Nabriva Therapeutics and Roivant Sciences, have launched a collaboration to develop and commercialize lefamulin in greater China. 

Lefamulin has completed a pivotal, international Phase 3 clinical trial for the treatment of adults with moderate to severe community-acquired bacterial pneumonia (CABP). Topline data from a second pivotal, international Phase 3 clinical trial are expected in the spring of 2018.
 

Under the license agreement, Nabriva has granted a Roivant subsidiary an exclusive license to develop and commercialize lefamulin in the greater China region, specifically 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. Nabriva will receive a $5 million upfront payment and will be eligible for up to approximately $90 million in additional payments tied to the successful completion of certain regulatory and commercial milestones related to lefamulin for CABP. In addition, Nabriva will be eligible to receive low double-digit royalties on sales upon approval in the covered territories. Roivant’s affiliate will be solely responsible for all clinical development and regulatory filings necessary to secure approval in the covered territories.

“Our partnership with Roivant underscores our commitment to ensuring rapid access to lefamulin for adults with CABP around the globe,” said Dr. Colin Broom, chief executive officer 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.”

“This partnership demonstrates our commitment to build out a robust pipeline of products in China in addition to derazantinib,” said Vivek Ramaswamy, founder and chief executive officer of Roivant Sciences. “It is also indicative of our desire to develop treatments for infectious diseases beyond hepatitis B virus. Increasing resistance to commonly prescribed anti-infectives represents a significant threat to public health, especially in China, but we believe that lefamulin’s novel mechanism of action represents a promising advance. Our partnership with Nabriva is an important step in our contribution to this area of medicine and this region of the world.”