Exclusive License Obtained to Key Patent from the University of Melbourne
MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX) today disclosed that human cytokine GM-CSF (Granulocyte macrophage-colony stimulating factor) is the target molecule for the company's proprietary MOR103 antibody program for the treatment of rheumatoid arthritis (RA). 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 also announced an agreement with the University of Melbourne providing MorphoSys with exclusive access to rights covering the use of inhibitors of GM-CSF, under a U.S. patent application and its progeny. 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. The University of Melbourne receives an upfront payment, milestone payments associated with clinical development and royalty payments based on net sales of products in the U.S. In addition to the intellectual property rights secured under the agreement with the University of Melbourne, MorphoSys has filed additional patent applications on the antibodies it has generated in its MOR103 program.
In December 2007, MorphoSys submitted a clinical trial application (CTA) in the Netherlands to initiate a phase 1 clinical trial using the HuCAL-derived antibody MOR103 for the treatment of Rheumatoid Arthritis. The phase 1 trial 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 as well as pharmacokinetics of escalating doses of MOR103.
GM-CSF was originally described as a white blood cell growth factor. Research at the University of Melbourne led by Professor John Hamilton and Professor Gary Anderson has focused attention on the role of this protein as a central mediator of inflammatory diseases. Due to its diverse functions in the immune system, GM-CSF can be considered a target for a broad spectrum of anti-inflammatory therapies. In pre-clinical studies, MOR103 has shown promising results in established RA disease models in rats. Furthermore, the number of synovial macrophages directly correlates with the level of articular destruction in human RA patients, further validating the target. 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.'
MorphoSys will hold a public conference call and live audio webcast on January 16, 2008, at 10:00 CET to provide detailed information on its lead compound MOR103.
Dial-in number for the Conference Call: +49 (0)69 9897 2623 (listen-only)
UK residents: +44 (0)20 7138 0843
Confirmation code: 5075940
Please dial in 10 minutes before the beginning of the conference.
MorphoSys AG offers participants the opportunity to follow the presentation through a simultaneous slide presentation online at http://www.morphosys.com
An audio replay and manuscripts of the conference will be available following the live event on http://www.morphosys.com/conferencecalls
For further information please contact: Dr. Claudia Gutjahr-Löser, Head of Corporate Communications & Investor Relations, Tel: +49 (0) 89 / 899 27-122, gutjahr-loeser@morphosys.com or Mario Brkulj, Manager Corporate Communications & Investor Relations, Tel: +49 (0) 89 / 899 27-454, brkulj@morphosys.com
About MOR103 to treat RA:
Rheumatoid arthritis (RA) is traditionally considered a chronic, inflammatory autoimmune disorder that causes the immune system to attack the joints and affects in particular a membrane, called synovium, which lines each movable joint. It is a disabling and painful inflammatory condition, which can lead to substantial loss of mobility due to pain and joint destruction. As a systemic disease, RA often affects extra-articular tissues throughout the body including the skin, blood vessels, heart, lungs, and muscles. The disease 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 HuCAL-based antibody MOR103 targets GM-CSF as a means to treat inflammatory diseases such as psoriasis, multiple sclerosis (MS), chronic obstructive pulmonary disease (COPD), asthma, and especially RA. The granulocyte macrophage colony-stimulating factor (GM-CSF) stimulates stem cells to produce granulocytes and other macrophages and subsequently activates these differentiated immune cells. GM-CSF is part of the natural immune and inflammatory cascade but has also been identified as an inflammatory mediator in autoimmune disorders like RA leading to an increased production of pro-inflammatory cytokines, chemokines and proteases and thereby ultimately to articular destruction. By neutralizing GM-CSF the HuCAL-based antibody MOR103 reduces undesired proliferation and activation of inflammatory granulocytes and macrophages and intervenes in several pathophysiological pathways. More information and picture material is available at: http://www.morphosys.com/en/mor103