wide range of industries, including health care, biotechnology, financial services, software development, venture capital and telecommunications.