Teva, Aventis launch pre-filled Copaxone injection in Europe

Copaxone PFS is more convenient to use, and reduces the risk of contamination.

Teva Pharmaceutical Industries (Nasdaq:TEVA). and Aventis Pharma (NYSE:AVE) have begun marketing multiple sclerosis (MS) therapy Copaxone in a pre-filled, ready-to-use syringe (PFS) in Europe. The PFS form means injection will be faster and more convenient. Acording to the companies, no mixing or preparation is required, and fewer supplies are needed, ensuring increased accuracy, better compliance, and reduced risk of contamination.

"The new pre-filled syringe is about meeting patients' needs for a treatment that is convenient, consistent and complete," said Teva president and CEO Israel Makov, "Copaxone PFS will increase Copaxone's appeal to additional MS patients throughout Europe. This is another step towards making Coapxone the drug of choice for MS patients in the European market."

The first country to launch Copaxone will be Germany, and the rest of the European Union will follow shortly. So far, Copaxone PFS has been successfully launched in US, Canada, and Israel where, according to Teva, virtually all patients have switched from the lyophilized to the PFS presentation.

Teva has also announced that the US Food and Drug Administration has granted final approval for its ANDA (abbreviated new drug application) for Adenosine Injection USP, 3 mg/mL, submitted by Teva subsidiary SICOR Inc. Shipment of this product, which has been approved in 2 mL and 4 mL vials, is expected to begin immediately.

Teva's Adenosine Injection USP is the generic equivalent of Fujisawa's Adenocard Injection. This product is indicated for conversion to sinus rhythm of paroxysmal supraventricular tachycardia (PSVT), including that associated with accessory bypass tracts (Wolff-Parkinson-White Syndrome).

The brand product has annual sales of approximately $13 million.

Published by Globes [online] - www.globes.co.il - on June 17, 2004

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