|Novan Announces Plan to Complete Development of SB204 Acne Candidate via Third Party Funding and Execution|
The proposed Phase 3 trial would be executed by the third party’s dermatology drug development team which plans to utilize a clinical research organization with extensive dermatology clinical trial experience.
Under the proposed transaction, a new entity established by the third party would provide both the necessary capital to fund and the clinical expertise to execute an additional Phase 3 pivotal trial for SB204. The financial return to the new entity would be a pre-determined multiple of the costs incurred to execute the trial, assuming successful completion of the trial and Novan’s election to retain all rights to the asset. The new entity would also be entitled to a milestone payment upon NDA approval, as well as potential future sales-based milestone payments tied to the commercial success of SB204 and potential future payments related to certain agreed variations of SB204 that may be subsequently developed. If
Having achieved an agreement in principle around the business terms of the transaction, the parties have entered into an exclusive negotiation period and anticipate finalizing binding definitive agreements for the proposed transaction and clinical trial execution following the parties’ joint discussion of the Phase 3 pivotal trial protocol with the
“The advancement of SB204 for the treatment of acne vulgaris is of critical importance to
Mr. Martin continued, “Additionally, we believe this creative structure will enable
“Lastly, the combination of the optionality on SB204 with the expansion of the nitric oxide technology into the areas of inflammatory skin diseases and virology allows
This press release contains forward-looking statements including, but not limited to, statements related to pharmaceutical development of nitric oxide-releasing product candidates and the negotiation, execution and expected terms of definitive agreements related to continued development of SB204 for acne vulgaris. Forward-looking statements are subject to a number of risks and uncertainties that could cause actual results to differ materially from our expectations, including, but not limited to, the risk the parties may not reach agreement and enter into binding agreements as contemplated by the non-binding term sheet, uncertainties and risks in the clinical development process and related to the proposed transaction, including, among others, that the parties may not be able to obtain commitments for adequate funding for the collaboration, the accounting treatment of the potential transaction is not yet determined, the contemplated Phase 3 trial may fail, and other risks and uncertainties described in our annual report filed with the