Now available: Wynzora® Cream (calcipotriene and
betamethasone dipropionate, w/w 0.005%/0.064%) once-daily
topical treatment of plaque psoriasis in adults 18 years of age
or older introduces use of PAD™
Technology.
· Wynzora is the first and only water-based cream that
uses PAD™ technology to help optimize the treatment
of plaque psoriasis (ref. USPI)
·
For 95% of adult psoriasis patients in the US a topical therapy is the first-line therapy used1
· When measured on a 50-point treatment convenience scale,
patients rated Wynzora at 84% on ease of application,
non-greasy application, and minimal disruption of daily
routine among other measures
Wynzora® Cream will be available for
commercial supply starting July 19, 2021,
in the United
States.
CHARLESTON, S.C. and COPENHAGEN, Denmark,
July 19, 2021 /PRNewswire/ --
EPI Health and MC2 Therapeutics, announced
today commercial availability in the
United States of Wynzora® Cream (calcipotriene and
betamethasone dipropionate, w/w 0.005%/0.064%) for the topical
treatment of plaque psoriasis in adults, 18 years
of age or older.
"Calcipotriene and betamethasone dipropionate are
well-established molecules for the treatment of plaque
psoriasis, with proven efficacy, safety and tolerability. Until now
they could not be combined into an aqueous cream, which is
less greasy and more user-friendly than other formulations." –
John Koo MD, Professor of Dermatology at University of California San Francisco medical
center and Co- Director, UCSF Psoriasis Treatment Center,
Phototherapy unit and Psychodermatology clinic.
Board certified in Dermatology and Psychiatry.
"As a leader in Dermatology, expanding our portfolio to help
address some of the issues faced by almost 8 million people
2 in the US with psoriasis aligns with our mission to
provide safe, beneficial, and effective medications, such as
Wynzora®, to the dermatology community." said John
Donofrio, President of EPI Health.
"The development and unique design of Wynzora® was
aimed at providing efficacy, safety, and convenience in a
single topical product." commented Jesper J. Lange, CEO of MC2 Therapeutics,
and continues, "Our collaboration with EPI Health in the
preparation of the launch has been excellent and
we are excited that Wynzora® is now available for
patients."
About Plaque Psoriasis
Psoriasis is a common, non-contagious, chronic skin disease,
with no clear cause or cure. The negative impact
of plaque psoriasis on people's lives can be
immense as it affects the appearance
of the skin with red, scaly plaques. The appearance
of flares of psoriasis can be unpredictable and affects people
of all ages. With a reported prevalence of 2-4% of the
population psoriasis constitutes a serious health problem with
more than 100 million individuals affected worldwide. More than 90%
of patients receiving treatment use topical drugs. According
to the National Psoriasis Foundation, itch is present
in between 70 and 90 percent of psoriasis patients, and
together with flaking and scaling, itching is the most
burdensome symptom to patients.3,4 Patients with
psoriatic disease are at an elevated risk of developing other
chronic and serious health conditions, including arthritis,
cardiovascular diseases, metabolic syndrome, inflammatory
bowel disease and depression.3
About Wynzora® 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 new
treatment option in their daily routines by combining the three
essentials of a topical therapy in one single product: high
efficacy, a favorable safety profile and convenience of use. In the
phase 3 trials conducted at multiple sites in the US and the
EU, Wynzora® Cream has demonstrated a
unique combination of compelling
clinical efficacy, a favorable safety
profile and high convenience.
For more information, please visit www.wynzora.com.
Wynzora® Cream (calcipotriene and betamethasone dipropionate, w/w 0.005%/0.064%) Indication and ISI4
Indication and Usage
Wynzora® (calcipotriene and betamethasone
dipropionate) Cream is indicated for plaque psoriasis
in adults. It is not known
if Wynzora Cream is safe and effective in
children.
Important Safety Information
-
Wynzora Cream is for topical use only.
-
Patients should not use more than 100g of Wynzora Cream per week.
-
Wynzora Cream should not be used near or in the
mouth, eyes, or intravaginally.
-
Patients should avoid using Wynzora Cream on
the face, groin, or
armpits, or if they have atrophy at
the treatment site.
-
Patients should apply Wynzora Cream to the affected areas
of the skin once a day for up
to 8 weeks.
-
Patients should discontinue use once the plaque psoriasis
is under control.
-
Patients should not use with occlusive dressings.
-
Hypercalcemia and hypercalciuria have been observed with use of topical calcipotriene.
-
Wynzora Cream can cause reversible HPA axis suppression with the potential for clinical glucocorticosteroid insufficiency during and
after withdrawal of treatment.
-
Wynzora Cream may cause vision problems, including increasing the risk of cataracts and glaucoma.
-
It is not known whether Wynzora Cream may harm your unborn baby.
-
Breastfeeding women should not apply Wynzora Cream directly to the nipple and areola.
- It is not known whether topically administered calcipotriene
and betamethasone dipropionate is absorbed in human
milk.
Please see accompanying full Prescribing Information for Wynzora cream.
You are encouraged to report side effects of prescription drugs
to the FDA. Visit www.fda.gov/medwatch
or call1-800-FDA-1088.
About EPI Health
Headquartered in Charleston, South
Carolina, EPI Health is a specialty pharmaceutical
company established as a leader and one of the fastest growing
companies in the US dermatology community. EPI is committed to
delivering innovative prescription therapies to dermatologists
while improving the quality of life for patients and providing
outstanding medical services. Its current portfolio
includes medicines to patients with rosacea, atopic
dermatitis, cold sores, and acne. EPI Health is a
wholly owned subsidiary of Evening
Post Industries.
For additional information please visit www.epihealth.com
About MC2 Therapeutics
MC2 Therapeutics is a privately held commercial stage
pharmaceutical company developing a
new standard of topical therapies for chronic inflammatory conditions. Using its PAD™
Technology it aims to set a new standard of
treatment experience for patients and to release the full potential
of novel topical drugs for the benefit of patients,
physicians, payers and societies. PAD™ Technology is
the cornerstone for the innovative pipeline of drug candidates
within atopic dermatitis, dry eye,
ocular rosacea, uremic pruritus and lichen
sclerosis.
For additional information please visit www.mc2therapeutics.com
About PAD™ Technology
PAD™ Technology formulations are tailor-made to meet the target
product profile for a
selected product candidate. PAD™ Technology enables the mixing of oil and water into a cream
using just a fraction of the emulsifier required in
conventional creams and lotions. Key features of
PAD™ Technology formulations are high penetration of active
ingredients to the target tissue,
improved solubility and stability of active ingredients, high tolerability and excellent treatment convenience.
1 Murage MJ, Kern DM, Chang L, Sonawane K, Malatestinic WN,
Quimbo RA, Feldman SR, Muram TM, Araujo AB. Treatment
patterns among patients with
psoriasis using a
large national payer database in the United States: a
retrospective study. J Med Econ. 2018 Oct
25:1-9.
2 https://www.psoriasis.org/psoriasis-statistics/
3 WHO Global report on Psoriasis 2016, p.13 - 16
4
Prescribing Information for Wynzora. July 2020.
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