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 at present introduced optimistic information demonstrating the impression of PAD Technology™ in WYNZORA® Cream in three posters featured on the 42nd Annual Fall Clinical Dermatology Conference® happening October 20-23, 2022, in Las Vegas, NV.
PAD Technology™, as defined in one of many posters, is a proprietary topical formulation and drug supply system that permits CAL and BDP to co-exist in an aqueous surroundings (WYNZORA® Cream), for the primary time.1 These energetic substances are secure at completely different pH ranges, and with out the distinctive properties of PAD Technology™ couldn’t co-exist in a water-based formulation.
In a second poster, diffusion of those energetic substances via human dermis was investigated in an in vitro Franz diffusion research. This demonstrated that persistently increased quantities of CAL and BDP subtle via the dermis with the PAD Technology™ primarily based cream in contrast with the CAL/BDP topical suspension. The outcomes have been statistically important in favor of CAL/BDP cream vs. CAL/BDP topical suspension (p<0.05) in any respect time factors for each actives.
Finally, WYNZORA® cream was in comparison with CAL/BDP topical suspension in a deposition research in 10 wholesome human volunteers utilizing tape strips taken at 1, 2, 4 and 8 hours. The outcomes confirmed that extra BDP was delivered to the stratum corneum and dermis with the PAD Technology™-driven cream formulation than with the CAL/BDP topical suspension at each time level.
“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 firm, and MC2 Therapeutics collectively market MC2 Therapeutics’ WYNZORA® (calcipotriene and betamethasone dipropionate) Cream within the US, a once-daily aqueous cream that mixes the advantages of a excessive efficiency steroid plus Vitamin D for the remedy of plaque psoriasis. WYNZORA® Cream demonstrates a fast onset of motion with outcomes seen in efficacy, scale and itch as early as 1 week and continued enchancment at 8 weeks.2,3
Under a Promotion and Collaboration Agreement between EPI Health and MC2 Therapeutics, EPI Health has unique detailing and distribution rights and the best to collectively with MC2 Therapeutics interact in promotional, regulatory and sure commercialization actions for WYNZORA® Cream within the United States.
About WYNZORA® (calcipotriene and betamethasone dipropionate) Cream
WYNZORA® Cream is a mounted dose mixture of calcipotriene and betamethasone dipropionate indicated for the topical remedy of plaque psoriasis in adults. Betamethasone dipropionate, a high-potency corticosteroid, has anti-inflammatory results leading to decreased expression of key TNF-α, IL-17A/F and IL-23 cytokines. Calcipotriene, a vitamin-D analog, provides to the anti-inflammatory impact of the corticosteroid by mediating psoriasis particular immune-modulating exercise, stabilizing the Th2- and T-reg cell exercise and inhibits epidermal hyperproliferation. WYNZORA® Cream makes use of PAD Technology™, which uniquely allows calcipotriene and betamethasone dipropionate to be mixed in a secure, convenient-to-use aqueous formulation. WYNZORA® Cream was designed to offer one product for prime efficacy, a favorable security profile and affected person satisfaction. While their pharmacologic and scientific results are recognized, the precise mechanisms of actions of betamethasone dipropionate and calcipotriene, and WYNZORA® Cream, in plaque psoriasis are unknown.
WYNZORA® Cream – Important Safety Information
Tell your healthcare supplier about all of your medical situations and all of the medicines you are taking, together with any corticosteroid medicines and every other merchandise containing calcipotriene.
Do not use different merchandise containing calcipotriene or a corticosteroid drugs with out speaking to your healthcare supplier first.
WYNZORA® Cream could trigger uncomfortable side effects, together with:
- Too a lot calcium in your blood or urine and/or adrenal gland issues
- Cushing’s syndrome, a situation that occurs when your physique is uncovered to massive quantities of the hormone cortisol
- High blood sugar and sugar in your urine
- Vision issues, together with an elevated danger of creating cataracts and glaucoma.
The most typical uncomfortable side effects embrace higher respiratory an infection, headache, and software website irritation. These will not be all of the attainable uncomfortable side effects. Call your healthcare supplier for medical recommendation about uncomfortable side effects.
This abstract isn’t complete. Visit www.wynzora.com to acquire the FDA-approved Full Prescribing Information.
About Novan
Novan, Inc. is a medical dermatology firm primarily targeted on researching, creating, and commercializing revolutionary therapeutic merchandise for pores and skin ailments. Our purpose is to ship protected and efficacious therapies to sufferers, together with creating product candidates the place there are unmet medical wants. We are creating SB206 (berdazimer gel, 10.3%) as a topical prescription gel for the remedy of viral pores and skin infections, with present emphasis on molluscum contagiosum.
Novan just lately accomplished the acquisition of EPI Health. EPI Health equips the corporate with a strong industrial infrastructure throughout gross sales, advertising and marketing, and communications, in addition to absolutely devoted market entry and pharmacy relation groups. Following the acquisition, the corporate employs roughly 100 employees, together with gross sales personnel presently protecting 42 territories, and promotes merchandise for plaque psoriasis, rosacea, pimples and dermatoses. Novan additionally has a pipeline of potential product candidates utilizing our proprietary nitric oxide-based know-how platform, NITRICIL™, to generate new remedies for a number of indications.
About MC2 Therapeutics A/S
MC2 Therapeutics A/S is a privately held industrial stage pharmaceutical firm dedicated to analysis in pores and skin biology and improvement of novel remedy paradigms for individuals with autoimmune and persistent inflammatory pores and skin situations.
Its revolutionary method to handle advanced challenges extra successfully is anchored in deep understanding of the pores and skin biology mixed with learnings from the pathophysiology throughout illness segments. Fueled by an entrepreneurial mindset and creativity, MC2 Therapeutics goals to set new requirements in remedy satisfaction for individuals with pores and skin situations.
For further info please go to www.mc2therapeutics.com
Forward-Looking Statements
Any statements contained on this press launch that don’t describe historic information could represent forward-looking statements as that time period is outlined within the Private Securities Litigation Reform Act of 1995. These statements could also be recognized by phrases comparable to “believe,” “expect,” “target,” “anticipate,” “may,” “plan,” “potential,” “will,” “look forward to” and related expressions, and are primarily based on the Company’s present beliefs and expectations. These forward-looking statements embrace, however will not be restricted to, statements associated to the potential advantages of the acquisition of EPI Health, the therapeutic worth and advantages of the Company’s promoted merchandise, together with WYNZORA® Cream, the potential therapeutic worth and advantages of the Company’s Nitricil™ platform know-how and its product candidates, the potential market alternative for the Company’s product candidates and promoted merchandise, the Company’s pharmaceutical improvement of nitric oxide-releasing product candidates, comparable to berdazimer gel, 10.3% (SB206) for molluscum contagiosum, the timing of regulatory filings, and the supply of potential financing choices. Forward-looking statements are topic to a variety of dangers and uncertainties that would trigger precise outcomes to vary materially from the Company’s expectations, together with, however not restricted to, dangers associated to the acquisition of EPI Health; dangers associated to the regulatory approval course of, which is prolonged, time-consuming and inherently unpredictable, together with the danger that the FDA is not going to agree with the Company’s method to a potential NDA submission, that the Company’s product candidates is probably not permitted or that further research could also be required for approval or different delays could happen, that the Company could not have enough portions of drug substance and/or drug product to help regulatory submissions and that the Company could not get hold of funding enough to increase its money runway or to finish the regulatory or improvement course of; the Company’s restricted expertise as a firm in acquiring regulatory approvals for and launching merchandise developed internally and its skill to recruit and retain certified personnel and key expertise; adjustments within the measurement and nature of the marketplace for the Company’s product candidates and promoted merchandise, together with potential competitors, affected person and payer perceptions and reimbursement determinations; the Company’s skill to develop revenues from promoted merchandise and the dangers that previous efficiency is probably not indicative of future efficiency; dangers and uncertainties within the Company’s ongoing or future product improvement actions and preclinical research, which can not show profitable in demonstrating proof-of idea, or could present adversarial toxicological findings, and even when profitable could not essentially predict that subsequent scientific trials will present the requisite security and efficacy of the Company’s product candidates, or that any of the Company’s product candidates, if permitted, will proceed to reveal requisite security and efficacy following their industrial launch; any operational or different disruptions as a results of the COVID-19 pandemic; dangers associated to the manufacture of uncooked supplies and completed drug product, comparable to provide chain disruptions or delays, failure to switch know-how and processes to 3rd events successfully or failure of these third events (or the Company in reference to the Company’s facility) to acquire approval of and keep compliance with the FDA or comparable regulatory authorities; the Company’s reliance on preparations with third events to help its operations and its improvement, manufacturing and commercialization efforts and the danger that such events is not going to efficiently perform their contractual duties or meet anticipated deadlines; the Company’s skill to acquire further funding or enter into strategic or different business relationships vital or helpful for the additional improvement or commercialization of the Company’s product candidates and the operation of its business on phrases which can be acceptable to the Company or in any respect or if such relationships or transactions are unsuccessful or the Company is unable to comprehend the potential financial advantages of such relationships or transactions; and different dangers and uncertainties described within the Company’s annual report filed with the Securities and Exchange Commission on Form 10-Okay for the twelve months ended December 31, 2021, and within the Company’s subsequent filings with the Securities and Exchange Commission. Such forward-looking statements communicate solely as of the date of this press launch, and the Company disclaims any intent or obligation to replace these forward-looking statements to replicate occasions or circumstances after the date of such statements, besides as could also be required by legislation.
INVESTOR AND MEDIA CONTACT:
Jenene Thomas
JTC Team, LLC
833-475-8247
[email protected]
Sam Widdicombe
EPI Health, LLC
[email protected]
949-331-0269
Lonni Goltermann
MC2 Therapeutics
[email protected]
+45 2018 1111
References:
1 Praestegaard M, Steele F, Crutchley N. Polyaphron dispersion know-how, a novel topical formulation and supply system combining drug penetration, native tolerability and comfort of software. 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
