OGS Announces Positive CPMP Opinion for Zavesca(TM)* for Type 1 Gaucher Disease in European Union
OXFORD, UK, July 26 /PRNewswire-FirstCall/ -- Oxford GlycoSciences Plc (LSE: OGS, Nasdaq: OGSI) today announced that the Committee for Proprietary Medicinal Products (CPMP) of the European Agency for the Evaluation of Medicinal Products (EMEA) has issued a positive opinion recommending approval of 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.
Zavesca is indicated for the oral treatment of mild to moderate type 1 Gaucher disease. Zavesca may only be used in the treatment of patients for whom Enzyme Replacement Therapy is unsuitable. The CPMP has recommended that the Marketing Authorisation is granted under exceptional circumstances** and has requested OGS to provide follow-up safety data derived from a post- marketing surveillance programme and additional clinical information.
"We are delighted to have received this positive opinion. We began the clinical investigation of Zavesca in type 1 Gaucher disease in 1998 and have now become one of the few biotech companies in the UK to achieve this important milestone," said Chris Moyses, M.D., Chief Medical Officer of OGS. "This opinion is the result of a centralised EU procedure and Marketing Authorisation can now be expected within the next few months."
Today, OGS has also announced the signature of a binding letter of intent with Actelion Ltd setting out the conditions of a partnership to support the marketing and distribution of Zavesca in Europe (see separate announcement).
"The combination of the positive CPMP opinion for Zavesca and our partnership with Actelion puts us in a position to expedite the delivery of this novel oral therapy to patients and physicians. In our view, this decision recognises OGS' innovative drug development expertise in the field of Gaucher disease," said David Ebsworth, Ph. D., Chief Executive Officer of OGS.
Regulatory background
The CPMP opinion serves as the basis for a European Commission (EC) final approval, which is typically issued in 90 to 120 days. EC approval of the centralised application for Zavesca would result in a single marketing authorisation with unified labelling valid in all 15 European Union-Member States.
OGS submitted its marketing authorisation application to the EMEA in July 2001. Zavesca has been granted orphan medicinal product status in Europe, allowing for a ten-year marketing exclusivity period following approval.
Gaucher Disease
Gaucher disease is a rare genetic disorder, which results from reduced activity of glucocerebrosidase, an enzyme responsible for glycosphingolipid (GSL - a subclass of fats) metabolism. Symptoms include enlargement of spleen and liver, bone disease and anaemia.
Treating Gaucher Disease with Zavesca
Zavesca has a novel mode of action as an oral inhibitor of glucosylceramide synthase, a key enzyme involved in GSL biosynthesis. The rationale for the use of Zavesca is to help balance the overall level of GSLs by inhibiting their production or synthesis - termed 'substrate reduction'.
Note: OGS and Actelion will host a conference call for analysts today at 9.00am UK time. Please call Claire Rowell on +44 (0)20 7831 3113 for further details. |
