Novan Announces Publication of Psoriasis Patient Data Demonstrating Need for Rapid Symptom Improvement¹

Published results from a National Psoriasis Foundation-fielded survey included responses from more than 400 patients across US¹

Findings highlight impact on patient adherence of early onset of improvement with topical psoriasis medications¹

WYNZORA® (calcipotriene and betamethasone dipropionate) Cream demonstrates rapid onset of action with results seen in efficacy, scale and itch as early as 1 week and continued improvement at 8 weeks^2,3  

DURHAM, N.C. and COPENHAGEN, Denmark, April 27, 2023 (GLOBE NEWSWIRE) -- Novan, Inc. ("the Company" or "Novan") (Nasdaq: NOVN), and MC2 Therapeutics today announced that results of a recently conducted survey to assess psoriasis patients' topical treatment experience, expectations, and preferences have been published in the Journal of Drugs in Dermatology (JDD). The survey was conducted by the National Psoriasis Foundation and was sponsored by the Company. Most of the participants self-reported having moderate psoriasis (83.9%); most were using systemic therapies (73.5%) and employing topical medications at least once per week (84%).

"The most effective medications are the ones that patients actually use. Understanding what factors impact adherence can help guide physicians in our choice of topical psoriasis treatments." commented Steven R. Feldman, M.D., Ph.D., Professor of Dermatology, Wake Forest University School of Medicine. "Findings from this survey demonstrated that psoriasis patients expect to see rapid improvement of their symptoms, or they report they will discontinue topical treatment. Selecting medications that work quickly and fit their formulation and vehicle preferences may improve adherence and successful treatment outcomes."

Key findings from the published results of the conducted survey include:

• More than 90% of respondents stated they suffered from itch frequently or always, with the majority of them rating this as moderate, severe or very severe (93%), and most often affecting the scalp, elbows and arms, and trunk.¹
  
  
• Nearly 80% of participants in the survey said they would discontinue a topical treatment if they did not notice an improvement in their symptoms in two weeks or less¹. Only 5% of patients surveyed would be willing to persevere for more than a month without seeing results.¹
  
  
• 40% of patients stated they would call a different dermatologist if a treatment they were prescribed caused an unwanted reaction.¹
  
  
• 75% of participants stated they would only use a medication for a week if they did not like a formulation that was prescribed for them. The attributes rated most important were application feel (55.2%), non-staining (49.9%), quick absorption (46.7%) and non-sticky texture (39.7%).¹
  

WYNZORA^® (calcipotriene and betamethasone dipropionate) Cream is a once-daily aqueous topical medication that combines the benefits of a high potency steroid plus Vitamin D for the treatment of plaque psoriasis. It demonstrates rapid onset of action with results seen in efficacy, scale and itch as early as 1 week and continued improvement at 8 weeks.^2,3

Under a Promotion and Collaboration agreement between Novan and MC2 Therapeutics Novan has exclusive detailing and distribution rights and the right to jointly with MC2 Therapeutics to engage in promotional, regulatory and certain commercialization activities for WYNZORA^® Cream in the United States. MC2 Therapeutics granted Novan an exclusive right and license under MC2 Therapeutics' intellectual property rights to sell, or detail (as defined in the agreement), and engage in certain commercialization activities for WYNZORA^® Cream, in the United States.

About WYNZORA^® (calcipotriene and betamethasone dipropionate) Cream

WYNZORA^® Cream is a fixed dose combination of calcipotriene and betamethasone dipropionate indicated for the topical treatment of plaque psoriasis in adults. Betamethasone dipropionate, a high-potency corticosteroid, has anti-inflammatory effects resulting in decreased expression of key TNF-?, IL-17A/F and IL-23 cytokines. Calcipotriene, a vitamin-D analog, adds to the anti-inflammatory effect of the corticosteroid by mediating psoriasis specific immune-modulating activity, stabilizes the Th2- and T-reg cell activity and inhibits epidermal hyperproliferation. WYNZORA^® Cream uses PAD Technologytm, which uniquely enables calcipotriene and betamethasone dipropionate to be combined in a stable, convenient-to-use aqueous formulation. WYNZORA^® Cream was designed to provide one product for high efficacy, a favorable safety profile and patient satisfaction. While their pharmacologic and clinical effects are known, the exact mechanisms of actions of betamethasone dipropionate and calcipotriene, and WYNZORA^® Cream, in plaque psoriasis are unknown.

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 focused on 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") accepted for filing Novan's New Drug Application ("NDA") seeking approval for berdazimer gel, 10.3% (SB206) for the treatment of molluscum contagiosum. The Company also has a pipeline of potential product candidates using its proprietary nitric oxide-based technology platform, NITRICILtm, 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 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 therapeutic value and benefits of the Company's promoted products, including WYNZORA^® Cream. 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, the risk that the Company's products and product candidates may pose safety issues, cause adverse events, have side effects or have other properties that could limit the commercial profile of an approved label or result in significant negative consequences; the Company's promoted products may not continue to demonstrate requisite safety and efficacy; 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 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; 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, 2022, 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
[email protected]

Sam Widdicombe
Novan Inc
[email protected]
949-331-0269

Lonni Goltermann MC2 Therapeutics
[email protected]
+45 2018 1111

References:
1. Curcio A. et al. J Drugs Dermatol. 2023;22(4): doi:10.36849/JDD.7372
2. Han G. et al. SKIN The Journal of Cutaneous Medicine. 2022;6(4), s42. https://doi.org/10.25251/skin.6.supp.42
3. Wynzora® Cream [package insert]. MC2 Therapeutics; 2020