- Nabriva Therapeutics on Monday gained U.S. approval for its pneumonia treatment lefamulin, bringing a new antibiotic option to a commercially difficult market.
- Lefamulin, which will be sold as Xenleta, was approved by the Food and Drug Administration as both an IV and oral treatment for adults with community-acquired bacterial pneumonia, or CABP. The small biotech plans to launch the pleuromutilin antibiotic in mid-September, the company said.
- The oral option could save health systems money, allowing patients to avoid or shorten hospital stays necessitated by IV delivery, Nabriva executives noted.
Nabriva notched its first regulatory approval just a few months after the FDA rejected its other leading drug candidate, Contepo (fosfomycin), as a complicated urinary tract infection treatment.
But the most difficult challenges for Xenleta may still be yet to come. Multiple Wall Street analysts asked the company Monday for specifics on its commercial plans, and how the small biotech expects to drive uptake in the hospital setting, which has proven to be difficult.
Achaogen, for instance, filed for bankruptcy within a year of securing regulatory clearance for its antibiotic. Most large drugmakers, meanwhile, have fled from antibiotics development in favor of other, more profitable therapeutic areas.
The effects of Nabriva's good news were short-lived on Wall Street. While the stock opened up more than 20% Tuesday morning, those gains evaporated by noon, with shares trading slightly down.
Approval of Xenleta also weighed on Melinta Therapeutics, a rival antibiotic drugmaker that has its own CABP treatment, Baxdela (delafloxacin), under FDA review. Melinta's stock declined 9% Tuesday and is trading at levels nearly 90% below its market value a year ago.
Even with commercial challenges ahead, Nabriva CEO Ted Schroeder emphasized the continued need for antibiotic development.
"There hasn't been a novel antibiotic class approved in nearly two decades," Schroeder said. "During that time, the most common bacterial strains causing CABP have become increasingly resistant to currently approved antibiotics."
The biotech plans to focus its 60 sales representatives on about 900 accounts, initially focused on emergency departments and hospital outpatient centers.
Alan Carr, a biotech analyst for Needham, said there are meaningful shortcomings in the other oral options for pneumonia, leading to "a broad migration to IV antibiotics (Ceftriaxone) and increased hospitalization."
Carr argued Xenleta could reverse that shift and reduce the number of patients admitted to the hospital from the ER. He estimated peak U.S. sales at between $350 million and $400 million by 2030.
Getting there, though, could require additional resources to support the commercial launch. As of the end of June, Nabriva had roughly $75 million in cash and equivalents.