The alliance enables Orion to manufacture Novan’s topical nitric oxide-releasing product candidates on behalf of Novan and Novan’s global strategic partners. The companies have executed a master contract manufacturing agreement to enable technology transfer and manufacturing of clinical trial materials for future clinical trials with Novan’s product candidates. Novan plans to transfer the technology for the manufacture of SB204, currently in Phase 3 development for the treatment of acne, and intends for Orion to be able to manufacture the drug product, or the finished dosage form of the gel, in accordance with Novan’s established manufacturing processes, in compliance with applicable regulatory guidelines, as appropriate for clinical trials and alongside Novan’s current manufacturing capabilities.
“This alliance with Orion allows us to expand our technical production capacity,” said Jeff Hunter, chief business officer, Novan. “Developing additive and modular capabilities for manufacturing our product candidates gives us the opportunity to expand our business, including and beyond the U.S., as or when those opportunities may arise.”
Regarding the choice of Orion, Mr. Hunter said, “Orion has an impressive profile with over 100 years in the pharmaceutical business and a manufacturing reputation that precedes itself. We are delighted with our decision to include them as an extension of our global business network.”
While the initial framework of the agreement enables the manufacture of SB204, the companies plan to evaluate expanding the agreement to include other product candidates for the manufacture of clinical trial materials and, potentially, commercial quantities.
Importantly, this alliance is intended to support major global markets in which Novan and its partners pursue regulatory approvals for Novan’s product candidates and complements existing Novan internal capabilities.