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Catalyst Pharma Group, Inc. Release: Novel Agent For Intermittent Claudication, NM-702, Shows Clinical Benefit Trends In Phase II Clinical Study


10/19/2005 5:10:32 PM

Results Presented at the American Heart Association Scientific Sessions 2003

ORLANDO, Fla.--(BUSINESS WIRE)--Nov. 12, 2003-- Phase II clinical results for NM-702, a novel agent in development for intermittent claudication, were presented this morning in a session titled "Peripheral Vascular Disease: Improving Outcomes" at the American Heart Association Scientific Sessions. The presentation by William R. Hiatt, M.D., lead investigator for the Phase II study, was titled "Benefit of NM-702, a phosphodiesterase inhibitor in the treatment of claudication." The multi-center, double-blind parallel group dose-response study evaluated 206 patients with intermittent claudication, who were randomized to receive NM-702 1 mg, 2 mg, or 4 mg twice a day. According to Dr. Hiatt, "The results of this study showed potential benefits for the use of NM-702 on a number of key clinical parameters in intermittent claudication including peak walking time and patient-assessed quality of life while maintaining an excellent safety profile, encouraging results that warrant further clinical development."

Dr. Hiatt is President of the Colorado Prevention Center and professor of medicine and chief of the Section of Vascular Medicine at the University of Colorado Health Sciences Center in Denver. Dr. Hiatt has served as president of the Society for Vascular Medicine and Biology, and is a member of the American Heart Association, the Council on Circulation, the American College of Physicians, and the Western Association of Physicians.

Nissan Chemical Industries Ltd. (Nissan Chemical) is developing NM-702 in Japan in collaboration with Taisho Pharmaceutical Co., Ltd. The companies are currently conducting a Phase IIb study of NM-702 in the United States. This study is evaluating 24 weeks of treatment with NM-702 at doses of 4 mg and 8 mg in terms of improvement in peak walking time in individuals with walking impairment due to intermittent claudication. The second study is anticipated to be completed by the end of 2004. Nissan Chemical is currently seeking a development and commercialization partner for NM-702 in the United States and Europe. Catalyst Pharmaceutical Research LLC is Nissan Chemical's exclusive licensing representative for NM-702 in the US and Europe.

About NM-702

NM-702 has a unique mechanistic profile for the treatment and chronic management of peripheral arterial disease as well as other indications related to blood flow via the overlapping effects of PDE-III and PDE-V. Pharmacologic effects of PDE-III/PDE-V inhibition include, vasodilation, smooth muscle relaxation and platelet aggregation inhibition, due to decreased degradation of cyclic adenosine monophosphate (cAMP) and cyclic guanosine monophosphate (cGMP). NM-702 has a global intellectual property package encompassing composition of matter and utility patents.

About Intermittent Claudication

Intermittent claudication is a common manifestation of peripheral vascular disease due to atherosclerosis. Intermittent claudication occurs when reduced blood flow to the legs results in inadequate oxygen to meet the demands of the muscles during exercise. Symptoms associated with intermittent claudication include cramping, aching, fatigue or discomfort that occurs in the muscles of the calves, thighs or buttocks. According to recent estimates there are nearly 6 million individuals in the United States with intermittent claudication, with only one-fourth of this population accurately diagnosed and treated.

About Nissan Chemical Industries Ltd. (Nissan Chemical)

Nisan Chemical is a leading manufacturer of industrial and specialty chemicals, electronic materials, agrochemicals, and pharmaceuticals. Nissan's pharmaceutical products include anti-hypertensive, anti-inflammatory, and lipid-lowering drugs. More background information on Nissan Chemical is available at the company web site: http://www.nissanchem.co.jp/english/pharm/index.html

About Taisho Pharmaceutical Co., Ltd. (Taisho)

Taisho is the leading over-the-counter (OTC) pharmaceutical company in Japan. Taisho is using cutting-edge development techniques and working together with research facilities in Japan and around the world in search of effective, innovative new drugs. More information on Taisho can be found at http://www.taisho.co.jp/outline/index-e.htm

About Catalyst Pharmaceutical Research LLC (Catalyst)

Catalyst (www.catalystpharm.com) is a contract research organization (CRO) and business development representative for Asian and early-stage U.S. pharmaceutical and biotechnology companies. Headquartered in Pasadena, Calif., with a phase I facility in San Antonio Texas, Catalyst has a trans-Pacific corporate culture with proven expertise and capabilities to facilitate licensing transactions between Asian, European and U.S. companies.

Contact:

For more information about licensing NM-702: Catalyst Pharmaceutical Research Carolyn Siegal, 626-568-8645 Fax: 626-568-8667 csiegal@catalystpharm.com or

For information about Nissan Chemical Industries Ltd.: Nissan Chemical America Corporation Isao Koda, 626-405-0867 Fax: 626-405-0964 Isao.koda@sbcglobal.net

Source: Catalyst Pharmaceutical Research


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