Date: 2015-09-20
Type of information: Production agreement
Compound: RV001 (teprotumumab)
Company: CMC Biologics (Denmark - USA) River Vision Development (USA - NY))
Therapeutic area: Ophtalmological diseases
Type agreement: manufacturing production
Action mechanism: monoclonal antibody. Teprotumumab is a fully human antibody targeting the Insulin-like Growth Factor-1 Receptor (IGF-1R). The product has been developed by Genmab under its collaboration with Roche. Clinical development of teprotumumab in ophthamalic indications will be conducted by River Vision Development Corporation, which licensed teprotumumab from Roche. Teprotumumab has been granted Orphan Drug Designation by the US FDA.
Disease: Grave’s orbitopathy and other indications
Details: * On July 29, 2015, CMC Biologics, a global leader in clinical and commercial manufacturing of therapeutic proteins, and River Vision Development Corporation (River Vision), a private company focused on ophthalmology, announced that they have entered into an agreement for the process transfer and cGMP production of RV001 (Teprotumumab) – a recombinant monoclonal antibody targeting insulin-like growth factor 1 that is in development for treatment of Grave’s Orbitopathy and other indications. Under the agreement, CMC Biologics will transfer River Vision’s manufacturing process for teprotumumab into its facility in Copenhagen, Denmark for process optimization, validation and cGMP manufacture to support River Vision’s Phase III clinical trials and future commercial supply requirements for both the United State and Europe. Teprotumumab has been designated with an Orphan Drug Indication in the US by FDA for Graves Orbitopathy.
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