Sanofi begins countdown for FDA isatuximab review; Cirrhosis-focused biotech presents another mini IPO
→ Sanofi has a milestone to celebrate today with its top late-stage prospect isatuximab as the FDA accepts the BLA for review. Positioned as a blockbuster rival to Darzalex from J&J and Genmab, isatuximab is an anti-CD38 drug that’s scored positive data in treating relapsed/refractory multiple myeloma. The EMA is also evaluating a marketing application as Sanofi and its entrenched competitors both continue to test their respective drugs in earlier settings.
→ In another example of tiny companies riding on the biotech IPO rush, BioVie has set terms for a $15 million pubic debut. The Los Angeles, CA-based company is pivoting toward a late-stage trial for BIV201 (continuous infusion terlipressin), which treats ascites due to liver cirrhosis. At the expected price of $11.88, the market cap of BioVie would stand at $64 million, according to Renaissance Capital.
→ After starting out with a couple million in seed funding two years ago, French biotech Osivax now has €8 million more to conduct some clinical proof-of-concept work for its experimental universal flu vaccine — one of the Holy Grails in biotech. Using a recombinant NucleoProtein, CEO and co-founder Alexandre Le Vert says eliminates the need to update the vaccine every year. Lead investor Noshaq is based in Belgium, where the company plans to set up a subsidiary office. Anaxago, an investment platform, also chipped in.
→ Charles River Laboratories is expanding its CRO offering on the West Coast by opening a new vivarium space in South San Francisco early next year. Complete with flexible rental programs, technical support and access to other in vivo services, the new site is modeled on another Charles River Accelerator and Development Lab (CRADL) in Cambridge, MA for clients pursuing animal research.
→ Shanghai Henlius, the joint biotech venture born out of a marriage between Fosun and Henlius, has refiled an IPO on the Hong Kong stock exchange after its first application from last December lapsed. The company is fielding a biosimilar for MabThera/Rituxan in its first commercial move, with copycats of Herceptin and Humira to follow.