Gilead outlining their research and development program for 2009.

The biopharmaceutical company presents its latest advances in clinical development during the telephone press conference on the financial results of 2008

Gilead Sciences, Inc. (Nasdaq: GILD), stressed during the telephone press conference on the financial performance of last year, the priorities of its clinical development program for 2009. Among the most significant upgrades include the agreement with the Food and Drug Administration (FDA) U.S. in the clinical development of the following products: elvitegravir, GS 9350 and the fixed dose regimen of elvitegravir GS + 9350 + Truvada ® (emtricitabine and tenofovir disoproxil fumarate). Moreover, the discussion has begun on the timing of communications darusentan clinics for 2009 and progress in the development of compounds to treat hepatitis C virus (HCV) and liver diseases.

"Currently the R & D program of Gilead, is wider than at any other time in our 21 years of history," said Dr. Norbert Bischofberger, Executive Vice President of Research and Development and Chief Scientist of Gilead Sciences. "As we enter 2009, we have several candidates for our product development portfolio, including several products that are about to enter Phase III studies and Phase II. Our efforts are directed to a certain therapeutic areas where we believe we are strongly positioned to move forward with our drug and the potential to become the best treatments of their kind. "

HIGHLIGHTS OF R & D PROGRAM FOR 2009:

Developing a new regime of one tablet per day for HIV
Gilead is developing elvitegravir, the integrase inhibitor under investigation for use in HIV patients treated with other antiretrovirals, the GS 9350, a new drug enhancer and a "four-in-one fixed dose (CDF, or fixed-dose combination) for people with HIV, which combines elvitegravir, GS 9350, tenofovir disoproxil fumarate and emtricitabine. Currently, the only once-daily drug is Atripla ® (efavirenz 600 mg / emtricitabine 200 mg / tenofovir disoproxil fumarate 300 mg), marketed in the U.S., Canada and Europe by Gilead Sciences and Bristol-Myers Squibb Company and distributed by Merck & Co. Inc. in 94 developing countries.
• The next scientific conference on HIV, Gilead will present the first data in humans in the compressed "in a four." Specifically, the results of Phase I on the leverage effect of the drug GS 9350, both as independent drug as part of the tablet "four-in-one with elvitegravir, tenofovir and emtricitabine.
• With the agreement of the FDA to proceed with the development agenda of the CDF, Gilead plans to initiate a Phase II study in naïve patients in the second quarter of 2009.


Advancing the treatment of liver disease
The 9450 GS is the main candidate of Gilead for the treatment of serious diseases of the liver. It is a novel caspase inhibitor in a daily dose to treat the inflammation and fibrosis, and HCV and non-alcoholic steatohepatitis (NASH).
The non-alcoholic steatohepatitis is a disease characterized by inflammation of the liver caused by an accumulation of fat. This condition is associated with obesity, high cholesterol and diabetes. The National Center for Infectious Diseases in U.S. predicts that by 2025 more than 25 million Americans are affected by this disease.
• The Phase IIa study that evaluated the safety, tolerability, efficacy and pharmacokinetics of GS 9450 in patients infected with HCV has been completed. The data from this study will be presented this year at a medical conference, and Gilead plans to begin a Phase IIb study in the second quarter.
• The Phase IIa study of GS 9450 in patients with non-alcoholic steatohepatitis, to evaluate its safety, tolerability, pharmacokinetics and efficacy was initiated in the third quarter of 2008. The results of this study are expected in the fourth quarter of 2009.
• Gilead is also evaluating a new polymerase inhibitor, the GS 9190, as a potential treatment for HCV. Is already underway in a Phase II study of GS 9190 in combination with pegylated interferon alfa 2a and ribavirin in patients infected with HCV (genotype 1).


Expanding the presence in the cardiovascular area
The main drug in cardiovascular research in the area is darusentan. This drug is an oral receptor antagonist of endothelin (ARE) to treat resistant hypertension. This disease affects approximately 2 to 3 million Americans who fail to reach an optimal blood pressure despite taking three treatments of hypertension drugs including a diuretic.
• The Phase III clinical trials, DAR 311 and DAR 312, waiting to be completed this year, Gilead and provides the data 311 of the DAR will be announced in the second quarter.
• In addition, Gilead is developing cicletanina for pulmonary arterial hypertension (PAH), since early 2009 expected to begin a Phase II clinical trial to assess the pattern of one and two daily doses. Cicletanina is an oral agent that is already approved in some European countries for the treatment of hypertension.
• In the second quarter of 2009, Gilead plans to initiate a Phase III study will evaluate ambrisentan, an oral AER for hypertension associated with idiopathic pulmonary fibrosis.


Identifying the priorities in the area of lung diseases
Gilead continues to focus its efforts on the development of aztreonam lysine for inhalation and ambrisentan to treat idiopathic pulmonary fibrosis. In addition, are evaluating the potential of GS 9310/11 for the treatment of cystic fibrosis and GS 9411 for lung disease.
• Gilead has recently initiated a Phase II study of aztreonam lysine for inhalation in patients with bronchiectasis.
• This month has started a Phase III study of ambrisentan for the treatm of idiopathic pulmonary fibrosis. The ARTEMIS study will include approximately 600 patients at 190 research centers in USA, Canada, Europe, Asia, New Zealand and Australia.
• In the fourth quarter of 2008, we initiated a Phase II study to evaluate the safety and efficacy of GS 9310/11, inhaled and co-formulated with fosfomycin and tobramycin for bacterial infections associated with cystic fibrosis.
• Gilead is also evaluating the safety and tolerability of GS 9411, a new blocker of the epithelial sodium channel is designed to increase airway hydration for treatment of lung disease. The Phase I study was initiated in the fourth quarter of 2008.


The drugs discussed in this press release are investigational and not yet proven its safety or efficacy in humans.

Truvada ® is a trademark owned by Gilead Sciences
Atripla ® is a trademark owned by Bristol-Myers Squibb and Gilead Sciences

About Gilead Sciences
Gilead Sciences is a biopharmaceutical company that is dedicated to discover, develop and commercialize innovative therapeutics in areas of medical need that have not been met. The company's mission is to advance the care of patients suffering from diseases that pose a threat to life. Headquartered in Foster City (California), Gilead operates in USA, Europe and Australia.