Genmab Announces Phase III Studies of Ofatumumab in Relapsing Multiple Sclerosis
- Phase III trials (ASCLEPIOS I and II) with the subcutaneous formulation of ofatumumab in Relapsing Multiple Sclerosis
- Studies expected to begin enrolling in September 2016
Copenhagen, Denmark; June 2, 2016 — Genmab A/S (Nasdaq Copenhagen: GEN) announced today that its collaboration partner Novartis will start Phase III studies of the subcutaneous formulation of ofatumumab in relapsing multiple sclerosis (MS) with enrolment of patients expected to start in September 2016. The studies will compare the efficacy and safety of subcutaneous ofatumumab versus teriflunomide in patients with relapsing MS. Details of the studies will shortly become available on clinicaltrials.gov.
"Ofatumumab has the potential to be a best-in-class anti B-cell therapy for relapsing MS," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab. "We look forward to swift execution and outcome of these trials and to further development of ofatumumab in this disease area."
About the ASCLEPIOS I and II studies
The Phase III trials are randomized, double-blind, double-dummy studies comparing the efficacy and safety of subcutaneous ofatumumab versus teriflunomide, a standard treatment in MS, in approximately 900 patients with relapsing MS per study. Patients will be randomized to receive either subcutaneous injections of ofatumumab every four weeks or of teriflunomide orally once daily. In order to blind for the different formulations, double-dummy masking will be used i.e. all patients will take injections (containing either active ofatumumab or placebo) and oral capsules (containing either active teriflunomide or placebo). The primary endpoint of the studies is annualized relapse rate (ARR), which is the number of confirmed relapses in a 12 month period. The studies will be conducted by Novartis.
About Multiple Sclerosis
Multiple Sclerosis (MS) is an inflammatory disease of the central nervous system that affects approximately 2.5 million people worldwide.1 MS is twice as common in females as in males, occurring with a peak incidence at the age of 30 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. Relapsing MS is characterized by unpredictable recurrent attacks and accounts for 80% of MS cases.2
Ofatumumab is a human monoclonal antibody that is designed to target the CD20 molecule found on the surface of normal B lymphocytes.
Ofatumumab is approved and marketed for intravenous use in certain chronic lymphocytic leukemia indications under the trade name Arzerra®. Please see full Prescribing Information, including Boxed WARNING for Arzerra.
Arzerra is marketed under a collaboration agreement between Genmab and Novartis. Novartis also has rights to develop ofatumumab in autoimmune indications, including multiple sclerosis.
Ofatumumab is not approved anywhere in the world as a treatment for relapsing MS.
Genmab is a publicly traded, international biotechnology company specializing in the creation and development of differentiated antibody therapeutics for the treatment of cancer. Founded in 1999, the company has two approved antibodies, Arzerra® (ofatumumab) for the treatment of certain chronic lymphocytic leukemia indications and DARZALEX® (daratumumab) for the treatment of heavily pretreated or double refractory multiple myeloma. Daratumumab is in clinical development for additional multiple myeloma indications and for non-Hodgkin's lymphoma. Genmab also has a broad clinical and pre-clinical product 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. The company intends to leverage these technologies to create opportunities for full or co-ownership of future products. Genmab has alliances with top tier pharmaceutical and biotechnology companies. For more information visit www.genmab.com.
Rachel Curtis Gravesen, Senior Vice President, Investor Relations & Communications
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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®; the HexaBody logo™; HuMax®; HuMax-CD20®; DuoBody®; HexaBody® and UniBody®. Arzerra® is a trademark of Novartis AG or its affiliates. DARZALEX® is a trademark of Janssen Biotech, Inc.
1. GlobalData. EpiCast Report: Multiple Sclerosis — Epidemiology Forecast to 2024. Published September 2015
2. Datamonitor. Multiple Sclerosis Treatment. Published January 2015
Company Announcement no. 28
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