The Chapel Hill, NC, company last year licensed Japanese development and commercialization rights for its solithromycin to Toyama Chemical Co. in a deal that could pay up to $60 million in milestones. Cempra now says Toyama completed Phase 1 trials of the antibiotic and received the regulatory go ahead to start Phase 2 trials, a milestone that triggers a $10 million payment to Cempra.
Toyama is currently testing solithromycin as a treatment for respiratory tract infections, and also holds Japanese rights to develop and commercialize the drug to treat other conditions. If Toyama is able to bring the drug to the Japanese market, the second largest antibiotic market in the world, Cempra stands to collect royalties from sales of the drug in a country that spends an estimated $4 billion per year on antibiotics.
Toyama’s clinical milestone has no direct bearing on Cempra’s own clinical trials of solithromycin. But Cempra CEO Prabhavathi Fernandes says that Toyama’s work contributes to solithromycin’s safety profile. This additional data could allow Cempra, if regulators allow, to conduct smaller trials as the company studies its antibiotic in a wide range of uses.
“If it’s safe and effective, it has a good chance of being a blockbuster,” Fernandes says.
Solithromycin is a macrolide, a class of antibiotics that has been widely used for decades to treat bacterial infections, such as pneumonia and Legionnaires’ disease. The last new macrolide to reach the market was azithromycin, which the FDA approved in 1988. Azithromycin totaled 51 million prescriptions in 2013, according to IMS Health.
Cempra’s lead target for solithromycin is community acquired bacterial pneumonia (CABP), a disease most commonly treated with the now generic azithromycin or another antibiotic, levofloxacin (Levaquin). But use of macrolides as a first-line treatment for respiratory tract infections has led to high rates of pneumococcus resistance to the drugs, according to the Center for Disease Dynamics, Economics & Policy.
Levofloxacin reached blockbuster status for its manufacturer, Johnson & Johnson (NYSE: [[ticker:JNJ]), peaking at $1.6 billion in 2007 sales before patent expirations started to chip away at the drug’s revenue. Fernandes says solithromycin’s safety profile could be an advantage against the older drug, which is associated … Next Page »