Novan Extends Technical Production Capacity and Reaches Agreement with Orion Corporation

Novan, Inc. today announced that the Company has established a strategic alliance with Orion Corporation, a Finnish full-scale pharmaceutical company with broad experience in manufacturing.

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," stated Jeff Hunter, Novan’s Chief Business Officer. Commenting further, Mr. Hunter added, "Developing additive and modular capabilities for manufacturing our product candidates gives us the opportunity to expand our business, including and beyond the United States, as or when those opportunities may arise." Regarding the choice of Orion, Mr. Hunter commented, "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." An interdisciplinary team of Jeff Hunter, Carri Geer, Vice President of Pharmaceutical Development, Andrew Novak, Chief Accounting Officer, and Johannes Roebers, Chief Executive Officer of Cilatus BioPharma AG, were responsible for conducting a multi-month assessment of potential partners.

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.

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