Biotech Values

[DewDiligence]

Tekturna PDUFA Date Extended 3 Months

[No surprise—NVS suggested at the R&D webcast on Nov 28 that this would likely happen in order for the FDA to review data from a colonoscopy study. Tekturna has poor bioavailability and hence relatively large amounts pass through the colon. This caused inflammation of the colon in rodents but not (so far) in humans.]

http://www.novartis.com

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14 Dec 2006, 07.15 AM CET

Novartis announces three-month extension of US regulatory review period for Tekturna®

• Tekturna seeking to become first drug in a new class of high blood pressure medicines

• Extension provides FDA time to review new clinical data supporting safety profile of Tekturna

• Novartis committed to working closely with FDA to gain approval for Tekturna, which has been studied in more than 6,000 people to date

Basel, December 14, 2006 - Novartis announced today that the US regulatory review period has been extended by up to three months for Tekturna® (aliskiren), which was submitted for approval earlier in 2006 to become the first in a new class of high blood pressure medicines for more than a decade.

The extension will provide the US Food and Drug Administration (FDA) with time to consider additional clinical data submitted by Novartis in early December. These data come from a study involving 30 healthy volunteers who received Tekturna at the proposed 300 mg once-daily dose for eight weeks to study potential changes of the colonic mucosa. Analysis of the data indicated that Tekturna did not induce any changes in the mucosal lining of the colon, as evaluated by colonoscopy and biopsies.

Novartis is confident that providing this additional information to the FDA will help secure approval for Tekturna in the US and allow for this important therapy to be offered to patients seeking to gain control of high blood pressure. Tekturna was developed in collaboration with Speedel.
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