Tuesday, April 15, 2014 10:49:09 PM
Keep your eye on the birdie :)
London, United Kingdom and Lincoln, RI, USA, January 3, 2006 - Amarin Corporation plc (NASDAQSC: AMRN) and Multicell Technologies Inc. (OTCBB: MCET) announced today that Amarin has licensed to Multicell exclusive, worldwide rights of LAX-202 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 before the end of the 2006.
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. Overall, greater than 75% of people with MS report having fatigue, and 50% to 60% report fatigue as the worst symptom of their disease. Fatigue can severely effect an individual’s quality of life and functioning, even if the level of disability appears to be insignificant to the outside observer. Moreover, fatigue in MS has a severe effect on a person’s ability to feel as if they have control over their illness. For approximately 30% of MS patients, fatigue predates other symptoms of MS.
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 trial 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.
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.”
Dr. Stephen Chang, President of Multicell said, “We are excited about in-licensing MCT-125 from Amarin to complement our emerging MS therapeutics program. MCT-125 targets the
http://www.sec.gov/Archives/edgar/data/897448/000095016206000002/ex99_1.htm
VHAI - Vocodia Partners with Leading Political Super PACs to Revolutionize Fundraising Efforts • VHAI • Sep 19, 2024 11:48 AM
Dear Cashmere Group Holding Co. AKA Swifty Global Signs Binding Letter of Intent to be Acquired by Signing Day Sports • DRCR • Sep 19, 2024 10:26 AM
HealthLynked Launches Virtual Urgent Care Through Partnership with Lyric Health. • HLYK • Sep 19, 2024 8:00 AM
Element79 Gold Corp. Appoints Kevin Arias as Advisor to the Board of Directors, Strengthening Strategic Leadership • ELMGF • Sep 18, 2024 10:29 AM
Mawson Finland Limited Further Expands the Known Mineralized Zones at Rajapalot: Palokas step-out drills 7 metres @ 9.1 g/t gold & 706 ppm cobalt • MFL • Sep 17, 2024 9:02 AM
PickleJar Announces Integration With OptCulture to Deliver Holistic Fan Experiences at Venue Point of Sale • PKLE • Sep 17, 2024 8:00 AM