In the first quarter of 2020, Revance entered into a distribution agreement with TEOXANE SA making Revance the exclusive commercialization partner of the company’s innovative RHA® or Resilient Hyaluronic Acid®) technology. Under the distribution agreement, Revance gained immediate and exclusive rights to commercialize TEOXANE’s RHA® collection of fillers in the U.S., starting with the FDA-approved RHA® 2, RHA® 3, and RHA® 4 products, which include lidocaine. The agreement also includes a fourth product, RHA® 1, currently in clinical trials in the U.S. with FDA approval anticipated in 2021, and includes an ongoing collaboration with TEOXANE SA for a robust pipeline of additional indications and next-generation dermal filler technologies. Additionally, the agreement contains a right of first negotiation to access TEOXANE’s novel cosmeceutical line that incorporates its propriety RHA® technology.
We have begun development of a biosimilar to BOTOX®, which would compete in the existing neuromodulator marketplace. In February 2018, we signed a collaboration and license agreement with Mylan N.V. for development and regulatory approval of a biosimilar to BOTOX®, to be followed with commercialization by Mylan in the U.S., Europe, and applicable markets across the globe, post regulatory approvals. Decision by Mylan on continuation of biosimilar to BOTOX® program is expected by April 30, 2020.
BOTOX® is a registered trademark of Allergan, Inc.
China Market License
We entered into a license agreement with Shanghai Fosun Pharmaceutical Industrial Development Co., Ltd., (Fosun Pharma Industrial), a wholly-owned subsidiary of Shanghai Fosun Pharmaceutical (Group) Co., Ltd. (Fosun Pharma), providing Fosun Pharma Industrial with the exclusive rights to develop and commercialize our proprietary DaxibotulinumtoxinA for Injection in mainland China, Hong Kong and Macau (the Territory).
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DaxibotulinumtoxinA for Injection is an investigational agent that has not been approved by the FDA. Anticipated approval in 2020