Oxford Biomedica and viragen Report Avian Transgenic Breakthrough

Oxford BioMedica (LSE: OXB) announced today that its partner Viragen, Inc (AMEX: VRA), along with Viragen’s collaborators at the Roslin Institute, have successfully achieved expression of significant quantities of the human protein, interferon beta-1a, in the whites of eggs laid by transgenic hens using the OVA™ System (Avian Transgenic Biomanufacturing) that employs Oxford BioMedica’s LentiVector® technology.

Interferon-beta is a key component of the human immune system and is the active ingredient in several leading multiple sclerosis (MS) therapies. These results are the first in a series of anticipated milestones demonstrating “Proof-of-Principle” with an avian-expressed version of interferon beta, and it is expected that the OVA™ System will be capable of cost-effectively expressing many types of therapeutic proteins.

Viragen and Roslin are conducting avian expression studies on various protein candidates including interferon beta-1a, which is currently marketed under two competing brand names for the treatment of MS. These MS products are Avonex®*, marketed by Biogen Idec, and Rebif®**, marketed by Serono, with combined annual global sales over $2.5 billion.

The Project’s Scientific Leader, Dr. Helen Sang of Scotland’s Roslin Institute, commented, “We are extremely pleased to report this key advance in our programme to develop a preferred platform for the production of selected biopharmaceutical proteins, having now successfully developed transgenic hens that are synthesising significant quantities of interferon beta as a component of their egg white. This is the second protein candidate with which we have achieved promising results, as we previously reported expression and recovery of a functional humanised antibody. As we fully characterize the interferon beta that is recovered, both biochemically and by functional tests, we expect such results will confirm our progress.”

“This is a truly remarkable achievement for our team in Scotland and represents a major event towards our goal to definitively position the OVA™ System as a revolutionary transgenic bio-manufacturing alternative,” stated Dr. Karen Jervis, Vice President and Managing Director of Viragen (Scotland) Ltd. “We will continue to collect eggs from these hens and subsequent generations to confirm quality and quantity of the protein. In addition, we will be analysing the carbohydrate profile of the product, which may represent another key advantage to OVA™-expressed proteins. Certain biotech drugs require post-translational modifications in order that the drug retains its full efficacy and is well tolerated when used as a human therapeutic. Although we must confirm the nature of the modifications conferred by the OVA™ System, we are hopeful that avian transgenic production may be able to retain these beneficial modifications, which may in turn translate to a lower cost of goods and a more economical process.”

While more data are required to provide a precise economic model, Viragen’s President & CEO, Charles A. Rice, stressed the significance of this achievement, “We are continuing to report historic scientific breakthroughs, as we achieve the essential prerequisites to develop a viable, cost-effective, transgenic bio-manufacturing system. To imagine the potential, based on the highest expression levels we have found, it is conceivable that a small flock of a couple of hundred hens could satisfy the entire US market demand for interferon beta-1a. These figures are preliminary, but certainly suggest why this technology might be so desirable to a company seeking new benefits in the manufacturing of current and future products. We congratulate our Scotland teams at VSL and the Roslin Institute for their commitment, patience, perseverance and fine work on this important project, and we look forward to even more dramatic results throughout this year.”

*Avonex® (interferon beta-1a) is a registered trademark of Biogen Idec, Inc.

** Rebif® (interferon beta-1a) is a registered trademark of Serono, Inc.

Viragen has no agreements with Biogen Idec or Serono and did not collaborate with either company in connection with these avian expression studies.