Ortho-McNeil-Janssen Pharmaceuticals (OMJPI) is paying Swedish firm Diamyd Medical $45 million up front for joint rights to develop and commercialize the latter’s Phase III-stage Diamyd® vaccine for the prevention and treatment of type 1 diabetes and related conditions. U.S. firm Metabolex separately reported signing a deal with OMJPI focused on the discovery and development of new compounds against type 2 diabetes and other related metabolic disorders.
The agreement with Diamyd could see OMJPI shell out another $580 million in development and sales milestones plus tiered royalties on future sales of the product. The agreement with Metabolex gives OMJPI an exclusive, worldwide license to develop, manufacture, and commercialize a number of its partner’s preclinical programs. Metabolex will receive an up-front fee and could earn another $330 million in development, regulatory, and commercial milestones plus royalties on worldwide sales.
Diamyd is currently undergoing separate Phase III trials in Europe and the U.S. Under the terms of the agreement OMJPI and Diamyd Medical will share continuing development costs until the European trial results are available, which is hopefully during the first half of 2011, the Swedish company suggests. OMJPI will then have the right to take over the Diamyd development program.
Diamyd Medical retains exclusive rights to commercialize the drug in the Nordic countries. The company also retains rights to other therapeutic uses of the GAD65 gene and derivatives as well as fragments and variants of the GAD65 protein.
Diamyd is designed to prevent, delay, or stop the autoimmune attack on beta cells that occurs in type 1 diabetes and other forms of authomimune diabetes. The Diamyd product portfolio is based on the 65 kDa isoform of the recombinant human glutamic acid decarboxylase protein, rhGAD65. Endogenous GAD65 is present in insulin-producing beta cells as well as in nerve and brain tissues, Diamyd Medical explains. The protein is also a major autoantigen in autoimmune diabetes.
Diamyd is intended to induce immunotolerization in patients with autoimmune diabetes, to slow or prevent the destruction of pancreatic beta cells, and to maintain endogenous secretion of insulin. A Diamyd product for patients with latent autoimmune diabetes (LADA) in adults is undergoing Phase II trials. LADA patients are typically adults and are distinguishable from type 2 diabetes patients by elevated levels of antibodies to GAD, Diamyd Medical says.
OMJPI’s second new partner, Metabolex, is dedicated to the discovery and development of novel therapeutics to treat type 2 diabetes and related metabolic disorders. The firm’s in-house clinical pipeline includes the insulin sensitizer MBX-102, which is currently in Phase II development. Another insulin sensitizer, MBX-2044, has completed a Phase IIa trial.
MBX-8025 is a potential first-in-class treatment for dyslipidemia that has completed a Phase II trial. MBX-2982 is a compound that targets the GPR-119 to stimulate glucose-sensitive insulin secretion. MBX-2982 is also in Phase II development.