Perrigo Company (PRGO) recently received some good news when the US Food and Drug Administration (FDA) cleared its generic version of hyperphosphatemia drug Phoslo Gelcaps.
Phoslo is approved for the treatment of hyperphosphatemia in patients suffering from end-stage kidney disease who are undergoing dialysis. According to data released by Wolters Kluwer Health total annual sales of the drug (branded and its generic equivalents) were approximately $95 million. We note that Perrigo’s dispute regarding Phoslo Gelcaps was settled last year. The settlement terms were not disclosed.
We note that Perrigo has received quite a few approvals on the generic front over the past few weeks. Last week, the FDA cleared Perrigo’s generic version of KV Pharmaceutical Company’s vaginal cream Gynazole. Moreover, the FDA also gave final approval to Perrigo to market Novartis‘ (NVS) heartburn drug Prevacid. Approval was granted to treat patients suffering from frequent heartburn (two or more days in a week). Perrigo launched the drug in the USfollowing the receipt of final approval from the FDA.
Also in May 2012, the FDA granted final approval to Tris Pharma’s abbreviated new drug application (ANDA) for its generic version of Reckitt Benckiser Group‘s (RBGPY) Delsym. Delsym is approved for the treatment of cough due to minor throat and bronchial irritation. Perrigo, Tris’ exclusive partner in distributing the product as a store-brand alternative to Delsym, intends to launch generic Delsym in the next flu season.
We note that the availability of generic equivalents will be easy on the pockets of patients as generic drugs are much cheaper than their branded counterparts.
Our Recommendation
We currently have a Neutral recommendation on Perrigo. The stock carries a Zacks #3 Rank (short-term Hold rating).
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