EPI Health, a Novan Company, and MC2 Therapeutics Present WYNZORA® (calcipotriene and ...

– New data analysis from previously completed successful Phase 3 study1 demonstrated WYNZORA® Cream to be effective and convenient for skin of color patients for the treatment of plaque psoriasis

DURHAM, N.C. and COPENHAGEN, Denmark, Sept. 15, 2022 (GLOBE NEWSWIRE) -- Novan, Inc. (“the Company” or “Novan”) (Nasdaq: NOVN), today announced that EPI Health, a Novan Company, and MC2 Therapeutics presented data from a previously unpublished subgroup analysis of the U.S. Phase 3 pivotal study of WYNZORA® Cream at the Skin of Color Update 2022 Conference held September 9-11, 2022, in New York, NY.

Published as a poster, this analysis from a previously completed Phase 3 randomized, multicenter, investigator-blind, parallel-group trial of WYNZORA® Cream (calcipotriene and betamethasone dipropionate) evaluated efficacy and convenience factors in skin of color patients compared to the total study population. Patients with skin of color (Fitzpatrick IV-VI) made up 36% of subjects in the WYNZORA® head-to-head study, and 8% were African American. The proportion of patients (37.4%) in the Fitzpatrick type IV-VI group achieving Physician Global Assessment (PGA) success (at least a 2-grade improvement from baseline and clear or almost clear) after 8 weeks of treatment with CAL/BDP (calcipotriene and betamethasone dipropionate) cream was similar to the total population (38.7%) and significantly different from CAL/BDP TS (topical suspension) (p=0.0042) and cream vehicle (p=0.0013). The change from baseline mPASI after 8 weeks of treatment in the skin of color population was 61.8% with CAL/BDP Cream and 47.7% with CAL/BDP TS (p=0.0003), compared to 62.2% CAL/BDP Cream and 52% CAL/BDP TS in the total population (p<0.0001). No cases of hypopigmentation were reported in the Phase 3 trial.

This subgroup analysis shows that skin of color patients treated with CAL/BDP cream have similar efficacy to the total trial population. Patient convenience and satisfaction for CAL/BDP cream were scored similarly or higher in patients with skin of color than in the total trial population and compared to CAL/BDP TS.

“Patients with skin of color are typically not well represented in topical psoriasis studies. This data enables us to understand the efficacy of WYNZORA® Cream in this population, which comprised more than one third of patients enrolled. The results from this analysis demonstrated similar efficacy and comparable or higher scores for convenience factors (such as how easy the treatment was to apply) in Fitzpatrick skin type IV to VI subjects, giving us further confidence in using WYNZORA® for these patients,” commented Fran Cook-Bolden M.D., Assistant Clinical Professor, Weill Cornell Medicine New York, NY and an investigator for the WYNZORA Cream US Phase 3 study.

About the Poster Presentation:

Title: Calcipotriene(CAL)andbetamethasonedipropionate(BDP)creamdemonstrateshigh efficacy and convenience in skin of color patients with plaque psoriasis
Authors: Valerie Callender, MD, Susan Taylor, MD and Fran Cook-Bolden, MD

1Stein Gold et al, J Drugs Dermatol 2021;20(4)

About WYNZORA® (calcipotriene and betamethasone dipropionate) Cream

WYNZORA® Cream is a cream-based fixed dose combination of calcipotriene and betamethasone dipropionate for topical treatment of plaque psoriasis. WYNZORA® Cream is based on PAD™ Technology, which uniquely enables stability of both calcipotriene and betamethasone dipropionate in a convenient-to-use aqueous formulation. WYNZORA® Cream was uniquely designed to provide patients a treatment option in their daily routines by combining the three essentials of a topical therapy in one single product namely high efficacy, a favorable safety profile and convenience of use.

WYNZORA Cream - Important Safety Information

Tell your healthcare provider about all your medical conditions and all the medicines you take, including any corticosteroid medicines and any other products containing calcipotriene.

Do not use other products containing calcipotriene or a corticosteroid medicine without talking to your healthcare provider first.

WYNZORA Cream may cause side effects, including:

• Too much calcium in your blood or urine and/or adrenal gland problems
• Cushing's syndrome, a condition that happens when your body is exposed to large amounts of the hormone cortisol
• High blood sugar and sugar in your urine
• Vision problems, including an increased risk of developing cataracts and glaucoma.

The most common side effects include upper respiratory infection, headache, and application site irritation. These are not all the possible side effects. Call your healthcare provider for medical advice about side effects.

This summary is not comprehensive. Visit www.wynzora.com to obtain the FDA-approved Full Prescribing Information.

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. We are developing SB206 (berdazimer gel, 10.3%) as a topical prescription gel for the treatment of viral skin infections, with current emphasis on molluscum contagiosum.

Novan recently completed the acquisition of EPI Health. EPI Health equips the company with a robust commercial infrastructure across sales, marketing, and communications, as well as fully dedicated market access and pharmacy relation teams. Following the acquisition, the company employs approximately 100 staff, including sales personnel currently covering 42 territories, and promotes products for plaque psoriasis, rosacea, acne and dermatoses. Novan also has a pipeline of potential product candidates using our proprietary nitric oxide-based technology platform, NITRICIL™, to generate new treatments for multiple indications.

About MC2 Therapeutics A/S

MC2 Therapeutics A/S is a privately held commercial stage pharmaceutical company committed to research in skin biology and development of novel treatment paradigms for people with autoimmune and chronic inflammatory skin conditions.

Its innovative approach to address complex challenges more effectively is anchored in deep understanding of the skin biology combined with learnings from the pathophysiology across disease segments. Fueled by an entrepreneurial mindset and creativity, MC2 Therapeutics aims to set new standards in treatment satisfaction for people with skin conditions.
For additional information please visit www.mc2therapeutics.com

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 benefits of the acquisition of EPI Health, the therapeutic value and benefits of the Company’s promoted products, the potential therapeutic value and benefits of the Company’s Nitricil™ platform technology and its product candidates, the potential market opportunity for the Company’s product candidates and promoted products, the Company’s pharmaceutical development of nitric oxide-releasing product candidates, such as berdazimer gel, 10.3% (SB206) for molluscum contagiosum, the timing of regulatory filings, and the availability of potential financing options. 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 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 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

Sam Widdicombe
EPI Health, LLC
swiddicombe@epihealth.com
949-331-0269

Lonni Goltermann
MC2 Therapeutics
log@mc2therapeutics.com
+45 2018 1111