Megabios and DSM Biologics Collaborate on DNA Plasmid Manufacturing
Megabios Corp. (Burlingame, CA) and DSM Biologics (Groningen, The Netherlands) have formed a broad, strategic partnership focused on the manufacture and supply of DNA plasmids and lipid-DNA complexes to the gene therapy industry. DNA plasmids are circular pieces of DNA that contain a therapeutic gene and instructional elements that regulate the activity of the gene. The partnership will create the first contract manufacturing facility that can produce high-quality, ultrapure material for plasmid-based therapeutics on every scale, from preclinical toxicology studies to commercial products.
Under the agreement, Megabios has licensed its proprietary manufacturing technology to DSM for use in its facility in Montreal, Canada. At some point the license may be extended to include DSM's facility in Groningen, The Netherlands. In return, DSM will pay license and milestone fees to Megabios, and both firms will share in the profits generated by the sale of material produced using Megabios' process. The term of the exclusive partnership is at least three years, and will continue for as long as the venture is profitable.
"This opportunity will potentially generate revenue for Megabios in the near-term,'' said Benjamin McGraw, Chairman, CEO, and President of Megabios. "This partnership is an example of Megabios' ability to leverage its technologies beyond our own gene-based therapeutic development programs. DSM Biologics, as a leading manufacturer of biological materials for the pharmaceutical industry, will through this venture provide the first source of high-quality, ultrapure plasmid-based material at any scale for clinical trials and products. Together we will be establishing the standard for the industry.''
DSM will have full responsibility for manufacturing material to be marketed to any company or institution working in the field of gene therapy. The partnership will use Megabios' proprietary methods for the manufacture of DNA plasmids and complexing that DNA with lipids. This arrangement could provide revenue for Megabios in advance of the launch of commercial gene-based products.
Megabios and DSM believe that the costs of DNA plasmids and lipid-DNA complexes produced under this agreement will be comparable to accepted manufacturing costs in the pharmaceutical industry. The manufacturing process can be used to produce any plasmid and is far simpler than that required to produce viral-based gene delivery systems.
The Megabios—DSM manufacturing method has already been used to produce material for a Phase I/II trial for Glaxo Wellcome, and a Phase I/II study conducted by Megabios and its academic collaborators at the University of Colorado Health Sciences Center.
The potential market size for clinical trials using DNA plasmids and lipid-DNA complexes is estimated to be in excess of 75 industry-sponsored clinical trials in 1999, each of which could be supplied by material made at DSM's facility. Potential customers include gene therapy, biotechnology and large pharmaceutical companies. While the majority of the current gene therapy clinical trials are at an early stage, commercial manufacturing for the first non-viral gene-based products could begin as early as 2001.
Megabios Corp. develops proprietary gene delivery systems and provides development expertise to create gene-based therapeutics designed for the treatment or prevention of genetic and acquired diseases. Megabios has developed several in vivo, non-viral gene delivery systems to address a number of potential therapeutic applications using a variety of therapeutic agents. Megabios has corporate partnerships with Glaxo Wellcome plc to develop a treatment for cystic fibrosis using the CFTR gene and with Eli Lilly & Co. to develop treatments for breast and ovarian cancer using the BRCA1 gene.
For more information: Benjamin McGraw, President, Megabios Corp., 863A Mitten Rd., Burlingame, CA 94010. Tel: 650.697.1900. Fax: 650.652.1990.
By Angelo DePalma