- Generics maker Mylan NV will team up with Revance Therapeutics Inc. to develop a biosimilar version of Allergan plc's multi-purpose treatment Botox, aiming to break into the high-value medical aesthetics market with a copycat competitor.
- Per the deal, Mylan will pay $25 million upfront to Revance, with another $100 million in potential clinical and regulatory milestones lined up if the biosimilar progresses as planned. Mylan will hold exclusive rights for development and commercialization of the candidate outside Japan.
- For Mylan, the collaboration is another example of the company's efforts to build a biosimilar portfolio. The drugmaker in December won the first U.S. approval of a copycat of Roche AG's Herceptin and hopes to launch a Neulasta copy in the states later this year.
Allergan has steadily grown Botox, a neurotoxin purified from Clostridium botulinum, into a $3-billion-a-year business that spans a wide range of therapeutic and aesthetic uses. Over the nearly three decades Botox has been on the market, the drug has shrugged off competitive challenges from Medicis Pharmaceutical (now owned by Valeant Pharmaceuticals International Inc.) and Merz Pharma GmbH & Co.
Interestingly enough, Revance also has designs to bring a branded competitor to market, currently developing a longer-acting neuromodulator known as RT002 for treatment of frown lines, cervical dystonia and plantar fasciitis. RT002 would be a direct rival to Botox, so developing a presumably cheaper copycat version might seem counterintuitive.
Cowen & Co analyst Ken Cacciatore doesn't see it that way, however.
"We believe that Revance would not have entered this deal with Mylan if they believed that this product would meaningfully alter the current opportunity for what we (and they) believe is the more valuable RT002," he wrote in a March 1 note.
Cacciatore noted that previous competitive entries by Medicis and Ipsen SA's Dysport (abobotulinumtoxinA) and Merz's Xeomin (incobotulinumtoxinA) did not lead to dramatic price discounting, and argued Mylan and Revance will have their work cut out to prove biosimilarity of their proposed candidate to Botox.
For Revance, however, the deal should provide near-term non-dilutive capital to help it develop RT002.
"Strategically, this partnership with Mylan allows Revance to remain focused on the development and launch of our own premium, long-acting RT002 neuromodulator, while also benefiting financially from potential future milestones and sales royalties on a short-acting biosimilar to Botox," said Revance CEO Dan Browne in a prepared statement.
Revance currently expects to file a Biologics License Application for RT002 with the Food and Drug Administration in the first half of 2019, with potential approval to follow by 2020.
Mylan said it would disclose further details of its development plans for the Botox biosimilar at its investor day in April. Cowen doesn't anticipate Mylan and Revance's Botox biosimilar reaching the market before 2021.