Bristol-Myers Squibb and Gilead Announce Data Supporting Bioequivalence for Single-Pill Fixed-Dose Regimen of Sustiva(R) (efavirenz) and Truvada(R) (emtricitabine and tenofovir disoproxil fumarate)

Bristol-Myers Squibb Company (NYSE:BMY) and Gilead Sciences, Inc.(Nasdaq:GILD) today announced they have obtained data supportingbioequivalence of a new formulation of the fixed-dose combination ofBristol-Myers Squibb's Sustiva(R) (efavirenz) and Gilead's Truvada(R)(emtricitabine and tenofovir disoproxil fumarate) with the componentsthat make up the new combination. The new fixed-dose regimen isintended for the treatment of HIV-1 infection in adults.

The fixed-dose regimen was developed using a bi-layer technologyto co-formulate Sustiva and Truvada as individually formulated layerscombined in one tablet. In August of 2005, Gilead announced that thecompanies were proceeding with the evaluation of three newformulations in parallel, based on bi-layer technology.

A bioequivalence study is required to demonstrate that aco-formulated product results in the same levels of medication in theblood as achieved when the individual products are dosedsimultaneously as separate pills. Gilead and Bristol-Myers Squibbanticipate filing a New Drug Application with the U.S. Food and DrugAdministration (FDA) in the second quarter of 2006.

"Tremendous progress has been made in the fight against HIV/AIDS,yet there is still work that needs to be done," said Anthony C.Hooper, President, U.S. Pharmaceuticals, Bristol-Myers Squibb."Together with our partner Gilead, Bristol-Myers Squibb will continueadvancing the development of this potential innovative treatmentoption for HIV patients."

"The advancement of our fixed-dose regimen represents an importantstep forward in the further simplification of HIV treatment," saidJohn C. Martin, PhD, President and Chief Executive Officer, GileadSciences. "Gilead and Bristol-Myers Squibb share a commitment to thetreatment of HIV, a disease for which significant unmet medical needcontinues to exist, and we look forward to working with regulatoryauthorities."

In December 2004, Gilead and Bristol-Myers Squibb announced theestablishment of a U.S. joint venture to co-formulate theantiretrovirals Truvada and Sustiva in a fixed-dose regimen. Ifapproved by the FDA, the new product would be the first completeHighly Active Antiretroviral Therapy (HAART) treatment regimen for HIVavailable in a fixed-dose combination tablet taken once daily.Fixed-dose combinations contain multiple medicines formulated togetherand may help simplify HIV therapy for patients and providers. Thejoint venture established by the two companies is the first of itskind in the field of HIV therapy.

Guidelines issued by the U.S. Department of Health and HumanServices (DHHS) list the combination of emtricitabine, tenofovirdisoproxil fumarate and efavirenz as one of the preferrednon-nucleoside reverse transcriptase inhibitor (NNRTI)-basedtreatments for use in appropriate patients that have never takenanti-HIV medicines before. Efavirenz should not be used during thefirst trimester of pregnancy due to the potential harm to the fetus.Pregnancy should be avoided in women receiving efavirenz. It isimportant that patients be aware that individual HIV medications mustbe taken as part of combination regimens, and that they do not cureHIV infection or prevent passing HIV to others.

Important Information About SUSTIVA(R) (efavirenz)

SUSTIVA is a prescription medicine used in combination with othermedicines to treat people who are infected with the humanimmunodeficiency virus type 1 (HIV-1). SUSTIVA does not cure HIV orhelp prevent passing HIV to others. SUSTIVA should not be taken withHismanal(R) (astemizole), Propulsid(R) (cisapride), Versed(R)(midazolam), Halcion(R) (triazolam), ergot medicines (for example,Wigraine(R) and Cafergot(R)), or Vfend(R) (voriconazole). This list ofmedicines is not complete. Patients should discuss all prescriptionand non-prescription medicines, vitamin and herbal supplements, orother health preparations (particularly St. John's wort) they aretaking or plan to take with their healthcare provider.

Patients taking SUSTIVA should tell their doctor right away ifthey have any side effects or conditions including: severe depression,strange thoughts, or angry behavior, which have been reported in asmall number of patients. A few reports of suicide have been made, butit is not known if SUSTIVA was the cause. Dizziness, trouble sleeping,drowsiness, trouble concentrating, and/or unusual dreams are common.These feelings tend to go away after taking SUSTIVA for a few weeks.

Women should not become pregnant or breastfeed while takingSUSTIVA. Serious birth defects have been seen in children of womentreated with SUSTIVA during pregnancy. Women must use a reliable formof barrier contraception, such as a condom, even if they also useother methods of birth control. Patients should tell their doctor ifthey have a history of mental illness or are using drugs or alcohol.Rash is a common side effect that usually goes away without any changein treatment. Rash may be a serious problem in some children. If achild develops a rash, their doctor should be contacted right away.Patients with liver disease, a history of seizures, or taking medicinefor seizures, may require the healthcare provider to check the liveror check drug levels in the blood.

Changes in body fat have been seen in some patients taking HIVmedicines, however, the cause and long-term effects of these changesare not known at this time. Other common side effects include:tiredness, upset stomach, vomiting and diarrhea. SUSTIVA should betaken on an empty stomach, preferably at bedtime, which may make someside effects less bothersome. SUSTIVA and other anti-HIV medicinesshould be taken exactly as instructed by healthcare providers. UnitedStates Full Prescribing Information for SUSTIVA is available atwww.SUSTIVA.com.

About Truvada

Truvada combines Emtriva(R) (emtricitabine) and Viread(R)(tenofovir disoproxil fumarate) in one tablet taken once a day incombination with other antiretroviral agents. In the United States,Truvada is indicated in combination with other antiretroviral agents(such as non-nucleoside reverse transcriptase inhibitors or proteaseinhibitors) for the treatment of HIV-1 infection in adults. Safety andefficacy studies using Truvada tablets or using Emtriva and Viread incombination are ongoing.

Emtriva and Viread have each been studied as part of multi-drugregimens and have been found to be safe and effective. In clinicalstudy 303 Emtriva and lamivudine (3TC) demonstrated comparableefficacy, safety and resistance patterns as part of multidrugregimens. These data, and those from study 903, in which lamivudineand tenofovir were used in combination, support the use of Truvada forthe treatment of HIV-1 infection in treatment-naive adults. Intreatment-experienced patients, the use of Truvada should be guided bylaboratory testing and treatment history.

There are no study results demonstrating the effect of Truvada onclinical progression of HIV-1, and it is not recommended that Truvadabe used as a component of a triple nucleoside regimen.

Truvada should not be used with Emtriva or Viread, or other drugscontaining lamivudine, including Combivir(R), Epivir(R),Epivir-HBV(R), Epzicom(TM) or Trizivir(R). Two-hundred eighty-threepatients have received combination therapy with Emtriva and Vireadwith either a non-nucleoside reverse transcriptase inhibitor orprotease inhibitor for 24 to 48 weeks in ongoing clinical studies.Based on these limited data, no new patterns of adverse events wereidentified and there was no increased frequency of establishedtoxicities. For additional safety information about Emtriva or Vireadin combination with other antiretroviral agents, please see "AboutEmtriva" and "About Viread," below.

Lactic acidosis and severe hepatomegaly with steatosis, includingfatal cases, have been reported with the use of nucleoside analoguesalone or in combination with other antiretrovirals. Viread, Emtrivaand Truvada are not indicated for the treatment of chronic hepatitis Bvirus (HBV) infection and the safety and efficacy of these drugs hasnot been established in patients co-infected with HBV and HIV. Severeacute exacerbations of hepatitis B have been reported in patients whohave discontinued Viread or Emtriva. Hepatic function should bemonitored closely with both clinical and laboratory follow-up for atleast several months in patients who discontinue Viread, Emtriva orTruvada and are co-infected with HIV and HBV. If appropriate,initiation of anti-hepatitis B therapy may be warranted.

Immune reconstitution syndrome has been reported in patientstreated with combination antiretroviral therapy, including Viread andEmtriva. Changes in body fat have been observed in patients takinganti-HIV medicines, including Viread and Emtriva. The cause and longterm health effect of these conditions are unknown.

The parent compound of one of the component drugs in Truvada,tenofovir disoproxil fumarate, was discovered through a collaborativeresearch effort between Dr. Antonin Holy, Institute for OrganicChemistry and Biochemistry, Academy of Sciences of the Czech Republic(IOCB) in Prague and Dr. Erik DeClercq, Rega Institute for MedicalResearch, Katholic University in Leuven, Belgium. The inventors haveagreed to waive their right to a royalty on sales of productscontaining tenofovir in the developing countries served by the GileadAccess Program to ensure the product can be offered at a no-profitprice in parts of the world where the AIDS epidemic has hit thehardest.

About Emtriva

In the United States, Emtriva is indicated, in combination withother antiretroviral agents, for the treatment of HIV-1 infection inpatients over three months of age. This indication is based onanalyses of plasma HIV-1 RNA levels and CD4 cell counts fromcontrolled studies of 48 weeks duration in antiretroviral-naivepatients and antiretroviral-treatment-experienced patients who werevirologically suppressed on an HIV treatment regimen. Inantiretroviral-treatment-experienced patients, the use of Emtriva maybe considered for adults with HIV strains that are expected to besusceptible to Emtriva as assessed by genotypic or phenotypic testing.In pediatric patients over three months of age, the safety andefficacy of emtricitabine is supported by data from three open-label,non-randomized clinical studies in which emtricitabine wasadministered to 169 HIV-1 infected treatment naive and experiencedpatients between three months and 21 years of age.

Adverse events that occurred in more than five percent of patientsreceiving Emtriva with other antiretroviral agents in clinical trialsinclude abdominal pain, asthenia (weakness), headache, diarrhea,nausea, vomiting, dizziness and rash (rash, pruritis, maculopapularrash, urticaria, vesiculobullous rash, pustular rash and allergicreaction). Approximately one percent of patients discontinuedparticipation because of these events. All adverse events werereported with similar frequency in Emtriva and control treatmentgroups with the exception of skin discoloration which was reportedwith higher frequency in the Emtriva treated group. Skindiscoloration, manifested by hyperpigmentation on the palms and/orsoles, was generally mild and asymptomatic. The mechanism and clinicalsignificance are unknown. For pediatric patients over three months ofage, the adverse event profile observed during clinical trials wassimilar to that of adult patients, with the exception of anemia and ahigher frequency of hyperpigmentation.

About Viread

In the United States, Viread is indicated in combination withother antiretroviral agents for the treatment of HIV-1 infection. Thisindication is based on analyses of plasma HIV-1 RNA levels and CD4cell counts in controlled studies of Viread in treatment-naive adultsand in treatment-experienced adults. There are no study resultsdemonstrating the effect of Viread on clinical progression of HIV-1.The use of Viread should be considered for treating adult patientswith HIV-1 strains that are expected to be susceptible to tenofovir asassessed by laboratory testing or treatment history.

Drug interactions have been observed when didanosine, atazanaviror lopinavir/ritonavir is co-administered with Viread and doseadjustments may be necessary. Data are not available to recommend adose adjustment of didanosine for patients weighing less than 60 kg.Patients on atazanavir or lopinavir/ritonavir plus Viread should bemonitored for Viread-associated adverse events which may requirediscontinuation. When co-administered with Viread, it is recommendedthat atazanavir 300 mg be given with ritonavir 100 mg. Atazanavirwithout ritonavir should not be co-administered with Viread.

Renal impairment, including serious cases, has been reported.Renal impairment occurred most often in patients with underlyingsystemic or renal disease or in patients taking concomitantnephrotoxic agents, though some cases have appeared in patientswithout identified risk factors. Decreases in bone mineral density(BMD) at the lumbar spine and hip and increases in biochemical markersof bone metabolism have been seen with the use of Viread. The clinicalsignificance of changes in BMD and biochemical markers is unknown andfollow-up is continuing to assess long-term impact. The most commonadverse events and those occurring in more than five percent ofpatients receiving Viread with other antiretroviral agents in clinicaltrials 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 one percent of patientsdiscontinued participation because of gastrointestinal events.

About Bristol-Myers Squibb

Bristol-Myers Squibb is a global pharmaceutical and relatedhealthcare products company whose mission is to extend and enhancehuman life. For more than a decade, Bristol-Myers Squibb Company hasbeen a global leader in the science of infectious diseases and hasinvested consistently in innovative research leading to thedevelopment of important treatments for people with HIV/AIDS. VisitBristol-Myers Squibb on the World Wide Web at www.bms.com.

About Gilead Sciences

Gilead Sciences is a biopharmaceutical company that discovers,develops and commercializes innovative therapeutics in areas of unmetmedical need. The company's mission is to advance the care of patientssuffering from life-threatening diseases worldwide. Headquartered inFoster City, California, Gilead has operations in North America,Europe and Australia. Visit Gilead on the World Wide Web atwww.gilead.com.

Bristol-Myers Squibb Forward-Looking Statement

This press release contains "forward-looking statements" as thatterm is defined in the Private Securities Litigation Reform Act of1995 regarding product development. Such forward-looking statementsare based on current expectations and involve inherent risks anduncertainties, including factors that could delay, divert or changeany of them, and could cause actual outcomes and results to differmaterially from current expectations. Among other risks, there can beno guarantee that the combination product will be submitted forregulatory approval, will receive regulatory approval, or, ifapproved, will be commercially successful. No forward-lookingstatement can be guaranteed. Forward-looking statements in this pressrelease should be evaluated together with the many uncertainties thataffect Bristol-Myers Squibb's business, particularly those identifiedin the cautionary factors discussion in Bristol-Myers Squibb's AnnualReport on Form 10-K/A for the year ended December 31, 2004 and in ourQuarterly Reports on Form 10-Q. Bristol-Myers Squibb undertakes noobligation to publicly update any forward-looking statement, whetheras a result of new information, future events or otherwise.

Gilead Forward-Looking Statement

This press release contains "forward-looking statements" as thatterm is defined in the Private Securities Litigation Reform Act of1995. The forward-looking statements include statements regardingapproval and licensure of the combination product. These statementsinvolve risks and uncertainties, which may cause results to differmaterially from those set forth in the statements, including the risksrelated to regulatory requirements to support approval of thecombination product, and the willingness of regulatory authorities togrant regulatory approval for the combination product based onavailable data. No forward-looking statement can be guaranteed, andactual results may differ materially from those projected. Gileadundertakes no obligation to publicly update any forward-lookingstatement, whether as a result of new information, future events orotherwise. Forward-looking statements in this press release should beevaluated together with the many uncertainties that affect Gilead'sbusiness, particularly those mentioned in the cautionary statements inthe company's Form 10-K for the year ended December 31, 2004, and inperiodic reports on Form 10-Q and Form 8-K.

Sustiva is a registered trademark of Bristol-Myers Squibb PharmaCompany.

Truvada, Viread and Emtriva are registered trademarks of GileadSciences, Inc.

All other trademarks are the property of third parties.