Company Announcement
- GSK plans to start additional pivotal studies of subcutaneous ofatumumab
- Phase III studies in relapsing-remitting multiple sclerosis (RRMS) expected to start in 2015
- IND filing planned for potential pivotal study in neuromyelitis optica (NMO)
Copenhagen, Denmark; May 30, 2014 – Genmab A/S (OMX: GEN) announced today its collaboration partner GlaxoSmithKline (GSK) has taken the decision to start additional pivotal studies with the subcutaneous formulation of ofatumumab. Phase III studies of subcutaneous ofatumumab in RRMS are expected to begin in 2015, following encouraging data from a Phase II study reported in October 2013.
In addition, GSK plans to file an IND for a potential pivotal study of subcutaneous ofatumumab in NMO, a rare autoimmune disorder which affects the optic nerve and spinal cord, in 2014. Further details about the RRMS and NMO programs will be available in due course. A Phase III study of subcutaneous ofatumumab in pemphigus vulgaris, a rare autoimmune disorder of the skin, was announced in 2013.
“We saw promising data in Phase II in relapsing-remitting multiple sclerosis at the end of 2013 so we are very pleased that development of subcutaneous ofatumumab will continue in this autoimmune disorder and look forward to further development in NMO,” said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.
About RRMS
Multiple Sclerosis (MS) is an inflammatory disease of the central nervous system. MS is twice as common in females as in males, occurring with a peak incidence at the age of 35 years and incidence varies widely in different populations and ethnic groups. The etiology of MS remains unknown, but the geographic variation points towards possible environmental and genetic factors. The most common form of MS is relapsing-remitting MS (RRMS) characterized by unpredictable recurrent attacks where the symptoms usually evolve over days and are followed by either complete, partial or no neurological recovery.1
About NMO
Neuromyelitis optica, also known as Devic disease, is an autoimmune disorder which leads to the loss of the protective covering (myelin) of the spinal cord and optic nerves. Symptoms of NMO include eye pain, vision loss and transverse myelitis which leads to numbness and paralysis of the arms and legs. Recovery from relapses in NMO is incomplete, with accumulation of disability. NMO is a rare disease with the highest reported incidence of four new cases diagnosed per one million people annually.1,2 There is currently no licensed therapy for NMO.
About ofatumumab
Ofatumumab is a human monoclonal antibody which targets an epitope on the CD20 molecule encompassing parts of the small and large extracellular loops.3 Ofatumumab is being developed under a co-development and collaboration agreement between Genmab and GSK. Under the companies' agreement, GSK is solely responsible for development of ofatumumab in autoimmune indications and all related costs. Ofatumumab is not approved or licensed anywhere in the world for RRMS or NMO.
About Genmab A/S
Genmab is a publicly traded, international biotechnology company specializing in the creation and development of differentiated human antibody therapeutics for the treatment of cancer. Founded in 1999, the company currently has one marketed antibody, Arzerra® (ofatumumab) for the treatment of certain chronic lymphocytic leukemia indications, a clinical pipeline with both late and early stage programs, and an innovative pre-clinical pipeline. Genmab's technology base consists of validated and proprietary next generation antibody technologies - the DuoBody® platform for generation of bispecific antibodies, and the HexaBody™ platform which creates effector function enhanced antibodies. Genmab's deep antibody expertise is expected to provide a stream of future product candidates. Partnering of selected innovative product candidates and technologies is a key focus of Genmab’s strategy and the company has alliances with top tier pharmaceutical and biotechnology companies. For more information visit www.genmab.com.
Contact:
Rachel Curtis Gravesen, Senior Vice President, Investor Relations & Communications
T: +45 33 44 77 20; M: +45 25 12 62 60; E: r.gravesen@genmab.com
This Company Announcement 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 pre-clinical and clinical development of products, 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 risk management sections in Genmab’s most recent financial reports, which are available on www.genmab.com. Genmab does not undertake any obligation to update or revise forward looking statements in this Company Announcement nor to confirm such statements in relation to actual results, unless required by law.
Genmab A/S and its subsidiaries own the following trademarks: Genmab®; the Y-shaped Genmab logo®; Genmab in combination with the Y-shaped Genmab logo™; the DuoBody logo™; HuMax®; HuMax-CD20®; DuoBody®; HexaBody™ and UniBody®. Arzerra® is a registered trademark of the GSK group of companies.
1 Noseworthy et al, N England J Med 2000; 343: 938–52
2 Marrie and Gryba, Int J MS Care 2013;15:113-118
3 Teeling et al, J Immunol 2006; 177:362-371
Company Announcement no. 29
CVR no. 2102 3884
Genmab A/S
Bredgade 34E
1260 Copenhagen K
Denmark
