ImmuPharma plc, the specialist discovery and development pharmaceutical company has provided an update on the development status of its Lupus drug candidate Lupuzor.
Following ImmuPharma’s IND (Investigational New Drug) filing with the FDA and the successful completion of the Phase 2b study run by ImmuPharma, the company licensed the global rights of Lupuzor to Cephalon in return of $45M upfront as part of a deal worth $500M plus royalties on product sales. As part of the deal, Cephalon became responsible for the continuation of development and as part of the overall development program, they commenced an additional Phase 2b study with a different formulation, which is still ongoing.
ImmuPharma recently regained rights to Lupuzor, due to the acquisition of Cephalon by Teva Pharmaceutical Industries Ltd. Following the review of information from Cephalon ImmuPharma reports the highlights of Lupuzor’s development status:
• An End of Phase 2 meeting package with ImmuPharma’s Phase 2b data was submitted to the FDA and the FDA responded to all the questions.
• The IMPD (Investigational Medicinal Product Dossier) submitted via the Voluntary Harmonized Procedure (VHP) in the EU was approved.
• The Scientific Advice meeting with the European Medicines Agency (EMA) was held; the recommendations were very similar to those in the FDA’s End of Phase 2 responses. Recommendations were incorporated into the Phase 2I pivotal program.
• The Japanese equivalent authorities (PMDA) have agreed to the initiation of clinical trials in Japan.
• The FDA has granted Lupuzor the approval to start Phase 3 with a Special Protocol Assessment (SPA).
• The FDA has granted Lupuzor Fast Track designation.
• The commercial validation batches of the active ingredient of Lupuzor necessary for Phase 2I have already been manufactured.
ImmuPharma is now in discussions with pharmaceutical companies for a corporate deal regarding Lupuzor.
Date: November 3, 2011
Source: ImmuPharma plc