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Raymond Schinazi |
Like so many successes, it started with a failure.
In May 1998, Emory researcher and Professor of Pediatrics Raymond Schinazi was a founder of Emory biotech start-up Pharmasset and Idenix Pharmaceuticals, and was working with these companies on an HIV drug sublicensed from Pharmasset to Idenix that, despite a $5 million investment, hadn’t worked out. “It bombed due to high metabolism. It was a drug dud,” Schinazi says. “Idenix was worried—it had raised more than $14 million and now had nothing significant in the pipeline. We had to do something immediately.”
So Schinazi, with colleagues Jean-Pierre Sommadossi, of the University of Alabama at Birmingham (UAB)) and Gilles Gosselin and Jean-Louis Imbach, of the Centre National de la Recherche Scientifique, quickly started working on another antiviral drug through Idenix, a hepatitis B compound designated LdT and later named telbivudine. “After testing was completed, the Executive Vice President of Research and Development at Idenix, Martin Bryant, decided to make it the lead compound for the company,” Schinazi says. “Here it was, almost accidental that the company had switched directions, and the drug moved into clinical trials in record time—less than seven years from discovery to U.S. Food and Drug Administration approval. That’s almost unheard of in this business.” Schinazi, colleagues, and researchers from UAB were still working on the LdT project in 2003 when the Swiss drug company Novartis bought a 51 percent majority stake in Idenix.
LdT eventually proved to be an effective drug against hepatitis B virus infections and was approved by the FDA in October 2006. It is currently marketed as Tyzeka® in the U.S. and Sebivo® in Europe.
UAB and Emory, however, were not included in any royalty payments from the sales of telbivudine. The universities filed a complaint and raised contractual disputes against the company related to intellectual property covering the use of certain synthetic nucleosides, including telbivudine. In July 2008, the Massachusetts-based Idenix entered a settlement of at least $15 million in payments to the two universities, with Emory entitled to a 40 percent share.
“Emory received a one-time payment of $1.6 million and will continue to collect payment obligations related to sales of products containing telbivudine through 2018,” says Mary Severson of Emory’s Office of Technology Transfer. “Emory’s total revenue under the settlement agreement is expected to reach at least $6 million.”
The settlement was named the 2009 “Deal of the Year” at the annual OTT Celebration of Technology and Innovation.
Schinazi, who is an inventor on over 80 issued patents in the U.S. and more than 400 worldwide, says he is gratified that the drug proved useful. “It’s the only approved hepatitis B drug that is selectively active against this virus; if you have someone who is co-infected with HIV and you treat them with a different Hep B drug, you can get an emergence of resistant HIV. With this drug, you don’t have to worry about that. It’s inactive against HIV in vitro and in humans,” he says.
Hepatitis B is a widespread virus that affects the liver and is 50 to 100 times more infectious than HIV. As many as 2 billion people have been infected by hepatitis B worldwide, 350 million of whom are chronically infected and can no longer seek help from a vaccine. Of these individuals, an estimated 1.2 million will die each year, making chronic hepatitis B infections one of the top 10 leading causes of death in the world. |
