Company is working with FDA to bring this once-commercialized drug back on the market.!--h2>
Nuron Biotech acquired assets relating to HibTITER, a vaccine for Hib disease, from Wyeth for the U.S. and other countries including Japan and Korea. HibTITER used to be marketed for children but was discontinued several years ago after Wyeth reprioritized its activities and in light of other available options.
HibTITER is a haemophilus b conjugate vaccine/diphtheria CRM197 protein conjugate. It was one of the first glycoconjugate technology vaccines for humans on the market, according to Nuron. The company says that it is currently working with the FDA to finalize the re-launch strategy for this vaccine.
“Our senior management team sees significant opportunity for HibTITER and looks forward to re-establishing this life-saving vaccine to help protect our children,” comments Shankar Musunuri, Ph.D., CEO, founder, Nuron Biotech. “Nuron has a highly focused product portfolio, and, consequently, we can devote significant attention to educating the medical and regulatory community on the value of this vaccine.”
HibTITER is Nuron’s only vaccine candidate. The rest of its pipeline comprises products for an autoimmune disease and for wound healing. Through a license agreement with BaroFold in May 2010, the company has a Phase III-ready drug for relapsing-remitting multiple sclerosis. BaroFeron™ (NU100) is a recombinant human interferon beta-1b. Earlier this year Nuron inked partnerships with Catalent covering delivery and supply as well as with the Merck BioManufacturing Network for production of the compound for Phase III trials.
Nuron has also acquired rights for a recombinant human epidermal growth factor product, NU200, for diabetic foot ulcers and burns. The product is marketed in other countries including India, Kenya, Peru, Nigeria, Thailand, and Ukraine. Nuron is working with regulatory agencies in the U.S. and EU for initiating clinical trials this year.