Regulator Approves Pfizer Drug for US Patients

The drug will be used in the US for treatment of anemia

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Pfizer Inc. (PFE, Financial) has informed the market that it received the U.S. Food and Drug Administration’s approval for a drug it has developed to treat anemia resulting from chemotherapy or chronic kidney disease.

The drug, Retacrit, is a biosimilar of Amgen's (AMGN) Epogen and the drug Procrit by Johnson & Johnson (JNJ).

The use of Retacrit is also intended for the treatment of anemia among people who are HIV-positive. Those patients experience a lower red blood cell count, as a result of taking the drug, Zidovudine, which is an antiretroviral medication to treat the status and prevention of AIDS.

Retacrit will reduce the need for red blood transfusions among people who undergo certain types of surgery.

Retacrit is a synthetic protein that helps the patient's body generate red blood cells. Retacrit works like erythropoietin, which is a human protein that stimulates the production of red blood cells (erythropoiesis) in the bone marrow.

The U.S. agency released the approval thanks to the submission of a package of broad data, which demonstrate that Pfizer’s Retacrit has a high degree of affinity with Epogen and Procrit in terms of efficacy and safety. The first application was rejected by the FDA because of problems at the manufacturing site in Kansas.

Berk Gurdogan, president of Pfizer's Essential Health division, commented: “As the first approved epoetin alfa biosimilar in the U.S., Retracrit may provide patients and their physicians with increased access to a high-quality, lower-cost alternative treatment option for anemia and the reduction of allogeneic red blood cell transfusions in certain patients.”

Gurdogan added: “We are proud of the progress of our biosimilars program to date, which will help address the evolving needs of patients and the broader healthcare community.”

Pfizer has fallen 2% this year and is trading at $35.69 per share. The stock in the healthcare company has a market capitalization of $208.771 billion.

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Pfizer has a price-earnings ratio of 9.91 times versus an industry median of 26.44 times, a price-book ratio of 3.03 times versus an industry average of 2.96 times and a forward priece-earnings ratio of 12.15 times versus an industry median of 20 times.

The forward dividend is $1.36 for a yield of 3.83%.

Pfizer is reporting about 5.85 billion shares outstanding. Institutions hold 76.11% of its shares while 0.24% is held by insiders.

Among the top institutional shareholders are Blackrock Inc. with 7.61% of total shares outstanding and the Vanguard Group Inc. with 7.27%. State Street Corp. holds 5.21%. Holdings are as of Dec. 30.

(Disclosure: I have no positions in Pfizer Inc.)