) and Impax Pharmaceuticals, the brand products division of
Impax Laboratories, Inc.
), recently announced the termination of their agreement for
Rytary (IPX066). Rytary is being developed for the symptomatic
treatment of adults suffering from idiopathic Parkinson's
We remind investors that in Dec 2010, Impax had entered into a
license, development and commercialization agreement with Glaxo
for Rytary. As per the terms of the agreement, Glaxo is
responsible for the development and commercialization of the
candidate outside the US and Taiwan.
Glaxo decided to return those rights to Impax, effective end Jul
2013. Delays in regulatory approval and launch dates in countries
that Glaxo has rights to led to the decision. Following Glaxo's
decision, Impax will be responsible for the development of the
candidate across the globe. The company will look for a partner
in ex-US markets.
We see the withdrawal of Glaxo from the Rytary deal as a huge
disappointment for Impax. In the US, the regulatory path for
Rytary has been far from smooth. In Jan 2013, Impax received a
major setback with the US Food and Drug Administration (FDA)
issuing a complete response letter (CRL) for the marketing
application for Rytary.
According to the CRL, the NDA may be approved only after a
satisfactory re-inspection of Impax's Hayward facility for which
a warning letter was issued in May 2011.The facility is involved
in the development of Rytary. However, in Mar 2013, when the FDA
completed its re-inspection of the company's manufacturing
facility at Hayward, it issued a new Form 483 with 12
observations. Impax is working diligently on the issues noted by
the FDA and expects to resolve the matter quickly. However, the
new Form 483 remains a major overhang on the stock.
Impax and Glaxo both currently carry a Zacks Rank #3 (Hold).
Companies that currently look attractive include
Catalyst Pharmaceuticals Partners Inc.
). Both stocks carry a Zacks Rank #1 (Strong Buy).
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