Nuron has acquired assets related to HibTITER® (Haemophilus b Conjugate Vaccine (Diphtheria CRM197 Protein Conjugate)) from Wyeth, a wholly owned subsidiary of Pfizer. Nuron has received favorable opinion from the FDA with regard to the relaunch strategy in the US. A Phase 2 clinical trial will be initiated in 2013. HibTITER® is the first conjugated vaccine used for the prevention of infection caused by Haemophilus Influenza Type B bacteria. HibTITER® has proven to be a market leader which has been responsible for the significant reduction of Hib disease in the U.S. HibTITER® is a ready to use formulation with no reconstitution required.
NU600/650 (Therapeutic and Prophylactic Vaccine for Hepatitis C)
Nuron holds an exclusive license for a novel therapeutic and prophylactic vaccine for Hepatitis B virus infection (HBV) and an option for an exclusive license for a novel therapeutic and prophylactic vaccine for Hepatitis C virus infection (HCV). This proprietary multi-antigen chimeric vaccine technology shows promise for Hepatitis B vaccines and Hepatitis C vaccines. Currently, 380 million people worldwide are infected by HBV chronically. HBV infections are not curable by any known therapy. Currently, more than 170 million people are infected by HCV worldwide. HCV infections are one of the leading causes of chronic liver disease, cirrhosis, liver transplantation, and hepatocellular carcinoma globally.
RELONSIV™ (the EMA-approved brand name for NU100) is a proprietary recombinant human interferon beta-1b being developed as a new molecular entity for the treatment of Multiple Sclerosis. Nuron completed enrollment of a pivotal Phase 3 study in November 2012.
RELONSIV™, a proprietary recombinant human interferon beta-1b produced utilizing a proprietary manufacturing technology, is being developed as a standalone molecule for the treatment of patients with Relapsing Remitting Multiple Sclerosis (RRMS). Interferon beta products are considered the ‘gold’ standard for first line treatment options in the management 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. RELONSIV™ is a liquid product with an autoinjector and is essentially aggregate free compared to other marketed interferon beta products. Therefore the absence of aggregates in RELONSIV™ should result in lower immune response in patients compared to other marketed products. By reducing or eliminating immune responses to interferon beta, RELONSIV™ should prevent the reduction in clinical efficacy and improve the tolerability and safety for RRMS patients who presently require therapy with interferon beta-1b. The 2012 annual market size for RRMS products (Interferon beta / glatiramer acetate) was forecast to be $10.5 billion globally.
NU400 is a long-acting version of Nuron’s proprietary recombinant human interferon beta-1b (NU100) produced using a combination of NU100 and proprietary pegylation technology. PEGylating NU100 can increase NU100’s circulating half-life and potentially improve other pharmaceutical properties including its solubility, stability and safety profile. NU400 should carry the benefit of NU100 with reduced injection frequency, potentially semi-monthly or monthly injection, for better patient compliance.
NU700 is a novel amyloid beta 42 (Aβ42) DNA vaccine for Alzheimer’s disease (AD). Unlike traditional peptide-based AD vaccines, which have generated an inflammatory response in the brain resulting in life-threatening meningoencephalitis, this adjuvant-free DNA vaccine does not contain amyloid beta itself but instead contains a piece of the gene coding for the protein. Once in the body, the vaccine stimulates an immune response in which antibodies bind to and significantly reduce amyloid plaque formation, up to 50 percent in preclinical models, without resulting in meningoencephalitis. In the United States alone,Alzheimer’s disease currently affects 5.4 million people and their families. The Alzheimer’s Association estimates that the disease results in $200 billion dollars of healthcare costs in the United States each year (“2012 Alzheimer’s Disease Facts and Figures.” Alzheimer’s Association).