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Amgen's Bone Cancer Drug Xgeva Gets FDA Approval

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Biotechnology giant Amgen Inc. (AMGN) announced Thursday that the U.S. Food and Drug Administration has approved Xgeva or denosumab, a subcutaneous RANK Ligand inhibitor, for the treatment of bone metastases to reduce skeletal related events in patients with cancer. The treatment is poised to be a blockbuster for Amgen, with a potential to fetch $2.5 billion in global sales by the middle of the decade, according to analysts.

This is the first bone targeted therapy for cancer patients to be approved in nearly a decade, and was approved based on the largest ever clinical program conducted in patients with bone metastases. The company noted that as many as 70% of patients with prostate cancer that have metastasized to the bone are not currently receiving therapy to prevent complications from these bone metastases.

The FDA approval of Xgeva is based on the results of three pivotal, phase III head-to-head trials where Xgeva was evaluated against Novartis AG's (NVS) bone drug Zometa. The clinical program for Xgeva spanned more than 50 tumor types in over 5,700 patients.

"Today's approval of Xgeva illustrates what is possible when scientific innovation, commitment and investment come together to advance medicine. A diagnosis of bone metastases is a major event for patients living with cancer, and the consequences can be devastating. We are pleased to offer this new advance to patients and their healthcare providers," Chairman and CEO Kevin Sharer said in a statement.

In mid-July, Xgeva got priority review designation, which is granted to drugs that offer major advances in treatment, or provide a treatment where no adequate therapy exists.

Bone metastases, the spread of tumors to the skeleton, are a serious concern for many patients with advanced lung, breast, prostate, kidney, thyroid cancers and multiple myeloma. When cancer spreads to the bone, the growing cancer cells weaken and destroy the bone around the tumor, often producing serious clinical consequences.

The company noted that as many as 3 out of 4 patients with advanced prostate, lung, and breast cancer will experience spread to their bones. Denosumab is the first therapy to target the important pathway to cancer-induced bone destruction.

Amgen reported that bone metastases occur in more than 1.5 million patients with cancer worldwide. The economic burden of U.S. patients with bone metastases is estimated to be $12.6 billion annually.

Thousand Oaks, California-based Amgen noted that Xgeva is not indicated for the prevention of skeletal related events in patients with multiple myeloma. Xgeva is also being investigated for its potential to delay bone metastases in prostate and breast cancer.

Denosumab was approved as a treatment for osteoporosis in post-menopausal women in June of this year and is marketed under the name Prolia for that indication. In the third quarter, Prolia generated sales of $10 million, well below analysts' estimate of over $30 million.

Amgen also revealed that it has submitted marketing applications for Xgeva in the European Union, Australia, Canada and Switzerland. In Japan, Amgen is working with its licensing partner, Daiichi-Sankyo Co. Ltd. (DSKYY.PK) and a marketing application was submitted in August.

AMGN closed Thursday's regular trading session at $55.14, up $1.27 or 2.36% on a volume of 8.36 million shares, higher than the three-month average volume of 5.67 million shares.

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