Tuesday, November 15, 2011

Vectibix® (Panitumumab) Granted Approval for Expanded Indications in the European Union

THOUSAND OAKS, Calif., Nov. 15, 2011 /PRNewswire via COMTEX/—Amgen (NASDAQ: AMGN) today announced that the European Commission (EC) has approved a variation to the marketing authorization for Vectibix® (panitumumab) to include indications for the treatment of patients with wild-type KRAS metastatic colorectal cancer (mCRC) in first-line in combination with FOLFOX and in second-line in combination with FOLFIRI in patients who have received first-line fluoropyrimidine-based chemotherapy (excluding irinotecan). This approval of Vectibix applies to all 27 European Union (EU) member states. Prior to this approval, Vectibix had received conditional approval in the EU as monotherapy. The monotherapy indication was also further revised to state that Vectibix is indicated for the treatment of patients with wild-type KRAS mCRC as monotherapy after failure of fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy regimens.

Read the rest of this entry

Posted in Press Releases

Monday, November 14, 2011

Amgen Statement on European Investor Visit

THOUSAND OAKS, Calif., Nov. 14, 2011 /PRNewswire via COMTEX/—Amgen (NASDAQ:AMGN) today issued the following statement:

Amgen will be meeting with investors in Europe this week with a view to raise $1-1.5 billion in Euro and Sterling denominated debt to support its share repurchase program, as well as for general corporate purposes. The timing of this potential offering will be subject to market conditions.

Read the rest of this entry

Posted in Press Releases

Monday, November 07, 2011

Amgen Announces Plan to Launch Tender Offer and Launch of Senior Notes Offering

THOUSAND OAKS, Calif., Nov. 7, 2011 /PRNewswire via COMTEX/—Amgen (NASDAQ: AMGN) today announced its plan to launch a modified Dutch auction tender offer to purchase up to $5 billion of its common stock, par value $0.0001 per share ("Common Stock"). Amgen also announced a public offering of its senior notes, the proceeds of which will be used to fund the tender offer and for general corporate purposes.

Read the rest of this entry

Posted in Press Releases

Saturday, November 05, 2011

Treatment With Enbrel® (etanercept) Shows Significant and Sustained Clinical Benefits in Rheumatoid Arthritis (RA) Patients With Moderately Active Disease

Amgen and Pfizer Announce Results From the Largest Completed Clinical Trial of a Biologic Therapy in Adults with Moderately Active RA

THOUSAND OAKS, Calif. and NEW YORK, Nov. 5, 2011 /PRNewswire via COMTEX/—Amgen (NASDAQ: AMGN) and Pfizer Inc. (NYSE: PFE) today announced results of the second and final period of the PRESERVE trial. PRESERVE is a two-period multi-center trial in patients with moderately active rheumatoid arthritis (RA) who achieved Disease Activity Score (DAS) 28 low disease activity (LDA) or clinical remission on combination Enbrel® (etanercept) plus methotrexate (MTX) in Period one and were randomized to continue on ENBREL plus MTX or MTX alone in Period two. Results of Period two showed that the percentage of patients who maintained LDA or achieved clinical remission at week 88 was significantly higher in patients receiving ENBREL plus MTX than those on MTX alone. These results have been accepted in the late-breaker poster presentation at the 2011 American College of Rheumatology Annual Scientific Meeting in Chicago, from Nov. 5-9, 2011.

Read the rest of this entry

Posted in Press Releases

Saturday, November 05, 2011

Prolia® (denosumab) Open-Label Extension Trial Showed Continued Increase in Bone Mineral Density Over Six Years With Similar Safety Profile Observed in Original Fracture Trial

THOUSAND OAKS, Calif., Nov. 5, 2011 /PRNewswire via COMTEX/—Amgen (NASDAQ: AMGN) today announced positive data from the first three years of the open-label extension study of the pivotal Phase 3 fracture trial showing that six years of Prolia® (denosumab) treatment in postmenopausal women with osteoporosis was associated with continued increase in bone mineral density (BMD) and consistent reduction in markers of bone turnover. These results will be presented on Nov. 8, 2011, at the 2011 American College of Rheumatology Annual Scientific Meeting in Chicago.

Read the rest of this entry

Posted in Press Releases