Novan Moves Forward with Unified Corporate Branding

Rhea-AI Summary

Novan, Inc. (Nasdaq: NOVN) has announced that its commercial subsidiary, EPI Health, will rebrand as Novan, creating a unified corporate identity ahead of the potential commercial launch of berdazimer gel, 10.3% (SB206). This integration follows Novan's acquisition of EPI Health in early 2022, which provided necessary commercial infrastructure to promote its lead product effectively. The FDA has accepted Novan's New Drug Application for berdazimer gel targeting molluscum contagiosum. The company aims to address unmet medical needs in dermatology with its proprietary nitric oxide-based technology platform, NITRICIL.

Positive

• Unified branding under Novan enhances market presence and recognition.
• Acquisition of EPI Health strengthens commercial infrastructure and capabilities for product launch.
• FDA acceptance of NDA for berdazimer gel opens potential for market approval.

Negative

• Risks related to regulatory approval process could delay product launch.
• Limited experience in launching internally developed products may impact performance.
• Dependence on third-party arrangements may lead to operational risks.

– Novan is a fully integrated pharmaceutical company with proven capabilities across drug development through to commercialization –

– EPI Health adopts Novan corporate branding, creating unified identity in advance of potential commercial launch of berdazimer gel, 10.3% (SB206) –

DURHAM, N.C., March 08, 2023 (GLOBE NEWSWIRE) -- Novan, Inc. (“the Company” or “Novan”) (Nasdaq: NOVN), today announced that its commercial subsidiary, EPI Health, will now unify under one brand name, Novan.

“Since the closing of our acquisition of EPI Health in March of 2022, we have made significant progress integrating our organizations into one cohesive business. As of today, we are pleased to move forward as one united brand, Novan, with the unified goal of building a premier medical dermatology company. We believe our integrated business will streamline our pre-commercial activities for berdazimer gel, 10.3%,” commented Paula Brown Stafford, President and Chief Executive Officer of Novan.

In early 2022, Novan completed the acquisition of EPI Health, equipping the Company with the commercial infrastructure necessary to bring to market, if approved, our lead product candidate, berdazimer gel, 10.3% (SB206). This infrastructure includes a highly experienced sales and marketing team, supply chain capabilities, market access knowledge, medical affairs experts, and a network of related partners. The combined organization is a fully integrated pharmaceutical company with capabilities across drug development and commercialization with a proven product portfolio across multiple disease states within dermatology.

About Novan

Novan, Inc. is a medical dermatology company primarily focused on researching, developing, and commercializing innovative therapeutic products for skin diseases. Our goal is to deliver safe and efficacious therapies to patients, including developing product candidates where there are unmet medical needs. Novan has a robust commercial infrastructure across sales, marketing, and communications, as well as fully dedicated market access and pharmacy relation teams, promoting products for plaque psoriasis, rosacea and acne. The U.S. Food and Drug Administration (“FDA”) has accepted Novan’s new drug application (“NDA”) submission for review for berdazimer gel, 10.3% (SB206) as a topical prescription gel for the treatment of molluscum contagiosum. The Company also has a pipeline of potential product candidates using its proprietary nitric oxide-based technology platform, NITRICIL™, to generate new treatments for multiple indications.

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,” “look forward to” 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 FDA approval of the Company’s NDA for berdazimer gel, 10.3% (SB206) for molluscum contagiosum, the therapeutic value and benefits of the Company’s Nitricil™ platform technology and its product candidates, including berdazimer gel, 10.3% (SB206), the capabilities of the Company’s commercial infrastructure, and the potential market opportunity for the Company’s product candidates. 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 acquisition of EPI Health; 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 our 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 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 extend its cash runway or to complete the regulatory or development process; the Company’s limited experience as a company in obtaining regulatory approvals for and launching products developed internally and its ability to recruit and retain qualified personnel and key talent; changes in the size and nature of the market for the Company’s product candidates and promoted products, including potential competition, patient and payer perceptions and reimbursement determinations; the Company’s ability to grow revenues from promoted products and the risks that past performance may not be indicative of future performance; risks and uncertainties in the Company’s ongoing or future product development activities and preclinical studies, which may not prove successful in demonstrating proof-of concept, or may show adverse toxicological findings, and even if successful may not necessarily predict that subsequent clinical trials will show the requisite safety and efficacy of the Company’s product candidates, or that any of the Company’s product candidates, if approved, will continue to demonstrate requisite safety and efficacy following their commercial launch; any operational or other disruptions as a result of the COVID-19 pandemic; risks related to the manufacture of raw materials and finished drug product, such as 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 Company’s 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 its development, manufacturing and commercialization efforts and the risk that such parties will not successfully carry out their contractual duties or meet expected deadlines; 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 and the operation of its business on terms that are acceptable to the Company or at all or if such relationships or transactions are unsuccessful or the Company is unable to realize the potential economic benefits of such relationships or transactions; 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, 2021, 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 the Company 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 the significance of Novan rebranding EPI Health?

Novan's rebranding of EPI Health under a unified identity aims to streamline pre-commercial activities for their lead product, berdazimer gel, enhancing market presence.

What is berdazimer gel and its FDA status?

Berdazimer gel, 10.3% (SB206) is Novan's lead product candidate awaiting FDA approval for treating molluscum contagiosum.

What are the potential risks for Novan regarding regulatory approvals?

The regulatory approval process for berdazimer gel may be lengthy and unpredictable, which poses risks for timely product launch.

How did the acquisition of EPI Health benefit Novan?

The acquisition provided Novan with essential commercial infrastructure, including sales and marketing expertise, to better support product launches.

What is Novan's focus as a company?

Novan focuses on researching and commercializing innovative therapeutic products for skin diseases, addressing unmet medical needs.