FDA, Clinical Trial News: $SVNT, $LO, $CIGX

Earlier this morning, Savient Pharma (NASDAQ:SVNT) announced that FDA accepted its BLA resubmission for Krystexxa (pegloticase) as a complete, Class 2 response with a six-month review and PDUFA action goal date of 9/14/10. SVNT is seeking approval for the treatment of chronic gout patients who do not respond to conventional treatments.

The first FDA Tobacco Products Scientific Advisory Committee meeting is being held this week (Tue/Wed) to review the health effects of menthol-flavored cigarettes, with a final report expected by next March. The debate centers on whether menthol flavoring in cigarettes results in a more addicting product compared to regular cigarettes. Lorillard (NYSE:LO), which markets the top-selling brand of menthol cigarettes as Newport, issued a statement today stating that the science is clear that menthol cigarettes do not present an additional health risk.

Earlier this year in February, Star Scientific (NASDAQ:CIGX) filed an application with FDA, seeking marketing approval for its Ariva-BDL as a “modified risk” tobacco product under the Family Smoking Prevention and Tobacco Control Act of 2009. This submission is the first such application to be filed with the Tobacco Products Center of the FDA, which has been established to oversee all aspects of tobacco regulation outlined in the 2009 Act.

Ariva-BDL is a dissolvable tobacco lozenge with wintergreen flavoring that is made with flue-cured tobacco that contains levels of tobacco-specific nitrosamines (TSNAs) that are below detectable limits (BDL) by most current standards of measure. Draft guidance posted at the Agency’s website indicates that the preliminary review period for applications of Modified Risk Tobacco Products (MRTP) (pending further guidance or rulemaking) is 360 days, which is twice as long as the expedited new drug review and also longer than the standard, 10-month new drug review period by the Agency.

The HavRx Global Tobacco Index has been a strong performer, posting a 67% gain for a basket of 21 stocks being tracked at Investars YOU since June 2009. The index includes companies that are actively developing and / or derive the majority of revenue from the distribution / manufacturing of any type of tobacco product (e.g. cigarettes, cigars, chewing tobacco), tobacco supplies (e.g. wrapping papers, tobacco leafs, filters), modified risk tobacco products (MRTP), and electronic cigarettes (e-cigarettes).

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