Mylan N.V. (NASDAQ: MYL) and Revance Therapeutics, Inc. (RVNC) today announced a global collaboration and license agreement for the development and commercialization of a proposed biosimilar to BOTOX® (onabotulinumtoxinA). BOTOX is the market-leading neuromodulator approved for the treatment of multiple indications and usage in the United States with additional approvals globally …
“This will be a significant opportunity for Mylan as we add another difficult-to-manufacture product to our pipeline. We have reviewed the work done to date by Revance and we are extremely excited and confident about our ability to bring this important product to market. Bringing an affordable biosimilar version of BOTOX to commercialization will offer patients a safe alternative to this popular and highly effective treatment,” commented Mylan President Rajiv Malik.
Revance will receive $25 million upfront, and milestones and royalties dependent upon net sales. Revance will also exclusively develop RT002 – its next-generation neuromodulator. A few months ago Revance reported two Phase 3 trials (SAKURA) for RT002 were positive pursuant to moderate-to-severe glabellar lines. If a longer-term safety trial is successful in the second of 2018 then Revance is expected to launch a Bilogics Licence Application next year. It hopes to launch RT002 in 2020 on approval.
Why The Mylan Revance Collaboration Matters
Clinical trials show that Revance’s R002 can potentially best Botox in certain areas. For instance, SAKURA 1 and SAKURA demonstrated RT002 could last six months, where Botox loses efficacy around four months. That could mean fewer visits to the doctor for patients using R002 vis-a-vis Botox. In terms of efficacy Revance appears to have a very competitive product. The fact that Mylan wants to partner with the company appears to be a major vote of confidence for Revance’s product expertise.
However, Revance is not well-capitalized as it is still in start-up mode. Through the first nine months of 2017 Revance suffered operating losses of about $85 million and cash flow from operations of -$67 million. It had cash on hand of $153 million and could need to raise more capital to finish clinical trials for RT002. Not only does Mylan bring financial resources to the table, but it can share its scientific, regulatory and manufacturing capabilities and commercialization expertise with Revance.
Mylan and Allergan have gone head-to-head on patent disputes in the past. They have been locked in a patent battle over Allergan’s blockbuster dry-eye drug Restatis. In October 2017 Judge William C. Bryson invalidated the Restasis patents in federal court due to “obviousness.” If Mylan wins an inter partes review (“IPR”) pursuant to the drug it could potentially bring generic Restasis to market within months.