On Aug 21, 2013, Zacks Investment Research upgraded Supernus Pharmaceuticals, Inc. (SUPN) to Zacks Rank #1 (Strong Buy).
Why the Upgrade?
The upgrade came on the back of the U.S. Food & Drug Administration’s (:FDA) approval of Trokendi XR for the treatment of epilepsy.
Trokendi XR is a novel once-daily extended release formulation of Johnson & Johnson's (JNJ) Topamax (topiramate). This epilepsy product will be launched in a few weeks.
Along with granting approval, the FDA also agreed to a deferral of submission of post-marketing pediatric pharmacokinetic assessments, which were due in 2019, followed by clinical assessments in 2025. Supernus also got an FDA waiver for certain pediatric study requirements.
In Jun 2013, Supernus had received tentative approval for Trokendi XR. Trokendi XR had initially received tentative FDA approval in Jun 2012. However, at that time, the FDA had said that final approval depended on the resolution of a marketing exclusivity issue raised by the FDA regarding a specific pediatric population.
A request for final approval was filed in Dec 2012 along with a safety data update, a new package insert and packaging configurations for Trokendi XR. The FDA had informed Supernus that they will most likely grant this request in the form of a tentative approval because the review period would be expected to conclude within the second quarter, prior to the Jun 22, 2013 expiration of Topamax’ pediatric exclusivity.
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