With the help of outsourcing partners, the small biotech firm Nabriva brought lefamulin to patients by itself. Now it needs to make a profit in the tough-to-crack antibiotic business
In November 2006, Rosemarie Riedl synthesized an antibacterial molecule that she logged into Nabriva Therapeutics’ database as BC-3781. It was not just another entry in a compound collection. In 2019, after almost 13 years of development and testing, the US Food and Drug Administration approved that same molecule, lefamulin, for the treatment of community-acquired bacterial pneumonia.
Marketed as Xenleta, lefamulin was the first antibiotic with a novel mechanism of action to win FDA approval for pneumonia in nearly two decades. With the help of contract manufacturing firms from across Europe and China, Nabriva took the drug to market without a big pharma partner.
Inventing a drug in its own labs and getting it approved solo is something few biotech firms have done. And yet it won’t be enough for the small company. Nabriva must now turn a profit on lefamulin, a goal that has eluded many independent antibiotic developers. Judging from Nabriva’s stock price, investors have their doubts that the firm will be in the black anytime soon.
Although Nabriva’s corporate offices are in the US, and its global headquarters are in Ireland, its research efforts are based in Vienna, where the culture is decidedly more European than American. Riedl, Nabriva’s senior director of medicinal chemistry, has been with the company and its predecessor, Sandoz, since earning her PhD in pharmaceutical chemistry. And she’s not the only long-tenured employee.