Newport Beach-based Evolus Inc. (Nasdaq: EOLS) said the European Commission is taking longer than expected to reach a decision on marketing approval for Nuceiva, its European version of the competitor to Allergan’s Botox.
“We remain confident in the merits of the Nuceiva’s” marketing authorization application, Rui Avelar, M.D., chief medical officer and head of research and development, said in a statement.
“We look forward to the timely resolution of this final step with the European regulators and plan to confirm our timeline for approval upon receipt of clarification from the European Commission,” he said.
Shares reacted negatively after the EC announcement, falling 6.8% to $13.19 and a $360 million market cap. The company’s shares have dropped in half since late April when its majority owner, Irvine-based Alphaeon Corp., disclosed plans to sell at least $75 million of its shares, reducing its stake from 56% to 41%.
The European Medicines Agency’s committee on medicinal products had granted approval on April 26. At that time, Evolus said it expected the marketing decision to be approved within 90 days.
Now, Evolus said the EC has requested more information on Nuceiva, which is marketed in the U.S. under the name Jeuveau. Evolus didn’t disclose exactly what information the EC requested.
Earlier this month, Evolus announced a new marketing campaign using the hashtag #newtoxnow, a play on its competition with larger rival Botox. Jeuveau launched in the U.S. last month with a large deal of fanfare. Its marketing push for the wrinkle-smoothing product was profiled in the May 20 issue of the Business Journal.
The company said that in three weeks, it enrolled 3,000 accounts in the Jeuveau Experience Treatment program. It’s also giving $75 each to consumers to try the program at participating practices.
