Nuron Biotech to Develop Long-acting Version of Proprietary Recombinant Human Interferon Beta-1b Utilizing PolyTherics' TheraPEGTM PEGylation Technology
EXTON, Pa.--(BUSINESS WIRE)--Nuron Biotech Inc., a specialty biologics and vaccines company, today announced that it has secured an exclusive option and license agreement utilizing PolyTherics' site-specific TheraPEGTM PEGylation technology to develop NU400, a long-acting version of Nuron's proprietary recombinant human interferon beta-1b (NU100). PEGylating NU100 can also potentially improve other properties including its solubility, stability and safety profile. NU100 is poised to enter Phase 3 clinical studies in 2011 based on recent positive regulatory advice from the European Medicines Agency (EMEA).
"In the last year Nuron has acquired products or licensed technologies to build our pipeline of four exciting programs to realize our vision of bringing better biologics to market with enhanced product profiles for better health of patients," commented Shankar Musunuri, PhD, MBA, Chief Executive Officer and Founder of Nuron Biotech. "This new program, NU400, is especially exciting for us in that it further enhances the product profile of our lead program for Relapse Remitting Multiple Sclerosis (RRMS) and supports long-term life cycle strategy in the MS area."
About NU400 (PEGylated Interferon Beta-1b)
NU400 is a proprietary PEGylated recombinant human interferon beta-1b being developed for the treatment of Multiple Sclerosis. NU400 is produced using a combination of NU100 and PolyTherics' proprietary TheraPEGTM technology. Interferon beta products are considered the 'gold' standard for first line treatment options in managing the progression of Multiple Sclerosis. However, clinical evidence and physician surveys indicate a need to improve upon the efficacy and safety of currently available therapies. MS patients treated with currently marketed Interferon beta-1b products have a prevalence of up to 30-40% neutralizing antibodies after two years of treatment. NU100 is essentially aggregate free and HSA free compared to other marketed interferon beta products. Therefore, absence of significant aggregates in NU100 should result in lower immune response in patients compared to other marketed products. By reducing or eliminating immune responses to interferon beta, NU100 is expected to prevent the reduction in clinical efficacy and improve the tolerability and safety for RRMS patients who presently require therapy with interferon beta-1b. NU400 should carry the benefit of NU100 with reduced injection frequency, potentially semi-monthly or monthly injection for better patient compliance. NU400 is scheduled to start early clinical studies in 2012. The current annual market size for Interferon beta products is $6.3 billion globally.
TheraPEGTM has been developed by PolyTherics Limited (London, UK) as a novel technology for the site-specific attachment of polyethylene glycol (PEG) polymer to therapeutic proteins. The innovative TheraPEG chemistry can be used to conjugate linear and branched PEG molecules to a diverse range of proteins and peptides. In contrast to other methods of PEGylating proteins, TheraPEG offers site-specific conjugation to disulfide bonds to achieve better product homogeneity and a more efficient PEGylation process for improved production economics. Patents for TheraPEG have been granted in USA, Europe, India, China and Australia.
PolyTherics is a biopharmaceutical company that applies precision chemistry to develop improved protein and peptide-based drugs. For more information, please visit www.polytherics.co.uk.
Nuron Biotech's vision is to bring better biologics to market with enhanced product profiles for better health of patients. Nuron's founders and management team are veteran biopharmaceutical industry executives who have made significant contributions in developing, launching and managing the life-cycle of various biologics.
Nuron has four products in development in three disease areas; central nervous system (CNS), wound healing and vaccines. Nuron is currently in discussions with other biotechnology companies to expand the portfolio in the areas of specialty biotech and vaccines. www.nuronbiotech.com