Amgen Gets Approval for Expansion of Cancer Drug

Xgeva is now prescribed to prevent the occurrence of skeletal-related events in solid tumor patients with bone metastases and in those who are being treated for multiple myeloma.

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Shares of Biotech giant Amgen Inc. (AMGN, Financial) jumped 1.31% to $168.22 a share after Tuesday's announcement that the European Commission has expanded the use of one of its cancer drugs to patients with multiple myeloma.

Xgeva, now available to patients with multiple myeloma, has been prescribed to prevent the occurrence of skeletal-related events in solid tumor patients with bone metastases.

Amgen received the green light from the European Commission, thanks to the results of a global study on multiple myeloma patients.

The international trial received funding in order to study ways to prevent common complication of bone metastases. The company says that the study was the largest-ever conducted by researchers in the field.

The study demonstrated that Xgeva is not inferior to Zoledronate in relation to how long it takes before the onset of skeletal-related events (SRE). With a median time to the first on-study SRE of 24 months, Xgeva exceeded Zoledronate by 1.2 months.

To prevent the occurrence of SREs, previous treatments were based on the use of bisphosphonates which, unlike Amgen’s Xgeva, caused serious side effects of renal toxicity.

Commenting the Commission’s approval, Dr. David M. Reese, senior vice president of translational sciences and oncology, highlighted Amgen’s dedication for healthcare advancement of multiple myeloma patients.

Amgen’s Xgeva is a human monoclonal antibody that inhibits bone destruction, which is mediated by the osteoclasts. The osteoclasts, which are a type of bone cell, are responsible for vertebral skeleton’s bones maintenance, reconstruction and reshaping, through a process called ‘bone reabsorption’. This leads to a calcium transfer to the blood from bone tissue breakdown.

Amgen is seeking worldwide approval of Xgena. The stock is up-trending since the beginning of 2018 and has lost 5% year to date.

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The stock in Amgen has a market capitalization of $121.21 billion and the current share price falls in a 52-week range of $152.16 to $201.23 per share.

The price-book ratio is 4.81 times versus an industry median of 4.51. The price-sales ratio is 5.41 times.

According to the statistics section of GuruFocus, Amgen invoiced customers for $22.849 billion over the trailing 12 months. The healthcare company’s economics dropped an earnings per share of $2.65, which leads to a price-earnings ratio of 63.48 times. The industry has a PE ratio median of 29.83. The stock has a beta of 1.64 and is reporting a volume of 720.56 million shares outstanding.

The Vanguard Group, Inc., FMR, LLC and Capital Research Global Investors are the top shareholders of Amgen with stakes of 7.26%, 7.20% and 7.07%. Holdings are as of Dec. 30. The overall institutional ownership equals 69.11% of Amgen’s total shares outstanding.

(Disclosure: I have no positions in any stock mentioned in this article.)