Impax Laboratories, Inc.
) received a major setback recently with the US Food and Drug
Administration (FDA) issuing a complete response letter (CRL) for
the company's New Drug Application (NDA) for Rytary (IPX066).
Rytary, an extended-release capsule formulation of
carbidopa-levodopa, is being developed for the symptomatic
treatment of Parkinson's disease.
According to the CRL, the NDA may be approved only after a
satisfactory re-inspection of the company's Hayward facility for
which a warning letter was issued in May 2011.The facility is
involved in the development of Rytary.
However, while the NDA was being reviewed, Impax had withdrawn
the Hayward site as an alternative site for the production of
Impax has a license, development and commercialization
) for Rytary. As per the terms of the Dec 2010 agreement, Glaxo
is completely responsible for the development and marketing of
the candidate outside the US and Taiwan.
The regulatory path for Rytary has been far from smooth. The
FDA, which was initially expected to respond on Rytary in Oct
2012, had extended the action date by three months to Jan
2013. The review period had been extended as Impax had
submitted certain information that had been requested by the
The CRL is a huge disappointment and Impax shares were down
more than 7.0% on the news. Currently, we have low visibility on
the extent of delay that Rytary is facing. Impax carries a Zacks
Rank #5 (Strong Sell).
Some pharmaceutical companies performing well are
Salix Pharmaceuticals Ltd.
Valeant Pharmaceuticals International, Inc.
), both of which carry a Zacks Rank #1 (Strong Buy).
GLAXOSMITHKLINE (GSK): Free Stock Analysis
IMPAX LABORATRS (IPXL): Free Stock Analysis
SALIX PHARM-LTD (SLXP): Free Stock Analysis
VALEANT PHARMA (VRX): Free Stock Analysis
To read this article on Zacks.com click here.