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Romark Laboratories Awarded Contract For Late-Stage Development Of New Influenza Drug

$44 Million Contract with U.S. Department of Health and Human Services to Fund Completion of Clinical Development and Preparation for Submission of New Drug Application for NT-300

TAMPA, Fla., Feb. 28, 2013 /PRNewswire/ -- Romark Laboratories has been awarded a contract with the U.S. Department of Health and Human Services (HHS) to complete the advanced development of NT-300 (nitazoxanide) as a treatment of acute uncomplicated influenza. The value of the cost plus fixed-fee contract is up to $44 million.

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The contract will be administered through the Biomedical Advanced Research and Development Authority (BARDA).  BARDA, an agency within the Office of the Assistant Secretary for Preparedness and Response, supports advanced development of and procures medical countermeasures that address the public health and medical consequences of chemical, biological, radiological, and nuclear accidents, incidents and attacks, pandemic influenza, and emerging infectious diseases. 

"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.  "BARDA plays an important role in the advanced development of new countermeasures for public health threats such as pandemic influenza, and we are pleased to have the opportunity to work with them."

The contract award followed BARDA's solicitation of proposals for development of antiviral therapeutics with new mechanisms of action against influenza. Areas of interest to BARDA addressed by Romark's development plan include a novel mechanism of action, targeting of host factors, potential for broad spectrum antiviral activity and combination therapeutic approaches using an influenza antiviral and a host modulating therapeutic. Importantly, NT-300 is administered orally, and it is being proposed for treatment of seasonal as well as pandemic 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.

Romark will begin work under the contract immediately in an effort to complete the development and seek approval of NT-300 as a treatment of acute uncomplicated influenza. Activities covered by the contract include non-clinical and clinical development and regulatory activities required to submit and manage a New Drug Application. 

Romark's Phase 3 clinical trial will evaluate the efficacy and safety of NT-300 or NT-300 plus oseltamivir compared to a placebo or to oseltamivir alone in treating outpatients 13 to 65 years of age with acute uncomplicated influenza.

About NT-300
NT-300, a controlled release tablet for oral administration containing 300 mg of nitazoxanide (NTZ) as active ingredient, is 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.

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