The U.S. global biopharmaceutical company Amgen Inc. (AMGN, Financial) informed the market Wednesday that it submitted to the US Food and Drug Administration FDA a supplemental Biologics License Application (sBLA) for one of its drugs.
Amgen is seeking approval to use its drug romiplostim (Brand name Nplate) to treat adult patients who are affected with an immune thrombocytopenia disorder for no more than one year. The treatment is for those who have not responded adequately either to a therapy based on corticosteroids and immunoglobulins or to splenectomy.
The U.S. agency already approved Amgen’s Nplate in August 2008 for the treatment of adult patients of immune thrombocytopenia over the long run.
Nplate is a hormone that regulates the production of platelets in the serum. The medication is administered through a subcutaneous injection.
Thrombocytopenia is a condition in which the patient shows abnormally low levels of platelets in the blood. In immune thrombocytopenia there is a massive destruction of platelets due to immune conditions. These immune conditions are several and range from immune and thrombocytopenic purpura to Gaucher's disease and infections with the dengue and Zika viruses.
Nplate contributed 3.2% of Amgen’s total revenues in the third quarter. The company invoiced Nplate customers for $177 million, reflecting an 11% increase from the prior-year quarter. Amgen reported total revenues of $5.51 billion in the third trimester of this year, up only 1% year-over-year.
Nplate belongs to that half of Amgen’s portfolio of products that is leading the progression in the trailing 12-month sales turnover. The top line shows a 6.2% average increase per year over the last five years.
Amgen closed at $185.49 per share on Wednesday for a market capitalization of $118.2 billion. The stock gained 5% for the 52 weeks through Dec. 19, outperformed the S&P 500 index by over 11% and trades far below the 100- and 50-day simple moving average lines and slightly below the 200-SMA line.
The 52-week range is $163.31 to $210.19 per share.
Amgen has a price-book ratio of 8.28 versus an industry median of 4.1 and a price-earnings ratio of 49.07 versus an industry median of 28.79.
The forward dividend yield is 3.13% compared to an industry median of 0.95%.
The average target price is $204.75 per share, and the recommendation rating is 2.3 out of 5.
Disclosure: I have no positions in any security mentioned.
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