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-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, stabilizes 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.
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, 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
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,
LLC833-475-8247NOVN@jtcir.com
Sam Widdicombe Novan Incswiddicombe@novan.com949-331-0269
Lonni Goltermann MC2 Therapeuticslog@mc2therapeutics.com+45 2018
1111
References:1. Curcio A. et al. J Drugs Dermatol. 2023;22(4):
doi:10.36849/JDD.73722. Han G. et al. SKIN The Journal of Cutaneous
Medicine. 2022;6(4), s42. https://doi.org/10.25251/skin.6.supp.423.
Wynzora® Cream [package insert]. MC2 Therapeutics; 2020
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