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

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

Value of Contract Increased from $44 Million to $75 Million

TAMPA, Fla. – August 13, 2014 – Romark Laboratories has been awarded a modification of its 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 has been increased from $44 million up to $75 million.

The contract is being 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-François 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."

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.

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. The Phase 3 clinical trial is expected to be completed during the 2014-2015 Northern Hemisphere flu season.

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 vertically integrated biopharmaceutical company committed to the discovery and development of innovative small molecule drugs for treating infectious diseases and cancers. The Company markets Alinia® (nitazoxanide) tablets, 500 mg in the United States through a specialty sales force focused on gastroenterologists and primary care physicians.

Romark is developing a class of small molecule drugs called thiazolides. The Company’s product, NT-300 (nitazoxanide), is presently undergoing Phase 3 clinical development on a global basis for treatment of acute uncomplicated influenza. The NT-300 development program is being conducted under contract HHSO100201300004C with the U.S. Department of Health and Human Services. Other new drugs from the Company’s platform technology are proposed for treatment of viral diseases and cancers.