March 16, 2005
Gilead Expands Global Access Program for HIV Therapies to Include Additional Countries in the Caribbean and Latin America; Bahamas Manufacturing Plant Established
FOSTER CITY, Calif., Mar 16, 2005 (BUSINESS WIRE) -- Gilead Sciences, Inc. (Nasdaq:GILD) today announced that the company's global Access Program for HIV medicines is being expanded to include additional countries in the Caribbean and Latin America.
The Gilead Access Program makes Gilead's Truvada(R) (emtricitabine and tenofovir disoproxil fumarate) and Viread(R) (tenofovir disoproxil fumarate) available to physicians and treatment programs in countries at the no-profit prices of US$29.75 per month (US$0.99 per day) and US$24.71 per month (US$0.82 per day), respectively.
Gilead's global Access Program was initiated in April 2003 and originally served 68 countries, including every country in Africa and 15 additional countries classified as "least developed" by the United Nations. Today's expansion means that 95 countries, representing an estimated 70 percent of the global epidemic, are now included in the company's access effort.
The expansion focuses largely on the Caribbean region, which is second only to Sub-Saharan Africa in prevalence of HIV. With this expansion, the lowest income countries in the Caribbean have access to Gilead antiretrovirals at no-profit prices. In addition, the program has been expanded to include the low-income Latin American countries of Bolivia, Guatemala, Guyana, Honduras and Nicaragua.
Gilead also announced the recent establishment of a facility in The Bahamas to manufacture tenofovir disoproxil fumarate (tenofovir DF), the active drug substance in Viread, through a cooperative effort between PharmaChem Technologies, Gilead Sciences and the Grand Bahama Port Authority. This plant has been designed for the cost-effective production of tenofovir DF, with enough initial manufacturing capacity to provide treatment for 500,000 people annually. Over time, that capacity may be increased to allow for treatment of up to 1 million people per year, including patients both in resource-limited parts of the world and in the developed world. The new plant complies with current U.S. Food and Drug Administration standards for Good Manufacturing Practices (GMPs).
"These announcements are milestones in our region's fight against AIDS," said The Honorable Perry Gladstone Christie, Prime Minister of The Bahamas. "The Caribbean has experienced a substantial HIV epidemic, and the countries of this region are too often overlooked in AIDS relief efforts. The need for effective drugs to treat HIV infection around the world is large and growing, and this new facility in The Bahamas will produce one of the leading drugs used to combat the virus. Together with the people of The Bahamas, I commend Gilead Sciences for making two important HIV medications more easily accessible for people living with HIV/AIDS in the Caribbean and beyond."
"As a company that focuses on developing therapeutic advancements for the treatment of infectious diseases, we understand the overwhelming need for broad global access to effective HIV medications," said John C. Martin, PhD, President and Chief Executive Officer of Gilead Sciences. "This need is particularly acute for individuals living with HIV/AIDS in the countries of the Caribbean and Latin America. We believe that through partnership with governments, healthcare providers and non-governmental organizations, we can make progress toward ensuring those who need our products receive them at the lowest possible price."
The parent compound of Viread, tenofovir, was discovered through a collaborative research effort between Dr. Antonin Holy, Institute for Organic Chemistry and Biochemistry, Academy of Sciences of the Czech Republic (IOCB) in Prague and Dr. Erik DeClercq, Rega Institute for Medical Research, Katholic University in Leuven, Belgium. Emtriva(R) (emtricitabine), one of the components of Truvada, was discovered by Dr. Raymond F. Schinazi, Dr. Dennis C. Liotta and Dr. Woo-Baeg Choi and licensed to Gilead by Emory University in 1996. Emory University and the inventors of both Viread and Emtriva, the components in Truvada, have agreed to waive their right to a royalty on sales of Truvada in the Gilead Access Program countries to ensure the product can be offered at a no-profit price in parts of the world where the epidemic has hit the hardest.
It is important that patients be aware that HIV medications must be taken as part of combination regimens and that they do not cure HIV infection, nor do they reduce its transmission.
Gilead's Global Access Program
In addition to providing HIV therapy at no-profit prices, Gilead's global Access Program is designed to meet the needs of treaters in resource-challenged settings by providing a rapid review of requests for product and by shipping product directly to treaters.
Treatment programs can participate in the Gilead Access Program by obtaining a temporary importation license from their Ministry of Health. If a country requires a pre-shipment certificate of inspection, Gilead will arrange an inspection and provide this certificate with the shipment. Gilead will also supply documentation about Truvada or Viread that may be necessary for local programs to gain an import license.
Complete program information and request forms are available at www.gileadaccess.org. Programs without Internet access can contact the Gilead Access Program in the United States at 650-574-3000 (option 1) or ARVaccess@gilead.com.
Important Safety Information from U.S. Prescribing Information for Truvada, Viread and Emtriva
Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues alone or in combination with other antiretrovirals. Truvada is not indicated for the treatment of chronic hepatitis B virus (HBV) infection and its safety and efficacy has not been established in patients co-infected with HBV and HIV. Severe acute exacerbations of hepatitis B have been reported in patients who have discontinued Truvada's component drugs, Viread or Emtriva. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who discontinue Truvada and are co-infected with HIV and HBV. If appropriate, initiation of anti-hepatitis B therapy may be warranted.
Changes in body fat have been observed in patients taking Truvada and other anti-HIV medicines. The cause and long term health effect of these conditions are unknown.
Truvada is indicated in combination with other antiretroviral agents (such as non-nucleoside reverse transcriptase inhibitors or protease inhibitors) for the treatment of HIV-1 infection in adults. Safety and efficacy studies using Truvada tablets or using Emtriva and Viread in combination are ongoing.
Emtriva and Viread have each been studied as part of multi-drug regimens and have been found to be safe and effective. In clinical study 303 Emtriva and lamivudine (3TC) demonstrated comparable efficacy, safety and resistance patterns as part of multidrug regimens. These data, and those from study 903, in which lamivudine and tenofovir were used in combination, support the use of Truvada for the treatment of HIV-1 infection in treatment-naive adults. In treatment-experienced patients, the use of Truvada should be guided by laboratory testing and treatment history.
There are no study results demonstrating the effect of Truvada on clinical progression of HIV-1, and it is not recommended that Truvada be used as a component of a triple nucleoside regimen.
Truvada should not be used with Emtriva or Viread, or other drugs containing lamivudine, including Combivir(R), Epivir(R), Epivir-HBV(R), Epzicom(TM) or Trizivir(R). Two-hundred eighty-three patients have received combination therapy with Emtriva and Viread with either a non-nucleoside reverse transcriptase inhibitor or protease inhibitor for 24 to 48 weeks in ongoing clinical studies. Based on these limited data, no new patterns of adverse events were identified and there was no increased frequency of established toxicities. For additional safety information about Emtriva or Viread in combination with other antiretroviral agents, please see "About Emtriva" and "About Viread," below.
In the United States, Viread is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection. This indication is based on analyses of plasma HIV-1 RNA levels and CD4 cell counts in controlled studies of Viread in treatment-naive adults and in treatment-experienced adults. There are no study results demonstrating the effect of Viread on clinical progression of HIV-1. The use of Viread should be considered for treating adult patients with HIV-1 strains that are expected to be susceptible to tenofovir as assessed by laboratory testing or treatment history.
Drug interactions have been observed when didanosine, atazanavir or lopinavir/ritonavir is co-administered with Viread and dose adjustments may be necessary. Data are not available to recommend a dose adjustment of didanosine for patients weighing less than 60 kg. Patients on atazanavir or lopinavir/ritonavir plus Viread should be monitored for Viread-associated adverse events which may require discontinuation. When co-administered with Viread, it is recommended that atazanavir 300 mg be given with ritonavir 100 mg. Atazanavir without ritonavir should not be co-administered with Viread.
Renal impairment, including serious cases, has been reported. Renal impairment occurred most often in patients with underlying systemic or renal disease or in patients taking concomitant nephrotoxic agents, though some cases have appeared in patients without identified risk factors. Decreases in bone mineral density (BMD) at the lumbar spine and hip have been seen with the use of Viread. The clinical significance of changes in BMD and biochemical markers is unknown and follow-up is continuing to assess long-term impact. The most common adverse events and those occurring in more than 5 percent of patients receiving Viread with other antiretroviral agents in clinical trials include asthenia, pain, abdominal pain, headache, nausea, diarrhea, vomiting, rash (rash, pruritis, maculopapular rash, urticaria, vesiculobullous rash and pustular rash), flatulence, dizziness and depression. Less than 1 percent of patients discontinued participation because of gastrointestinal events.
In the United States, Emtriva is indicated, in combination with other antiretroviral agents, for the treatment of HIV-1 infection in adults. This indication is based on analyses of plasma HIV-1 RNA levels and CD4 cell counts from controlled studies of 48 weeks duration in antiretroviral-naive patients and antiretroviral-treatment-experienced patients who were virologically suppressed on an HIV treatment regimen. In antiretroviral-treatment-experienced patients, the use of Emtriva may be considered for adults with HIV strains that are expected to be susceptible to Emtriva as assessed by genotypic or phenotypic testing.
Adverse events that occurred in more than 5 percent of patients receiving Emtriva with other antiretroviral agents in clinical trials include abdominal pain, asthenia (weakness), headache, diarrhea, nausea, vomiting, dizziness and rash (rash, pruritis, maculopapular rash, urticaria, vesiculobullous rash, pustular rash and allergic reaction). Approximately 1 percent of patients discontinued participation because of these events. All adverse events were reported with similar frequency in Emtriva and control treatment groups with the exception of skin discoloration, which was reported with higher frequency in the Emtriva treated group. Skin discoloration, manifested by hyperpigmentation on the palms and/or soles, was generally mild and asymptomatic. The mechanism and clinical significance are unknown.
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, Gilead has operations in North America, Europe and Australia.
PharmaChem Technologies (Grand Bahama) Ltd., with headquarters in Freeport, Grand Bahama, is a joint venture that synergistically combines the industry specific know-how of the management team at PharmaChem Technologies and the business development expertise of the Grand Bahama Port Authority. PharmaChem's new plant in Freeport conforms to all FDA requirements for Good Manufacturing Practices.
About the Grand Bahama Port Authority, Limited
In Freeport, city management and economic development are the mandates of a private corporation, The Grand Bahama Port Authority Limited (GBPA). The GBPA, by virtue of special government legislation, is responsible for regulating all commercial, industrial and residential development within the 230 square mile economic zone, known as the "Port Area," on the island of Grand Bahama. For more information, visit www.gbpa.com.
This press release includes forward-looking statements, within the meaning of the Private Securities Litigation Reform Act of 1995, that are subject to risks, uncertainties and other factors. These risks and uncertainties could cause actual results to differ materially from those referred to in the forward-looking statements. Risks are described in detail in the Gilead Annual Report on Form 10-K for the year ended December 31, 2004 and in Gilead's Quarterly Reports on Form 10-Q, all of which are on file 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.
Truvada, Viread and Emtriva are registered trademarks of Gilead Sciences, Inc.
For more information on the Gilead Access Program, please visit www.gileadaccess.org.
For complete U.S. prescribing information, please visit www.truvada.com, www.viread.com or www.emtriva.com.
For more information on Gilead Sciences, please visit www.gilead.com or call the Gilead Public Affairs Department at 800-GILEAD-5 (800-445-3235).
SOURCE: Gilead Sciences, Inc.
Gilead Sciences, Inc.
Susan Hubbard, 650-522-5715 (Investors)
Jenna Conley, 650-522-5078 (Media)