New Pfizer Drug Approved to Enter European Market

Pfizer Pharmaceuticals (PFE) has recently received European Commission approval for the injectable form of Revatio (sildenafil) for patients who have already been prescribed the oral alternative. The medication is used to treat pulmonary arterial hypertension (PAH), a rare disease that affects approximately 100,000 people worldwide. Revatio is the only phosphodiesterase 5 inhibitor approved in both oral and injection formulations in the EU for the treatment of PAH.

This is good news for Pfizer after a recent series of setbacks. The company had to terminate a phase III trial of figitumumab as a first-line treatment for advanced small-cell lung cancer. The study was discontinued because an independent committee decided that the drug was unlikely to meet its main objective of enhanced overall survival compared to chemotherapy alone. Also, Pfizer experienced another setback with longer delays in the approval of the highly-anticipated new drug, Prevnar. The US Food and Drug Administration have not reviewed the application and have been delaying the approval beyond its Prescription Drug User Fee Act date of December 30, 2009.

Timely approvals are very important for Pfizer as it is scheduled to lose patent exclusivity for its highest selling drug Lipitor in a few years. Lipitor provided an estimated 25% of Pfizer’s total revenues in 2008. Due to this, the company must figure out how to compensate for some of the lost sales that will come after competitors start producing generic versions of Lipitor.

 Pfizer is also making an effort to increase its existence in emerging markets. Understanding the huge potential of this region, Pfizer recently entered into a deal with Japan’s largest drug manufacturer, Takeda Pharmaceuticals, under which Pfizer will co-endorse Takeda’s Actos (pioglitazone HCl) with Tianjin Takeda Pharmaceuticals in China. 

In the next little while, Pfizer aspires to achieve a growth rate that will exceed 25% per year in China bolstered by Wyeth’s operations. Almost every pharmaceutical company is focusing on emerging markets to help stabilize their foundation business when a majority of the industry’s patent rights run out between 2010-15.

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