Novan Appoints Brian M. Johnson as Chief Commercial Officer and Receives Conditional FDA Acceptance of Proposed Brand Name KINSOLUS™ for SB206 in Molluscum Contagiosum

Rhea-AI Summary

Novan, Inc. (Nasdaq: NOVN) has appointed Brian M. Johnson as Chief Commercial Officer, marking his return to the role he previously held from 2015 to 2018. Johnson brings over 30 years of experience in dermatology. The company also announced that the FDA has conditionally accepted KINSOLUS™ as the brand name for SB206, a topical antiviral gel aimed at treating molluscum contagiosum. The New Drug Application (NDA) for SB206 is on track for submission in Q3 2022, crucial for potentially addressing a significant unmet medical need.

Positive

• Appointment of Brian M. Johnson as Chief Commercial Officer enhances leadership with extensive dermatology experience.
• FDA's conditional acceptance of KINSOLUS™ as a brand name for SB206 signals progress in the pre-commercialization process.
• Expected NDA submission for SB206 in Q3 2022 could lead to the introduction of a much-needed treatment for molluscum contagiosum.

Negative

• No FDA-approved therapies currently exist for molluscum contagiosum, indicating potential market risks.
• Conditional acceptance of KINSOLUS™ is not a final approval, leaving uncertainty in the commercialization strategy.

– Mr. Johnson brings broad commercial expertise with over 30 years of leadership spanning dermatology marketing, sales, sales management, digital marketing and managed care –

– Company received conditional acceptance from U.S. FDA for use of KINSOLUS™ as brand name for SB206, if approved –

– First New Drug Application (NDA) remains on target with submission expected in Q3 2022 –

DURHAM, N.C., Nov. 02, 2021 (GLOBE NEWSWIRE) -- Novan, Inc. (“the Company” or “Novan”) (Nasdaq: NOVN), today announced the appointment of Brian M. Johnson as its Chief Commercial Officer. Additionally, the Company received notice that the U.S. Food and Drug Administration (FDA) has conditionally accepted KINSOLUS™ as the brand name for SB206, a topical antiviral gel for the treatment of molluscum contagiosum (a viral skin infection), if approved.

Mr. Johnson is a well-established executive with more than three decades of commercialization experience in leading products to dominant market positions across multiple therapeutic areas. He has a successful track record of implementing commercial strategy and message development through tactical planning and execution at dermatology companies including Ortho Pharmaceutical Corporation, Medicis, and Galderma. From 2015 to 2018, Mr. Johnson served as Chief Commercial Officer of Novan, where he led the Company’s pre-commercial activities including the assessment of the molluscum contagiosum market opportunity and the acne market sizing and segmentation project.

“We are pleased to welcome back Brian as our Chief Commercial Officer. His intimate knowledge of Novan and expertise in dermatology position him to be the best suited individual to lead our pre-launch and commercialization efforts as we advance SB206. Brian’s appointment is a key component as we build our internal infrastructure to interface with our commercial solutions provider, Syneos Health, and advance SB206 toward potential commercialization,” commented Paula Brown Stafford, President and Chief Executive Officer. “I am also pleased the FDA has conditionally accepted KINSOLUS™ as the brand name for SB206. In planning for success, this represents an important step in our pre-commercial activities and brings us closer to being able to potentially offer an effective treatment to patients in a condition with no current FDA approved therapeutic option. We believe there is significant commercial potential within our development pipeline, and we are pleased with the progress we continue to make.”

Mr. Johnson joins Novan having most recently served as a Principal at Two Hearts Group, a pharmaceutical and life science consulting firm. While at Two Hearts he acted as UCB’s Head, Digital Marketing, Psoriasis in the Global Mission for bimikizumab. Notably, at Galderma he served as Vice President of Prescription Marketing and Chief Digital Officer. While there, he and his team successfully launched seven products and quadrupled sales from $275 million to over $1 billion led by Epiduo^®, Clobex^® and Oracea^®. Other career appointments of note are President, Revian, Inc and Director, Peer to Peer Marketing at Novartis. Mr. Johnson holds an MBA from Southern Methodist University and a BS in Business Administration from the University of Kansas. He is a member American Acne and Rosacea Society, Masters of Dermatologic Society, Women’s Dermatology Society and the American Academy of Dermatology.

“Novan’s NITRICIL™ technology and the ability to apply it in so many areas across dermatology is an exciting opportunity with vast possibilities to address areas of significant unmet medical need. In the years since having last worked with Novan, I continued to work in dermatology gaining even more valuable knowledge and experience that I believe well-positions me to successfully complete what I consider the unfinished business I began years ago. Based on the results the Novan team has generated, I believe SB206, if approved, not only has significant potential to provide patients with a much-needed treatment benefit, but also serve as a solid foundation from which the Company can grow and build value across the dermatology space,” added Mr. Johnson. “With the work to build a successful, commercial-stage company now underway, I look forward to completing the business of helping unlock Novan’s full potential.”

The name KINSOLUS™ (pronounced “Kin-SOL-us”) was developed in compliance with FDA’s Guidance for Industry, Contents of a Complete Submission for the Evaluation of Proprietary Names. A request for proprietary name review and final approval for KINSOLUS™ will be included when Novan submits its NDA for SB206.

About Novan

Novan, Inc. is a pre-commercial nitric oxide-based pharmaceutical company focused on dermatology and anti-infective therapies. We leverage our core synergies of science, capital, resources and patient needs to create value by bringing new nitric oxide-based medicines to market. Our goal is to create the world’s leader in nitric oxide-based science, technology, and clinical translation in support of delivering safe and efficacious therapies using our proprietary nitric oxide-based technology platform, NITRICIL™ to generate macromolecular New Chemical Entities (NCEs) to treat multiple indications.

About KINSOLUS™ (SB206)

Berdazimer, the active ingredient in KINSOLUS (SB206), is a new chemical entity that stores nitric oxide gas in a stable, solid form by chemically loading it on a macromolecule, or polymer. Nitric oxide is released in a targeted manner to kill microbial pathogens, including bacteria, fungi and viruses. The topical semi-solid formulation of SB206 tunes the release of berdazimer in a solid form on demand specific to disease. SB206 is being developed as a topical anti-viral gel for the treatment of viral skin infections, with a current focus on molluscum contagiosum.

About Molluscum Contagiosum

Molluscum is a common, contagious skin infection caused by the molluscipoxvirus, affecting millions of people in the U.S. annually, with the greatest incidence in children. Approximately 70% of patients are below the age of 10. There are currently no U.S. FDA approved therapies for the treatment of molluscum. More than half of patients diagnosed with the infection are untreated.

Forward-Looking Statements

Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as “believe,” “expect,” “target,” “anticipate,” “may,” “plan,” “potential,” “will,” and similar expressions, and are based on the Company’s current beliefs and expectations. These forward-looking statements include, but are not limited to, statements related to the potential therapeutic value of the Company’s NITRICIL™ platform technology, the Company’s pharmaceutical development of nitric oxide-releasing product candidates, the potential timing of clinical trials, stability testing and FDA submission(s), and that conditional proprietary brand name approval will support the Company’s commercialization strategy, if KINSOLUS™ is approved;. Forward-looking statements are subject to a number of risks and uncertainties that could cause actual results to differ materially from the Company’s expectations, including, but not limited to, risks related to the regulatory approval process, which is lengthy, time-consuming and inherently unpredictable, including the risk that the FDA will not agree with the Company’s approach to a potential NDA submission, that the Company’s product candidates may not be approved or that additional studies may be required for approval or other delays may occur, that the FDA may not give final approval of the KINSOLUS™ brand name; that the Company may not have sufficient quantities of drug substance and/or drug product to support regulatory submissions and that the Company may not obtain funding sufficient to complete the regulatory or development process; the Company’s limited experience as a company in obtaining regulatory approvals and commercializing pharmaceutical products; changes in the size and nature of the market for our product candidates, including potential competition; any operational or other disruptions as a result of the COVID-19 pandemic; the Company’s ability to obtain additional funding or enter into strategic or other business relationships necessary or useful for the further development or commercialization of the Company’s product candidates; risks related to the manufacture of raw materials, including the Company’s active pharmaceutical ingredient and drug product components utilized in clinical trial materials, including supply chain disruptions or delays, failure to transfer technology and processes to third parties effectively or failure of those third parties (or the Company in connection with the upfit of the Company’s new facility) to obtain approval of and maintain compliance with the FDA or comparable regulatory authorities; the Company’s reliance on arrangements with third parties to support its operations and development efforts and the risk that such parties will not successfully carry out their contractual duties or meet expected deadlines; and other risks and uncertainties described in the Company’s annual report filed with the Securities and Exchange Commission on Form 10-K for the twelve months ended December 31, 2020, and in the Company’s subsequent filings with the Securities and Exchange Commission. Such forward-looking statements speak only as of the date of this press release, and Novan disclaims any intent or obligation to update these forward-looking statements to reflect events or circumstances after the date of such statements, except as may be required by law.

INVESTOR AND MEDIA CONTACT:
Jenene Thomas
JTC Team, LLC
833-475-8247
NOVN@jtcir.com

FAQ

What is KINSOLUS™ and its significance for Novan (NOVN)?

KINSOLUS™ is the proposed brand name for SB206, a topical antiviral gel aimed at treating molluscum contagiosum. Its conditional acceptance by the FDA represents a critical step towards commercialization.

Who is Brian M. Johnson and what does his appointment mean for Novan (NOVN)?

Brian M. Johnson is a seasoned executive with over 30 years in dermatology. His appointment as Chief Commercial Officer is expected to strengthen Novan's leadership and pre-commercial efforts.

What is the timeline for the New Drug Application (NDA) of SB206?

The NDA for SB206 is on track for submission in Q3 2022, which is vital for moving forward in the regulatory process.

What is the current treatment landscape for molluscum contagiosum and why is SB206 important?

Currently, there are no FDA-approved treatments for molluscum contagiosum, making SB206 potentially significant for addressing this unmet medical need.