Wednesday, March 12, 2008

Amgen to Discuss Romiplostim Application at FDA ODAC Meeting

Orphan Drug Romiplostim Reviewed as Potential New Treatment Approach for Serious Bleeding Disorder

THOUSAND OAKS, Calif.—March 12, 2008—Amgen Inc. (NASDAQ: AMGN) will discuss the proposed Biologic License Application (BLA) for romiplostim, an investigational thrombopoietin mimetic peptibody, for the treatment of thrombocytopenia in adult patients with chronic immune (idiopathic) thrombocytopenic purpura (ITP) today at the Oncologic Drugs Advisory Committee (ODAC). Patients with chronic ITP, a serious autoimmune disorder characterized by low platelet counts in the blood (thrombocytopenia) face the risk of bleeding events. Treatment of thrombocytopenia in adult patients with chronic ITP is considered an unmet medical need by the U.S. Food and Drug Administration (FDA) and has received orphan drug designation.

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Posted in Press Releases, Pipeline News

Monday, March 10, 2008

Amgen Statement on Briefing Materials Prepared for March 12, 2008 ODAC Meeting

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Monday, February 04, 2008

Amgen and Takeda Announce Exclusive Collaboration in Japan on up to 13 Amgen Clinical Candidates

THOUSAND OAKS, Calif. & OSAKA, Japan, Feb 04, 2008 – Amgen (NASDAQ:AMGN) and Takeda Pharmaceutical Company Limited (TSE: 4502) today announced an agreement under which Takeda will develop and commercialize for the Japanese market up to 13 molecules from Amgen’s pipeline, one of which is included as an option. This collaboration validates the significant value of Amgen’s clinical stage pipeline and further ensures Japanese patients will have access to Amgen’s innovative potential medicines for serious illnesses. The collaboration includes early to mid-stage clinical-stage candidates across a range of therapeutic areas, including oncology, inflammation, and pain.

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Thursday, January 31, 2008

Pooled Phase 3 Study of Nplate(TM) (Romiplostim) in Adult Patients with Chronic ITP Published in The Lancet

THOUSAND OAKS, Calif., Jan 31, 2008 – Amgen Inc. (NASDAQ: AMGN) today announced data from two Phase 3 studies which evaluated the administration of Nplate(TM) (romiplostim) on increasing and sustaining platelet counts in both splenectomized (spleen removed) and non-splenectomized patients with chronic Immune Thrombocytopenic Purpura (ITP). The data will be published in the Feb. 2, 2008, issue of The Lancet.

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Thursday, January 24, 2008

Denosumab Osteoporosis Study Met Primary and All Secondary Bone Mineral Density Endpoints in a Head-to-Head Comparison with Weekly Alendronate (FOSAMAX(R))

THOUSAND OAKS, Calif., Jan 24, 2008 – Amgen (NASDAQ:AMGN) today announced findings from a head-to-head, double-blind study comparing the effects of twice-yearly subcutaneous injections of denosumab versus weekly oral doses of alendronate (FOSAMAX(R)) on bone mineral density (BMD) in postmenopausal women with low bone mineral density. The study met primary and all secondary endpoints.

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