Regulatory Update from Impax


Updates on the regulatory front are eagerly awaited by investors in the pharma/biotech sector as they impact the share price of the concerned company. Regulatory updates include events like filing of marketing applications, acceptance of these applications for review by the regulatory agencies, reviews by advisory panels and finally, a response from the regulatory agency regarding the approval status.

An update on the regulatory front was provided last week by Impax Laboratories Inc. (IPXL). The company announced that it has resubmitted a new drug application (:NDA) for Rytary (an investigational extended release capsule formulation of carbidopa and levodopa) with updated safety and stability information for approval in the U.S. Impax is looking to get the drug approved for the symptomatic treatment of Parkinson's disease (PD.TO).

Impax expects the U.S. Food and Drug Administration (:FDA) to re-inspect the Hayward manufacturing facilities, which are involved in the production of Rytary. The FDA has assigned a Class 2 resubmission status to Rytary for reviewing, which indicates that the agency will respond within 14 calendar days on the acceptability of the NDA resubmission.

We remind investors that the FDA had served a complete response letter (CRL) to Impax for Rytary last year, indicating that a re-inspection of the Hayward manufacturing facility is required before the NDA for Rytary is approved.

Meanwhile, Impax is preparing to submit a Market Authorization Application (MAA) to the European Medicines Agency (EMA.TO) for Rytary during the second half of 2014. Impax is also looking for commercialization partners for Rytary outside the U.S.

Impax is also looking to build its pipeline through internal and external business development activities.

Some drugs approved for the treatment of the signs and symptoms of PD are UCB’s (UCBJF) Neupro and Teva Pharmaceutical’s (TEVA) Azilect.

Impax carries a Zacks Rank #2 (Buy). A better-ranked stock in the health care sector is Mallinckrodt plc (MNK) carrying a Zacks Rank #1 (Strong Buy). Teva also carries a Zacks Rank #2.

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