Nabriva Therapeutics has entered into a licensing agreement valued at up to $95 million that covers the development and commercialization of its experimental antibiotic product in China.
Under the terms of the agreement, Roivant Sciences of Hong Kong will make an upfront payment of $5 million to Nabriva, which is based in Dublin, Ireland, and has its U.S. headquarters in King of Prussia. Narbiva (NASDAQ: NBRV) would be eligible for additional payments, described as “about $90 million,” tied to achieving milestones related to the development of its new drug candidate Lefamulin. If the product is approved in China, Nabriva would also receive royalty payments.
Lefamulin has completed an international phase-III clinical trial testing its effectiveness as a treatment for adults with moderate to severe community-acquired bacterial pneumonia (CABP). Results from a second international phase-III clinical trial are expected later this spring.
Under the terms of the license agreement, Nabriva has granted a Roivant subsidiary an exclusive license to develop and commercialize Lefamulin in the greater China region consisting of the People’s Republic of China, Hong Kong, Macau and Taiwan. The companies will establish a joint development committee to review and oversee all development and commercialization plans.
“Our partnership with Roivant underscores our commitment to ensuring rapid access to Lefamulin for adults with CABP around the globe,” said Dr. Colin Broom, CEO of Nabriva Therapeutics. “Roivant has a broad therapeutic portfolio and deep development and commercialization expertise, making the company an excellent partner as we pursue bringing an important and much-needed new treatment option for CABP — and potentially other serious bacterial infections — to China and surrounding territories.
Broom said the funding from this agreement will contribute to his company’s efforts to prepare for launching Lefamulin in the United States, should the drug receive regulatory approval.
Nabriva expects to file a new drug application for Lefamulin with the Food and Drug Administration during the second half of 2018.
Vivek Ramaswamy, founder and CEO of Roivant, said in a statement the deal with Nabriva “demonstrates our commitment to build out a robust pipeline of products in China.… It is also indicative of our desire to develop treatments for infectious diseases beyond the hepatitis B virus.”
Pneumonia is a leading cause of infectious disease mortality worldwide. In China, pneumonia is the fourth leading cause of death in urban areas and the leading cause of death in rural areas.