Mylan Teams Up with Revance Therapeutics to Develop Botox Biosimilar


Mylan signed a global collaboration and license deal with Revance Therapeutics, Inc. to develop and market a biosimilar to Botox (onabotulinumtoxinA).

Mylan paid Revance $25 million upfront. Revance will be eligible for milestone payments based on clinical, regulatory and sales targets, as well as royalties.

Botox is marketed by Allergan, Inc., primarily in the aesthetic market to smooth out wrinkles and frown lines. Botox is developed from the bacterial toxin that causes botulism. It blocks nerve activity in the muscles.

“Global neuromodulator sales today are estimated at $4 billion and forecasted to grow steadily, exceeding $7 billion by 2024,” said Dan Browne, president and chief executive officer of Revance Therapeutics, in a statement. “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 benefitting financially from potential future milestones and sales royalties on a short-acting biosimilar to Botox. We believe Mylan is the ideal partner to co-develop, seek regulatory approval and market a biosimilar to Botox, due to its significant expertise in the field and its global commercial infrastructure.”

The announcement comes at the same time Mylan released its fourth-quarter earnings report. For the fourth quarter, earnings dropped because of declining EpiPen revenue and soft generic drug prices in the U.S. Net income for the quarter was $244.3 million, or 46 cents per share. That’s a drop from $417.5 million in the same quarter in 2016, or 78 cents a share. Revenue for the quarter dropped 1 percent to $3.24 billion, missing average analyst projections of $3.3 billion.

Although it’s difficult to prove the correlation, investors seemed to like the deal with Revance. Despite the soft earnings report, Mylan shares rose 1.4 percent to $40.89 in after-hours trading yesterday. Revance shares remained the same, but Allergan shares dropped half a percent to $153.46.

In the company’s conference call yesterday, executives noted several recent or upcoming launches. One is a generic to Allergan’s Restasis, for dry eye, a generic multiple sclerosis (MS) version of Teva Pharmaceuticals, Inc.’s Copaxone in Europe, Glatiramer Acetate, a hepatitis C generic to Gilead Sciences, Inc.’s Epclusa in India called MyHep All, and a generic HIV medication, Efavirenz, a generic version of Bristol-Myers Squibb Company’s Sustiva.

“With all this said, Mylan was by no means immune in 2017 to the industry’s turbulence, particularly as experienced in the U.S., the world’s largest pharmaceutical market,” said Heather Bresch, Mylan’s chief executive officer, during the conference call. “But we believe we were best positioned to absorb the impact, deliver growth and expand access. In fact, it was precisely because we saw where the industry was heading that we embarked about a decade ago on our journey to transform Mylan and move into the much larger and more stable global community we now live.”

Of the Revance deal, Rajiv Malik, Mylan’s president, said in a statement, “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.”

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