Key Developments For Amgen Inc.
Amgen Inc. (AMGN.O) (Nasdaq)
Amgen, Inc. Announces Overall Survival Results For Vectibix In First-Line Metastatic Colorectal Cancer
Amgen, Inc. announced that the Phase 3 PRIME 203 trial evaluating Vectibix (panitumumab) administered in combination with FOLFOX (an oxaliplatin-based chemotherapy) as a first-line treatment of metastatic colorectal cancer (mCRC) failed to meet a secondary endpoint of overall survival. Earlier this year, it was announced that the trial met its primary endpoint by significantly prolonging progression-free survival (PFS) in the first-line treatment of patients with KRAS wild-type mCRC. The prospective analysis of the 203 study showed that Vectibix, when added to a FOLFOX chemotherapy regimen in patients with KRAS wild-type mCRC, resulted in a median overall survival of 23.9 months compared to 19.7 months for patients treated with FOLFOX alone. The median overall survival difference of 4.2 months in the Vectibix arm did not reach statistical significance (HR=0.83, p=0.072). Overall survival appeared to be reduced in patients with KRAS mutant tumors receiving Vectibix. Although not statistically significant, this result emphasizes the importance, as described in product labeling, of ensuring that patients receiving Vectibix( )do not bear tumors containing KRAS mutations. Overall, the adverse event profile was as anticipated for an anti-EGFR antibody in combination with oxaliplatin-based chemotherapy, including known events such as rash, diarrhea and hypomagnesemia. Vectibix-related grade 3 infusion reactions were reported for two patients (less than 1%).
Amgen, Inc. Announces Study Of Anemia Treatment In Chronic Kidney Disease Patients Not On Dialysis Failed To Meet Primary Efficacy Endpoints
Amgen, Inc. announced the publication of results from TREAT (the Trial to Reduce Cardiovascular Events with Aranesp Therapy), a large, randomized, double blind, placebo controlled, Phase 3 pivotal study of patients with chronic kidney disease (CKD) not on dialysis, moderate anemia and type 2 diabetes. The study, failed to meet its primary objectives of demonstrating a reduction in all cause mortality, cardiovascular morbidity, including heart failure, heart attack, stroke, or hospitalization for myocardial ischemia, or end stage renal disease (ESRD). The primary endpoints of the study were a composite of time to all-cause mortality or cardiovascular morbidity and a composite of time to all cause mortality or ESRD. Among the components of the primary cardiovascular composite endpoint, the risk of stroke increased by almost two fold in patients in the Aranesp arm (101 patients vs. 53 patients; hazard ratio, 1.92; 95% confidence interval, 1.38 to 2.68; P<0.001). Although stroke is a recognized risk with erythropoiesis-stimulating agent (ESA) therapy, and has been identified in warnings in United States (U.S.) labeling since 2001, the risk observed in TREAT is of higher magnitude than that seen in previous clinical trials in CKD patients not on dialysis. A post hoc analysis indicates that there were no significant differences between treatment arms in the incidence of cancer or of all-cause deaths in patients who developed cancer during the trial.
Amgen, Inc. and AmerisourceBergen Corp. Sued Over Drug Kickback Scheme-Reuters
Reuters reported that Amgen, Inc. and AmerisourceBergen Corp. were sued on Friday by 14 U.S. states and the District of Columbia over an alleged kickback scheme designed to boost sales of Amgen's anemia drug, Aranesp. New York Attorney General Andrew Cuomo announced the lawsuit, which was filed in federal court in Boston. It joins a related whistleblower lawsuit filed in the same court in 2006 and is one of many lawsuits accusing drugmakers of illegally marketing their products. The lawsuit alleges Amgen and two AmerisourceBergen units, International Nephrology Network and ASD Healthcare, conspired to encourage doctors to bill third party payers such as Medicaid for Aranesp that was provided at no cost. It said this resulted in 'thousands of false claims to be paid by the state Medicaid programs that were ineligible for payment,' causing millions of dollars of damages. The lawsuit also alleges that kickbacks, including 'sham consultancy agreements and weekend junkets,' were made to medical providers to induce them to buy and prescribe Aranesp.
Amgen, Inc. Reiterates FY 2009 Revenue Outlook; Raises FY 2009 EPS Outlook
Amgen, Inc. reiterated its fiscal 2009 outlook and expects revenues towards the upper end of the current outlook range of $14.4-$14.8 billion. It now expects fiscal 2009 adjusted earnings per share (EPS) to be in the range of $4.90-$5.05, an increase from the previous range of $4.80-$4.95. According to Reuters Estimates, analysts were expecting the Company to report revenues of $14.7 billion and EPS of $4.88 for the same period.
Amgen, Inc. Provides Update On Status of Prolia (Denosumab) Biologics License Application Submitted to U.S. Food and Drug Administration
Amgen, Inc. announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter for the Biologic License Applications (BLA) for Prolia (denosumab) in the treatment and prevention of postmenopausal osteoporosis. The FDA issues Complete Response Letters to request additional information needed to complete the review of applications for product approval. The Complete Response Letter related to the Prolia applications requested several items, including further information on the design of Amgen's previously submitted post-marketing surveillance program. This letter does not require additional pre-marketing clinical trials to complete the review of the treatment indication. The FDA has requested a new clinical program to support approval of Prolia for the prevention of postmenopausal osteoporosis indication. The FDA has determined that a Risk Evaluation and Mitigation Strategy (REMS) is necessary for Prolia and must include a medication guide, a communication plan, and a timetable for submission of assessments of the REMS. The FDA acknowledged receipt of Amgen's previously submitted proposed REMS materials. The FDA has also requested all updated safety data related to Prolia. Amgen is reviewing the Complete Response Letter and will work with the FDA to determine the appropriate next steps regarding these applications.
