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Debiopharm S.A. And DeveloGen AG Announce Partnering Of Myasthenia Gravis Program



10/19/2005 5:09:09 PM

LAUSANNE, Switzerland and GOETTINGEN, Germany, August 16 /PRNewswire/ -- Debiopharm S.A., the independent drug development company specialising in oncology, endocrinology and niche products and DeveloGen AG, a biopharmaceutical company focusing on novel treatments for metabolic disorders, today announced an exclusive worldwide collaboration and licensing agreement, by which Debiopharm will develop PTR-262, a novel peptide drug for the treatment of myasthenia gravis (MG), before out-licensing to global partners for commercialisation.

Under the terms of the agreement, DeveloGen will receive milestone payments and, upon commercialisation of the product, royalties based on Debiopharm's revenues from worldwide sales.

Rolland-Yves Mauvernay, President and CEO of Debiopharm said, "PTR-262 is a novel approach that may replace the currently used immunosuppressive drugs and avoid the side-effects that myasthenia gravis sufferers may experience. PTR-262 will be the first disease-modifying drug for the treatment of myasthenia gravis, as it aims at specifically abrogating the production of disease-causing antibodies. This represents a significant improvement over current therapies and a promising treatment for myasthenia gravis patients".

Guenther Karmann, CEO of DeveloGen said: "We are very pleased that Debiopharm has chosen to continue the development of PTR-262 as a potential treatment for this debilitating disease. We are confident that Debiopharm's extensive experience will ensure the rapid advancement of PTR-262 into the market".

The PTR-262 program

PTR-262, discovered at the laboratories of Professors Michael Sela and Edna Mozes at the Weizmann Institute of Science, Rehovot Israel, is a synthetic peptide which down regulates immune responses associated with myasthenogenic peptides. PTR-262 is derived from the myasthenogenic epitopes of the acetylcholine receptor (AChR) alpha-subunit, which specifically arrests the autoimmune destruction of AChR.

In preclinical models of MG, treatment by PTR-262 creates a shift in the immune system from a Th1 to a Th2/Th3 response, resulting in significant improvement of a number of clinical parameters including grip strength and electromyography. Furthermore, in peripheral blood serum derived from MG patients, PTR-262 inhibits the proliferation of T-cell populations that are responsible for myasthenogenic autoimmune mediated reactions and thus the development of MG.

About Myasthenia Gravis

MG comes from the Greek and Latin words meaning, "grave muscular weakness." The most common form of MG is a chronic autoimmune neuromuscular disorder that is characterized by fluctuating weakness of the voluntary muscle groups. MG is characterized by T-cell mediated autoantibody attacks on the AChR at neuromuscular junctions, causing weakness and fatigue of cranial and skeletal muscles. MG has a prevalence of 15/100,000 population, with approximately 36,000 cases in the United States. Available treatment options include cholinesterase inhibitors, immunosuppressive medication, plasma exchange and thymectomy, all with substantial side effects and which do not address the underlying cause of the disease. MG meets the criteria for an orphan disease with significant unmet medical need.

About Debiopharm

Debio is an established group of five complementary companies, Debiopharm, Debioinnovation, Debio R.P., Debioclinic and H3 Pharma. Debiopharm, founded in 1979 in Lausanne, Switzerland, focuses on evaluating compounds with promising in-vivo results in animals to in-license, develop for global registration, and out-license to sales and marketing pharmaceutical partners. Debiopharm has proven expertise in drug development, having registered three products: Eloxatin(R), one of sanofi-aventis' leading marketed products, Decapeptyl(R), the leading product of Ipsen, and Trelstar(R) (1-and 3-month) a registered trademark of Watson Pharmaceuticals, Inc. Together, their combined sales were in excess of $1.8 bn in 2004. Debioinnovation was set up to complement the core business objectives of Debiopharm through addressing the financing and partnering needs of biotechnology, pharmaceutical start-up companies and life science incubators. Debio R.P. is a leader in polymer-based controlled release technologies that allow certain drugs like proteins, peptides and anti-cancers to be delivered in customized, sustained-release formulation. From its FDA-inspected manufacturing facility in Martigny, Switzerland, Debio R.P. also conducts feasibility studies, formulation selection, optimization, scale-up and cGMP manufacturing from clinical trial supplies to commercial scale. Debioclinic, based in Paris, is a contract research organization, specialized in oncology and dedicated to clinical development, providing regulatory, biometric and clinical support in line with cGCP. Montreal-based H3 Pharma is a pharmaceutical product development company, focusing on oncology and endocrinology. For more information on Debiopharm, please visit: www.debio.com.

About DeveloGen

DeveloGen is a biopharmaceutical company focusing on the development of treatments for metabolic disorders, such as diabetes, obesity and metabolic syndrome. DeveloGen has a rich and innovative pipeline from lead discovery to phase II clinical development. DeveloGen's lead product DiaPep277 for the treatment of type 1 diabetes and LADA (Latent Autoimmune Diabetes in Adults) is currently in late phase II clinical trials. DiaPep277 is a novel immunomodulatory peptide derived from the heat shock protein hsp60, which protects the insulin producing beta cells from autoimmune destruction. The product Somatoprim is currently in preclinical development for the treatment of diabetic retinopathy. Further drug discovery approaches focus on the development of functional Pax4 agonists, secreted proteins and synthetic compounds aimed at the regeneration of the pancreatic beta-cell mass for the treatment of type 1 and type 2 diabetes. Proprietary targets in key metabolic pathways and inhibitors of key metabolic enzymes are developed by functional genomics based drug discovery for the treatment of type 2 diabetes, obesity and the metabolic syndrome. DeveloGen is headquartered in Goettingen, with additional sites in Rehovot, Israel, and Erkrath, Germany. For more information on DeveloGen, please visit our website at www.develogen.com.

Debiopharm S.A.

CONTACT: Debiopharm S.A., Mrs Kim Bill, VP, Business Development &Licensing, Tel: +41-21-321-01-11, Fax: +41-21-321-01-69, E-mail:kbill@debio.com, DeveloGen AG, Kathrin Shem-Tov, Manager Corporate Affairs,Tel: +49-551-50558-525, Fax: +49-551-50558-586, E-mail: info@develogen.com,www.develogen.com, Additional Media Contacts: In London: Maitland NoonanRusso, Brian Hudspith, Tel: +44-20-7379-5151, bhudspith@maitland.co.uk, InNew York: Euro RSCG Life NRP, Emily Poe, Assistant Vice President, Tel:+1-212-845-4266, emily.poe@eurorscg.com, Kirchhoff Consult, Dr. Kay Baden,DeveloGen Consultant, Tel: +49-40-609186-39, Fax: +49-40-609186-71, E-mail:baden@kirchhoff.de, www.kirchhoff.de


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