Biopharmaceutical company Amgen Inc. (AMGN, Financial) announced Aug. 30 the U.S. Food and Drug Administration will review its supplemental New Drug Application for Kyprolis.
Kyprolis is the brand name under which Amgen markets carfilzomib, a selective proteasome inhibitor that acts as an anti-cancer drug. It is used for the treatment of relapsed or refractory multiple myeloma patients. Carfilzomib is approved to be used with either dexamethasone or lenalidomide plus dexamethasone, which are other drugs used to treat patients affected by multiple myeloma.
The goal of this new application is to have the overall survival data from the Phase 3 Endeavor study added to the prescription information.
The data from the study shows  treatment-resistant multiple myeloma patients, who were administered a Kyprolis plus dexamethasone combined therapy, had a 21% reduced risk of death and a 7.6-month increase in overall survival compared to Takeda Pharmaceutical's (FSE:4502) (NGO:4502) Velcade plus dexamethasone combined therapy. Velcade is the brand name under which Takeda  markets bortezomib.
The results of the study were presented at the 16th International Myeloma Workshop at the beginning of the year and during the European Hematology Association’s 22nd Congress.
Multiple myeloma is a type of blood cancer caused by malignant plasma cells. Plasma cells are an important part of the immune system as they are the result of the maturation of B lymphocytes. Together with T lymphocytes, they represent the two main types of cells involved in the immune response. The key role of plasma cells, which are found mainly in bone marrow, is fighting infections through the production and release of antibodies that target etiologic agents. When plasma cells become cancerous, they can produce a tumor, which can later lead to further health issues.
The FDA's action date is April 30, 2018.
Sales of Kyprolis are booked under the company's “other products sales,” which usually account for approximately 10% to 11% of Amgen’s annual revenue.
The exponential increase of multiple myeloma (about 439,000 cases were diagnosed between 1990 and 2015) demands a commitment from Amgen and other pharmaceutical companies to enhance the therapy’s efficacy.
In 2015, approximately 488,000 people around the world were living with multiple myeloma.Â
Amgen is trading around $173.65 per share with a market capitalization of $126.71 billion, a price-earnings (P/E) ratio of 15.8, a price-book (P/B) ratio of 4, a price-sales (P/S) ratio of 5.6 and an EV/EBITDA ratio of 9.75.
The company distributes an annual dividend of $4.60 through quarterly payments of $1.15 per share, for a dividend yield of 2.67% according to the most recent share price.
Disclosure: I have no positions in any stocks mentioned in this article.
