Amgen Inc. waits for approval for denosumab from FDA to start making profit.
Amgen Inc. is an international biotechnology company headquartered in Thousand Oaks, California. Amgen is the largest independent biotech firm. The company's first products on the market - Epogen and Neupogen - were the two most successful biopharmaceutical products at the time of their respective releases.
BusinessWeek ranked Amgen fourth on the S&P 500 for being the most "future-oriented" of those five hundred corporations.
The company developed denosumab formerly known as AMG 162, proposed trade name Prolia is a fully-human monoclonal antibody which is being studied in the treatment of osteoporosis, treatment-induced bone loss, bone metastases, rheumatoid arthritis, multiple myeloma and giant cell tumor of bone.
The Food and Drug Administration asked for more information about the design of Amgen’s risk-management plan for use of the drug in treating older women with osteoporosis. The FDA also requested a new clinical program to support approval of denosumab in preventing postmenopausal osteoporosis.
Amgen hopes denosumab to increase company's profit as demand slows for the company’s core products, the anemia drugs Aranesp and Epogen. The delay at the FDA hurts the sales potential for denosumab.
Amgen expects to receive a separate response for its application for Prolia in the treatment and prevention of bone loss due to hormone ablation in breast and prostate cancer patients. The company is reviewing the FDA’s so-called complete response letter and will discuss with the agency the next steps to be done.
Today’s letter could lead to a 10-month delay. Denosumab could sell more than $3 billion a year by 2015, if post menopausal osteoporosis and oncology indications are both approved.
In August, independent advisers to the FDA recommended that denosumab be approved for treating postmenopausal women with osteoporosis and men undergoing prostate cancer therapy. The panel, which questioned Amgen representatives about a lack of long-term safety data for the drug, recommended that denosumab not be used as a preventive therapy for osteoporosis or to treat bone loss in breast-cancer patients.
U.S. approval would gain Amgen entry to the $8.4 billion market for osteoporosis drugs, a category that includes Merck & Co.’s Fosamax, generic versions of Fosamax, Roche Holding AG’s Boniva and Novartis AG’s Zometa.
Denosumab should generate sales of $910 million in 2011 for treatment for osteoporosis alone, according to analysts.
Amgen is cooperating with London-based GlaxoSmithKline Plc to market denosumab. Amgen plans to sell the drug for osteoporosis in the U.S. and Canada, while Glaxo will sell the drug in Europe and countries where Amgen doesn’t have a presence, such as Brazil, China and India, the companies announced July 28.
Bloomberg has contributed to the report.