Oxyrane Establishes US Operation; Brings on Board Senior Commercial, Regulatory and Clinical Team

MANCHESTER, England -- (BUSINESS WIRE) -- Oxyrane, a privately-owned biotechnology company with a head office in Manchester, (England) and research operations in Gent, (Belgium), announced today that it has opened a new operation in Burlington, Massachusetts (USA). The new operation is an important step in the company’s evolution as it progresses clinical development of its innovative enzyme replacement therapy-based solution that has the potential to address numerous unmet clinical needs across a range of lysosomal storage disorders (LSDs).

“Establishing a dedicated operation in the United States strengthens our presence in the largest healthcare market in the world and Massachusetts is the capital of orphan disease drug development,” said Philip Astley-Sparke Non-Executive Chairman of the Board of Oxyrane. Philip, who was previously President and Chief Executive Officer of BioVex Group, Inc, now part of Amgen, provides a wealth of valuable experience in the development of biologics, having spent 11 years directing the successful development of BioVex from an early stage to an established company. In his role as Non-Executive Chairman, he is focussing predominantly on overseeing the shaping of Oxyrane’s commercial plans and increasing its market profile.

As part of the process of building a US operation, Oxyrane has made a number of senior appointments. The first step was to appoint Dr Charles “Charlie” Richard as Chief Medical Officer. Charlie is an expert in LSDs with over 10 years’ drug development experience in the rare and orphan disease space. He joins from Shire Human Genetic Therapies where, since 2006, he was Principal Medical Director and Head of Translational Medicine in Clinical R&D. Prior to Shire, Charlie was Vice President and Head of the Department of Genomics at Wyeth Discovery Research from 1999 to 2005, having joined as Senior Director in Neuroscience Clinical R&D in 1997. Prior to this, he was Assistant Professor of Psychiatry & Human Genetics at the University of Pittsburgh.

Dr Richard has made two further senior appointments, based at the Burlington office.

• James “Jim” Weston, Vice President of Regulatory Affairs – Jim has over 30 years’ experience in the development of biological and pharmaceutical products and has directed strategy for development programs in the US, Canada, Europe, Australia and Japan resulting in the approval of 11 drugs/biologics worldwide. James joins Oxyrane from his previous role as US Head of Regulatory Affairs for rare and orphan diseases at Shire Human Genetic Therapies.
• Susan Flint, Executive Director and Head Clinical Operations – Susan is an accomplished senior executive with over thirty years’ experience in multinational drug development including: executive management, regulatory affairs, clinical operations and has led several international multi-million dollar clinical trials in a variety of therapeutic areas. Susan joins Oxyrane from her previous role as Program Director at Navidea Biopharmaceuticals.

Commenting on the on the establishment of a US operation, Michael Campbell, Chief Executive Officer of Oxyrane, said, “We now have in place a top team of commercial, clinical and regulatory experts with a proven track record of success in the orphan space. I look forward to working with them as we progress towards developing our clinical programme and beyond.”

About LSDs

Lysosomal storage disorders (LSDs) represent a group of about 50 genetic disorders caused by deficiencies of lysosomal proteins. Most involve genetic mutations causing loss of function of key catabolic enzymes residing in the lysosome that are involved in the degradation of macromolecules. The missing lysosomal protein causes a build-up of toxic metabolites in the cells of patients, leading to progressive multisystem disease and premature death. Although individually rare, the combined prevalence of all lysosomal disorders is estimated to be 1 in 8000 births.

Enzyme Replacement Therapy involves restoration of the missing enzyme through periodic intravenous infusion of recombinant enzyme. Exogenously administered lysosomal enzyme re is taken up in cells through cell-surface mannose-6-phosphare receptors, and transported to the lysosome in order to degrade the toxic build-up of accumulated metabolite.

About Oxyrane

Oxyrane is a privately-owned biotechnology company with a head office in Manchester, (England), research operations in Gent, (Belgium) and medical/regulatory activities in Boston (US); dedicated to developing enzyme replacement therapies (ERTs) for lysosomal storage diseases (LSDs).

Oxyrane is developing an ERT for Pompe disease using its proprietary yeast host that is engineered to produce high levels of the targeting motif M6P with the goal of obtaining highly potent therapeutic product. In addition, Oxyrane’s process enables cost-effective batch production at very large industrial scale using relatively low-cost, standard production equipment/facilities.