- Allergan and Paratek Pharmaceuticals' plan to file their acne medication for U.S. approval later this year following positive early data from two pivotal Phase 3 trials.
- The placebo-controlled studies tested sarecycline as a treatment for moderate to severe acne. Topline results showed patients receiving the drug had significantly fewer inflammatory lesions than those who didn't. Across the two studies, 1.4% of sarecycline-treated patients had to stop participating due to adverse effects.
- The treatment is one in a group of antibiotics known as tetracyclines that work to prevent bacterial protein development. The companies plan to submit a New Drug Application (NDA) for the once-daily, oral medication in the second half of 2017.
A sarecycline approval would bring Paratek into the ranks of commercial-stage biotechs. Investor reaction reflected that news, with stock up nearly 10% to $17.38 per share in Monday morning trading.
Such a reaction makes sense given revenue estimates for the drug and the growing acne treatment market. Back in November 2015, Allergan anticipated peak annual sales of sarecycline would reach as high as $300 million, according to the most recent Paratek 10-K filing with the Securities and Exchange Commission.
Meanwhile, a recent study from market research firm Technavio anticipated the global acne drug market would have a compound annual growth rate of 3% from 2016 to 2020, reaching $4.4 billion by that out year.
Cognizant of the consumer demand, Allergan has been working to flesh out its skin care portfolio. Revenues for the company's medical dermatology unit, for example, grew 11% in 2016 to $397 million, according to its most recent 10-K filing.
Allergan has also pursued M&A in other skin-related therapeutic areas. For example, the company agreed to acquire Vitae Pharmaceuticals in September for about $640 million, giving it access to a pair of Phase 2 candidates — one for psoriasis, the other for eczema. Allergan also gained U.S. rights to sarecycline through its merger with Actavis, which was completed in 2015.
Allergan shares also rose slightly, trading up less than 1%.