Research shows PAD (Polyaphron Dispersion) Technology™ leads to more efficient delivery of Calcipotriene (CAL) and Betamethasone Dipropionate (BDP) than CAL/BDP topical suspension
DURHAM, N.C. and COPENHAGEN, Denmark, Oct. 21, 2022 (GLOBE NEWSWIRE) — Novan, Inc. (“the Company” or “Novan”) (Nasdaq: NOVN), EPI Health, a Novan Company, and MC2 Therapeutics today announced positive data demonstrating the impact of PAD Technology™ in WYNZORA® Cream in three posters featured at the 42nd Annual Fall Clinical Dermatology Conference® taking place October 20-23, 2022, in Las Vegas, NV.
PAD Technology™, as explained in one of the posters, is a proprietary topical formulation and drug delivery system that allows CAL and BDP to co-exist in an aqueous environment (WYNZORA® Cream), for the first time.1 These active ingredients are stable at different pH levels, and without the unique properties of PAD Technology™ could not co-exist in a water-based formulation.
In a second poster, diffusion of these active ingredients through human epidermis was investigated in an in vitro Franz diffusion study. This demonstrated that consistently higher amounts of CAL and BDP diffused through the epidermis with the PAD Technology™ based cream compared with the CAL/BDP topical suspension. The results were statistically significant in favor of CAL/BDP cream vs. CAL/BDP topical suspension (p<0.05) at all time points for both actives.
Finally, WYNZORA® cream was compared to CAL/BDP topical suspension in a deposition study in 10 healthy human volunteers using tape strips taken at 1, 2, 4 and 8 hours. The results showed that more BDP was delivered to the stratum corneum and epidermis with the PAD Technology™-driven cream formulation than with the CAL/BDP topical suspension at every time point.
“These studies, comparing two formulations with identical concentrations of active ingredients, demonstrate that vehicles and delivery technology play an important role in the absorption of those actives. The variances shown in these posters may explain the difference in efficacy of WYNZORA® Cream and CAL/BDP topical suspension demonstrated in the pivotal Phase 3 study,”2 commented Zoe Diana Draelos, MD, FAAD, President, Dermatology Consulting Services, PLLC.
EPI Health, a Novan company, and MC2 Therapeutics jointly market MC2 Therapeutics’ WYNZORA® (calcipotriene and betamethasone dipropionate) Cream in the US, a once-daily aqueous cream that combines the benefits of a high potency steroid plus Vitamin D for the treatment of plaque psoriasis. WYNZORA® Cream demonstrates a 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 EPI Health and MC2 Therapeutics, EPI Health has exclusive detailing and distribution rights and the right to jointly with MC2 Therapeutics engage in promotional, regulatory and certain commercialization activities for WYNZORA® Cream in the United States.
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-α, 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, stabilizing the Th2- and T-reg cell activity and inhibits epidermal hyperproliferation. WYNZORA® Cream uses PAD Technology™, 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.
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.
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.
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
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, including WYNZORA® Cream, 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:
JTC Team, LLC
EPI Health, LLC
+45 2018 1111
1 Praestegaard M, Steele F, Crutchley N. Polyaphron dispersion technology, a novel topical formulation and delivery system combining drug penetration, local tolerability and convenience of application. Accepted for publication in Dermatology & Therapy, 2022
2 Wynzora® Cream [package insert]. MC2 Therapeutics; 2020
3 Han et al. Poster Presentation. SKIN Vol 6 (4) 2022: S42