Oxford GlycoSciences Plc and Actelion Ltd have signed a binding letter of intent setting out the conditions for a European marketing and distribution partnership for Zavesca. Zavesca is an oral formulation of miglustat, a small molecule developed by OGS for the treatment of type 1 Gaucher disease, and was previously known under the trademark Vevesca.
OGS received a positive opinion from the Committee for Proprietary Medicinal Products (CPMP) recommending approval of Zavesca in the European Union (for details, see separate announcement). To ensure rapid availability of Zavesca to patients in need, Actelion will bring to this partnership its established clinical information, regulatory, marketing and distribution infrastructure. The company will also provide drug safety and post-marketing surveillance experience gained from the launch of its lead product Tracleer, a dual endothelin receptor antagonist for the treatment of pulmonary arterial hypertension.
Under the terms of this partnership, which will be for an initial period of five years, OGS will remain the marketing authorisation licence holder for the drug, retaining responsibility for manufacturing and regulatory activities. Actelion will be responsible for marketing and sales activities, and will handle, jointly with OGS, the post-approval pharmacovigilance specified in the CPMP positive opinion. The partnership will be managed by a joint steering committee. This committee will also decide on further development programmes of Zavesca, which will be implemented and executed by Actelion. Actelion will book sales of Zavesca and OGS will be paid an undisclosed share of the net revenues.