Synpac/Genzyme Deal Worth $19.5m

Synpac/Genzyme Deal Worth $19.5m

Synpac (North Carolina) Inc. of Research Triangle Park and Genzyme General (Nasdaq: GENZ) of Cambridge, Mass., have formed an agreement in which Genzyme will obtain exclusive, worldwide rights to develop and commercialize Synpac’s [Pompase.sup.TM] enzyme replacement therapy for Pompe disease.

Synpac will receive an initial payment of $19.5 million for the potential therapy against the lethal, hereditary muscle disorder.

Genzyme has formed a partnership with Pharming Group N.V. of Leiden, the Netherlands, to commercialize [Pompase.sup.TM]. Pharming will issue a convertible note to Genzyme for an aggregate principal amount of $10 million. Other terms of the agreement were not disclosed. Genzyme and Pharming expect to initiate pivotal clinical trials of [Pompase.sup.TM] in the second half of this year.

Pompe disease is caused by the lack of alpha-Glucosidase activity, an enzyme involved in the breakdown of glycogen into glucose, a primary source of energy for the human body. Patients suffering from this disease show accumulation of glycogen in various tissues, which degrades skeletal, heart and lung muscles.

[Pompase.sup.TM] is a recombinant form of the enzyme human alpha-Glucosidase produced in mammalian cell culture using Synpac technology licensed from Duke University of Durham. An initial clinical trial of the product was completed in 1999. Three infants with Pompe disease received treatment with [Pompase.sup.TM] for three months, and all patients remain on therapy. Results of the trial, which was conducted under the supervision of Dr. Y.T. Chen at Duke Medical Center, were recently submitted for publication.

“Genzyme is a recognized leader in the development of therapies for rare genetic disorders,” said Leslie Koo, chairman of Synpac. “We believe that their expertise, commitment and substantial global resources provide the best opportunity to make this therapy available to patients with Pompe disease as quickly as possible.”

Synpac’s preclinical studies for Pompe disease therapy were funded in part by the North Carolina Biotechnology Center.

Genzyme General and Pharming plan to equally fund the commercialization of [Pompase.sup.TM] and share in the program accordingly. The companies established a joint venture in 1998 to develop human alpha-Glucosidase as an enzyme replacement therapy for Pompe disease.

The agreement between Genzyme and Synpac is subject to clearance under the Hart-Scott-Rodino Anti-Trust Improvements Act and customary closing conditions. The agreement between Genzyme and Pharming is subject to receipt of corporate approvals.

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