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.

Quotient Sciences has extended its commercial partnership with Ipsen, focusing on the production of Sohonos (Palovarotene) for fibrodysplasia ossificans progressiva (FOP) FOP is an ultra-rare condition, impacting fewer than 1,000 people worldwide. The collaboration involves containment, specialised handling, and sustained supply of this highly potent molecule. The agreement includes Ipsen’s investment in additional equipment at Quotient Sciences’ facility in Boothwyn, Pennsylvania, US. This comprises a Pneumatic Closed Transfer System, which maintains blend integrity during safe material transfer, and a Flexible Dispensing Isolator designed to improve operator safety and remove the need for specialised cleaning procedures. Quotient Sciences now has expanded capabilities for handling highly potent active pharmaceutical ingredients (HPAPI) and products with occupational exposure limits (OELs) at or below 1µg/m³. The new additions also allow seamless integration with existing equipment, facilitating the production process for complex drug molecules. The extended partnership aims to guarantee a reliable commercial supply of FOP therapy while expanding capacity to handle multiple highly potent compounds at commercial scale. This supports the need for flexible solutions in treating rare diseases where patient populations are small and product volumes are limited. Ipsen selected Quotient Sciences for its established operational capabilities and extensive experience in managing global shipments. The company will be responsible for ensuring the secure and timely delivery of the therapy to international markets. Quotient Sciences Philadelphia vice-president and general manager Marlene Leuenberger said: “This significant investment in advanced containment and manufacturing technology at our Boothwyn facility underscores Quotient Sciences’ unwavering commitment to supporting patients with ultra-rare diseases. “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 specialised needs, especially for highly potent compounds.” In September 2025, Quotient Sciences entered a partnership with the UK’s Centre for Process Innovation (CPI) to expedite the creation of ribonucleic acid (RNA)-based treatments. The content above comes from the network. if any infringement, please contact us to modify.