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CNS Therapeutics Gets FDA Nod

CNS Therapeutics Gets FDA Nod [Pioneer Press, St. Paul, Minn.]

From Saint Paul Pioneer Press (MN) (November 23, 2010)

Nov. 23--CNS Therapeutics, which likely is the only pharmaceutical company based in the city of St. Paul, said Monday it has received approval from the U.S. Food and Drug Administration to sell its first product.

Called Gablofen, the drug is approved for use in the management of a condition known as severe spasticity and is designed to be administered through implantable drug pumps made by Fridley-based Medtronic.

Gablofen is the generic version of a medication called Lioresal from pharmaceutical giant Novartis. Lioresal is the only choice for the estimated 60,000 spasticity patients who now use Medtronic pumps, said John Foster, the chief executive officer of CNS Therapeutics.

Foster said that the Novartis medication -- for which Medtronic owns the marketing rights in the U.S. -- costs about $3,000 a year when used in medication pumps.

"We will have a discount to Lioresal, so patients will see lower co-pays and greater access to therapy," Foster said. While Gablofen is a generic drug, CNS Therapeutics doesn’t want to be a generic drug company.

CNS Therapeutics decided to launch a generic as its first product because such medications can obtain FDA approval more quickly than new drugs. The idea is that generic sales would then fund development of new drugs to treat spasticity, Parkinson’s disease and chronic pain. CNS Therapeutics hires out the job of making the medication to a contract manufacturer. The company employs about 20 people, including a dozen

in the First National Bank Building downtown.

Medtronic does not release information about sales of its medication pumps, which deliver small quantities of drugs directly into the intrathecal space in the spine. The devices are used to treat chronic, intractable pain and severe spasticity associated with cerebral palsy, multiple sclerosis, spinal cord and traumatic brain injuries and stroke.

The pumps are part of Medtronic’s Fridley-based business in neuromodulation products, which posted $1.56 billion in sales for the fiscal year ending in April.

Earlier this month, Medtronic announced plans to work with a drug company to develop a drug-device treatment that uses Medtronic’s medication pumps to help patients with a genetic disorder called Huntington’s disease.

Christopher Snowbeck can be reached at 651-228-5479.

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Posted: November 2010