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University of Melbourne licenses key patent for novel rheumatoid arthritis treatment to MorphoSys AG

Media Release, Friday 18 January 2008

Research led by the University of Melbourne into a key factor involved in inflammatory diseases such as rheumatoid arthritis (RA) is set to be tested in the clinic by MorphoSys AG.

The University of Melbourne has announced a license agreement with MorphoSys AG providing them with exclusive access to rights under a U.S. patent application, covering the use of specific inhibitors of GM-CSF to treat patients with diverse inflammatory diseases suchas rheumatoid arthritis (RA) psoriasis, multiple sclerosis (MS), chronic obstructive pulmonary disease (COPD) and asthma.

MorphoSys AG disclosed that GM-CSF is the target molecule for the company’s proprietary MOR103 antibody program for the treatment of rheumatoid arthritis. MOR103 is the first fully human antibody against GM-CSF to enter clinical trials. The drug could offer an innovative treatment option for RA based on a mechanism of action distinct from anti-TNF and other competing approaches.

MorphoSys believes that the University of Melbourne patent applications, once allowed, will lead to market exclusivity for therapeutic antibodies targeting GM-CSF for anti-inflammatory indications in the U.S., which represents the lion’s share of the total RA market.

In 2004, the market for biopharmaceuticals to treat RA amounted to US$ six billion worldwide and is expected to further increase to US$ 14 billion in 2009.

GM-CSF which was originally described as a white blood cell growth factor has been discovered to be a central mediator of inflammatory diseases.

The research was lead by Professor John Hamilton and Professor Gary Anderson of the University’s Department of Medicine at the Royal Melbourne Hospital and the Department of Pharmacology.

“This is very exciting stage for the development of new treatments for RA and other debilitating inflammatory diseases, says Professor Hamilton. “ It is extremely rewarding to be able to ultimately offer new options for treating these health conditions and improve the lives of millions of people, “he said.

The University of Melbourne receives an upfront payment, and will received milestone payments associated with clinical development of MOR103 and royalty payments based on net sales in the U.S.

The phase one trial set to start in 2008, is a randomized, double-blind, placebo-controlled, single-ascending dose trial and will be conducted in healthy volunteers. The study will evaluate the safety and tolerability of the MOR103 antibody program.

Rheumatoid arthritis (RA) affects approximately 4-6 million people worldwide. In patients suffering from RA, white blood cells move from the bloodstream into the synovium. Here, these blood cells appear to play an important role in causing the synovial membrane to become inflamed. The antibody MOR103 targets GM-CSF as a means to treat inflammatory diseases.

In pre-clinical studies, MOR103 has shown promising results in established RA disease models in rats. By neutralizing GM-CSF, the antibody intervenes in the disease pathway and reduces undesired proliferation and activation of inflammatory granulocytes and macrophages.

“There is a high unmet medical need in RA treatment, since fewer than 25% of patients are currently adequately treated. Antibodies neutralizing GM-CSF could represent a new generation of anti-inflammatory drugs and offer new treatment options for these patients,” commented Dr. Marlies Sproll, Chief Scientific Officer of MorphoSys AG.

“Professor John Hamilton and Professor Gary Anderson have long been leaders in the field of basic GM-CSF biology and understanding its role in inflammatory disease pathways. Their fundamental work in this area is increasingly acknowledged as the basis for targeted anti-GM-CSF therapy,” said Dr. Charlie Day, General Manager of Melbourne Ventures, the technology commercialization company of the University of Melbourne.

“We’re delighted to see the fruits of the University of Melbourne's excellent research capabilities being applied in the marketplace to help bring real benefits to patients.“

For more information, please contact:
Dr. Charlie Day
General Manager
Melbourne Ventures, University of Melbourne
Phone: +61 3 8344 3190
Fax: +61 3 9347 5888
charles.day@unimelb.edu.au

Dr. Claudia Gutjahr-Löser
Head of Corporate Communications and Investor Relations
Tel: +49 (0) 89 / 899 27-122
Fax: +49 (0) 89 / 899 27-5122
gutjahr-loeser@morphosys.com

Rebecca Scott
Media Officer
University of Melbourne
Mobile: 0417 164 791
rebeccas@unimelb.edu.au

More information about this article:

Rebecca Scott
Media Promotions Officer
rebeccas@unimelb.edu.au
Tel: +61 3 8344 0181
Mob: 0417 164 791

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