Perrigo to make the creams

Anonymous

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Perrigo Receives FDA Approval for Butoconazole Nitrate 2% Vaginal Cream
ALLEGAN, Mich., May 22, 2012 /PRNewswire via COMTEX/ -- Perrigo Company /quotes/zigman/77083/quotes/nls/prgo PRGO -1.35% today announced that it has received final approval from the U.S. Food and Drug Administration for its abbreviated new drug application (ANDA) for butoconazole nitrate 2% vaginal cream, the generic equivalent of Gynazole-1®. Perrigo was the first applicant to submit a substantially complete ANDA with a paragraph IV certification and is entitled to 180-days of marketing exclusivity. Perrigo is working exclusively with KV Pharmaceutical Company on a collaboration to launch the product by the end of calendar year 2012.



So this is how KV are going to get Clindesse back to the market - they obviously struck a deal with Perrigo. I am surprised that the market has not reacted positvely to this news as the return of Clindesse will add $30-40M in sales at 85% GP - this could be enough to prevent BK.
 






but they will loose the potential for Gynazole as it has now gobe generic? I guess this was the smaller product. If Clindesse is certain of returning this is good news but there have been several false starts.
 






Perrigo Receives FDA Approval for Butoconazole Nitrate 2% Vaginal Cream
ALLEGAN, Mich., May 22, 2012 /PRNewswire via COMTEX/ -- Perrigo Company /quotes/zigman/77083/quotes/nls/prgo PRGO -1.35% today announced that it has received final approval from the U.S. Food and Drug Administration for its abbreviated new drug application (ANDA) for butoconazole nitrate 2% vaginal cream, the generic equivalent of Gynazole-1®. Perrigo was the first applicant to submit a substantially complete ANDA with a paragraph IV certification and is entitled to 180-days of marketing exclusivity. Perrigo is working exclusively with KV Pharmaceutical Company on a collaboration to launch the product by the end of calendar year 2012.



So this is how KV are going to get Clindesse back to the market - they obviously struck a deal with Perrigo. I am surprised that the market has not reacted positvely to this news as the return of Clindesse will add $30-40M in sales at 85% GP - this could be enough to prevent BK.


Read the announcement this is an authorized generic. Translation is the Gynazole a brand is dead KV will only get royalties. Don't be fooled this gives KV a fraction of dollars compared to what they received when Gynazole was in the market. KV had no choice, either accept pennies on the dollar of get nothing. If this is the plan implemented for Clindesse this is not a good thing for the company.
 






Agreed. This is a sign of desperation, which is why the share price has not responded. Perrigo offers KV / Ther-Rx a few bucks in exchange for letting them make a generic version of the product. KV / Ther-Rx can still come out with the brand in the future at some point, but it will never sell against it's complete generic equivalent. If Perrigo offers this same deal for Clindesse, then pack up the mules.
 












Agreed. This is a sign of desperation, which is why the share price has not responded. Perrigo offers KV / Ther-Rx a few bucks in exchange for letting them make a generic version of the product. KV / Ther-Rx can still come out with the brand in the future at some point, but it will never sell against it's complete generic equivalent. If Perrigo offers this same deal for Clindesse, then pack up the mules.

So this is the grand strategy that Greg was working on the whole time to bring the creams back to the market? You have to be kidding. This is just another example that shows this company has no chance for a come back.
 












Perrigo needs a brand on the market in order to benefit from substitution. However, if the brand comes back, it would be limited due to the generic. Sales were not really that great before it was pulled from the market and now the market has switched to other products. Seems like a losing proposition, regardless of which way the product goes. As for Clindesse, that market is gone as well. Everything else has gone generic, so there is no reason that insurance companies will pay for this product.