Palovarotene

Quotient Sciences extended a deal with Ipsen to manufacture Sohonos, currently the only FDA-approved treatment for the ultra-rare disease fibrodysplasia ossificans progressiva. Quotient Sciences, a CDMO that specializes in "niche and smaller volume" drugs that it says are often overlooked by bigger contract manufacturers, has extended a deal with Ipsen to produce Sohonos (palovarotene) capsules.Sohonos is currently the only medication approved by the FDA to treat the ultra-rare disease fibrodysplasia ossificans progressiva (FOP).FOP is a progressive genetic disorder wherein bone gradually supplants muscles and connective tissues on the outside of the skeleton. This can restrict movement and lead to loss of mobility over time. The condition affects less than 1,000 people globally, Quotient said in a Feb. 26 press release.As for Sohonos, the drug—a retinoic acid receptor gamma agonist approved by the FDA in 2023—is highly potent and requires "specialized handling and containment" to protect both the production facility and operators, Quotient explained. Although financial details of the deal weren’t disclosed, Ipsen has invested in new equipment for Quotient’s manufacturing facility in Boothwyn, Pennsylvania, including a pneumatic closed transfer system that allows safe material transfer without impacting blend segregation, Quotient said. The cash infusion from Ipsen is also backing a new flexible dispensing isolator, which improves safety for operator employees and gets rid of certain cleaning requirements, Quotient added. The expanded team-up with Ipsen will grow Quotient's ability to handle and produce highly potent API drug molecules and products, according to the CDMO's release. “By expanding our capabilities in handling highly potent compounds, we are not only ensuring a reliable supply of critical therapies like Sohonos (palovarotene) for the FOP community, but also reinforcing our promise to deliver flexible, high-quality solutions for our partners with specialized needs, especially for highly potent compounds,” Marlene Leuenberger, Quotient's Philadelphia VP and general manager, said in a statement.  Ipsen isn’t alone in developing treatments for FOP.Just a few weeks ago, Regeneron announced that the FDA accepted its priority BLA review for garetosmab, which also targets the rare disease. That application followed the completion last fall of a pivotal phase 3 trial that saw a 90% or greater reduction in bone lesions in patients treated with the drug.The company said in February that it expects the FDA to make a decision on approval in August.