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