Ipsen, a global specialty-driven pharmaceutical company with total sales exceeding €1.1 billion in 2010, reported that it has sold its North American development and marketing rights for Apokyn indicated in the United States for the acute, intermittent treatment of hypomobility “off” episodes associated with advanced Parkinson’s disease to Britannia Pharmaceuticals.
According to Ipsen press release, the Apokyn US sales in 2010 amounted to $7.9 million (€6.0 million) and the company will no longer record Apokyn sales in its accounts from November 30, 2011 onwards.
In terms of the agreement, Britannia Pharmaceuticals will ensure continuity of supply and support of Apokyn to patients through USWorldMeds, a US-based specialty company with a focus on neurology, who will commercialise Apokyn in the United States as of December 1, 2011.
Apokyn (apomorphine hydrochloride injection) is the only therapy available in the US for the acute treatment of “off” episodes (re-emergence of Parkinson’s disease symptoms) associated with advanced Parkinson’s disease. It is used as an adjunct to other Parkinson’s disease medications and is administered, as needed, by means of an injector pen to treat periods of poor mobility in people with advanced disease. In April 2004, Apokyn received FDA approval with Orphan Drug designation to treat advanced Parkinson's disease patients in the US who experience the severe "on/off" motor fluctuations that are unresponsive to other oral Parkinson’s disease therapies.
Pierre Boulud, Ipsen’s executive vice president, strategy, business development and market access, said: “The new strategy announced in June is based on an increased focus on Ipsen’s core activities and platforms. Apokyn’s sale results in the alignment of the US organization around our key franchises and a focus on Ipsen’s main products Somatuline and Dysport. Resources freed by the sale of Apokyn rights will be reallocated to our priorityprojects. Our neurology sales force in North America will now be fully committed to the commercial success of Dysport, a key drug whose current indication in cervical dystonia may be extended to various spasticity indications in the future, subject to the successful completion of our four ongoing phase III clinical trials. We are confident that Britannia Pharmaceuticals and its partner will provide the resources necessary to ensure continued patient access to Apokyn. We are working together to ensure continuity of support, services and supply of Apokyn to this important patient population”.
Britannia and Mylan Pharmaceuticals achieved US registration in for Apokyn in 2004. In 2006, Vernalis Inc. acquired Apokyn rights from Mylan Pharmaceuticals. In July 2008, Ipsen acquired the US subsidiary of Vernalis plc, and the North American rights for Apokyn.
In the deal announced, Britannia Pharmaceuticals will pay more than one time the 2010 sales to Ipsen for the North American1 development and marketing rights for Apokyn. Ipsen will complete an ongoing study to assess Tigan and Apokyn as part of the post-marketing commitments.