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Monday, August 07, 2006

Generic Lamisil Already?



Stock Tickers: PRGO, NVS

We could be seeing lower prices on toenail fungus treatments as soon as the end of the year. Perhaps the best news out there is that women who have long-complained over the "creepy Lamisil creature" appropriately named Digger on TV ads, may get a reprieve after this year over the commercials.

The Perrigo Company (PRGO-NASDAQ) today announced that its partner, InvaGen Pharmaceuticals, Inc., has received tentative approval from the FDA on its abbreviated new drug application for Terbinafine Hydrochloride Tablets, 250 mg (base). Final approval is subject to the expiration of any applicable periods of patent protection for the reference tested drug (LamisilĀ® Tablets 250 mg (base), Novartis Consumer Healthcare, Inc.) listed in the FDA's Orange Book, including pediatric exclusivity extension. The listed patent will expire on December 30, 2006, subject to an additional pediatric extension. Perrigo will market the products produced under InvaGen Pharmaceuticals' ANDA. Annual sales for Lamisil(R) are approximately $750 million, according to NDC data.

Perrigo had fiscal 2005 revenues of 1.024 Billion, and we will see the fiscal 2006 (June is their end) this week. Analysts expect $1.34 Billion in revenues for the quarter. While Novartis (NVS-ADR/NYSE) does not want to see any of its patents ending, the company generates in excess of of $32 Billion in annual revenues.

Jon C. Ogg
August 7, 2006
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