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Biotech / Medical : Zonagen (zona) - good buy?
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To: Linda Kaplan who wrote (6766)5/14/1999 4:06:00 PM
From: RWReeves  Read Replies (2) of 7041
 
There are entire classes of products which are either never approved or only later approved in the US. " Morning- after" birth control pills such as RU486 were available in Europe and Asia for years before the US. And made money. My personal favorite is a actually a banned food- cyclamate, which is a multi billion dollar business outside the US.

Many companies in Europe don't even bother coming to the US with some or all of their products since they don't want to deal with the greater regulatory requirements.

What interested me is that ZONA has stated that they are selling in Mexico and Latin America. This isn't the best recommendation for a drug company, but a potential to sell and show efficacy and acceptable side effects. Latin America accounts for about 17% of the worldwide antibiotic market for example, and most of this is OTC. They didn't mention Asia, where of the 19 countries in this bloc, only 3 have serious restrictions on the sale of pharmaceuticals.

Mexico is the interesting case, since you do require approval and a local marketing partner. I don't know who ZONA is using there but this is an interesting angle.

I agree the key point for ZONA as far as the US will be to prove any difference in safety profile over Viagra. On this basis, approval may be quite possible. Many if not most pharmaceuticals have side effects, and the question is really if the benefits outweigh the risk. For some patients, this may be the case. Labelling is also critical. Thalidomide was approved in the US based on labeling. "Not approvable" isn't the kiss of death unless you are out of money. It means "try again" if you think you've got something.
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