COPENHAGEN, Denmark, Sept. 16, 2010 (GLOBE NEWSWIRE) -- Summary: GlaxoSmithKline and Genmab A/S announce plans to refocus the development program of ofatumumab in autoimmune indications.
GlaxoSmithKline (GSK) and Genmab A/S (Copenhagen:GEN); Following the 1st July announcement by GSK and Genmab of an amendment to the collaborative agreement for ofatumumab in which GSK assumed development responsibility for autoimmune indications, GSK and Genmab announced today plans to refocus the development program of ofatumumab in autoimmune indications. After review of the program's full development strategy, GSK will focus development efforts on the subcutaneous delivery of ofatumumab in autoimmune indications and will stop further development work on the intravenous route of administration in autoimmune disease.
Based on the positive results from the Phase I/II study in multiple sclerosis (MS) that were announced on 10th September, GSK plans to begin a Phase IIB dose ranging study in MS using the subcutaneous administration of ofatumumab in 2011
following discussion with regulatory authorities. Further work in rheumatoid arthritis (RA) with a subcutaneous administration of ofatumumab is under review.
"Although the intravenous delivery of ofatumumab has previously demonstrated positive results in MS and RA studies, the autoimmune program is being refocused on the subcutaneous delivery of ofatumumab because GSK believes this route of administration has the potential to offer added convenience and improved tolerability," said Ian Tomlinson, SVP Biopharmaceuticals R&D, GSK.
"Genmab initiated the early development of ofatumumab in the autoimmune indications and we are pleased and highly supportive of GSK's continued commitment to the development of ofatumumab in these chronic diseases," said Jan
G. J. van de Winkel, Ph.D., President and CEO, Genmab.
Ofatumumab is currently not licensed for any autoimmune indications. GSK and Genmab will continue their development of ofatumumab in multiple oncology indications with the intravenous route of administration.
About Genmab A/S
Genmab is a leading international biotechnology company focused on developing fully human antibody therapeutics for the potential treatment of cancer. Genmab's world class discovery and development teams are using cutting-edge technology to create and develop products to address unmet medical needs. Our primary goal is to improve the lives of patients who are in urgent need of new treatment options. For more information on Genmab's products and technology, visit .
One of the world's leading research-based pharmaceutical and healthcare companies - is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For further information please visit www.gsk.com.
This Stock Exchange 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. For a further discussion of these risks, please refer to the section "Risk Management" in Genmab's Annual Report, which is available on . Genmab does not undertake any obligation to update or revise forward looking statements in this Stock Exchange Release nor to confirm such statements in relation to actual results, unless required by law.
Genmab(R); the Y-shaped Genmab logo(R); HuMax(R); HuMax-CD20(R); HuMax-EGFr(TM); HuMax-IL8(TM); HuMax-TAC(TM); HuMax-HepC(TM); HuMax-CD38(TM); HuMax-CD32b(TM); HuMax-TF(TM); HuMax-Her2(TM); HuMax-VEGF(TM); HuMax-Wnt; HuMax-cMet(TM) and UniBody(R) are all trademarks of Genmab A/S. Arzerra(R) is a trademark of GlaxoSmithKline.
CONTACT: Genmab A/S Helle Husted, Vice President, Investor Relations +45 33 44 77 30 Mobile: +45 25 27 47 13 email@example.com