Policy & Regulation
Vivet Therapeutics and Pfizer Enter into Manufacturing Agreement for Vivet's Investigational Gene Therapy for Wilson Disease
23 September 2020 - - French gene therapy biotech company Vivet Therapeutics and US-based pharmaceutical company Pfizer Inc. (NYSE: PFE) have entered into a manufacturing agreement, under which Pfizer will provide clinical supply for a Phase 1/2 clinical trial evaluating Vivet's proprietary, investigational gene therapy, VTX-801, for the potential treatment of Wilson disease, a rare and potentially life-threatening liver disorder, the companies said.

The trial is expected to commence in early 2021. Terms of the agreement were not disclosed.

In March 2019, the companies announced that Pfizer had acquired a minority equity interest in Vivet and secured an exclusive option to acquire all outstanding shares.

The companies also announced that they would collaborate on the development of VTX-801, for which an Investigational New Drug application is planned to be filed with the US Food and Drug Administration in 2020.

The Phase 1/2 clinical supply for VTX-801 will be manufactured in Pfizer's facility in Chapel Hill, North Carolina.

In recent years, Pfizer has made significant investments in the company's gene therapy manufacturing facilities in North Carolina to strengthen its ability to produce both clinical and commercial scale quantities of gene therapies for patients living with rare diseases around the world.

Vivet Therapeutics is an emerging biotechnology company developing novel gene therapy treatments for rare, inherited metabolic diseases.

Vivet is building a diversified gene therapy pipeline based on novel adeno-associated virus technologies developed through its partnerships with, and exclusive licenses from, the Fundación para la Investigación Médica Aplicada, a not-for-profit foundation at the Centro de Investigación Medica Aplicada, University of Navarra based in Pamplona, Spain.

Vivet's lead programme, VTX-801, is a novel investigational gene therapy for Wilson disease which has been granted Orphan Drug Designation by the Food and Drug Administration and the European
Commission.

This rare genetic disorder is caused by mutations in the gene encoding the ATP7B protein, which reduces the ability of the liver and other tissues to regulate copper levels causing severe hepatic damages, neurologic symptoms and potentially death.

Vivet's second gene therapy product, VTX-803 for PFIC3, received US and European Orphan Drug Designation in May 2020.

Vivet is supported by international life science investors including Novartis Venture Fund, Roche Venture Fund, HealthCap, Pfizer Inc., Columbus Venture Partners, Ysios Capital, Kurma Partners and Idinvest Partners.
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