MARTINSRIED, Germany, Nov. 7, 2005 (PRIMEZONE) -- A feasibility study conducted by Wacker Biotech GmbH on behalf of MorphoSys AG (Frankfurt:MOR) (Prime Standard Segment, TecDAX) using Fab fragments, demonstrated that Wacker's E. coli secretion system can offer a far simpler and more cost-effective way of obtaining high yields of antibody fragments, which are used for research, diagnostic and therapeutic applications. Under the joint agreement, MorphoSys obtains the right to use Wacker's secretion system for antibody-fragment production in research quantities for therapeutic projects both on its own behalf and with its commercial partners.
Wacker's E. coli-based secretion system is a well established system for the production of monomeric proteins. However, the feasibility study commissioned by MorphoSys proved for the first time that production of Fab antibody fragments is also possible. Wacker's E. coli-based secretion system proved highly effective in the expression of a MorphoSys antibody fragment with therapeutic potential. Yields of secreted and active antibody fragments exceeded 2 grams per liter in the supernatant. This result is especially remarkable since the antibody fragments are assembled from two different sub-units and have intramolecular disulfide bridges. Wacker's system has already been used to produce other proteins in yields as high as 7 grams per liter. The extracellular secretion facilitates straightforward purification of recombinant products and makes the whole manufacturing process far more efficient and cost effective. Under the joint agreement, MorphoSys gains access to Wacker's secretion system for producing antibody fragments. MorphoSys application will focus on the research phase for antibody generation, in both of MorphoSys's operating units.
Antibody fragments are engineered parts of whole antibodies and a relatively new class of therapeutics. Several antibody fragment based medicines are already undergoing phase 3 clinical trials; one therapeutic antibody fragment is currently marketed under the brand name ReoPro(r). Fragments have several advantages over whole antibodies, in particular, lower manufacturing costs and faster production cycles.
"We are very pleased at the positive outcome of our cooperation and the scientifically remarkable results of the joint study," says Dr. Marlies Sproll, Chief Scientific Officer of MorphoSys AG. "Wacker's unique secretion system gives us the opportunity to produce antibody fragments even more efficiently for our own purposes and for our partnered projects."
"The successful cooperation with MorphoSys shows that Wacker Biotech not only offers years of experience in producing actives according to GMP standards, but also provides highly attractive expression systems," says Dr. Thomas Maier, Managing Director of Wacker Biotech. "Our innovative technology greatly reduces the cost-of-goods factor, creating substantial added value for customers."
The study targeted a promising candidate from the MorphoSys proprietary development pipeline -- a HuCAL(r)-Fab antibody fragment. HuCAL(r) stands for Human Combinatorial Antibody Library and is meanwhile a state-of-the-art concept for the in-vitro production of highly specific human antibodies and antibody fragments for diagnostic and therapeutic purposes. HuCAL(r) technology offers a high-throughput process for the fast generation and selective optimization of antibodies.
Wacker's proprietary E. coli K12-based expression system transfers recombinant proteins in native form to the fermentation broth during fermentation. The system consists of specific expression plasmids and a proprietary E. coli K12 strain that transfers proteins from the periplasma into the medium in high yields. The E. coli strain is stable during fermentation.
About MorphoSys:
MorphoSys develops and applies innovative technologies for the production of synthetic antibodies, which accelerate drug discovery and target characterization. Founded in 1992, the Company's proprietary Human Combinatorial Antibody Library (HuCALa) technology is used by researchers worldwide for human antibody generation. The Company currently has licensing agreements and/or research collaborations with Bayer (Berkeley, California/USA), Boehringer Ingelheim (Ingelheim, Germany), Bristol-Myers Squibb (New Jersey/USA), Centocor Inc. (Malvern, Pennsylvania/USA), GPC Biotech AG (Munich/Germany), Hoffmann-La Roche AG (Basel/Switzerland), ImmunoGen Inc. (Cambridge, Massachusetts/USA), Novartis AG (Basel, Switzerland), Novoplant GmbH (Gatersleben, Germany), Pfizer Inc. (Delaware/USA), ProChon Biotech Ltd. (Rehovot/Israel), Schering AG (Berlin/Germany), Shionogi & Co., Ltd. (Osaka/Japan), Xoma Ltd. (Berkeley, California/USA) and others. Additionally, MorphoSys is active in the antibody research market through its Antibodies by Design business unit. Antibodies by Design was founded in 2003 for the purpose of exploiting the MorphoSys non-therapeutic antibody markets. MorphoSys' activities in the research antibody segment were significantly strengthened through the acquisition of the U.K. and U.S.-based Biogenesis Group in January 2005. For further information please visit the corporate website at: http://www.morphosys.com/.
Statements included in this press release which are not historical in nature are intended to be, and are hereby identified as, "forward-looking statements" for purposes of the safe harbour provided by Section 21E of the Securities Exchange Act of 1934, as amended by the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by words including "anticipates", "believes", "intends", "estimates", "expects" and similar expressions. The company cautions readers that forward-looking statements, including without limitation those relating to the company's future operations and business prospects, are subject to certain risks and uncertainties that could cause actual results to differ materially from those indicated in the forward-looking statements. Factors that may affect future operations and business prospects include, but are not limited to, clinical and scientific results and developments concerning corporate collaborations and the company's proprietary rights and other factors described in the prospectus relating to the company's recent public offering.
About Wacker Biotech GmbH:
Wacker Biotech GmbH is an experienced full-service contract manufacturer of active pharmaceutical proteins (biologics). Its portfolio ranges from molecular biology and process development, through GMP-compliant production of clinical test samples and actives for commercial market supply as well as comprehensive analytical services. Above all, Wacker Biotech offers proprietary technologies that satisfy market needs for cost-efficient and high-quality production. Two examples are its E. coli-based secretion system and the high-cell-density fermentation technology. Jena-based Wacker Biotech is a wholly-owned WACKER subsidiary, operating since early 2005 as the direct successor of ProThera GmbH. For further information please visit the corporate website at: http://wacker.com/biologics