A large drugmaker is betting half of a billion dollars more than it already has on gene therapy.

New York-based Pfizer said Wednesday that it would spend $500 million on its gene therapy manufacturing plant in Sanford, North Carolina, which it said would support its research and development investments. The site also manufactures components for Pfizer’s vaccines business.

The plant in question is a legacy facility from Wyeth, which Pfizer acquired in 2009 for $68 billion, a spokesperson noted in an email.

The company said the expansion would help advance its work in manufacturing gene therapies that use custom-made recombinant adeno-associated virus vectors.

Most gene therapies in development and on the market use AAV vectors, including Philadelphia-based Spark Therapeutics’ Luxturna (voretigene neparvovec-rzyl), for biallelic RPE65 gene mutation-associated retinal dystrophy, and Swiss drugmaker Novartis’ Zolgensma (onasemnogene abeparvovec-xioi), for spinal muscular atrophy. Pfizer is partnered with Spark in the development of SPK-9001 (fidanacogene elaparvovec) for hemophilia B, currently in a Phase III study. Switzerland’s Roche entered a deal to acquire Spark for $4.3 billion in February. Other gene therapies also use different vectors, such as bluebird bio’s Zynteglo, which won European Medicines Agency approval for beta-thalassemia in June and is based on a lentiviral platform.

While manufacturing is important for any medical product, it is especially so for cell and gene therapies, which are far more challenging to produce than traditional pharmaceuticals and biologics and, in many cases, must be tailor-made for each patient.

At the Alliance for Regenerative Medicine’s Cell & Gene Therapy Investor Day, which took place in March in New York, a panel of investors and industry insiders agreed that manufacturing remains one of the biggest barriers for cell and gene therapy. One panelist added that it becomes “question one, two and three” when investors are getting to know a gene therapy company. Several investors and industry leaders have also said that in-house manufacturing is preferable to using contract manufacturers because it lowers long-term costs and allows for greater flexibility.

Photo: Getty Images



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