Status update of RT001, the first botulinum toxin A gel for topical use.
Revance Therapeutics, Inc. (Revance) announced in October 2012 a settlement and termination agreement for its contractual relationships with Medicis Pharmaceutical Corporation 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.
In April 2013 Revance Therapeutics, Inc. (Revance) announced that it has raised $33 million of its Series E growth financing. In addition, Revance announced the conversion of $71 million in convertible debt into the Series E preferred stock. This closing of the financing included significant investment from new investors as well as participation from existing institutional investors.
The proceeds of the financing will be used to support US Phase 3 trials for the topical delivery of botulinum toxin type A to reduce the severity of crow’s feet wrinkles, as well as to support other neuromodulation clinical studies.
"We are pleased to welcome new shareholders to Revance as we continue our lead Phase 3 program, and are grateful for the ongoing support from our existing investors," said Dan Browne, President and Chief Executive Officer of Revance. "We plan to utilize these funds to further expand our clinical trials that are underway and advance the development of our product candidates, RT001 and RT002."
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 currently in US Phase 3 trials for the topical delivery of botulinum toxin type A to reduce the severity of crow's feet wrinkles by temporarily relaxing the orbicularis oculi muscle around the eyes. RT001 is also currently in Phase 2 trials for the topical treatment of hyperhidrosis (excessive sweating), and chronic migraine headache.
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. RT002 is currently in Phase 1/2 trials.
Anne-Marie van Geloven
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