FDA Grants Priority Review Designation to Denosumab Biologics License Application for the Reduction of Skeletal Related Events in Advanced Cancer Patients

FDA Accepts Submission Which Includes Data from Three Pivotal Phase 3 Trials

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Jul 16, 2010, 05:51 ET

THOUSAND OAKS, Calif., July 16 /PRNewswire-FirstCall/ -- Amgen (Nasdaq: AMGN) today announced that the U.S. Food and Drug Administration (FDA) has granted priority review designation to denosumab, a subcutaneous RANK Ligand inhibitor, for the treatment of bone metastases to reduce skeletal related events (SREs) in patients with cancer. Filed in mid-May with the FDA, the Biologics License Application (BLA) submission summarizes clinical experience from nearly 6,900 patients across 18 clinical studies, including approximately 5,700 patients with advanced cancer in the three pivotal Phase 3 head-to-head trials versus Zometa® (zoledronic acid).

Priority review designation is granted to drugs that offer major advances in treatment, or provide a treatment where no adequate therapy exists. Consistent with priority review guidelines, the FDA will target an Agency action within six months of the application submission date, resulting in a Prescription Drug User Fee Act (PDUFA) action date of Thursday, November 18.

"Many cancer patients with skeletal metastases suffer debilitating complications, despite receiving the best available therapies," said Roger M. Perlmutter, M.D., Ph.D., executive vice president of Research and Development at Amgen. "In clinical trials, denosumab has consistently demonstrated an ability to reduce the burden of complications from skeletal metastases, with a positive benefit-risk profile. We believe that this priority review designation underscores the potential for denosumab to provide a meaningful advance over the current standard of care for patients with metastatic bone disease."

Bone metastases, the spread of tumors to the skeleton, are a serious concern for many patients with advanced cancer. When cancer spreads to the bone, the growing cancer cells weaken and destroy the bone around the tumor, often producing serious clinical consequences such as fractures, spinal cord compression, or the need to receive radiation or surgery to bone. These events are collectively called SREs. The RANK/RANKL pathway is believed to play a central role in cancer-induced bone destruction, regardless of cancer type. Denosumab is the first therapy to target this important pathway.

Amgen has also submitted marketing applications in the European Union, Australia, Canada and Switzerland. In Japan, Amgen is working with our licensing partner, Daiichi-Sankyo Limited and a submission is planned in the near future.

Bone Metastases: Prevalence and Impact

Bone metastases occur in more than 1.5 million patients with cancer worldwide and are most commonly associated with cancers of the prostate, lung, and breast, with incidence rates as high as 75 percent of patients with metastatic disease [i].

The economic burden of U.S. patients with bone metastases is significant and is estimated to be $12.6 billion annually [ii]. Patients with bone metastases who experience an SRE incur significantly higher medical costs compared with those who do not experience an SRE [iii].

About Denosumab and Amgen's Research in Bone Biology

Denosumab is the first fully human monoclonal antibody in late stage clinical development that specifically targets RANK Ligand, the essential regulator of osteoclasts (the cells that break down bone). The denosumab development program is the largest ever initiated by Amgen. This broad and deep development program demonstrates Amgen's commitment to researching and delivering pioneering medicines to patients with unmet medical needs. Amgen is studying denosumab in numerous tumor types across the spectrum of cancer-related bone diseases. Over 11,000 patients have been enrolled in the denosumab oncology clinical trials, testing the drug for the reduction of SREs in patients with breast and prostate cancer, as well as other solid tumors and multiple myeloma, for the amelioration of treatment-induced bone loss in patients with non-metastatic breast or prostate cancers, and for its potential to delay bone metastases in prostate cancer.

About Amgen

Amgen discovers, develops, manufactures and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realize the new science's promise by bringing safe and effective medicines from lab, to manufacturing plant, to patient. Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, and other serious illnesses. With a deep and broad pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people's lives. To learn more about our pioneering science and our vital medicines, visit www.amgen.com.

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