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Under the terms of the agreement, NU100 will be produced at Catalent's facility in Brussels, Belgium, where this injectable product will be formulated, filled and packaged in a prefilled syringe. Nuron Biotech is currently planning to take NU100 into Phase III clinical trials in 2011.
“For decades, Catalent's sterile technology business has a proven track record of partnering with innovators like Nuron Biotech to efficiently take products to market faster. We are excited to have the opportunity to apply our sterile delivery expertise to support Nuron through this complex and important stage of product development,” said Sheila Dell, Ph.D., Vice President Business Development, Catalent. “In addition to preparing and supplying NU100 for Phase III clinical trials, we are pleased to be able to support commercial manufacturing during the product's first three years on the market.”
“Our senior managers have come to know and trust the Catalent team during previous business relationships, and we are pleased to re-establish this mutually beneficial partnership,” commented Shankar Musunuri, PhD, MBA, Chief Executive Officer, Founder, Nuron Biotech. “We have strong confidence in Catalent's ability to support Nuron with NU100 and with other future scale-up and launch opportunities.”
More than 2.1 million people worldwide are thought to be affected by MS, an inflammatory disease of the central nervous system that is often debilitating. Nuron believes that NU100 will be differentiated from other interferon-beta products by virtue of a certain, patent protected manufacturing technology that Nuron utilizes, that creates a novel interferon beta-1b product that is free of human serum albumin (HSA) and is essentially free of aggregates.
Catalent's Sterile Technologies business provides development, clinical and commercial manufacturing services for sterile injectables and sterile Blow-Fill-Seal products. Catalent's manufacturing capabilities in this complex arena incorporate an extensive range of sterile injectable offerings, including filling drugs or biologics into vials, pre-filled syringes, bags and other stable delivery formats.
“For decades, Catalent's sterile technology business has a proven track record of partnering with innovators like Nuron Biotech to efficiently take products to market faster. We are excited to have the opportunity to apply our sterile delivery expertise to support Nuron through this complex and important stage of product development,” said Sheila Dell, Ph.D., Vice President Business Development, Catalent. “In addition to preparing and supplying NU100 for Phase III clinical trials, we are pleased to be able to support commercial manufacturing during the product's first three years on the market.”
“Our senior managers have come to know and trust the Catalent team during previous business relationships, and we are pleased to re-establish this mutually beneficial partnership,” commented Shankar Musunuri, PhD, MBA, Chief Executive Officer, Founder, Nuron Biotech. “We have strong confidence in Catalent's ability to support Nuron with NU100 and with other future scale-up and launch opportunities.”
More than 2.1 million people worldwide are thought to be affected by MS, an inflammatory disease of the central nervous system that is often debilitating. Nuron believes that NU100 will be differentiated from other interferon-beta products by virtue of a certain, patent protected manufacturing technology that Nuron utilizes, that creates a novel interferon beta-1b product that is free of human serum albumin (HSA) and is essentially free of aggregates.
Catalent's Sterile Technologies business provides development, clinical and commercial manufacturing services for sterile injectables and sterile Blow-Fill-Seal products. Catalent's manufacturing capabilities in this complex arena incorporate an extensive range of sterile injectable offerings, including filling drugs or biologics into vials, pre-filled syringes, bags and other stable delivery formats.
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