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Romark and Chugai Pharmaceutical Enter Into Exclusive Licensing Agreement for Nitazoxanide in Japan
Date:2/17/2009

Chugai Pharmaceutical Gains Rights to Develop and Market Nitazoxanide for the Treatment of Chronic Hepatitis C

TAMPA, Fla., Feb. 17 /PRNewswire/ -- Romark Laboratories, a privately held biopharmaceutical company, and Chugai Pharmaceutical Co. Ltd., a member of the Roche Group, today announced that the two companies have entered into an exclusive license agreement for the development and commercialization of nitazoxanide as a treatment of chronic hepatitis C in Japan.

Under the terms of the agreement, Chugai has paid an upfront payment to Romark, and will make additional payments based on the achievement of certain clinical and regulatory milestones. Romark will participate in profits from product sales in Japan through a supply agreement and royalties.

"Chugai is an excellent partner for us in Japan. They bring substantial expertise in the development and marketing of treatments for chronic hepatitis C exemplified by their experience with Pegasys(R) and Copegus(R)," said Jean-Francois Rossignol, M.D., Ph.D., Chairman and Chief Science Officer of Romark Laboratories, and inventor of the thiazolides. "This agreement is an important step in accelerating the worldwide development and commercialization of nitazoxanide for treating this disease."

Tatsuro Kosaka, Senior Vice President, Head of Lifecycle Management & Marketing Unit of Chugai Pharmaceutical said, "We believe nitazoxanide will be an important addition to current and future treatment regimens for chronic hepatitis C. This agreement demonstrates our commitment to providing innovative new treatments for chronic hepatitis C in Japan."

About Nitazoxanide and Hepatitis C

Nitazoxanide, the first of a new class of broad spectrum antiviral drugs known as the thiazolides, is undergoing worldwide development as a treatment of chronic hepatitis C. Nitazoxanide is a potent inhibitor of hepatitis C virus (HCV) replication in HCV genotype 1-derived replicon cell lines, and in vitro studies have shown that it does not induce mutations in the virus that confer resistance. In phase II clinical trials, the addition of nitazoxanide to peginterferon alfa-2a with or without ribavirin significantly increased sustained virologic response rates in patients with chronic hepatitis C infected with HCV genotype 4. Phase II clinical trials are ongoing in the United States in patients with HCV genotype 1.

About Romark Laboratories

Romark Laboratories (www.romark.com), a privately held biopharmaceutical company, has discovered and developed a new class of small molecule anti-infectives known as thiazolides. The Company is developing nitazoxanide, the first of the thiazolide class, for the treatment of chronic hepatitis C, and is developing other new thiazolides for treating viral diseases including chronic hepatitis B, herpes and influenza. Alinia(R) (nitazoxanide) is approved by the U.S. Food and Drug Administration and marketed by Romark for the treatment of infections caused by Cryptosporidium or Giardia.

About Chugai Pharmaceutical

Chugai Pharmaceutical, specialized in prescription pharmaceuticals and based in Tokyo, is one of Japan's leading research-based pharmaceutical companies with strengths in biotechnology products. Since the start of its strategic alliance with Roche in October 2002, Chugai has been actively involved in prescription pharmaceutical R&D activities in Japan and abroad as an important member of the Roche Group. Specifically, Chugai is working to develop innovative products with global applications, focusing on the disease areas of oncology, renal disease, and bone and joint. In Japan, Chugai's research facilities in Gotemba and Kamakura are collaborating to develop new pharmaceuticals and Ukima is conducting research for technology development for industrial production. Overseas, Chugai Pharma USA and Chugai Pharma Europe are engaged in clinical development activities in the United States and Europe. The consolidated sales in 2008 of Chugai totaled 326.9 billion yen and the operating profit was 51.6 billion yen. The company is aiming to achieve consolidated sales of 460 billion yen and operating profit of 800 billion yen in 2012, as stated in its new mid-term business plan "Sunrise 2012".


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SOURCE Romark Laboratories
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