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Ortho-McNeil-Janssen Inks Two Diabetes-Focused Deals Together Worth over $1B

Diamyd Medical will get $45 million up front and up to $580 million in milestones, while Metabolex agreement could total $330 million. Ortho-McNeil-Janssen Pharmaceuticals (OMJPI) is paying Swedish firm Diamyd Medical $45 million up front for joint rights to d

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Diamyd Medical will get $45 million up front and up to $580 million in milestones, while Metabolex agreement could total $330 million.

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.

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Related questions

01How stable is the antibody?

A crucial question often addressed during preclinical development focuses on the in vivo stability of therapeutic antibodies. Increasing the half-life of a therapeutic antibody has several benefits ranging from higher treatment efficacy to increased advantages for the patients who will have a fewer number of therapy sessions and a reduced cost. Given these compelling benefits, following the identification of therapeutic antibodies with the desired specificity, developers usually subject them to a refinement step to increase their stability. This process is often hindered by the lack of reliable experimental tools to predict the half-life of antibodies in patients. The major hurdle of using mouse models to predict antibody stability in the serum lies in the way immunoglobulin proteins are processed by the organism. In mammals, most proteins circulating in the serum undergo constant uptake by endothelial cells and are routed through the endosomes to the lysosomal compartment for degradation. In the endosomes, immunoglobulin G (IgG) proteins are recognized and bound by a transmembrane protein, called the neonatal Fc receptor (FcRn), which mediates their recycling to the plasma membrane and subsequent release back into the serum. As a result, the half-life of IgGs are significantly extended by this mechanism. Since most therapeutic antibodies belong to the IgG class, this recycling system is very relevant for their relative stability in the body. Remarkably, the relative affinity between IgGs and FcRn is extremely disparate between different species, with the mouse receptor showing a much higher affinity than its human counterpart.

Source: www.genengnews.com ↗
02Undruggable or unscreenable?

Another obstacle to discovering new PPI inhibitors is the lack of libraries designed to hunt for them, points out Philippe Roche, PhD, senior scientist at the Integrative Structural and Chemical Biology team at the Cancer Research Center of Marseilles, France. “If you screen PPIs using libraries that were designed for kinases or GPCRs, that’s why you don’t get a lot of good results,” he says. To that end, his group began assembling a library focused on orthosteric inhibitors of PPIs. The result was 2P2Idb, a hand-curated, structural database cataloguing orthosteric inhibitors of PPIs for which the interface had been 3D characterized. From analyzing these known PPI inhibitors, and what structures they had in common, Roche and his colleagues developed a model to predict whether compounds would likely inhibit PPIs. Using this method, 2P2Idb creates an enriched screening library that dramatically increases the hit rate compared to standard libraries. Having proven their success with a small library of 1600 compounds, they are in the process of expanding the library to 10,000 compounds. Once that’s published, “the idea is to make this library available to labs around the world,” Roche says. “We will provide the library free of charge for people to be able to screen PPI targets.”

Source: www.genengnews.com ↗
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