Bristol-Myers Squibb and Gilead Sciences Submit New Drug Application to U.S. FDA for a Once-Daily Single Tablet Regimen of Sustiva® and Truvada® for HIV Treatment

Business Wire, April 27, 2006

PRINCETON, N.J. & FOSTER CITY, Calif. -- Bristol-Myers Squibb Company (NYSE:BMY) and Gilead Sciences, Inc. (Nasdaq:GILD) today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for approval of a product that combines the anti-HIV medications Sustiva(R) (efavirenz), manufactured by Bristol-Myers Squibb, and Truvada(R) (emtricitabine and tenofovir disoproxil fumarate), manufactured by Gilead Sciences, in a once-daily single tablet regimen. Truvada itself is a fixed-dose product that contains two of Gilead's anti-HIV medications, Viread(R) (tenofovir disoproxil fumarate) and Emtriva(R) (emtricitabine), in a single once-daily tablet. If approved by the FDA, the new single tablet regimen would be the first and only product that contains a complete Highly Active Antiretroviral Therapy (HAART) regimen in a single once-daily tablet, intended for the treatment of HIV-1 infection in adults as a complete regimen or in combination with other antiretrovirals.

The collaboration between Bristol-Myers Squibb and Gilead is the first of its kind in the field of HIV therapy. On December 20, 2004 the companies established a U.S. joint venture to develop and commercialize the single tablet regimen in the United States. The work necessary to file the NDA for the single tablet regimen, including bioequivalence studies and the initiation of stability studies, has since been completed.

"The partnership between Bristol-Myers Squibb and Gilead was founded on the companies' shared commitment to addressing the needs of people living with HIV," commented John C. Martin, PhD, President and Chief Executive Officer, Gilead Sciences. "Significant progress in science and medicine has been achieved since the advent of the first combination regimens 10 years ago, but more work is needed and we view this partnership to create the first-ever once-daily single tablet regimen for HIV as an important step toward further simplifying dosing of HIV therapy for physicians and patients."

"Bristol-Myers Squibb is pleased to partner with a company that, like us, values scientific and commercial innovation to help patients," said Anthony C. Hooper, President, U.S. Pharmaceuticals, Bristol-Myers Squibb. "The collaboration between the companies is an important milestone for patients living with HIV. Working together, Bristol-Myers Squibb and Gilead Sciences are ushering in a new era of collaboration driven by the need to deliver HIV therapies to patients in need."

The proposed once-daily single tablet regimen contains 600 mg of efavirenz, 200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate. All three active ingredients work by blocking reverse transcriptase, an enzyme necessary for HIV replication. It is important for patients to be aware that these medications do not cure HIV infection or prevent passing HIV to others.

Subject to marketing approval of the once-daily single tablet regimen, Bristol Myers-Squibb and Gilead will share responsibility for commercializing the product in the United States. Both companies will provide funding and field-based sales representatives in support of promotional efforts for the combination product. Bristol-Myers Squibb and Gilead will receive revenues from future net sales at percentages relative to the contribution represented by their individual products that comprise the once-daily single tablet regimen. Sustiva, Truvada, Viread and Emtriva will continue to be sold by the respective companies as individual products.

Guidelines issued by the U.S. Department of Health and Human Services (DHHS) list the combination of efavirenz, emtricitabine and tenofovir disoproxil fumarate as one of the preferred non-nucleoside reverse transcriptase inhibitor (NNRTI)-based treatment regimens for use in appropriate patients who have never taken anti-HIV medicines before. Efavirenz should not be used during the first trimester of pregnancy due to the potential harm to the fetus. Pregnancy should be avoided in women receiving efavirenz.

About HIV/AIDS

2006 marks the 25th anniversary of the start of the AIDS epidemic. The first cases of HIV/AIDS were reported by the U.S. Centers for Disease Control and Prevention (CDC) in the June 5, 1981 issue of the Morbidity and Mortality Weekly Report (MMWR). Today, the CDC estimates that more than one million Americans are infected with HIV, the virus that causes AIDS. Of these, approximately 25 percent are unaware of their infection. Although HIV treatment options have expanded rapidly in recent years, the CDC estimates that 216,000 Americans who are HIV infected and eligible for antiretroviral treatment are currently not receiving it.

Important Information About SUSTIVA(R) (efavirenz)

SUSTIVA is a prescription medicine used in combination with other medicines to treat people who are infected with the human immunodeficiency virus type 1 (HIV-1). SUSTIVA does not cure HIV or help prevent passing HIV to others. SUSTIVA should not be taken with Hismanal(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 of medicines is not complete. Patients should discuss all prescription and non-prescription medicines, vitamin and herbal supplements, or other health preparations (particularly St. John's wort) they are taking or plan to take with their healthcare provider.