July 31, 2008

Noven’s Patch-Less Bipolar Drug Gets OK

By John Dorschner, The Miami Herald

Jul. 31--Noven Pharmaceuticals, the drug maker with headquarters in South Miami-Dade, said the U.S. Food and Drug Administration has approved Stavzor, a delayed-release capsule used to treat patients with bipolar disorder, certain types of seizures and migraine headaches.

Stavzor will be the first pipeline drug to reach the marketplace that was developed by Noven Therapeutics, a subsidiary specializing in medications that don't use patches, said Noven spokesman Joseph Jones. The subsidiary was formerly known as JDS Pharmaceuticals, which Noven bought last year.

The marketing of Stavzor is a major development for Noven, which saw many investors turn away from its stock after its $125 million purchase of JDS. The deal represented a major move to broaden Noven's pharmaceutical reach, which until then focused on drugs delivered by patches.


Noven shares traded at about $24 in July 2007 when the deal was announced and fell to a low of $8.49 in May. The stock closed Wednesday at $11.87, up 2.59 percent on the day.

Jones said the company was not releasing estimates of Stavzor's sales, but expected the drug to be "an important contributor to our revenue" in 2009. He said U.S. sales of a rival product, Depakote, are about $800 million a year. Noven had $83.2 million in 2007 revenue.

Stavzor's main ingredient is valproaic acid, which Jones described as a "new formulation of a well known and trusted medication," that is already used in Depakote, which is made by Abbott, and in other tablets.

Noven is billing Stavzor's advantage as its "soft, easy-to-swallow gel cap that is 40 percent smaller than Depakote tablets at the 500-milligram dosage."

Scientists aren't certain how valproaic acid works but believe it regulates the balance of brain chemicals, Noven said in a press release.


The substance increases the amount of the natural chemical called gamma-aminobutyric, which decreases the brain's excitability. "It helps you think more calmly and clearly."

The product is expected to be available in pharmacies later next month, the company said.


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