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Amgen Applies to Have Kyprolis' Label Updated

- By Alberto Abaterusso

Amgen Inc. (AMGN) informed the stock market through the PRNewswire Friday that it has filed two new applications for Kyprolis, the brand name under which Amgen markets carfilzomib, a selective proteasome inhibitor acting anti-cancer drug, with the Food and Drug Administration and the European Medicines Agency.

With these two new applications Amgen is seeking approval to have the overall survival data added to the label of its Kyprolis .

The results that showed a 7.6-month survival benefit over Velcade - the brand name under which Takeda (FSE:4502)(NGO:4502) markets bortezomib - came from the Endeavor study, phase 3.

The results of phase 3 of the Endeavor study were shown during the 16th International Myeloma Workshop at the beginning of this year as well as during the European Hematology Association's 22nd Congress.

The medication is used for the treatment of patients affected with relapsed or refractory multiple myeloma. These patients have already received in the past one or more treatments for multiple myeloma, and Kyprolis can be administered to these patients alone or in combination with other drugs used for the treatment of multiple myeloma: Amgen's carfilzomib is approved to be used together with either dexamethasone or lenalidomide plus dexamethasone.

Multiple myeloma is a cancer that affects the plasma cells, an important component of the immune system. Plasma cells are the result of the maturation of B lymphocytes, which together with T lymphocytes represent the two main types of cells involved in the immune response. The role of plasma cells, which are found mainly in bone marrow, is to produce and release antibodies to fight infections. In some cases their growth proceeds wildly causing the tumor. The anomalous growth of plasma cells may also cause problems with other blood cells (white blood cells, red blood cells and platelets), anemia or coagulation defects. It is not rare that patients affected with multiple myeloma experience bone fractures due to stimulation of osteoclasts that are responsible for the destruction of bone tissue.

In full fiscal 2016, revenue from the sale of Kyprolis in the U.S. came in at $554 million and in the rest of the world came in at $138 million. Sales of Kyprolis are booked under "other products sales" in the financial statements of Amgen. Total other product sales account for approximately 10% to 11% of Amgen's annual revenue.

In 2015, it was estimated that approximately 488,000 people globally were living with multiple myeloma which resulted in 101,100 deaths in the same year. From 1990 to 2015 the incidence of multiple myeloma increased by almost 439,000 more cases - or 896%.

The exponential increase of this type of cancer demands a commitment from Amgen and other pharmaceutical companies to enhance the therapies' efficacy.

Amgen is trading at $176.64 per share with a market capitalization of $129.9 billion, a price-earnings (P/E) ratio of 16.78, a price-book (P/B) ratio of 4.24, a price-sales (P/S) ratio of 5.67 and an EV to EBITDA ratio of 10.39.

The company distributes an annual dividend of $4.60 - through quarterly payments of $1.15 per share - for a dividend yield of 2.65% according to the most recent share price.

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

This article first appeared on GuruFocus.