FDA Approves Cheaper Botox Rival

NEW YORK, United States — An injection to treat forehead wrinkles is set to rival Allergan's Botox after U.S. regulators approved Evolus Inc's cheaper treatment on Friday, sending its shares up about 5 percent after the bell.

The approval of Evolus's Jeuveau to treat frown lines comes about eight months after the agency declined to approve the drug, citing deficiencies related to the chemistry and manufacturing of the product. "We see Evolus' entry into this market as very disruptive," Evolus Chief Executive Officer David Moatazedi said in an interview prior to the FDA's decision.

Evolus expects Jeuveau to be priced between 20 and 25 percent lower than Botox and is likely to be available throughout the United States at physician offices starting Spring 2019, the company said.

While Botox is expected to face challenges for its therapeutic uses from rival treatments, its cosmetic uses have so far remained largely unchallenged.

Botox was launched in 2002 and over the years it has evolved from a cosmetic injection to a treatment for migraines and bladder dysfunction, bringing in $3.58 billion in sales for Allergan in 2018.

Alternatives to Botox such as anti-wrinkle injections like Nestle's Dysport or Merz Pharma's Xeomin have failed to achieve Botox's success as they are either required to be taken more frequently.

As it prepares to face competition, Allergan said last year it was planning to double its spending on direct-to-consumer advertising and to expand its Botox sales force.

Newark, California-headquartered Revance Therapeutics is also developing a rival to Botox, which could have longer effect in treating wrinkles.

"The combination of Allergan doubling their investment in advertising for Botox, the under-penetration of the consumer category...our entry with Jeuveau will attract a significant amount of interest not just with the doctor ... but also for consumers," Moatazedi said.

By Manas Mishra; Editors: Sai Sachin Ravikumar and Arun Koyyur