Romark Laboratories Initiates Phase 3 Trial of New Influenza Drug

Global Phase 3 Clinical Trial to Study NT-300 for Treatment of Acute Uncomplicated Influenza

TAMPA, Fla., April 18, 2013 /PRNewswire/ -- Romark Laboratories announced that it has begun enrolling patients in a global Phase 3 clinical trial of NT-300 (nitazoxanide) for treatment of acute uncomplicated influenza.

(Logo:  http://photos.prnewswire.com/prnh/20100201/FL47022LOGO )

The Phase 3 clinical trial has been initiated in the United States, will continue in Australia and New Zealand in the southern hemisphere and is expected to be completed during the 2013-2014 flu season in the northern hemisphere.

"There is a pressing need for new drugs to treat influenza," said Jean-Francois Rossignol, M.D., Ph.D., Chairman and Chief Science Officer of Romark. "This trial is designed to provide data required to support an application for approval to market NT-300 for treatment of influenza.  We are also addressing the opportunity to combine treatment with NT-300 and
oseltamivir in an effort to further improve treatment outcomes and mitigate the risk of oseltamivir resistance."

The clinical trial will enroll 1,400 patients with fever and other symptoms of influenza. Patients are being randomly assigned to receive treatment with either NT-300, placebo (sugar pill), oseltamivir (Tamiflu®) or NT-300 plus oseltamivir. The primary objectives of the study are to demonstrate that (i) NT-300 reduces the duration of symptoms compared to
treatment with placebo and (ii) NT-300 co-administered with oseltamivir reduces the duration of symptoms compared to NT-300 alone and to oseltamivir alone.

After completing this clinical trial, Romark plans to submit a New Drug Application seeking FDA approval to market NT-300 administered alone or in combination with oseltamivir as a treatment of acute uncomplicated influenza.

Currently, there are only two classes of drugs approved in the United States for treating influenza, and only the neuraminidase inhibitors, oral Tamiflu® (oseltamivir) and inhaled Relenza® (zanamivir), are recommended for use. There has not been a new drug approved in the United States for treating influenza since Tamiflu® and Relenza® were approved in 1999. New drugs with different mechanisms of action could be important in overcoming drug resistance and providing better treatment for patients with influenza.

The Phase 3 clinical trial of NT-300 will be fully funded by the U.S. Department of Health and Human Services (HHS)/Office of the Assistant
Secretary of Preparedness and Response (ASPR)/Biomedical Advanced Research and Development Authority (BARDA) under contract HHSO100201300004C. The value of the cost plus fixed-fee contract is up to $44 million.

For further information on this clinical trial, visit http://www.clinicaltrials.gov/ct2/show/NCT01610245.

About Influenza

Influenza (flu) is a contagious respiratory illness caused by influenza viruses.  According to the United States Centers for Disease Control and Prevention (CDC), seasonal flu affects, on average, 5% to 20% of the United States population per year leading to approximately 200,000 hospitalizations and 3,000 to 49,000 deaths.  Pandemic influenza refers to a global outbreak of flu
caused by a new emerging influenza virus that has the ability to infect and be passed among humans and to which there is little or no immunity.  The threat of pandemic influenza is a major concern because of its potential effect on human life as well as the economy, national security and the basic functioning of society.

About NT-300

NT-300, a controlled release tablet for oral administration containing 300 mg of nitazoxanide (NTZ) as active ingredient, is an investigational new drug being developed by Romark Laboratories for treatment of influenza. NTZ inhibits replication of a broad range of influenza viruses in cell culture assays, including oseltamivir- and amantadine-resistant strains, as well as other respiratory viruses that may cause flu-like symptoms in humans including the paramyxoviridae and the coronaviridae.  In cell culture assays, NTZ and oseltamivir act synergistically in inhibiting replication of influenza viruses.  In a Phase 2b/3 clinical trial conducted in the United States during the 2010-2011 influenza season, NT-300 administered 600 mg orally twice daily for 5 days reduced the duration of symptoms of acute uncomplicated influenza compared to a placebo and reduced viral titers in nasal swabs collected during treatment.

About Romark Laboratories

Romark Laboratories, L.C. is a biopharmaceutical company committed to the discovery and development of innovative small molecule drugs for treating infectious diseases and cancers. The company is developing a new class of broad-spectrum antiviral drugs called thiazolides. Romark markets Alinia® (nitazoxanide) tablets, 500 mg and Alinia® (nitazoxanide) for Oral Suspension, 100 mg/5 mL in the United States.

SOURCE Romark Laboratories, L.C.

CONTACT: Callie LoCascio, Romark Laboratories, L.C., 813-282-8544

Web Site: http://www.romark.com

Posted: April 2013

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