Impax Laboratories Inc’s (IPXL) shares jumped 11.7% and attained a 52-week high on the FDA approval of Rytary, an extended-release oral capsule formulation of carbidopa-levodopa. The FDA has approved Rytary for the treatment of patients suffering from Parkinson’s disease and post-encephalitic parkinsonism, and parkinsonism that may follow carbon monoxide intoxication and / or manganese intoxication.
We note that Rytary’s approval path has not exactly been smooth with the company receiving a complete response letter for the drug in Jan 2013. The new drug application (NDA) was resubmitted by Impax in Apr 2014. However, the initial FDA action date of Oct 2014 was pushed out to Jan 2015 due to an amendment in the chemical, manufacturing and control (CMC) section of the resubmitted NDA.
Rytary will be available for commercial distribution in Feb 2015 and Impax is currently seeking EU approval for the drug.
According to the press release issued by Impax, Parkinson’s disease affects nearly 1 million people in the U.S., with 50,000 – 60,000 new cases diagnosed each year in the U.S. alone.
Rytary’s approval is a major positive for the company. We expect investor focus to remain on further updates regarding the product launch, sales potential and the upcoming Tower Holdings and Lineage Therapeutics acquisitions.
Impax is a Zacks Rank #3 (Hold) stock. Some better-ranked stocks in the health care sector include Evoke Pharmaceuticals (EVOK), Mylan Inc. (MYL) and Teva Pharmaceutical (TEVA). While Evoke is a Zacks Rank #1 (Strong Buy) stock, Mylan and Teva carry a Zacks Rank #2 (Buy).
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