Swedish Orphan Biovitrum AB (publ) (Sobi(TM)) today 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.
“We are excited to extend the manufacturing agreement and further develop our successful partnership with Pfizer,” said Kirsti Gjellan, Senior Vice President Biologics Development and Supply at Sobi. “We are also very pleased to be able to transfer our Kineret drug substance manufacturing to Pfizer’s world class manufacturing site in Strängnäs, Sweden, to meet the increasing demand from healthcare professionals treating patients with autoinflammatory diseases around the world.”
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About ReFacto AF®/XYNTHA®
ReFacto AF® (moroctocog alfa)/XYNTHA® (Antihemophilic Factor (Recombinant)) is a recombinant protein drug for treatment and prevention of bleeding in patients with haemophilia A, a rare, chronic, genetic disorder in which the ability of a person’s blood to clot is impaired due to missing or reduced levels of a protein known as factor VIII. People with haemophilia A experience bleeding episodes that may cause pain, irreversible joint damage and life-threatening haemorrhages. ReFacto AF® is the trademark for the product in Europe and XYNTHA® is the registered trademark in the US, Canada, Australia and other markets.
About Kineret®
Kineret® (anakinra) is a recombinant protein drug that blocks the biological activity of IL-1a and IL -1b by binding to interleukin-1 type 1 receptor (IL-R 1), expressed in a variety of tissues and organs, and thereby blocking the interleukin-1 (IL-1) signalling. IL-1 is a key mediator of inflammation and a significant contributor to autoinflammatory diseases. Kineret has a well-established safety profile, a rapid onset of action and a short half-life.
About Sobi(TM)
Sobi(TM) is an international speciality healthcare company dedicated to rare diseases. Our mission is to develop and deliver innovative therapies and services to improve the lives of patients. The product portfolio is primarily focused on Haemophilia, Inflammation and Genetic diseases. We also market a portfolio of speciality and rare disease products across Europe, the Middle East, North Africa and Russia for partner companies. Sobi is a pioneer in biotechnology with world-class capabilities in protein biochemistry and biologics manufacturing. In 2015, Sobi had total revenues of SEK 3.2 billion (USD 385 M) and approximately 700 employees. The share (STO:SOBI) is listed on NASDAQ OMX Stockholm. More information is available at www.sobi.com.
