Wednesday, March 30, 2011

Amgen to Appeal CHMP Opinion on Vectibix® (Panitumumab) Use With Chemotherapy in Metastatic Colorectal Cancer in Europe

THOUSAND OAKS, Calif., March 30, 2011 /PRNewswire via COMTEX/—Amgen (Nasdaq: AMGN) announced today that it has submitted a request to the European Medicines Agency (EMA) for a re-examination of the negative opinion issued in March by the Committee For Medicinal Products for Human Use (CHMP)for the use of Vectibix in combination with chemotherapy for patients with wild-type KRAS metastatic colorectal cancer (mCRC).

Posted in Press Releases

Wednesday, March 30, 2011

Top-Line Results Announced of Pivotal Phase 3 Motesanib Trial in Advanced Non-Squamous Non-Small Cell Lung Cancer Patients

THOUSAND OAKS, Calif., CAMBRIDGE, Mass. and OSAKA, Japan, March 30, 2011 /PRNewswire via COMTEX/—Amgen (Nasdaq: AMGN), Millennium: The Takeda Oncology Company, and Takeda Pharmaceutical Company Limited (TSE: 4502) today announced top-line results from the MONET1 pivotal Phase 3 trial evaluating motesanib administered in combination with paclitaxel and carboplatin in 1,090 patients with advanced non-squamous non-small cell lung cancer (NSCLC). The trial did not meet its primary objective of demonstrating an improvement in overall survival (OS) (hazard ratio 0.90, 95 percent CI 0.78 - 1.04, p=0.14).

Posted in Press Releases

Wednesday, March 23, 2011

Treatment With Prolia® (denosumab) Associated With Significantly Greater Adherence, Compliance and Persistence Compared to Alendronate

New 2-Year Open-Label Study Shows More Than 90 Percent of Patients Preferred Prolia Injection Every Six Months Over Weekly Oral Alendronate

THOUSAND OAKS, Calif., March 23, 2011 /PRNewswire via COMTEX/—Amgen (Nasdaq: AMGN) today announced new data that showed postmenopausal women with osteoporosis had significantly greater adherence, compliance, and persistence during Prolia® (denosumab) treatment than during alendronate treatment, an oral bisphosphonate commonly used to treat osteoporosis.

Posted in Press Releases, Product News

Wednesday, March 23, 2011

Prolia® (denosumab) Open-Label Extension Trial Showed Continued Increase in Bone Mineral Density Over Five Years of Treatment With Similar Safety Profile Observed in Pivotal Trial

THOUSAND OAKS, Calif., March 23, 2011 /PRNewswire via COMTEX/—Amgen (Nasdaq: AMGN) today announced new long-term data showing that during the fourth and fifth years of Prolia® (denosumab) treatment, postmenopausal women with osteoporosis receiving Prolia continued with further, statistically significant, year-over-year increases in lumbar spine and total hip bone mineral density (BMD), a key measurement of bone strength. The overall adverse event profile was similar for the fourth and fifth years of consecutive Prolia treatment.

Posted in Press Releases, Product News