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Journey Medical Corporation Enters into a Definitive Agreement with Dermira, Inc., a Wholly-Owned Subsidiary of Eli Lilly and Company, to Acquire QBREXZA The first and only prescription cloth towelette approved to treat

Key Takeaway: Journey Medical Corporation Enters into a Definitive Agreement with Dermira, Inc., a Wholly-Owned Subsidiary of Eli Lilly and Company, to Acquire QBREXZA The first and only prescription cloth towelette approved to treat primary axillary hyperhidrosis in people nine-years of ag

Full Press Release Details

Journey Medical Corporation Enters into a Definitive
Agreement with Dermira, Inc., a Wholly-Owned Subsidiary of Eli Lilly and Company, to Acquire QBREXZA
The first and only prescription cloth towelette
approved to treat primary axillary hyperhidrosis in people nine-years of age and older is Journey Medical's seventh marketed dermatology
Scottsdale, AZ and New York, NY - April
1, 2021 - Journey Medical Corporation ("Journey Medical"), a partner company of Fortress Biotech, Inc. (NASDAQ:
FBIO) ("Fortress"), today announced that it has entered into a definitive agreement to acquire QBREXZA (glycopyrronium) in
the U.S. from Dermira, Inc., a wholly-owned subsidiary of Eli Lilly and Company.
The transaction is expected to close early in
the second quarter of this year. QBREXZA generated $24 million in net sales in the U.S. in 2020.
QBREXZA is the only topical product to be approved
by the U.S. Food and Drug Administration (FDA) for treatment of primary axillary hyperhidrosis in adult and pediatric populations (ages
nine-years and older) and is self-administered by patients. Additionally, QBREXZA is noted as a first-line treatment therapy for primary
axillary hyperhidrosis by the International Hyperhidrosis Society (IHHS).
Claude Maraoui, President and Chief Executive
Officer of Journey Medical, stated, "We are thrilled to expand our footprint in dermatology with the addition of QBREXZA to our
growing portfolio of prescription dermatology brands. Acquiring QBREXZA will allow us to provide an accessible and convenient product
to the millions of Americans who seek relief from excessive underarm sweating, many of whom remain undiagnosed and untreated."
In two key pivotal trials within adult and pediatric
patients with primary axillary hyperhidrosis, use of QBREXZA resulted in clinically meaningful improvements in gravimetrically measured
sweat production and disease severity, as measured by the Axillary Sweating Daily Diary, which was a validated, disease-specific patient-reported
outcome developed in consultation with the FDA. The safety and efficacy of QBREXZA have been established in clinical trials with treatment
Hyperhidrosis is a condition of sweating beyond
what is physiologically required for normal thermal regulation and affects an estimated 4.8% of the U.S. population, or approximately
15 million people.1 Of these, 65 percent, or nearly 10 million people, suffer from sweating localized to the underarms
(axillary disease). Studies have demonstrated that excessive sweating often impedes normal daily activities and can also result in occupational,
emotional, psychological, social and physical impairment.1,2
Lindsay A. Rosenwald, M.D., Chairman, President
and Chief Executive Officer of Fortress, added, "The acquisition of QBREXZA marks continued progress for our partner company, Journey
Medical, and demonstrates the success of Fortress' unique business model, which is designed to acquire and rapidly advance potentially
transformative products and product candidates to patients."
For additional information about QBREXZA, please
About QBREXZA (glycopyrronium) cloth
QBREXZA (pronounced kew brex' zah) is an anticholinergic indicated for topical treatment of primary axillary hyperhidrosis in adult
and pediatric patients, nine years of age and older. QBREXZA is applied directly to the skin and is designed to block sweat production
by inhibiting sweat gland activation. For more information visit www.QBREXZA.com.
Important Safety Information
Contraindications: QBREXZA is contraindicated in patients with medical conditions that can be exacerbated by the anticholinergic
effect of QBREXZA (e.g., glaucoma, paralytic ileus, unstable cardiovascular status in acute hemorrhage, severe ulcerative colitis, toxic
megacolon complicating ulcerative colitis, myasthenia gravis, Sjogren's syndrome).
Warnings and Precautions
Worsening of Urinary Retention: QBREXZA
should be used with caution in patients with a history or presence of documented urinary retention. Prescribers and patients should be
alert for signs and symptoms of urinary retention (e.g., difficulty passing urine, distended bladder), especially in patients with prostatic
hypertrophy or bladder-neck obstruction. Instruct patients to discontinue use immediately and consult a physician should any of these
signs or symptoms develop. Patients with a history of urinary retention were not included in the clinical studies.
Control of Body Temperature: In the
presence of high ambient temperature, heat illness (hyperpyrexia and heat stroke due to decreased sweating) can occur with the use of
anticholinergic drugs such as QBREXZA. Advise patients using QBREXZA to watch for generalized lack of sweating when in hot or very warm
environmental temperatures and to avoid use if not sweating under these conditions.
Operating Machinery or an Automobile: Transient
blurred vision may occur with use of QBREXZA. If blurred vision occurs, the patient should discontinue use until symptoms resolve. Patients
should be warned not to engage in activities that require clear vision such as operating a motor vehicle or other machinery or performing
hazardous work until the symptoms have resolved.
The most common adverse reactions seen in 2%
of subjects treated with QBREXZA were dry mouth (24.2%), mydriasis (6.8%), oropharyngeal pain (5.7%), headache (5.0%), urinary hesitation
(3.5%), vision blurred (3.5%), nasal dryness (2.6%), dry throat (2.6%), dry eye (2.4%), dry skin (2.2%) and constipation (2.0%). Local
skin reactions, including erythema (17.0%), burning/stinging (14.1%) and pruritus (8.1%) were also common.
Anticholinergics: Coadministration
of QBREXZA with anticholinergic medications may result in additive interaction leading to an increase in anticholinergic adverse effects.
Avoid coadministration of QBREXZA with other anticholinergic-containing drugs.
Instructions for Administering QBREXZA
Instruct patients to use one cloth to apply QBREXZA
to both axillae by wiping the cloth across one underarm, ONE TIME. Using the same cloth, apply the medication to the other underarm, ONE
Inform patients that QBREXZA can cause temporary
dilation of the pupils and blurred vision if it comes in contact with the eyes.
Instruct patients to wash their hands with soap
and water immediately after discarding the used cloth.
Use in Specific Populations
Pregnancy: There are no available data
on QBREXZA use in pregnant women to inform a drug-associated risk for adverse developmental outcomes.
Lactation: There are no data on the
presence of glycopyrrolate or its metabolites in human milk, the effects on the breastfed infant, or the effects on milk production. The
developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for QBREXZA and any
potential adverse effects on the breastfed infant from QBREXZA or from the underlying maternal condition.
Renal Impairment: The elimination
of glycopyrronium is severely impaired in patients with renal failure.
Please see Full Prescribing Information
About Journey Medical Corporation
Journey Medical Corporation ("Journey Medical")
is focused on identifying, acquiring and strategically commercializing innovative, differentiated dermatology products through its efficient
sales and marketing model. The company currently markets seven products that help treat and heal common skin conditions. The Journey Medical
team is comprised of industry experts with extensive experience commercializing some of the most successful prescription dermatology brands.
Journey Medical is located in Scottsdale, Arizona and is a partner company of Fortress Biotech, Inc. (NASDAQ:FBIO). For additional information
about Journey Medical, visit www.journeymedicalcorp.com.
About Fortress Biotech
Fortress Biotech, Inc. ("Fortress")
is an innovative biopharmaceutical company that was ranked in Deloitte's 2019 and 2020 Technology Fast 500 , annual rankings
of the fastest-growing North American companies in the technology, media, telecommunications, life sciences and energy tech sectors, based
on percentages of fiscal year revenue growth over three-year periods. Fortress is focused on acquiring, developing and commercializing
high-potential marketed and development-stage pharmaceutical products and product candidates. The company has seven marketed prescription
pharmaceutical products and over 25 programs in development at Fortress, at its majority-owned and majority-controlled partners and at
partners it founded and in which it holds significant minority ownership positions. Such product candidates span six large-market areas,
including oncology, rare diseases and gene therapy, which allow it to create value for shareholders. Fortress advances its diversified
pipeline through a streamlined operating structure that fosters efficient drug development. The Fortress model is driven by a world-class
business development team that is focused on leveraging its significant biopharmaceutical industry expertise to further expand the company's
portfolio of product opportunities. Fortress has established partnerships with some of the world's leading academic research institutions
and biopharmaceutical companies to maximize each opportunity to its full potential, including Alexion Pharmaceuticals, Inc., AstraZeneca,
City of Hope, Fred Hutchinson Cancer Research Center, St. Jude Children's Research Hospital and Nationwide Children's Hospital.
Last updated: Apr 1, 2021