NOTE, the corporate presentation states that Vitaros has been "Approved in 22 countries in Europe under the DCP, of which 17 have further approved Vitaros for commercialization at the national phase level"...however where is the list of the 17 that are ready for commercialization implying ready to launch?
I think the biggie on your list is Mexico which will open up Latin America. Unfortunately, Latin America will probably wait for the FDA, which is another reason why FDA approval is so important. I hope Mexico is ready to launch and its inclusion was not just a sloppy statement in the presentation.
The 17 Countries that you are asking about - are the 17 European Countries that have been approved to Commercialize Vitaros by their respective National Agencies. You might remember that we originally filed for approval in 10 Countries with the EMA, then we had an additional 12 approved countries around August 2015 at the EMA level. That would be a total of 22 Countries in Europe. Out of the 22 - 17 have further approved labeling / cost at a National Level. Here is the press release that informed us about the additional 12 countries approved by EMA through the decentralized procedure.
ir.apricusbio.com
The list:
They are, the original 10: The United Kingdom, Germany, Italy, Belgium, Luxemburg, the Netherlands, Sweden, France, Spain and Ireland .
And then we have 7 additional Countries out of the additional 12 approved, that have approved Vitaros at their National level. They are: Denmark, Finland, Iceland, Norway, Portugal, Romania and I am missing the seventh and last country. As I don't have a document to reference it to.
Here is where I got my information to complete my list:
Page 6 10K 2015
Partner
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Licensed Territory
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Approved Countries (*Launched)
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Abbott Laboratories Limited, now a subsidiary of Mylan N.V. (“Mylan”)
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Canada
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Canada
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Takeda
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UK
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UK*
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Sandoz
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Germany, Austria, Belgium, Luxemburg, the Netherlands, Denmark, Finland, Iceland, Norway, Sweden and Switzerland, Malaysia, Indonesia, the Philippines, Thailand, Taiwan, Vietnam, Hong Kong and Singapore
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Germany*, Belgium*, Luxembourg*, the Netherlands, Denmark, Finland, Iceland, Norway, Sweden*
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Majorelle
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France, Monaco and certain African countries
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France*
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Bracco
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Italy, Vatican City and San Marino
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Italy*
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Recordati
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Spain, Ireland, Portugal, Greece, Cyprus, the CEE countries (Central and Eastern Europe), Russia and the rest of the CIS countries (former Soviet republics), Ukraine, Georgia, Turkey and certain African countries
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Spain*, Ireland, Portugal, Romania
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Neopharm Scientific Limited (“Neopharm”)
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Israel and the Palestinian National Authority
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Elis Pharmaceuticals Limited (“Elis”)
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Gulf States and certain Middle Eastern countries
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Global Harvest Pharmaceutical Corporation (“Global Harvest”)
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Australia and New Zealand
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Ferring Pharmaceuticals
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Certain Latin American countries
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My belief is that Apricus shows us the countries in the Approved Column only for those countries that are approved at a National Level. Take our thorn in our side CANADA as an example. It's approved! Health Canada will allow the sale of it in it's territory, it's Mylan ( Abbott ) who would not launch it because they were not happy with current approved specifications.
Note that only 16 European countries are in that column. We must have had another National Approval finalized after the 10K came out.
If you cross reference the Corporate Presentation list with the list above. You can determine that theoretically - Demark, Ireland, Portugal, Finland and Norway + another country would be the first to be able to launch. |
