OGS extends Actelion relationship as Zavesca approved
pharmafile | October 22, 2003 | News story | |Â Â Â
Oxford GlycoSciences has announced the EU approval of its first product, Zavesca, and an extension to its co-marketing agreement with Actelion.
An existing agreement that gave Actelion marketing rights in Europe has now been extended to world-wide markets except Israel, where the majority of the drug's potential patients are.
The drug treats type 1 Gaucher's disease, a rare lipid storage disease that is the most common genetic disorder affecting Jewish people of Eastern European descent.
OGS Chief Executive David Ebsworth said: "With Actelion's experience in marketing on a global basis with the product Tracleer, it was a logical decision to extend our relationship beyond Europe. This extension moves OGS another step closer to meeting its strategic objective of making its Inherited Storage Disorders business unit profitable by the end of 2005. It will also assist in reducing the company's cash burn".
The European Commission has fast-tracked the drug's approval but is requesting follow-up safety data from a post-marketing surveillance programme and extra clinical data, which Actelion will now provide.
Earlier this year, patients in clinical trials had shown possible neurological side-effects from taking the drug, with one patient developing dementia.
These concerns prompted the US FDA to reject the drug this summer, but has now agreed that it can marketed safely to a restricted number of patients, with OGS submitting an updated application early next year.
Zavesca will be launched in Europe in spring 2003 and, if successful, could allow OGS to grow without seeking a merger partner.
David Ebsworth has indicated his willingness to discuss a merger or acquisition since his arrival this summer, and has re-focused the company around in-house development of its cancer drug candidates.
