Roivant Sciences is adding another late-phase medication to its pipeline: Nabriva Therapeutics’ lefamulin, a pleuromutilin antibiotic for the treatment of pneumonia. Roivant is now responsible for developing and selling the drug in greater China.
Roivant is handing over $5 million up front and is on the hook for another $90 million in regulatory and commercial milestones, Nabriva said. In return, a Roivant subsidiary is picking up an exclusive license to develop and market lefumalin in the People’s Republic of China, Hong Kong, Macau and Taiwan.
While the pair is setting up a joint committee to oversee development and commercialization, it falls on Roivant to develop and seek approval for lefamulin. The drug has finished a pivotal phase 3 trial in moderate to severe community-acquired bacterial pneumonia (CABP) and is currently in a second pivotal trial, which is set to read out this spring.
“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. The company gained the rights to derazantinib in greater China from ArQule in February.
“Our partnership with Roivant underscores our commitment to ensuring rapid access to lefamulin for adults with CABP around the globe,” said Nabriva CEO, Colin Broom, M.D. “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. The funding from this agreement will also contribute to our efforts to prepare for a successful launch should lefamulin be approved in the United States.”
But the deal comes after a catastrophic few months for Roivant’s neuroscience unit, Axovant. Axovant built its pipeline in classic “vant” fashion—it picked up a pair of pharma castoffs, intepirdine and nelotanserin, to develop for Alzheimer’s disease and for Parkinson’s and Lewy Body dementia (LBD).
Intepirdine missed its endpoints in a phase 3 trial in Alzheimer’s last fall. In January, Axovant presented data at the J.P. Morgan Healthcare Conference showing that the drug had failed in Lewy Body dementia as well, spelling out its demise. Still, it looked as though nelotanserin could save Axovant—the company announced data showing it had an effect on visual hallucinations and sleep disorders in patients with LBD or Parkinson’s disease dementia. But a day later, the company about-faced, admitting it had gotten its numbers wrong and that the data were not, in fact, statistically significant after all.