Agreement provides Sarepta with committed capacity and dedicated manufacturing slots for GMP-grade plasmid production for its micro-dystrophin Duchenne muscular dystrophy (DMD) gene therapy program, as well as plasmid capacity for future gene therapy programs
Cambridge, Mass., January 2, 2019 - Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases and Aldevron, the leading producer of custom nucleic acids, proteins, and antibodies for the biotechnology industry, announced today that they have entered into a long-term strategic relationship for the supply of plasmid DNA to fulfill Sarepta’s needs for its gene therapy clinical trials and commercial supply.
Under the terms of the agreement, Aldevron will provide GMP-grade plasmid for Sarepta’s micro-dystrophin Duchenne muscular dystrophy (DMD) gene therapy program and Limb-girdle muscular dystrophy (LGMD) programs, as well as plasmid source material for future gene therapy programs, such as Charcot-Marie-Tooth, MPS IIIA, Pompe and other CNS diseases.
“One of our highest priorities is building a robust supply chain and scalable manufacturing that can accelerate and ensure robust patient access to our pipeline of promising gene therapies on an accelerated timeline,” said Doug Ingram, Sarepta’s president and chief executive officer. “Aldevron, one of the top plasmid DNA manufacturers in the world, is an important partner in fulfilling our strategic objectives. This agreement is anticipated to provide sufficient plasmid supply to support our ambitious development and commercial gene therapy objectives.”
“Our greatest satisfaction comes in helping companies whose research is making an impact on the lives of patients and we are proud to partner with Sarepta, a company dedicated to extending and saving lives,” said Michael Chambers, chief executive officer and co-founder of Aldevron. “Aldevron has made significant investments in people, processes and facilities to support the pre-clinical, clinical and commercial production of new, genetically-based therapies that have significant potential in transforming disease.”
Founded in 1998, Aldevron supplies plasmid DNA and gene editing enzymes to biopharmaceutical researchers developing advanced gene-based medicines. The company employs a team of 270 across its three locations in Fargo, North Dakota, Madison, Wisconsin, and Freiburg, Germany. Its 70,000 square foot facility in Fargo is the largest plasmid DNA GMP manufacturing facility in the world.
About Sarepta Therapeutics
Sarepta is at the forefront of precision genetic medicine, having built an impressive and competitive position in Duchenne muscular dystrophy (DMD) and more recently in gene therapies for 5 Limb-girdle muscular dystrophy diseases (LGMD), Charcot-Marie-Tooth (CMT), MPS IIIA, Pompe and other CNS-related disorders, totaling over 20 therapies in various stages of development. The Company’s programs and research focus span several therapeutic modalities, including RNA, gene therapy and gene editing. Sarepta is fueled by an audacious but important mission: to profoundly improve and extend the lives of patients with rare genetic-based diseases. For more information, please visit www.sarepta.com.
Aldevron serves the biotechnology industry with custom production of nucleic acids, proteins, and antibodies. Thousands of clients use Aldevron-produced plasmids, RNA and gene editing enzymes for projects ranging from discovery research to clinical trials to commercial applications. These products are critical raw materials and key components in commercially available drugs and medical devices. Aldevron specializes in GMP manufacturing and is known for inventing the GMP-SourceTM quality system. Company headquarters are in Fargo, North Dakota, with additional facilities in Madison, Wisconsin, and Freiburg, Germany.