Amgen's NEUPOGEN approved in U.K. to treat neutropenia in people with advanced HIV infection.

THOUSAND OAKS, Calif.--(BUSINESS WIRE)--March 7, 1996--Amgen (NASDAQ:AMGN) Thursday announced that its recombinant granulocyte colony-stimulating factor (rHuG-CSF) NEUPOGEN(R) (Filgrastim) has been approved for use in the United Kingdom as a supportive therapy to treat neutropenia in people with advanced HIV infection, enabling them to receive myelosuppressive therapies.

Neutropenia is a condition caused by too few neutrophils, a type of white blood cell that is the body's first defense against infection.

NEUPOGEN is the first rHuG-CSF to be licensed for this use. The newly approved use for people with advanced HIV infection and neutropenia (Absolute Neutrophil Counts, or ANC, below 1,000) will enable patients to receive their medications as scheduled.

This approval will enable Amgen and F. Hoffman-La Roche, its NEUPOGEN collaborator in the European Community (EC), to seek similar approvals in other EC countries. NEUPOGEN is currently in clinical trials in the United States to evaluate its safety and efficacy in treating neutropenia in people with HIV infection.

People infected with HIV often are neutropenic. Neutropenia can be due to the virus' effect on the bone marrow (the source of neutrophils) or the myelosuppressive effect of certain treatments for opportunistic infections associated with HIV infection.

Neutropenia increases the risk of infection and often results in dose reduction or delayed delivery of myelosuppressive therapy, thereby compromising treatment outcome. NEUPOGEN stimulates the bone marrow to increase the production of neutrophils, which help fight bacterial infections.

The new approved use of NEUPOGEN will improve the ability of patients to receive the medications integral to the management of HIV and the associated complications.

These medications include antivirals such as zidovudine for treatment of primary HIV infection, ganciclovir to slow the progression of cytomegalovirus (CMV) infection, antibacterials such as co-trimoxazole to reduce opportunistic infections and chemotherapy used to treat HIV-associated cancers.

The efficacy of NEUPOGEN to treat neutropenia was confirmed in a multi-center trial in 200 HIV-infected patients, in which a dose of up to 300 mcg of NEUPOGEN corrected neutropenia in 98 percent of the patients. Patients treated one to seven times a week effectively maintained neutrophil counts at greater than or equal to 2.0 x 10(9) cells per liter.

In this study, NEUPOGEN was well tolerated, with the main drug- related adverse event being bone pain, which is usually treated with non-prescription pain relievers.

NEUPOGEN is available as a ready-to-use solution. In the United States, it has been licensed for the reduction of neutropenia in four indications: as an adjunct to cancer chemotherapy, to support a procedure known as Peripheral Blood Progenitor Cell (PBPC) transplants, in conjunction with BMT (bone marrow transplants) and to prevent infections in people with a rare blood disorder known as Severe Chronic Neutropenia (SCN) in which the body fails to manufacture sufficient infection-fighting neutrophils.

Amgen is a global biotechnology company that discovers, develops, manufactures and markets human therapeutics based on advanced cellular and molecular biology.

CONTACT: Amgen, Thousand Oaks

David Kaye, 805/447-6692 (media)

Sarah Crampton, 805/447-1659 (investors)