Recently, Pfizer (PFE) received European Commission approval for Revatio (sildenafil) in injectable form for patients who have been prescribed the oral alternative. The drug is used to treat pulmonary arterial hypertension (PAH), a rare disease affecting an estimated 100,000 people globally. Revatio is the only phosphodiesterase 5 (PDE5) inhibitor approved in both oral and injectable formulations in the EU for the treatment of PAH. 

This good news comes after a few setbacks for Pfizer. The company had to discontinue a phase III trial of figitumumab as a first-line treatment for advanced non-adenocarcinoma non-small-cell lung cancer. The decision of termination was taken since an independent committee observed that the drug was unlikely to meet its primary endpoint of improved overall survival compared to chemotherapy alone. In addition, Pfizer received another setback with further delays in the approval of the much awaited new Prevnar. The US Food and Drug Administration is yet to review the application thereby has been pushing back the approval beyond its Prescription Drug User Fee Act (PDUFA) date of December 30, 2009. 

New approvals are very significant for Pfizer as it is slated to lose patent exclusivity for its highest selling drug Lipitor in a few years. Lipitor accounted for about 25% of Pfizer’s total revenues in 2008. As a result, the company’s pipeline must recoup some of the lost sales with the genericization of Lipitor. 

Pfizer is also attempting to increase its presence in emerging markets. Viewing the huge potential of this region, Pfizer recently entered into a deal with Japan’s biggest drug maker, Takeda Pharmaceuticals, under which Pfizer will co-promote Takeda’s Actos (pioglitazone HCl) with Tianjin Takeda Pharmaceuticals in China. 

Pfizer, in due course, aims to achieve a growth rate exceeding 25% per year in China bolstered by Wyeth’s operations. Almost all the players in the pharmaceutical space are eyeing the emerging markets, expecting their growth to stabilize the base business during the industry’s 2010-15 patent cliffs. Emerging markets are a key growth driver today and going forward as well.
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