Novan Provides Update on SB204 Development Program
MORRISVILLE, N.C., March 06, 2017 (GLOBE NEWSWIRE) -- Novan, Inc. (“the Company” or “Novan”) (NASDAQ:NOVN) today announced that, after further analysis of the results from the NI-AC301 and NI-AC302 pivotal clinical trials for the Company’s topical nitric oxide-releasing product candidate, SB204, it intends to proceed with the SB204 development program. Following announcement of the top-line results for NI-AC301 and NI-AC302 last month, Novan conducted an in-depth examination of the data sets and engaged consultants in biostatistics and regulatory affairs. Based on the results of this process and its ongoing analysis, Novan intends to pursue a pre-submission meeting with the U.S. Food and Drug Administration, or FDA, to discuss the entirety of the SB204 development program in the third quarter of 2017, which could lead to a new drug application, or NDA, submission targeted in the first quarter of 2018.
“The safety and tolerability of SB204 was evident from the trials conducted to date, and we look forward to moving ahead with the program,” said Nathan Stasko, PhD, President and CEO of Novan. “We remain committed to delivering the prescribing community a safe, non-antibiotic alternative to help combat the widespread overuse of antibiotics in the treatment of acne and look forward to working with regulatory bodies around the world in making this meaningful innovation available for patients.”
Novan continues to believe that the Company’s cash on hand is sufficient to fund operations at least through the end of 2017, advancing each of the Company’s development programs through its nearest-term milestone. Novan anticipates that additional funding will be required to support SB204 through the FDA process, including the cost of an additional well-controlled trial, as well as to fund operations beyond 2017. Management is reviewing a number of potential financing options, including non-dilutive partnership opportunities across the Company’s pipeline, as well as traditional private and public equity financings.
Conference Call and Webcast
Novan will host a conference call at 8 a.m. Eastern Time on Mar. 6, 2017, to provide additional information on the SB204 development program. Callers should dial in approximately 10 minutes prior to the start of the call. No reservation is necessary to participate on the call. The phone number to join the conference call is +1 (844) 707-0661 (toll-free in the United States and Canada) or +1 (703) 318-2240 (international). The conference ID for the live call is 77470993. A live webcast will be accessible from the Events page of the Company’s website at http://Events.Novan.com. The webcast will be archived on the Company’s website for 90 days following the live call.