- Source : Press Release
- Date : 2008-04-02
- Event type : Approved
- Companies : Akorn, Inc., Kyowa Kirin International plc
Xomolix Receives Additional Key European Approvals
Galashiels, Scotland, 2nd April, 2008 – ProStrakan Group plc (LSE: PSK), the international specialty pharmaceutical company, announces that it has been granted additional key Marketing Authorisations for Droperidol (to be branded Xomolix) in a number of European countries.
Xomolix (Droperidol) is a branded, injectable drug, indicated for the prevention and treatment of post-operative nausea and vomiting (PONV) in adults and, as a second line, in children. It is also indicated for the prevention of nausea and vomiting induced by morphine derivatives during post-operative patient controlled analgesia (PCA) in adults. ProStrakan already markets Droperidol in eight European countries, including France, the Netherlands and Portugal, with sales of £4.2m in 2007. The Company had initiated a new regulatory procedure in order to gain licences across Europe and successfully completed this European Decentralised Procedure (DCP) in September 2007. ProStrakan announces today that Xomolix has now been granted Marketing Authorisations in eight further European countries, in particular in Germany and the UK. The approval of Xomolix in Germany is seen as particularly significant as Germany is viewed as the largest potential PONV market in Europe, with an estimated potential total market size in excess of ¼P7KH&RPSDQ\SODQVWRODXQFKWKHSURGXFWLQ*HUPDQ\LQ Commenting on the announcement, Wilson Totten, ProStrakan’s Chief Executive, said: "The roll-out of Xomolix across Europe further extends ProStrakan’s pan-EU portfolio of products and, importantly, means that we can make this product available in additional countries where we know there to be a substantial level of unsatisfied patient need."
ProStrakan Group plc is a rapidly growing international specialty pharmaceutical company engaged in the development and commercialisation of prescription medicines for the treatment of unmet therapeutic needs in major markets. ProStrakan’s head office and development facilities are situated in Galashiels in Scotland. EU-wide sales and marketing of ProStrakan’s portfolio of products are handled by commercial subsidiaries in the UK, US, France, Germany, Spain and other EU countries. www.prostrakan.com