(RTTNews) -  Pharmaceutical company Pfizer Inc. (PFE: News ) Wednesday announced that it has submitted pediatric data for its cholesterol-lowering drug Lipitor to the European Medicines Agency, or EMEA. The company said it has also developed a new chewable form of Lipitor, including a pediatric-appropriate 5 mg dose, which is also a part of the submission.

Pfizer said its data submission reflects a European Union initiative encouraging research, development and availability of medicines for children. In 2007, the EU enacted a new regulation requiring pharmaceutical companies to research their medicines for use by children. The requirements cover new medicines, and existing ones under certain circumstances.

Last year, the EMEA's Paediatric Committee approved Pfizer's pediatric investigation plan to study the use of Lipitor in children aged 6 to under 18. This week, the Committee concluded that Pfizer's pediatric atorvastatin program has been implemented in compliance with its requirements.

About one in 500 people suffer from an inherited disorder, called Familial Hypercholesterolemia, which causes high levels of LDL-cholesterol, or bad cholesterol, and an increased risk of heart disease. Pfizer said it expects that additional scientific data about the use of Lipitor in children with Familial. Hypercholesterolemia will help improve diagnosis and treatment of the condition.
Lipitor is one of the drug industry's historical best-selling drugs with annual sales of about $12 billion. The drug logged in global sales of $8.3 billion in the last nine months, reflecting a decline of 11% from the comparable period last year. The decline in sales of the drug is a tell-tale sign of a dying Lipitor franchise. In the U.S., the basic patent for Lipitor is slated to expire next year. Recently, Indian drug maker Dr Reddy's Laboratories filed for marketing a generic version of Lipitor.

PFE closed Tuesday's regular trading at $17.94 per share on the New York Stock Exchange.

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by RTT Staff Writer

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