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news.Apricus Biosciences (APRI), a biopharmaceutical company advancing innovative medicines to meet the needs of patients, has announced the launch in Germany of Vitaros, Apricus' novel topical on-demand treatment for erectile dysfunction (ED), by Hexal AG, an affiliate within the Sandoz Division of the Novartis Group of Companies (Sandoz).
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Earlier this month, Sandoz launched Vitaros in Sweden.
Richard Pascoe, Chief Executive Officer of Apricus, commented, "We are pleased to announce the launch of Vitaros in Germany, one of the largest ED markets in the European Union. This is the third launch in as many months, following introductions in the United Kingdom and Sweden, and we believe this is another clear signal of the continuing, strong momentum of commercialization in Europe."
According to the most recent and updated figures from IMS Health, the ED market in Germany was over $150 million in 2013. Also according to the most recent estimates, the European ED market in 2013 was above $1.3 billion, and analyst estimates for ex-US Vitaros sales are approximately $300 million at peak.
In December 2013, Apricus expanded its exclusive license agreement with Sandoz for the commercialization of Vitaros in Austria, Belgium, Denmark, Finland, Iceland, Luxemburg, the Netherlands, Norway, Sweden and Switzerland (the "Expanded Territory"), in addition to Germany.
Under the terms of the agreement, Apricus is eligible to receive up to approximately $63 million from Sandoz in upfront, regulatory, launch and sales milestone payments for Vitaros in Germany and the Expanded Territory, which includes up to $4.5 million in new upfront and launch milestone compensation for the Expanded Territory.
Apricus continues to receive multiple commercial product orders of Vitaros from its partners, and is currently manufacturing multiple product batches through its contract manufacturer in Canada to support launches in Europe.
The commercialization of Vitaros has been fully licensed to these partners, with Apricus positioned to earn tiered double-digit royalties and more than $200 million in potential milestone payments.