Romark to Develop Alinia¨ (nitazoxanide) as New Treatment for Chronic Hepatitis C
24-Week Data from International Phase II Study Demonstrates Virologic Response to Oral Monotherapy

Press Release: Jan 10, 2006

TAMPA, FLA. - Romark Laboratories announced that it is initiating U.S. clinical development of Alinia¨ (nitazoxanide) tablets for treating chronic hepatitis C.
The company has filed an Investigational New Drug (IND) Application with the United States Food & Drug Administration and plans to seek Fast-Track designation for treating chronic hepatitis C. The initial clinical study in the United States will evaluate Alinia administered orally 500 mg twice daily for 24 weeks as monotherapy compared to a placebo in patients who have previously failed pegylated interferon and ribavirin combination therapy.
An estimated 3.4 million people in the U.S. are infected by hepatitis C virus. Globally, an estimated 170 million people are chronically infected, with three to four million new cases reported each year, according to the World Health Organization. Some patients can be successfully treated with interferon-based treatment regimens, but safety and tolerability issues and suboptimal response rates leave a large number of patients without an effective treatment option.
Alinia (nitazoxanide) is the first of a new class of drugs called the thiazolides. Members of this class of drugs are small molecules that suppress replication of certain viruses by selectively inhibiting synthesis of virus structural proteins. Studies have shown that nitazoxanide and its circulating metabolite, tizoxanide, suppress replication of hepatitis B and C viruses in cell culture at low (nanomolar to low micromolar) concentrations.
A phase II, double-blind, placebo-controlled clinical trial of Alinia as oral monotherapy in patients with chronic hepatitis C was initiated in early 2005 at the Romark Digestive Disease Research Center in Egypt. The patients were infected with HCV genotype 4. Approximately 10% of the patients had previously failed pegylated interferon and ribavirin combination therapy.
An interim analysis of the first 20 patients enrolled in the study showed that 50% of patients receiving Alinia administered orally as one 500 mg tablet twice daily with food had undetectable HCV RNA in serum at the end of 24 weeks of treatment compared to none of the patients in the placebo group (P=0.03). Importantly, the drug has been well tolerated by the patients with no significant side effects. The study is continuing with patients being followed up to evaluate the durability of response off-treatment.
Ongoing international studies are also evaluating Alinia in combination with pegylated interferon.
Results of preclinical and clinical studies are expected to be presented in medical journals and congresses later this year.
ÒThis is an exciting development program,Ó said Jean-Fran?ois Rossignol, M.D., Ph.D., chairman and chief Science officer of Romark and the inventor of nitazoxanide and other thiazolides. ÒThere is a tremendous need for a new treatment of chronic hepatitis C. Our results to date are encouraging, and we look forward to expanding our knowledge with the launch of clinical trials in the U.S.Ó
ÒIt is important that the mechanism of action of this class of drugs against hepatitis C virus is novel and differs from that of interferon and other traditional antiviral drugs,Ó added Rossignol. ÒFurther study will be needed to fully understand the implications of this unique mechanism of action, but potential benefits may include synergistic effects with other antiviral drugs and reduced risk of developing drug-resistant viruses.Ó
Alinia is approved for marketing in the United States for treatment of diarrhea caused by Cryptosporidium parvum and Giardia lamblia and is under development for treating Clostridium difficile-associated disease and CrohnÕs disease, in addition to chronic hepatitis C.

Nitazoxanide was first developed because of its unique broad-spectrum activity against intestinal parasites and anaerobic bacteria and its favorable safety profile compared to metronidazole. It is the first drug proven effective in treating intestinal disease caused by the coccidian protozoan, Cryptosporidium. A recently completed study demonstrated non-inferiority of nitazoxanide compared to metronidazole (standard of care) in treating hospitalized patients with Clostridium difficile-associated disease.
The antiviral activity of nitazoxanide was discovered as part of a development program for treating Cryptosporidium infection in patients with human immunodeficiency virus (HIV). The development program for AIDS-related cryptosporidiosis also provided safety data related to extended durations of treatment with nitazoxanide.
Based upon in vitro studies demonstrating activity of nitazoxanide and its active circulating metabolite, tizoxanide, in inhibiting replication of hepatitis B and C viruses, Romark initiated a series of phase II clinical trials at its Digestive Disease Research Center in Egypt early in 2005 to evaluate the effectiveness of oral nitazoxanide as monotherapy in treating chronic hepatitis B and C. The research center in Egypt had previously conducted clinical trials required for obtaining FDA approval of Alinia for treating diarrhea caused by Cryptosporidium spp. and Giardia lamblia.
ÒThe development of Alinia as a treatment of chronic hepatitis C is an important step for our company,Ó said Marc Ayers, president and chief executive officer of Romark. ÒThis development program underscores our ongoing commitment to bring innovative new first-in-class and best-in-class pharmaceutical products to the marketplace.Ó
For more information:
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info@romark.com
About Hepatitis C
Hepatitis C is a liver disease caused by the hepatitis C virus (HCV), a virus spread through direct contact with the blood of infected people. While many people with hepatitis C do not experience symptoms, others experience jaundice, abdominal pain, fatigue and fever. Chronic HCV infection may cause liver cirrhosis or hepatocellular carcinoma.
About Romark Laboratories
Romark Laboratories, L.C. (www.romark.com) is a pharmaceutical company dedicated to the discovery and development of innovative new first-in-class and best-in-class pharmaceutical products. Headquartered in Tampa, Florida, Romark conducts research and commercializes its products in the United States and in Latin America.
About Alinia
Alinia (nitazoxanide) is indicated in the United States for treatment of diarrhea caused by Cryptosporidium parvum or Giardia lamblia in patients one year of age and older. Alinia has not been shown to be superior to placebo for the treatment of diarrhea caused by Cryptosporidium parvum in HIV-infected or immunodeficient patients. The most common adverse events reported by patients receiving Alinia have been abdominal pain, diarrhea, headache and nausea. In controlled trials, the frequency of these events has been similar to patients receiving a placebo. Worldwide, more than 10 million people have been treated with nitazoxanide.
Alinia is under development in the United States for treatment of a range of digestive diseases including Clostridium difficile-associated diarrhea, CrohnÕs disease and chronic hepatitis C. It is considered an investigational new drug for each of these indications. Alinia has not been approved by the FDA as safe or effective in treating Clostridium difficile-associated disease, CrohnÕs disease or chronic hepatitis B or C.
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Romark News

Romark to Develop Alinia¨ (nitazoxanide) as New Treatment for Chronic Hepatitis C
24-Week Data from International Phase II Study Demonstrates Virologic Response to Oral Monotherapy
Jan 10, 2006
Romark Advances Development of Alinia in Treating Clostridium difficile-Associated Disease
New Clinical Study Shows No Interaction with Warfarin
Dec 8, 2005


Alinia is a new, first-in-class anti-infective developed by Romark Laboratories. more ...

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