Martinsried/Munich, Germany, February 12, 2008 - MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX) today announced that the regulatory authorities in the Netherlands have approved the clinical trial application (CTA) to initiate a phase 1 study of the HuCAL-derived antibody MOR103. MorphoSys had submitted the clinical trial application in December 2007. In parallel, MorphoSys has received a manufacturing license from the Bavarian Government, allowing MorphoSys to release clinical trial material for MOR103 clinical studies as a sponsor.
MOR103 is a fully human HuCAL antibody directed against GM-CSF (granulocyte macrophage-colony stimulating factor), being developed in the area of inflammatory diseases, such as rheumatoid arthritis, where current treatment options are inadequate. Due to its diverse functions in the immune system, GM-CSF can be considered a target for a broad spectrum of anti-inflammatory therapies. 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.
“We are very pleased to see our first proprietary drug candidate advance quickly into the clinic,” commented Dr. Marlies Sproll, Chief Scientific Officer of MorphoSys AG. “The smooth process and quick approval by the Dutch authorities illustrate the quality of our clinical trial application process and the strength of the underlying data package.”
About MorphoSys: MorphoSys is a publicly traded biotechnology company focused on the generation of fully human antibodies as a means to discover and develop innovative antibody-based drugs against life-threatening diseases. MorphoSys’s goal is to establish HuCAL as the technology of choice for antibody generation in research, diagnostics and therapeutic applications. The Company currently has therapeutic and research alliances with the majority of the world largest pharmaceutical companies including Bayer-Schering, Boehringer Ingelheim, Centocor/Johnson & Johnson, Novartis, Pfizer and Roche. Within these partnerships, more than 40 therapeutic antibody programs are ongoing in which MorphoSys participates through exclusive license and milestones payments as well as royalties on any end products.
Additionally, MorphoSys is active in the antibody research market through its AbD Serotec business unit. The business unit has operations in Germany (Munich), the U.S. (Raleigh, NC) and U.K. (Oxford). For further information please visit http://www.morphosys.com/
HuCAL(R) and HuCAL GOLD(R) are registered trademarks of MorphoSys AG
This communication contains certain forward-looking statements concerning the MorphoSys group of companies. The forward-looking statements contained herein represent the judgment of MorphoSys as of the date of this release and involve risks and uncertainties. Should actual conditions differ from the Company’s assumptions, actual results and actions may differ from those anticipated. MorphoSys does not intend to update any of these forward-looking statements as far as the wording of the relevant press release is concerned.
