COPENHAGEN, Denmark, Oct. 18 /PRNewswire-FirstCall/ -- Genmab A/S (CSE: GEN) will announce steps it is taking to build for a commercial future during today’s Research, Development and Business Update presented live in London at 2PM local time and also available by webcast at http://www.genmab.com. Highlights will include the unveiling of UniBody(TM), a proprietary new antibody technology, expanded development plans for the HuMax-CD20(TM) (ofatumumab) and HuMax-EGFr(TM) (zalutumumab) clinical programs, and future development plans for the company’s pre-clinical pipeline as well as an expanded list of upcoming milestones.
Key Highlights -- UniBody Genmab will unveil UniBody, a proprietary new technology that is a stable, smaller antibody format with an anticipated longer therapeutic window than current antibody formats. Genmab believes its UniBody technology has the potential to expand the market for targeted therapeutics, in particular for some cancer and autoimmune diseases. Genmab plans to build value with the UniBody technology by creating products for itself and also making it available to partners. “We believe that UniBody constitutes the next generation in antibody development,” said Jan G. J. van de Winkel, Ph.D., Chief Scientific Officer at Genmab. “It does not activate the immune system, so it may be useful to treat autoimmune disease where the goal is to regulate and preserve the target cells. It may also be effective against certain cancer targets where it is not expected to cause unwanted cell growth.” -- HuMax-CD20 The HuMax-CD20 clinical development program will expand with a first line study of the combination with CHOP for treatment of follicular non-Hodgkin’s lymphoma expected to begin by the end of 2006. The Chronic Lymphocytic Leukemia indication is also expected to move to front line studies with a Phase II trial combining HuMax-CD20 with fludarabine and cyclophosphamide planned before the end of this year. A Phase III program in rheumatoid arthritis is expected to begin in 2007, pending results of the ongoing Phase II program. “We believe that the pivotal studies we are conducting this year and next are laying the groundwork for the introduction of HuMax-CD20 into the commercial market,” said Claus Moller, M.D., Ph.D., Chief Operating Officer at Genmab. “In addition, we are working to expand the potential use of HuMax-CD20 with the upcoming front line studies.” -- HuMax-EGFr Genmab is planning two front line Phase II studies to enlarge the HuMax-EGFr program. One will add a new indication, by treating patients with newly diagnosed stage III non-small cell lung cancer. Patients in this new study will be treated with HuMax-EGFr in combination with chemotherapy and radiation. The study’s objective will be to investigate the efficacy of HuMax-EGFr in combination with chemo/radiation compared to chemo/radiation alone. The other front line study will explore HuMax-EGFr in combination with chemotherapy and radiation for Head and Neck cancer patients. -- HuMax-CD4(R) Genmab also expects the HuMax-CD4 program to be enlarged with the addition of an exploratory study in non-cutaneous T-cell lymphoma (NCTCL) patients. This study will investigate HuMax-CD4 used in combination with chemotherapy. Recruitment is also expected to close for the ongoing Phase II NCTCL study shortly. -- Pre-clinical Pipeline Genmab will provide details on its growing pre-clinical pipeline, now containing 18 programs, including nine cancer and six inflammation programs and cardiovascular, infectious disease and allergy projects. Fourteen additional cancer and angiogenesis targets are also being investigated on an exploratory basis. -- HuMax-EGFr Pre-clinical Data New pre-clinical data for HuMax-EGFr shows broad killing activity as the antibody appears to be more effective against variations of the EGF receptor than other EGFr directed treatments.
“Genmab has made significant progress in every aspect of our business. With the three clinical products into Phase III, and a total of 38 development programs, Genmab is building for a commercial future. We continue to move toward the goal we established at Genmab’s inception - helping people with life-threatening and debilitating diseases,” said Lisa N. Drakeman, Ph.D., Chief Executive Officer of Genmab.
Please go to http://www.genmab.com to view the live webcast of today’s presentation or call +44 (0) 2085152316 and say you are dialing in for the Genmab webcast. It is possible to ask questions during the Q&A session by phone.
In addition to today’s presentation and webcast in London, an additional meeting will be held in New York City at 10AM local time on October 23, 2006.
About Genmab A/S
Genmab A/S is a biotechnology company that creates and develops human antibodies for the treatment of life-threatening and debilitating diseases. Genmab has numerous products in development to treat cancer, infectious disease, rheumatoid arthritis and other inflammatory conditions, and intends to continue assembling a broad portfolio of new therapeutic products. At present, Genmab has multiple partnerships to gain access to disease targets and develop novel human antibodies including agreements with Roche, Amgen and Serono. A broad alliance provides Genmab with access to Medarex, Inc.'s array of proprietary technologies, including the UltiMAb(R) platform for the rapid creation and development of human antibodies to virtually any disease target. Genmab, furthermore, develops antibody therapeutics based on its proprietary UniBody(TM) format. Genmab has operations in Copenhagen, Denmark, Utrecht, the Netherlands, Princeton, New Jersey, US and Hertfordshire in the United Kingdom. For more information about Genmab, visit http://www.genmab.com.
This press release contains forward-looking statements. The words “believe,” “expect,” “anticipate,” “intend” and “plan” and similar expressions identify forward-looking statements. Actual results or performance may differ materially from any future results or performance expressed or implied by such statements. The important factors that could cause our actual results or performance to differ materially include, among others, risks associated with product discovery and development, uncertainties related to the outcome and conduct of clinical trials including unforeseen safety issues, uncertainties related to product manufacturing, the lack of market acceptance of our products, our inability to manage growth, the competitive environment in relation to our business area and markets, our inability to attract and retain suitably qualified personnel, the unenforceability or lack of protection of our patents and proprietary rights, our relationships with affiliated entities, changes and developments in technology which may render our products obsolete, and other factors. Genmab is not under an obligation to update statements regarding the future following the publication of this release, nor to confirm such statements in relation to actual results, unless this is required by law.
Genmab(R); the Y-shaped Genmab logo(R); HuMax(R); HuMax-CD4(R); HuMax-EGFr(TM); HuMax-Inflam(TM); HuMax-CD20(TM); HuMax-TAC(TM); HuMax-HepC(TM); HuMax-CD38(TM); and UniBody(TM) are all trademarks of Genmab A/S.
UltiMAb(R) is a trademark of Medarex, Inc.
Genmab A/S
CONTACT: Helle Husted, Director, Investor Relations, Genmab A/S, T: +45 3344 77 30 or M: +45 25 27 47 13 or E: hth@genmab.com
Web site: http://www.genmab.com/
