Gilead Grants Intellectual Property Rights for Tenofovir Topical Gel to the International Partnership for Microbicides and CONRAD.FOSTER CITY, Calif. & SILVER SPRING, Md. & ARLINGTON, Va. -- Gilead Sciences, Inc. (Nasdaq:GILD), the International Partnership for Microbicides The International Partnership for Microbicides or IPM is a non-profit product development partnership (PDP) established in 2002 to prevent HIV transmission by accelerating the development and availability of a safe and effective microbicide for use by women in developing (IPM) and CONRAD Conrad, Latin king of Jerusalem Conrad, d. 1192, Latin king of Jerusalem (1192), marquis of Montferrat, a leading figure in the Third Crusade (see Crusades). He saved Tyre from the Saracens and became (1187) its lord. today announced an agreement under which Gilead has granted rights to IPM and CONRAD to develop, manufacture and, if proven efficacious, arrange for distribution in resource-limited countries of tenofovir as a microbicide to prevent infection with HIV HIV (Human Immunodeficiency Virus), either of two closely related retroviruses that invade T-helper lymphocytes and are responsible for AIDS. There are two types of HIV: HIV-1 and HIV-2. HIV-1 is responsible for the vast majority of AIDS in the United States. , the virus that causes AIDS. There are currently several microbicide candidates in clinical development designed to prevent HIV transmission and possibly other sexually transmitted infections. Tenofovir gel has previously been evaluated in a Phase I study, and Phase II studies are being conducted through the National Institutes of Health's HIV Prevention Trials Network The HIV Prevention Trials Network is an international organization that develops and tests the safety and efficacy of primarily non-vaccine interventions designed to prevent the transmission of HIV. External links [1] - their main website. . "We are grateful to Gilead for their leadership in the development of microbicides for women," said Dr. Zeda Rosenberg, Chief Executive Officer of the International Partnership for Microbicides. "Tenofovir has a successful track record as a therapeutic, and an excellent safety profile. We are pleased to be working with CONRAD, the NIH "Not invented here." See digispeak. NIH - The United States National Institutes of Health. and the US Agency for International Development to further study tenofovir as a microbicide candidate. IPM and CONRAD will also investigate tenofovir in combination with other antiretroviral agents." Under the terms of the agreement, Gilead will provide to both IPM and CONRAD a royalty-free license to develop and, if proven efficacious, distribute tenofovir as a microbicide in approximately 100 resource-limited countries hardest hit by the HIV epidemic. Gilead will also facilitate the manufacturing of tenofovir by third-party contract manufacturers to supply ongoing clinical studies for two years, after which time other suppliers, including generic manufacturers, may be utilized. As a female-initiated technology, microbicides could fill an important prevention gap for women who are unable to successfully negotiate mutual monogamy, condom use, or other safer sex practices. According to the latest UN report on the global AIDS epidemic, in every region of the world more women than ever before are living with HIV/AIDS HIV/AIDS Human Immunodeficiency Virus/Acquired Immune Deficiency Syndrome . The 17.7 million women living with HIV/AIDS in 2006 represent an increase of over one million compared with 2004, making the need for female-initiated prevention tools especially urgent. "Collaboration within the microbicide field is crucial to our eventual success," said Dr. Henry Gabelnick, Executive Director of CONRAD. "It is through public-private partnerships and the combined expertise of organizations like CONRAD and IPM that we will get an effective microbicide quickly to the women who urgently need this technology." "The International Partnership for Microbicides and CONRAD have broad expertise in the development of microbicides for the potential prevention of HIV," said John C. Martin, PhD, President and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. , Gilead Sciences. "Their knowledge and leadership will help ensure the appropriate clinical studies to evaluate the potential of tenofovir as a microbicide advance as quickly as possible." Tenofovir was discovered through a collaborative research effort between Dr. Antonin Holy, Institute of Organic Chemistry and Biochemistry, Academy of Sciences of the Czech Republic The Academy of Sciences of the Czech Republic Czech: Akademie věd České republiky, abbr. AV ČR (IOCB) in Prague and Dr. Erik DeClercq, Rega Institute for Medical Research The Rega Institute for Medical Research is a Belgian scientific establishment that is part of the Catholic University of Leuven (Leuven) in central Belgium. The Rega Iinstitute is an interfacultary biomedical research institute of the Catholic University of Leuven and consists of , Katholic University in Leuven, Belgium. The inventors have agreed to waive their right to a royalty on sales of products containing tenofovir in the 97 developing countries served by the Gilead Access Program to ensure the product can be offered at a no-profit price in parts of the world where the AIDS epidemic has hit the hardest. About IPM IPM was established in 2002 to accelerate the development and accessibility of microbicides to prevent the transmission of HIV in women. By screening compounds, designing optimal formulations, establishing manufacturing capacity, developing trial sites and conducting efficacy trials, the organization works to improve the efficiency of all efforts to develop and deliver safe and effective microbicides as soon as possible. More information on IPM is available at www.ipm-microbicides.org. About CONRAD CONRAD is a cooperating agency of USAID committed to improving reproductive health by expanding the contraceptive choices of women and men and by helping to prevent the transmission of HIV/AIDS and other sexually transmitted diseases Sexually transmitted diseases Infections that are acquired and transmitted by sexual contact. Although virtually any infection may be transmitted during intimate contact, the term sexually transmitted disease is restricted to conditions that are largely . CONRAD is administered through the Department of Obstetrics and Gynecology obstetrics and gynecology Medical and surgical specialty concerned with the management of pregnancy and childbirth and with the health of the female reproductive system. at Eastern Virginia Medical School Eastern Virginia Medical School, in Norfolk, Virginia is a public medical school. (EVMS) in Norfolk, VA, with the main office located in Arlington, VA. More information on CONRAD is available at www.conrad.org. About Gilead Sciences Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide. Headquartered in Foster City, California
This press release includes forward-looking statements, within the meaning of the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and of 1995, that are subject to risks, uncertainties and other that could cause actual results to differ materially from those referred to in the forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. These and other risks are described in detail in the Gilead Annual Report on Form 10-K for the year ended December 31, 2005, filed with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to Gilead and Gilead assumes no obligation to update any such forward-looking statements. |
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