Patheon has entered into a Manufacturing Services Agreement with Synageva BioPharma Corp. to perform fill/finish services for Kanuma™ (sebelipase alfa). The Services Agreement expires on December 31, 2019, unless earlier terminated by either party, and automatically renews for successive two-year periods following the initial term, unless either party provides sufficient written notice before the end of the current term that it will not renew the Services Agreement.
According to a Synageva press release, “During the term of the Services Agreement, Patheon is required to perform fill/finish services and deliver, and we are required to purchase, certain amounts of the Product based upon specified minimum and maximum purchase obligations. The amount that we pay to Patheon is based upon the volume of the Product that we order, and is subject to periodic adjustments over the term of the Services Agreement.”
Kanuma (sebelipase alfa) is an investigational recombinant form of the human LAL enzyme being developed by Synageva as an enzyme replacement therapy for Lysosomal Acid Lipase Deficiency (LAL D). It has been granted orphan designation by the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the Japanese Ministry of Health, Labour and Welfare. Additionally, sebelipase alfa received Fast Track designation by the U.S. FDA, and Breakthrough Therapy designation by the U.S. FDA for LAL D presenting in infants. LAL D is a serious, underdiagnosed disease that manifests with significant morbidity and early mortality and can lead to sudden and unpredictable clinical complications. LAL D often manifests in childhood, but can be diagnosed at all ages with a simple blood test. LAL D is caused by genetic mutations that result in decreased LAL enzyme activity in the lysosomes across multiple body tissues leading to the buildup of fatty material in the liver, blood vessel walls and other tissues.
Patheon is a Founding Member of the Pharma & Biopharma Outsourcing Association.