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Romark Laboratories Initiates Phase 3 Trial of New Influenza Drug
Date:4/18/2013

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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

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SOURCE Romark Laboratories, L.C.
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