(Reuters) - A potential rival for Allergan Plc’s blockbuster Botox has passed a late-stage study, putting drug developer Revance Therapeutics Inc on course to file for U.S. marketing approval next year.
Revance shares climbed as much as 13 pct to $23.60 on Tuesday.
More than 95 percent of patients administered with Revance’s long-acting neuromodulator injection RT002 were found to have none or mild frown lines after four weeks, according to data from the third late-stage study.
The treatment, which requires two or less doses a year, was effective in maintaining reduced wrinkle severity in patients for a median duration of 24 weeks.
Revance Chief Executive Dan Browne said on a conference call the treatment, if approved, could receive a 24-week label.
Analysts have noted that patients are keen on long-lasting alternatives as opposed to treatments like Botox, which is labeled to be administered in 12-16 week or longer intervals.
Revance said the market for nerve activity regulating neuromodulators, which recorded total global sales of $4 billion in 2017, remains underpenetrated as currently available products do not address patient need for long-term results.
Revance’s treatment, which has a six-month median duration of effect, provides a meaningful advantage over competitive products such as Botox, analysts said.
The trial lessened some concerns investors had with respect to repeat dosing, SunTrust Robinson Humphrey analyst John Boris said in a note.
“Data was in-line with our expectations and supports premium pricing for RT002 when it’s launched in 2020,” said Boris, who expects the drug to bring in sales of $400 million in 2023.
Separately, Revance signed a license deal with China’s Fosun Pharma, covering exclusive rights to develop and commercialize RT002 in mainland China, Hong Kong and Macau.
According to the deal, Revance will receive an upfront payment of $30 million and is eligible to receive additional milestone payments of up to $230.5 million, besides tiered low-double-digit to high-teen royalty payments on future net sales.
Reporting by Tamara Mathias, Manogna Maddipatla and Saumya Sibi Joseph in Bengaluru; Editing by James Emmanuel and Shinjini Ganguli
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