MultiCell Technologies In-Licenses Phase IIb/III Drug for the Treatment of Fatigue in Multiple Sclerosis from Amarin Corporation
Tuesday January 3, 9:00 am ET
LINCOLN, R.I. & LONDON--(BUSINESS WIRE)--Jan. 3, 2006--MultiCell Technologies, Inc. (OTCBB: MCET - News) and Amarin Corporation plc (NasdaqSC: AMRN) announced today that MultiCell has exclusively licensed LAX-202 from Amarin for the treatment of fatigue in patients suffering from multiple sclerosis (MS). MultiCell will rename LAX-202 to MCT-125, and will further evaluate MCT-125 in a pivotal Phase IIb/III clinical trial which is expected to begin during 2006.
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Multiple sclerosis is an autoimmune disease in which immune cells attack and destroy the myelin sheath protecting neurons in the brain and spinal cord. About two million people worldwide are afflicted with MS and an estimated 10,000 new MS cases are diagnosed annually in the USA. Over 75% of people with MS report fatigue, and 50% to 60% report fatigue as the worst symptom of their disease. Fatigue can severely affect an individual's quality of life and functioning, even if the level of disability appears insignificant to outside observers. Moreover, fatigue in MS has a severe effect on a person's ability to feel they have control over their illness. For approximately 30% of MS patients, fatigue is the first symptom.
In a 138 patient, multi-center, double-blind placebo controlled Phase IIb clinical trial conducted in the UK by Amarin, LAX-202 demonstrated efficacy in significantly reducing the levels of fatigue in MS patients enrolled in the study. LAX-202 proved to be effective within 4 weeks of the first daily oral dosing, and showed efficacy in MS patients who were moderately as well as severely affected. LAX-202 demonstrated efficacy in all MS patient sub-populations including relapse-remitting, secondary progressive and primary progressive. Patients enrolled in the Phase IIb trial conducted by Amarin also reported few if any side effects following daily oral dosing of LAX-202. MultiCell intends to proceed with the anticipated pivotal Phase IIb/III trail of MCT-125 using the data generated by Amarin for LAX-202 following discussions with the FDA. If MCT-125 is approved for the treatment of fatigue in MS patients by the FDA and other such regulatory agencies, and is successfully commercialized, MultiCell estimates MCT-125 could generate up to $3 billion in cumulative worldwide sales during the time MCT-125 is under patent protection. If such revenue forecasts are realized by MCT-125, under the terms of the agreement, Amarin could receive up to $275 million in milestone payments and cumulative royalty payments during the same period.
Dr. Stephen Chang, President of MultiCell, commented "We are excited about in-licensing MCT-125 from Amarin to complement our emerging MS therapeutics program. MCT-125 targets the fatigue symptom while MCT-175, our internally developed humanized antibody therapeutic, is for treatment of the underlying cause of MS. As we undertake additional clinical studies, we are optimistic MCT-125 will continue to demonstrate efficacy for the treatment of fatigue in MS patients."
Rick Stewart, Chief Executive Officer of Amarin, stated, "We are delighted to have entered into this license agreement with MultiCell which will further develop LAX-202 as a therapy for this clear unmet medical need. The development strength and expertise within MultiCell offers a rapid and clear route to market for this product opportunity."
About MultiCell Technologies, Inc.
MultiCell Technologies, Inc. is a developer of therapeutic products, and a supplier of immortalized human cell lines for drug discovery applications. With its majority-owned subsidiary MultiCell Immunotherapeutics, Inc., MultiCell is working to commercialize new therapeutics for the treatment of degenerative neurological diseases, metabolic and endocrinological disorders, and infectious diseases. MultiCell's research labs are in Lincoln, RI. MultiCell Immunotherapeutics is located in San Diego, CA. For more information about MultiCell see multicelltech.com. Information on our website is not part of this press release. |
