- Manufacturing issues have tripped up two experimental drugs, resulting in the Food and Drug Administration handing their respective makers Complete Response Letters this week.
- Heron Therapeutics disclosed Wednesday the regulator had rejected HTX-011, a non-opioid painkiller for postoperative pain. According to Heron, the FDA wants additional information on chemistry, manufacturing and controls to proceed, along with more non-clinical data.
- Nabriva Therapeutics, meanwhile, said late Tuesday that its drug for complicated urinary tract infections was turned down by the agency. "The CRL requests that Nabriva address issues related to facility inspections and manufacturing deficiencies at one of Nabriva's contract manufacturers," the biotech stated.
Shares in both biotechs suffered double-digit percentage drops Wednesday.
The news helped to boost shares of Heron's rival Pacira, however, as the setback to Heron's would-be competitor benefits its hold on the market.
Pacira's Exparel (bupivacaine) was approved in 2011 for post-surgical analgesia. HTX-011, by contrast, is a mixture of bupivacaine and meloxicam, a non-steroidal anti-inflammatory drug.
Amid the ongoing national opioid epidemic, Heron has run clinical studies to position HTX-011 as an opioid-sparing treatment. A key test of that approach, which the FDA has now delayed with its rejection, will be whether the agency agrees and gives the drug a corresponding label.
Wall Street analysts expect Heron to resubmit the drug and generally forecast a 2020 launch, saying further clarity from a future FDA meeting will help solidify a timeline.
For Nabriva, Contepo (fosfomycin) did not receive approval for complicated urinary tract infections.
The issues raised by the FDA — according to Nabriva, at least — relate to its manufacturing supply and deficiencies flagged at the company's contract manufacturer.
For the biotech, it's yet another challenge to overcome.
The antibiotics market is already commercially difficult. Most large drugmakers have exited the space, and the biotechs which have remained have not had any better luck. Most recently, Achaogen filed for bankruptcy, while Melinta Therapeutics has struggled financially.
Following Achaogen's bankruptcy announcement, Jeremy Farrar, director of the Wellcome Trust, warned a "disaster is unfolding," writing in the Financial Times about the need for government intervention in the antibiotics market.
"Capital-starved smaller companies will fold. Innovation will die on the vine," he wrote. "Money already invested by governments and charities will be squandered."
Achaogen had actually secured approval for its antibiotic, but that proved insufficient to stave off a bankruptcy filing less than a year later.
Even if Nabriva eventually does win an OK for Contepo, that appears no guarantee of future success.