FDA approves EPZICOM( Research Triangle Park NC August 2 2...),Health

Research Triangle Park, NC August 2, 2004 - EPZICOM^TM, a new product combining two HIV medicines into one tablet dosed once a day (QD) with no food or fluid requirements, was cleared for prescription use today by the U.S. Food and Drug Administration (FDA). EPZICOM combines two widely-used nucleoside reverse transcriptase inhibitors (NRTIs), EPIVIR(R) (lamivudine, 3TC) and ZIAGEN(R) (abacavir sulfate, ABC) for use in combination with other antiretroviral drugs. The brand name, EPZICOM, is an acronym for EPIVIR and ZIAGEN in COMbination. EPZICOM Tablets are recommended for use in combination with antiretroviral drugs from different pharmacological classes and not with other nucleoside/nucleotide reverse transcriptase inhibitors.

GlaxoSmithKline (GSK), manufacturer of EPZICOM, announced today that it is initiating a voucher program for EPZICOM that will provide a 60 day supply of EPZICOM directly to patients at no cost. These vouchers will be available in limited supply through participating healthcare providers for a limited time. Vouchers can be used to initiate antiretroviral therapy for therapy-nave patients or for therapy-experienced patients who require a change in regimen.

"EPZICOM marks an important advance in GSK's ongoing commitment to provide new options in antiretroviral therapy for HIV patients," said Doug Manion, vice president for HIV Clinical Research for the Infectious Diseases Medicines Development Center (MDC) for GSK. "The voucher program will be particularly beneficial to people who are not covered by private health care plans or in specific states where the drug is not yet available on all formularies."

Dr. Manion added that EPZICOM provides patients and treaters with a flexible and potent dosing option that combines two NRTIs that have been widely used in antiretroviral therapy for years. "Prescribers are familiar with these medications, which have an established resistance and long-term safety p
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Contact: Annie Noland
anoland@pcipr.com
Public Communications Inc.
2-Aug-2004

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