Duke University, Sep. 20, 2008 — In addition to pruning cells out of the way during embryonic development, the much-studied process of programmed cell death, or apoptosis, has been newly found to exert significant mechanical force on surrounding cells.

This mechanical force may be harnessed throughout biology by tissues to aid wound formation, organ development and other processes that require cell movement, according to a Duke University team that melds biology with physics to investigate force at the cellular level.

Cells are known to move in coordinated fashion during the closure of an eye-shaped opening on the back of a developing fruit fly embryo, a model system Duke biophysicists have been working on for nearly a decade. Duke biology chair Dan Kiehart likens this dorsal closure event to drawing the strings on a sleeping bag.

The newly discovered force created by apoptotic cells imploding and withdrawing “is making a force sort of like a friend helping you tuck the edge of the sleeping bag in,” Kiehart said.

Dying cells appear to occur at random times across the plane of cells comprising the shrinking opening, in a pattern that totals about 10 percent of the population of cells. When Kiehart first observed them in 2000, he thought “well if it’s only 10 percent, I can ignore it.”

Physics post-doctoral researcher Yusuke Toyama thought that the apoptotic cells might be particularly significant for force production. Toyama, who’s training started in particle physics but has moved toward biology, began carefully measuring the motion of cells immediately surrounding a dying cell.

What he saw through the microscope, by laser-induced fluorescence, was that as a dying cell collapsed and sunk beneath the surface, it contributed to the forces pulling the edges of the opening closer together.

“So apoptosis is not a single cell event but is amplified by the five-to-seven surrounding cells,” Toyama said.

On balance, these dying cells exert perhaps a third to a half of the force that is moving the edges of the opening together, so it’s a very significant part of the process, said Glenn Edwards, professor of physics and director of Duke’s Free Electron Laser Lab. “The forces at work here are measured in perhaps billionths of a Newton, but that’s because you’re moving cells,” Edwards said. At the cellular scale, these forces are quite substantial.

The group’s findings appear in the Sept. 19 edition of Science. Funding for the research was provided by the National Institutes of Health.

Though this finding is so far limited to dorsal closure in the fruit fly embryo, Edwards and Kiehart are going to begin looking for the mechanical force of apoptosis elsewhere. Their earlier findings on the fruit fly model so far have appeared applicable to wound closure and organ development in vertebrates like humans.

It’s entirely possible, Kiehart said, that evolution has harnessed the mechanical force created by dying cells in many other ways. “In evolution, biology uses what is available to it.”

Patch Provides Five Days of Continuous Control for Highly Feared Side Effect of Chemotherapy

BEDMINSTER, N.J., September 15, 2008 /News Release — ProStrakan Group plc today announced the U.S. Food and Drug Administration (F.D.A) approval of SANCUSO(R) (Granisetron Transdermal System), the first and only patch to provide up to five consecutive days of control of nausea and vomiting for patients receiving a moderately and/or highly nausea-inducing chemotherapy regimen.

Chemotherapy-induced nausea and vomiting (CINV) are commonly cited by patients undergoing chemotherapy as highly feared side effects. In addition to its social and emotional effects, if left untreated, CINV can lead to dehydration, malnutrition, treatment delay, or even discontinuation of treatment.

“We’ve made significant progress in our understanding of chemotherapy and how to prevent its side effects, yet undergoing chemotherapy remains a challenging experience on many levels,” said Barbara Rogers, CRNP, MN, AOCN, Adult Hematology-Oncology Nurse Practitioner, Fox Chase Cancer Center. “We should have zero tolerance for CINV. A patch that can be applied before treatment, releasing medication consistently into the bloodstream over a number of days, has the potential to impact patient comfort and quality of life.”

Despite advances in treatment, CINV remains a significant issue. Some patients expect to endure unpleasant symptoms in order to continue chemotherapy and may suffer at home while not under the supervision of a health-care professional. With one application of Sancuso, patients receive up to five consecutive days of CINV treatment.

“When my doctor told me I would need chemotherapy, my first reaction was to wonder how the treatment would affect my life,” said Melvin Hren, a participant in the Sancuso clinical trial, whose tumour originated from his thymus gland. “But the patch helped alleviate my fears of some of chemotherapy’s side effects. It didn’t interfere with my daily activities, and I was able to complete my cancer treatment without feeling nauseous and sick.”

Clinical Result: Continuous and Reliable CINV Control

Sancuso is a transdermal system, or skin patch, that delivers granisetron, its active component and an established inhibitor of nausea and vomiting, through a thin layer of adhesive that attaches the patch to the skin. The medicine is then released slowly and continuously into the bloodstream for up to five consecutive days.

The F.D.A. approved Sancuso for the prevention of CINV based on the results of a multicenter Phase III randomized, double-blind, double-dummy controlled study comparing the efficacy, tolerability and safety of Sancuso with once-daily oral granisetron (2 mg). The trial enrolled 641 patients who received moderately or highly nausea-inducing multi-day chemotherapy, and met its primary endpoint of achieving complete control of CINV, working as well as oral granisetron. Complete control was defined as no vomiting and/or retching, no more than mild nausea and no rescue medication from first administration of Sancuso until 24 hours after the last day of chemotherapy.

Sancuso was generally well-tolerated by patients in clinical trials. Adverse reactions considered drug-related by investigators occurred in 8.7 percent of patients receiving Sancuso. The most common drug-related adverse reaction was constipation. Application site reactions were reported but were mild and did not lead to discontinuation of use. The incidence of skin reactions was comparable to placebo.

Product Approval Introduces ProStrakan Inc.

F.D.A. approval of Sancuso marks the official introduction of ProStrakan Inc. in the U.S. The company is also working with regulatory authorities to bring Sancuso to market in Europe. An international pharmaceutical organization, ProStrakan has introduced a range of products in a number of EU territories.

“ProStrakan was founded on a commitment to developing innovative products to better meet the needs of patients,” said company CEO Wilson Totten, MD. “We believe that Sancuso, used within an individualized approach to therapy, can help lift the burden that CINV can have on both patients and health-care providers.”

As part of the company’s commitment to better meeting the needs of patients, ProStrakan has developed a patient assistance program to ensure that Sancuso is available to any qualified patients who would benefit from it.

In order to strengthen the U.S. portfolio of the company, ProStrakan has partnered with NovaQuest, the managed partnership group of Quintiles Transnational, to recruit a 67-person sales force to commercialize ProStrakan’s products in the U.S., including Sancuso.

Important Safety Information About SANCUSO(R)

Sancuso is contraindicated in patients with known hypersensitivity to granisetron or to any of the components of the patch.

Granisetron may mask a progressive ileus and/or gastric distention caused by the underlying condition. Mild application site reactions have occurred; remove patch if severe reactions or a generalized skin reaction occur. Patients should avoid direct exposure of application site to natural or artificial sunlight by covering with clothing while wearing the patch and for 10 days after removing it.

The most common adverse reaction is constipation. No clinically relevant drug interactions have been reported in clinical studies with Sancuso.

About ProStrakan

ProStrakan is one of Europe’s fastest growing pharmaceutical companies, with new U.S. headquarters in Bedminster, New Jersey. ProStrakan is committed to developing innovative therapies to improve the lives of patients. Our current products range from cancer, women’s health, men’s health, anesthesiology, and cardiovascular disease. For more information on ProStrakan, please visit www.ProStrakan-USA.com.

PARSIPPANY, N.J., September 17, 2008, PR News Release — Daiichi Sankyo, Inc. today announced the filing of a supplemental New Drug Application (sNDA) with the United States Food and Drug Administration (FDA) for the combination treatment AZOR(R) (amlodipine and olmesartan medoxomil) as initial therapy in patients likely to need multiple antihypertensive agents to achieve their blood pressure goal. AZOR is indicated for the treatment of hypertension, alone or with other antihypertensive agents. Presently, AZOR is not indicated for the initial therapy of hypertension. AZOR may be substituted for its individually titrated components. AZOR may also be used to provide additional blood pressure lowering for patients not adequately controlled with any calcium channel blocker (CCB) or any angiotensin receptor blocker (ARB) alone.

The sNDA filing was based upon data from the pivotal registrational trial, which provided estimates of the probability of patients attaining blood pressure goals with AZOR compared to amlodipine or olmesartan medoxomil alone.

“Research suggests that more than two-thirds of patients often require multiple medications to help achieve blood pressure goals,” said Matthew R. Weir, MD, , Department of Nephrology. “If approved, this filing would support JNC-7 guideline recommendations to start patients likely to need multiple antihypertensive agents to reach their blood pressure goal on combination drugs as initial therapy.”

High blood pressure can cause permanent changes to blood vessels and the heart that may create serious problems elsewhere in the body.(1) Hypertension is one of the most prevalent conditions in the United States affecting approximately one in three American adults (about 73 million people age 20 and older) and approximately one billion people worldwide.(2,3) It is often difficult to control, and of those with high blood pressure, approximately 65 percent do not have the condition under control.(4) The number of people with high blood pressure is expected to reach about 1.6 billion worldwide by 2025.(5)

“Given the prevalence of patients with high blood pressure, the approval of AZOR as initial therapy would give physicians a valuable treatment option to help more patients reach their blood pressure goal,” said William R. Sigmund II, MD, Daiichi Sankyo Vice President of Medical Affairs. “Research and innovation in cardiovascular care is a therapeutic focus for Daiichi Sankyo, and expansion of AZOR’s label is in line with our vision to contribute to the health of people in the United States.”

AZOR is a convenient, once daily, single tablet combination of amlodipine, the most prescribed CCB on the market(6), which inhibits the entrance of calcium into the blood vessel walls, with olmesartan medoxomil, the active ingredient in Benicar(R), which blocks angiotensin II receptors. Angiotensin II is a hormone that causes blood vessels to tighten and narrow. Together the two medicines relax the blood vessels so that blood can flow more easily. Benicar (olmesartan medoxomil), Daiichi Sankyo’s flagship ARB product, is the fastest growing medication in the fastest growing class of blood pressure-lowering drugs.(7)

The U.S. Food and Drug Administration (FDA) granted marketing approval for AZOR in September 2007. AZOR is indicated for the treatment of hypertension, alone or with other antihypertensive agents. Presently, AZOR is not indicated for the initial therapy of hypertension. AZOR may be substituted for its individually titrated components. AZOR may also be used to provide additional blood pressure lowering for patients not adequately controlled with any calcium channel blocker or any angiotensin receptor blocker alone. In the pivotal registrational trial, AZOR demonstrated that eight weeks of double-blind treatment with combination therapy resulted in larger mean reductions in seated blood pressure and brought more patients to goal in comparison to the corresponding monotherapies.

When pregnancy is detected, AZOR should be discontinued as soon as possible. See .

In patients with an activated renin-angiotensin system, such as volume- and/or salt-depleted patients, symptomatic hypotension due particularly to the olmesartan component may occur after initiation of treatment with AZOR. Treatment should start under close medical supervision.

Since the vasodilation attributable to amlodipine in AZOR is gradual in onset, acute hypotension has rarely been reported after oral administration. Nonetheless, caution, as with any other peripheral vasodilator, should be exercised when administering AZOR, particularly in patients with severe aortic stenosis.

Patients, particularly those with severe obstructive coronary artery disease, may develop increased frequency, duration, or severity of angina or acute myocardial infarction on starting calcium channel blocker therapy or at the time of dosage increase.

In general, calcium channel blockers should be used with caution in patients with heart failure.

In studies of ACE inhibitors in patients with unilateral or bilateral renal artery stenosis, increases in serum creatinine or blood urea nitrogen (BUN) have been reported. There has been no long-term use of olmesartan medoxomil in patients with unilateral or bilateral renal artery stenosis, but similar effects would be expected with AZOR because of the olmesartan medoxomil component.

Since amlodipine is extensively metabolized by the liver and the plasma elimination half-life (t1/2) is 56 hours in patients with severely impaired hepatic function, caution should be exercised when administering AZOR to patients with severe hepatic impairment.

There was a greater decrease in hemoglobin and hematocrit in the combination product compared to either component alone.

The only adverse reaction that occurred in greater than or equal to 3% of patients treated with AZOR and more frequently than placebo was edema. The placebo-subtracted incidence was 5.7% (5/20 mg), 6.2% (5/40 mg), 13.3% (10/20 mg), and 11.2% (10/40 mg). The edema incidence for placebo was 12.3%.

Adverse reactions seen at lower rates but at about the same or greater incidence as in patients receiving placebo included hypotension, orthostatic hypotension, rash, pruritus, palpitation, urinary frequency, and nocturia.

In individual clinical trials of amlodipine and olmesartan medoxomil, other commonly reported adverse reactions included headache, dizziness, and flushing.

For more information on AZOR go to the web site www.azor.com.

Daiichi Sankyo, Inc., headquartered in Parsippany, New Jersey, is the U.S. subsidiary of Tokyo-based Daiichi Sankyo Co., Ltd. This global pharma innovator was established in 2005 through the merger of two leading Japanese pharmaceutical companies. The integration created a more robust organization that allows for continuous development of novel drugs that enrich the quality of life for patients around the world. A central focus of Daiichi Sankyo’s research and development is cardiovascular disease, including therapies for dyslipidemia, hypertension, diabetes, and acute coronary syndrome. Equally important to the company is the discovery of new medicines in the areas of infectious diseases, cancer, bone and joint diseases, and immune disorders. For more information, visit www.dsus.com.

First approval for Bayer’s new oral, once-daily anticoagulant / Marketing to start immediately / First-in-class product to demonstrate superior efficacy to standard of care / Most studied oral, direct Factor Xa inhibitor in the world today.

LEVERKUSEN, Germany /TORONTO, Canada, September 16, 2008 – Health Canada has granted Bayer HealthCare marketing authorization for the anticoagulant Xarelto® (rivaroxaban), taken as one tablet, once-daily, for the prevention of venous thromboembolic events (VTE) in patients who have undergone elective total hip or total knee replacement surgery. This decision marks the first approval for Xarelto worldwide. Bayer will start marketing the product immediately.

“Xarelto, discovered in Bayer’s Wuppertal laboratories in Germany, is a first-in-class product and the only oral anticoagulant to demonstrate superior efficacy over the standard of care, enoxaparin,” said Arthur Higgins, CEO of Bayer HealthCare. “The approval in Canada marks an important milestone for the most extensively studied product of its class and Bayer HealthCare has achieved a major step forward in establishing a new era in antithrombosis therapy.”

“Xarelto has the potential to revolutionize how we prevent dangerous blood clots after elective total hip or knee replacement surgery in Canada,” said Dr. A.G.G. Turpie, Professor of Medicine, McMaster University, Canada, and Principal Investigator for the RECORD program. “The existing treatment standards have limitations, so new therapies such as Xarelto can help doctors to prevent the potentially lethal effects of venous blood clots.”

The approval from Health Canada was based on data from the extensive RECORD clinical program that included three Phase III trials of Xarelto involving nearly 10,000 patients undergoing elective hip or knee replacement surgery (RECORD1, 2 and 3 trials). Results from these three studies demonstrated the superior efficacy of Xarelto, both in head-to-head comparisons with enoxaparin (RECORD1 and 3), and when comparing extended-duration (5 weeks) Xarelto with short-duration (2 weeks) enoxaparin (RECORD2). In all three trials, Xarelto and enoxaparin had similar safety profiles including low rates of major bleeding.

Xarelto has also been recommended for approval by the European Committee for Medicinal Products for Human Use (CHMP) and Bayer expects the marketing authorization across all EU-member states very soon.

About Venous Thromboembolism
Venous thromboembolism (VTE) is a serious life-threatening condition which kills more people each year than breast cancer, AIDS, prostate cancer and traffic accidents combined. Overall, it is estimated that there are 15,000 to 20,000 VTE cases in Canada annually.

During hip or knee replacement procedures, the large veins of the leg that carry blood back to the heart are damaged which significantly increases the risk of VTE for patients undergoing such major orthopedic surgery. In fact, venous blood clots occur in 40-60% of patients undergoing major orthopedic surgery who do not receive preventative care. In 2005-2006, there were nearly 69,000 hospitalizations for hip and knee replacements in Canada alone.

To learn more about VTE please visit www.thrombosisadviser.com.

About Xarelto® (rivaroxaban)
The extensive clinical trial program supporting Xarelto makes it the most studied oral, direct Factor Xa inhibitor in the world today. Almost 50,000 patients are expected to be enrolled into the Xarelto clinical development program which will evaluate the product in the prevention and treatment of a broad range of acute and chronic blood-clotting disorders including VTE treatment, stroke prevention in patients with atrial fibrillation, VTE prevention in hospitalized, medically ill patients and secondary prevention of acute coronary syndrome.

Xarelto was recently submitted to the U.S. Food and Drug Administration (FDA). On approval, Ortho-McNeil, a Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc., will market the drug in the United States. In addition to the FDA submission, filings are under review with regulatory agencies in more than 10 other countries.

Xarelto was invented in Bayer’s Wuppertal laboratories in Germany, and is being jointly developed by Bayer HealthCare and Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

About Bayer HealthCare

The Bayer Group is a global enterprise with core competencies in the fields of health care, nutrition and high-tech materials. Bayer HealthCare, a subsidiary of Bayer AG, is one of the world’s leading, innovative companies in the healthcare and medical products industry and is based in Leverkusen, Germany. The company combines the global activities of the Animal Health, Consumer Care, Diabetes Care and Pharmaceuticals divisions. The pharmaceuticals business operates under the name Bayer Schering Pharma. Bayer HealthCare’s aim is to discover and manufacture products that will improve human and animal health worldwide. Find more information at www.bayerhealthcare.com.

Bayer Schering Pharma is a worldwide leading specialty pharmaceutical company. Its research and business activities are focused on the following areas: Diagnostic Imaging, General Medicine, Specialty Medicine and Women’s Healthcare. With innovative products, Bayer Schering Pharma aims for leading positions in specialized markets worldwide. Using new ideas, Bayer Schering Pharma aims to make a contribution to medical progress and strives to improve the quality of life. Find more information at www.bayerscheringpharma.de.

Forward-looking statements

This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer Group or subgroup management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

NUTLEY, N.J., September 18, 2008 /News Release — Roche today announced that the U.S. Food and Drug Administration (FDA) has issued a complete response letter for the Biologics License Application (BLA) for ACTEMRA (tocilizumab), the first interleukin-6 (IL-6) receptor-inhibiting monoclonal antibody studied for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA).

The FDA has not requested any new clinical studies surrounding the efficacy or safety of ACTEMRA as a prerequisite for approval. The FDA has requested additional documentation related to the manufacturing of ACTEMRA and certain other outstanding components, such as final labeling. Roche is committed to working with the FDA to promptly address any outstanding matters. Upon satisfactory completion of the FDA’s requests and an approved label, Roche does not foresee any issues that would impact the quality, availability and supply of ACTEMRA in the U.S.

“Roche is committed to working with the FDA to make this important new therapy available to RA patients as soon as possible,” said George Abercrombie, CEO and president of Roche. “We will continue to work closely with the agency to address its questions and define the path forward for ACTEMRA. We are confident that we will be able to resolve any outstanding matters in the near future.”

Roche submitted the BLA for ACTEMRA to the agency on November 18, 2007. The BLA for ACTEMRA is based on the results of an extensive multi-national clinical development program, which included more than 4,000 patients in 41 countries, including the U.S. These studies demonstrated that treatment with ACTEMRA – alone or combination with methotrexate or other DMARDs (disease modifying anti-rheumatic drugs) – significantly reduced RA signs and symptoms, regardless of previous therapy or disease severity, compared with DMARDs alone. On July 29, 2008, the Arthritis Advisory Committee of the FDA voted 10-1 to recommend approval of ACTEMRA.

ACTEMRA is the first humanized interleukin-6 (IL-6) receptor-inhibiting monoclonal antibody for RA. Studies demonstrate that reducing the activity of IL-6, one of several key cytokines involved in the inflammatory process, relieves both inflammation of the joints and certain systemic effects of RA. The extensive clinical development program conducted by Roche includes five clinical studies and has enrolled more than 4,000 patients in 41 countries, including the United States. Four Phase III studies are completed and have reported meeting their primary endpoints. The fifth Phase III study, the LITHE trial evaluating ACTEMRA in RA is an ongoing two-year study, which is expected to report complete data evaluating the effects of ACTEMRA on the inhibition of structural joint damage in 2009. ACTEMRA is under review in the United States and Europe.

ACTEMRA is part of a co-development agreement with Chugai Pharmaceuticals Co. In June 2005, ACTEMRA was launched by Chugai in Japan as a therapy for Castleman’s disease; in April 2008, additional indications for rheumatoid arthritis, juvenile idiopathic arthritis and systemic-onset juvenile idiopathic arthritis were also approved in Japan.

The serious adverse reactions reported in ACTEMRA clinical studies include serious infections, gastrointestinal perforations and hypersensitivity reactions including anaphylaxis. The most common adverse reactions reported in clinical studies were upper respiratory tract infection, nasopharyngitis, headache, hypertension and increased ALT. Increases in liver enzymes (ALT and AST) were seen in some patients; these increases were generally mild and reversible, with no evidence of hepatic injuries. Laboratory changes, including increases in lipids (total cholesterol, LDL, HDL, triglycerides) and decreases in neutrophils and platelets, were seen in some patients without association with clinical outcomes. Treatments that suppress the immune system, such as ACTEMRA, may cause an increase in the risk of malignancies.

IL-6 is a common protein found in all joints in the body and is a natural substance that can raise inflammation. Everyone has IL-6 in their body, but people with RA may have too much. When approved, ACTEMRA will be the first and only medication to specifically target IL-6 in patients with RA.

Rheumatoid arthritis is a progressive, systemic autoimmune disease characterized by inflammation of the membrane lining in the joints. This inflammation causes a loss of joint shape and function, resulting in pain, stiffness and swelling, ultimately leading to irreversible joint destruction and disability. Characteristics of RA include redness, swelling, pain and movement limitation around joints of the hands, feet, elbows, knees and neck that leads to loss of function. In addition, the systemic symptoms of RA include fatigue, decreased hemoglobin, osteoporosis and may contribute to shortening life expectancy by affecting major organ systems. After 10 years, less than 50 percent of patients can continue to work or function normally on a daily basis. RA affects more than 21 million people worldwide with approximately 1.3 million adults affected in the United States.

Hoffmann-La Roche Inc. (Roche), based in Nutley, N.J., is the U.S. pharmaceuticals headquarters of the Roche Group, one of the world’s leading research-oriented healthcare groups with core businesses in pharmaceuticals and diagnostics. For more than 100 years in the U.S., Roche has been committed to developing innovative products and services that address prevention, diagnosis and treatment of diseases, thus enhancing people’s health and quality of life. An employer of choice, in 2007 Roche was named Top Company of the Year by , one of the Top 20 Employers () and ranked the No. 1 Company to Sell For (). In previous years, Roche has been named as a Top Company for Older Workers (AARP) and one of the Best Companies to Work For in America (). For additional information about the U.S. pharmaceuticals business, visit our website: http://www.rocheusa.com. Product and treatment information for U.S. healthcare professionals is available at www.RocheExchange.com.

FOSTER CITY, Calif.–(BUSINESS WIRE)–Sep 16, 2008 – Gilead Sciences, Inc. (Nasdaq:GILD) today announced that the company has received a complete response letter from the U.S. Food and Drug Administration (FDA) for its New Drug Application (NDA) for aztreonam lysine for inhalation, an investigational therapy in development for people with cystic fibrosis who have Pseudomonas aeruginosa (P. aeruginosa).

In this letter, the FDA informed Gilead that the review of the company’s NDA has been completed. The agency stated that they cannot approve the application in its current form and an additional clinical study will be required. Gilead will continue its dialogue with the FDA to determine whether further analyses of existing data could lead to approval, or whether the company will need to conduct the additional study as stated in the letter.

“Cystic fibrosis-related pseudomonal infections represent an area of significant and urgent unmet medical need. Our goal is to work with the FDA to deliver this product to the medical community and to people living with cystic fibrosis as quickly as possible,” said John C. Martin, PhD, Chairman and CEO, Gilead Sciences. “The FDA has not raised any significant concerns regarding the safety profile of aztreonam lysine. Therefore, we will continue our expanded access program for those individuals who have limited treatment options and are at risk of disease progression.”

Gilead submitted its NDA for aztreonam lysine for inhalation to the FDA on November 16, 2007. Marketing applications for aztreonam lysine for inhalation are under review by regulatory agencies in the European Union, Australia, Switzerland, Turkey and Canada.

About Aztreonam Lysine for Inhalation:

Aztreonam lysine for inhalation is an antibiotic candidate for people with cystic fibrosis who have P. aeruginosa. Aztreonam has potent activity against Gram-negative bacteria such as P. aeruginosa. Aztreonam formulated with arginine is a FDA-approved agent for intravenous administration. Aztreonam lysine is a proprietary formulation of aztreonam developed specifically for inhalation. It has been designated with orphan drug status in the United States and Europe.

In August 2007, Gilead initiated an expanded access program (EAP) to provide aztreonam lysine for inhalation to people with cystic fibrosis and P. aeruginosa who have significantly compromised lung function despite currently available therapies.

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.

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 the risk that existing data from any ongoing or from any further clinical trials that we may commence to satisfy FDA concerns will not support FDA approval of aztreonam lysine for inhalation and that this may cause Gilead to incur considerable expense, would lead to further delays or cause the company to abandon further development of the product. In addition, any further clinical trials would cause Gilead to incur significant expense. There is also the risk that health authorities in other countries where new drug applications are pending will undertake similar additional reviews which would compound the risks described above. 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 Gilead’s Annual Report on Form 10-K for the year ended December 31, 2007 and its Quarterly Report on Form 10-Q for the second quarter of 2008, as 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.

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.