Further manufacturing woes could spell disaster for UCB

The last thing UCB needs is yet another delay to its entry into the US psoriasis market, but continuing issues at one of its manufacturing facilities could potentially see bimekizumab hit with a second complete response letter. The FDA has issued another Form 438 relating to manufacturing deficiencies. While these appear to be less severe than those that earned UCB a CRL in May 2022, another FDA rejection could push bimekizumab’s US approval to the second quarter of 2024, two years later than hoped. This would see bimekizumab lose even more ground in psoriasis to the likes of Abbvie's Skyrizi and Novartis’s Cosentyx. Further delay would also stall UCB’s expansion plans for bimekizumab in the important hidradenitis suppurativa (HS) indication, where Jeffries analysts are predicting peak sale of €3bn ($3.2bn). Cosentyx is already filed in this indication and Acelyrin’s rival IL-17 antagonist izokibep could potentially launch in the next two or three years. Shares in UCB were down 4% today, but as bimekizumab is UCB’s best hope of ameliorating the current and future patent losses of some of its biggest products including Cimzia and Vimpat, another CRL could see the shares really drop.