Date: 2016-04-29
Type of information: Production agreement
Compound: ReFacto AF® (EU)/Xytna® (USA) (moroctocog alfa), Kineret®
Company: Pfizer (USA - NY) Swedish Orphan Biovitrum (Sobi) (Sweden)
Therapeutic area: Hematologic diseases - Genetic diseases - Rare diseases
Type agreement: manufacturing production
Action mechanism:
Disease: treatment and prophylaxis of bleeding in patients with hemophilia A (congenital factor VIII deficiency), Cryopyrin-Associated Periodic Syndromes (CAPS): neonatal-onset multisystem inflammatory disease (NOMID) Chronic Infantile Neurological, Cutaneous, Articular Syndrome (CINCA) Muckle-Wells Syndrome (MWS) Familial Cold Autoinflammatory Syndrome (FCAS)
Details: On February 16, 2012, Sobi and Pfizer have extended their supply agreement for ReFacto AF®/Xyntha® until 31 December 2020, with an option to be further renewed. The previous agreement was due to expire in 2015. Sobi will continue to be the global supplier of the drug substance for ReFacto AF®/Xyntha®, which is produced in the company’s plant in Stockholm.
Financial terms: In a separate agreement, Sobi and Pfizer have agreed that Sobi will return the co-promotion rights for ReFacto® and BeneFIX® in the Nordic region to Pfizer as of 15 February 2012 in exchange for a payment to Sobi in the amount of $ 47.5 M. Sobi’s total revenues from ReFacto AF®/XYNTHA® in the first nine months of 2011 amounted to SEK 542 M, of which manufacturing accounted for SEK 374 M, royalties for SEK 95 M and co-promotion for SEK 73 M. Sobi’s agreement regarding royalties from Pfizer’s global sales of ReFacto AF®/XYNTHA® is unchanged.
Latest news: * On April 29, 2016, Swedish Orphan Biovitrum (Sobi)) announced that Sobi has extended the existing manufacturing agreement with Pfizer for the drug substance for ReFacto AF®/Xyntha®. The agreement has been extended until December 31, 2023, and the drug substance will continue to be manufactured in Sobi's Good Manufacturing Practice (GMP) biologics facility in Stockholm, Sweden.
In addition, building on the companies' long and successful relationship Sobi has decided to move production of Kineret® drug substance to Pfizer's manufacturing site in Strängnäs, Sweden. The technology transfer will enable a more cost-effective supply and will also significantly expand capacity to support the growth of Kineret® in existing and planned indications. The technology transfer has been initiated and is expected to be completed in time to support the launch of Kineret® in the potential new indications.
