Pharmaceutical company Amgen (AMGN, Financial) announced Aug. 27 that it has filed a supplemental New Drug Application with the U.S. Food and Drug Administration for a weekly single dosing option of KYPROLIS (carfilzomib), coupled with dexamethasone, for the treatment of relapsed/refractory multiple myeloma patients.
Multiple myeloma is a tumour of the immune system that predominantly originates in the bone marrow. Here, the production of plasma cells proceeds in an uncontrolled manner degenerating into the tumour. The plasma cell is the result of the maturation of B lymphocytes which, together with the T lymphocyte, represents the two main cellular types involved in the immune response.
The therapeutic intent of Amgen’s KYPROLIS is blocking the undisciplined proliferation of those plasma cells.
The abnormal growth of plasma cells can also cause problems for other white blood cells, red blood cells, platelets and bone tissue cells leading to a weakening of immune defences, anaemia or blood coagulation defects. Multiple myeloma patients are also exposed to frequent bone fractures.
The treatments used for multiple myeloma patients are chemotherapy and radiotherapy, while surgery is edged to a small number of specific conditions. The discovery of the so-called stem cells in the bone marrow is giving a relevant contribution to the treatment of multiple myeloma patients, because they are able to create a new bone marrow.
Multiple myeloma is typical in elderly patients and is slightly more common in men than women. The spread of this rare form of immune system tumour has remained stable over time, while mortality is slightly going down.
According to statistics, there are about 114,000 new diagnoses of multiple myeloma and about 80,000 deaths in the worldwide population every year.
Since 2012 relapsed/refractory multiple myeloma U.S. patients are receiving KYPROLIS either as a single agent or in combination. The combined therapy is Kyprolis with dexamethasone or Kyprolis with dexamethasone and lenalidomide. These patients have already been administered at least one line of therapy, to a maximum of three lines in the case of a combined use of KYPROLIS.
The medication is already approved for use in several countries worldwide.
From the sale of KYPROLIS, Amgen made revenues for $263 million in the second quarter of fiscal 2018 or 4.6% of the total product sales of about $5.68 billion. Sales of KYPROLIS are growing mainly because of a higher unit demand. Sales of the anti-cancer drug went up 25% compared to the same trimester of fiscal 2017. For full fiscal 2018 the turnover from the sale of Kyprolis is projected to approach approximately $1.1 billion, which will represent about 4.8-5% of Amgen’s total product sales. Those are predicted to be about $23.12 billion.
Amgen stock climbed 12% so far this year and is trading at $198.60 per share. The market capitalization is $128.55 billion. The stock has a price-book ratio of 8.65 versus an industry median of 4.1, a price-sales ratio of 6.04 and a price-earnings ratio of 53.97 versus an industry median of 28.79.
For full fiscal 2018 analysts are projecting earnings per share of $13.98. The forward PE ratio is 14.10. The industry has a median value for the ratio of 28.41.
Amgen is reporting 647.27 million shares outstanding, of which 84.1% is held by institutions and 0.43% is held by insiders.
The health care company is paying dividends to its shareholders. The forward dividend is $5.28 per ordinary share yielding 2.69%.
The 52-week range is $163.31 to $201.23.
Disclosure: I have no positions in any securities mentioned in this article.
