The news at Insmed ($INSM) tends to run hot and cold for investors. When their experimental antibiotic Arikayce hits trouble, its stock price goes cold and shrivels. Good news runs hot on the market. On Monday, though, the share price plunged after the biotech laid out plans for a lengthy pair of late-stage studies, squashing hopes for a quick dash to the FDA for an early approval.
By the end of day Monday Insmed's stock price was down about 27% as investors reacted to Insmed's plans to run a pair of late-stage studies in order to gain U.S. approval. Following discussions with regulators, the Bridgewater, NJ-based biotech says it will launch a late-stage study of Arikayce for a broad population of patients suffering from nontuberculous mycobacteria (NTM) lung infections with a second, smaller study to test the inhaled antibiotic on mycobacterium avium complex (MAC) NTM lung infections in order to confirm earlier data.
The smaller study should wrap in 2016 with data from the larger Phase III rolling in in 2017--well after some investors had been hoping to see the therapy on the U.S. market.
Insmed isn't waiting around for more data in Europe, though. There the biotech says it plans to file for an approval later this year, drawing up a blueprint for a market launch, provided the EMA comes through. But it's hard for Europe, with its single-purchaser restrictions and hardball negotiating tactics, to compare with the U.S. market, which offers more of a cornucopia with few price limitations.
Just a little more than a month ago the news and stock price at Insmed ran hot when news spread that the FDA had provided breakthrough drug status for Arikayce. Regulators handed out the coveted designation on Phase II NTM data, sending its share price up 42%. But the antibiotic, a reformulated version of amikacin designed for extended use, also failed a primary endpoint in a Phase II in March, continuing the roller coaster ride for investors drawn to the high-wire act of drug development. The BTD stoked hopes for an accelerated approval--a key feature of what the FDA is offering--but not every arm of the agency acts consistently when it comes to breakthroughs.
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| Insmed CEO Will Lewis |
"Our planned filing in Europe is a significant step forward in our goal to bring Arikayce to market to benefit the thousands of European NTM patients refractory to standard therapy, as well as cystic fibrosis patients with Pseudomonas aeruginosa lung infections," said Insmed CEO Will Lewis in a statement. "We will continue to resource our clinical, commercial and manufacturing capabilities in order to expedite our regulatory submissions and prepare for commercial launch, initially in Europe."
- here's the release