April 25, 2005
Gilead Sciences and Aspen Pharmacare Sign Letter of Intent to Establish Non-Exclusive Licensing and Distribution Agreement for Antiretrovirals Truvada and Viread in Developing World Countries
FOSTER CITY, Calif. & JOHANNESBURG, South Africa--(BUSINESS WIRE)--April 25, 2005--Gilead Sciences, Inc. (Nasdaq:GILD) and JSE Securities Exchange listed Aspen Pharmacare (APN) today announced that the companies have signed a letter of intent under which they have committed to enter into a non-exclusive licensing and distribution agreement for Gilead's antiretroviral (ARV) products Truvada(R) (emtricitabine and tenofovir disoproxil fumarate) and Viread(R) (tenofovir disoproxil fumarate). Aspen will manufacture finished product for the 95 resource-limited countries included in Gilead's global Access Program and will distribute the products in every country in Africa.
Under the terms of the collaborative agreement, Aspen will manufacture Truvada and Viread, according to U.S. standards for Good Manufacturing Practices (GMP), and distribute the products under their global tradenames in specified countries. Gilead will provide active pharmaceutical ingredient (API) for its products to Aspen and will transfer the necessary technology for tableting of the products in Aspen's U.S. Food and Drug Administration (FDA) approved facilities in South Africa. In addition, Aspen will pursue regulatory approval for the products in the countries in Africa where one or both products are not already registered. By leveraging Aspen's capabilities to rapidly expand the numbers of countries in which registrations for Gilead's antiretrovirals are sought, the companies hope to increase access to therapy in those countries most in need.
As detailed in the signed letter of intent, Aspen has agreed to sell the products at the current prices established through Gilead's global Access Program. As economies of scale and process improvements are achieved, these prices may be further reduced.
"Gilead has continually explored ways to broaden and expedite access to our antiretrovirals in resource-limited parts of the world where HIV is impacting the lives of so many individuals," said John C. Martin, PhD, President and Chief Executive Officer, Gilead Sciences. "We share this goal with Aspen Pharmacare, and this collaboration allows us to ensure safe and effective HIV therapy reaches as many people as possible."
Stephen Saad, Aspen Pharmacare Group CEO, said, "This initiative between Aspen and Gilead further lightens the burden on ARV global capacities and enables both companies to expand access and affordability of key AIDS medication to some of the world's most resource constrained countries, who also happen to be the ones hit hardest by the HIV/AIDS pandemic. This collaboration with Gilead, one of the world's leading antiviral research and scientific based companies, further underscores the manufacturing, quality and technical capabilities of Aspen and displays how north-south collaboration can be used to provide solutions to some of the world's biggest socio-economic challenges."
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.
Important Safety Information from U.S. Prescribing Information for Truvada, Viread and Emtriva
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.
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.
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, Gilead has operations in North America, Europe and Australia.
About Aspen Pharmacare
Aspen is the leading listed pharmaceutical company on the JSE Securities Exchange and the African continent's largest pharmaceutical manufacturer. Aspen is a major supplier of branded pharmaceutical and healthcare products to the African continent and selected international markets and also the largest supplier of generics to both the private and public sectors in South Africa.
Aspen has an extensive basket of quality, effective and affordable products in the branded, generic, over-the-counter (OTC), personal care, fast moving consumer goods (FMCG), nutriceutical and infant nutritional formulations (INFs) categories. Aspen is also acknowledged as the world's first pharmaceutical manufacturer to be granted approval by the U.S. Food and Drug Administration (FDA) to manufacture combination therapy ARVs in a co-packed form.
Gilead Forward-Looking Statement
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, including risks related to ability of Gilead and Aspen Pharmacare to reach a definitive agreement and risks related to the ability of both companies to supply developing world countries because of unanticipated product demand. These risks, uncertainties and other factors 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, 2004, 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.
Truvada, Viread and Emtriva are registered trademarks of Gilead Sciences, Inc.
For more information on Gilead, please call the Gilead Public Affairs Department at 1-800-GILEAD-5 (1-800-445-3235) or visit www.gilead.com.
CONTACT: Gilead Sciences, Inc.
Susan Hubbard, 650-522-5715 (Investors)
Amy Flood, 650-522-5643 (Media)
Stephen Saad, 09 27 13 5808602
Shauneen Beukes, 09 27 13 6618467 (Media)
SOURCE: Gilead Sciences, Inc.