Last month, the U.S. Patent and Trademark Office awarded the patent on the antiviral drug 3TC (also known as Epivir or lamivudine) to Emory. 3TC is an important component of the new AIDS "cocktail" therapies, in which two or more drugs that exert different kinds of selective pressures on the virus are administered together.
3TC was approved by the U.S. Food and Drug Administration for marketing and sale on Nov. 17, 1995, in combination with AZT for the treatment of HIV infection and AIDS as a "first line" therapy. Since its approval, the drug has obtained an impressive share of the HIV market. It is estimated that first-year sales in this country may reach $300 million for the treatment of HIV. Some analysts estimate that worldwide sales of the drug could reach $1 billion per year or more for HIV treatment.
3TC also is now in clinical trials for the treatment of hepatitis B virus in the United States, Japan, China and other markets. Approval of 3TC for the treatment of hepatitis B virus will significantly increase the sales of this drug over the HIV sales estimates.
"Emory's 3TC patent is tangible evidence of the strength of Emory's antiviral research program and Emory's commitment to protecting important research results," said Vince La Terza, director of Patents and Licensing for Emory. "Our portfolio of 3TC patent rights will significantly improve our ability to continue to fund this cutting-edge and vital research effort."
3TC is currently marketed in the United States by Glaxo Wellcome Inc., a subsidiary of Glaxo Wellcome plc, a British corporation, under a license from BioChem Pharma Inc., a Canadian corporation. 3TC is one of the two components of BCH-189, which originally was discovered by Bernard Belleau at BioChem Pharma. In technical terms, BCH-189 is a "racemate," which means that it is a mixture of two compounds that are mirror images of each other (called "optical isomers," or "enantiomers"). Belleau and Nghe Nguyen-Ba filed a patent application in the United States on Feb. 8, 1989, that disclosed how to obtain the mixture (BCH-189), but not the individual optical isomer that is being marketed as Epivir (3TC).
Dennis Liotta and Woo-Baeg Choi of Emory discovered a process to separate the mirror image compounds of BCH-189 using certain enzymes, and filed a patent application that described this invention on Feb. 1, 1990. Liotta, former chair of Emory's chemistry department, is now the vice president for research at Emory. Choi currently is a research fellow at Merck Inc.
Professor of Pediatrics Raymond Schinazi, who has been closely involved with the 3TC discovery, called 3TC "one of the most exciting drugs resulting from the collaborative research efforts between scientists in Georgia. Its true potential will become apparent when it is approved for the treatment of hepatitis B virus."