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Vivendy’s initiates natural history program for Morbus Morquio


Basel, Switzerland, October 17, 2008 – Vivendy Therapeutics Ltd. today announced that the first MPS IVA-Morbus Morquio patient has been recruited to its Natural History Program (NHP). Vivendy’s NHP is a 12-month observational study of pediatric patients with Mucopolysaccharidosis Type IVA also known as Morbus Morquio.

The purpose of this study is to provide the Company with essential information regarding the natural progression of the disease, as well as the feasibility and variability of potential Phase III clinical endpoints. Patients enrolled in the study will not be receiving treatment but will undergo regular laboratory and clinical assessments. A NHP program is in line with regulatory expectations and the resulting data are important when the Company designs its clinical development program. Vivendy’s potential treatment for Morbus Morquio was recently granted Orphan Drug designation by the Food and Drug Administration (FDA).

'We are pleased with the enthusiasm with which clinicians and patients have joined our NHP program” stated Gertrud Thormann-Huber, Ph.D. Clinical Director, “we believe that the outcome of this study will provide important data that will allow us to optimize our development program.”


About Vivendy Therapeutics Ltd.

Vivendy Therapeutics Ltd., a pharmaceutical company developing an enzyme replacement therapy (ERT) for Mucopolysaccharidosis (MPS) IVA (Morbus Morquio) was founded in March 2006, as a spin-off of Inotech Biotechnologies AG. The company's mission is the development of an enzyme replacement therapy (ERT) for Morbus Morquio. In June, 2008, Saint Louis University (SLU), Office of Innovation and Intellectual Property, St. Louis, Missouri, USA and Vivendy Therapeutics Ltd., finalized and signed a License Agreement where SLU granted to Vivendy Therapeutics the exclusive license to use its patents for the research, development, manufacturing, marketing, sales and other use of the licensed products in the field of Enzyme Replacement Therapy (ERT) compositions intended for the treatment of patients having MPS IVA (Morbus Morquio). For more information please visit www.vivendy.ch


Further Information:

Gosse B. Bruinsma MD
Executive Director
Vivendy Therapeutics Ltd.
T: +41 (0)61 271 8780
E: bruinsma@vivendy.ch

Douglas Pretsell
Account Director, Munich Bureau Chief
College Hill
T : +49 (0)89 5700 1806
E: douglas.pretsell@collegehill.com

Notes for Editors:

About Vivendy’s Enzyme Replacement Therapy (ERT)

Vivendy’s ERT seeks to replace the lack of or deficient activity of the N-acetylgalactosamine-6-sulfatase (GALNS) enzyme in MPS IVA by administering a recombinant human GALNS enzyme that has been specifically modified – potentially enhancing the efficacy of the therapy in MPS IVA significantly. Compared to the native enzyme, preclinical studies lead Vivendy to believe that its enzyme modification has the potential to improve the delivery of the enzyme to efficiently clear the storage materials in target tissues and organs.

About Mucopolysaccharidosis (MPS) IVA

Mucopolysaccharidosis (MPS) IVA (MPS IVA, also known as Morbus Morquio A is a rare lysosomal storage disease characterized by a gene mutation that causes a lack or deficient activity of the N-acetylgalactosamine-6- sulfatase (GALNS) enzyme. This in turn causes excessive lysosomal storage of keratin sulfate (KS) and Chondroitin-6-Sulfate (C6S) which leads to multiple systemic skeletal, spine and joint abnormalities as well as malformations of the chest. Additionally, patients may suffer hearing loss, vision impairment, and heart valve disease. Accurate epidemiological data regarding the rate of incidence of MPS IVA is only sporadically available, but estimates vary between 1 in 250,000 live births to 1 in 500,000 live births.


Publisher Contact Information:

Vivendy Therapeutics
+41 (0)61 271 8780
bruinsma@vivendy.ch

Company profile of Vivendy Therapeutics
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