Amgen Drug Receives Approval

The approval for the drug used to treat a rare form of leukemia is based on overall survival data from the Phase 3 TOWER study

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Shares of the U.S.-based biotechnology company, Amgen Inc. (AMGN, Financial) jumped 1.22% to $186.19 per share on Tuesday after market close..

The increase occurred on the heels of full European approval of the company's drug, Blincyto, which is used to treat adult patients affected with Philadelphia chromosome-negative relapsed/refractory B-cell precursor in acute lymphoblastic leukemia. The disease is a rare form of leukemia.

The Phase 3 TOWER study has backed the approval and its data on the overall survival show that patients, who received Amgen’s Blincyto during the trial, experienced a median overall survival of 7.7 months. Those patients who were under standard-of-care treatment experienced a median overall survival of four months.

Blincyto is the trade name under which blinatumomab is commercialized. Blinatumomab is a constructed monoclonal antibody that helps the human immune system in the fight against tumor cells. The drug exerts its action on malignant B cells selectively by linking the targeted cells to T-cells, which release their cytotoxic activity. Blincyto also induces cytotoxic activation in T-cells.

The Philadelphia chromosome is a specific genetic abnormality in leukemia cancer cells' chromosome 22. This abnormal and defective chromosome is also present in acute lymphoblastic leukemia.

Acute lymphoblastic leukemia is a blood cancer that originates in the bone marrow and is characterized by a proliferation of lymphocytes in the blood, bone marrow and other organs of the body. The lymphocytes are a particular type of white blood cells and the term "acute" refers to the high speed with which the disease progresses.

Lymphocytes are a class of immune system cells that keep the body under surveillance and activate defenses against micro-organisms or cancer cells. Depending on the type of activated response, they are distinguished in B or T-cells. Therefore, the disease is called either B or T-cells acute lymphoblastic leukemia, if it originates from B or T-cells lymphocytes.

The disease arises because the lymphocyte undergoes a process of tumor transformation. That is, the maturation of the lymphocyte freezes, resulting in a proliferation of young and immature line of lymphocytes in the blood and various organs of the body.

The exposure to radiation and certain chemicals are among the environmental factors triggering the disease. The male gender is among the non-modifiable factors in adult patients. However, there is no evidence that the disease can be inherited.

Symptoms occur early and usually the diagnosis is performed shortly thereafter. Symptoms can be divided into three categories. Symptoms, such as fatigue, loss of appetite, night sweats and fever are initial and non-specific. Others, such as exhaustion, anemia, infections and bleeding can occur later. Systemic symptoms include widespread muscular and osteo-articular pains, a sense of general malaise and weight loss. Furthermore the spleen, liver and lymph nodes are enlarged if the disease has spread to other organs and headaches and other neurological signs may occur if the nervous system has also been reached.

Acute lymphoblastic leukemia is a relatively rare disease.

The stock is up 9% so far this year and has a market capitalization of $123.2 billion. The 52-week range is $162.69 to $201.23.

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Amgen has a price-book ratio of 7.96 times versus an industry median of 4.51 times, a price-sales ratio of 5.90 times and a price-earnings ratio of 59.86 times versus an industry median of 29.83.

Other indicators on Amgen tell that the forward price-earnings ratio is 13.57 versus an industry median of 24.45 and that the forward dividend is $5.28 per share yielding 2.85%. The industry has a forward dividend yield of 1.09%.

(Disclosure: I don’t have any position in Amgen.)