SCOTTSDALE, Ariz., Feb. 11 10, 2022 (GLOBE NEWSWIRE) — Journey Medical Corporation (NASDAQ:DERM) (“Journey Medical”), a commercial-stage pharmaceutical company focused on the development and commercialization of pharmaceutical products for the treatment of dermatology, today announced having received notice from its exclusive licensing partner in Japan, Maruho Co., Ltd. (“Maruho”), indicating that the Japanese Ministry of Health, Labor and Welfare (“MHLW”) has approved Rapifort® 2.5% (glycopyrronium tosylate hydrate) wipes for the treatment of axillary hyperhidrosis primary. This approval triggers a $10 million milestone payment to Journey Medical, of which $7.5 million will be paid to Dermira, Inc. (“Dermira”), a wholly owned subsidiary of Eli Lilly and Company, pursuant to under the terms of the Asset Purchase Agreement between Journey and Dermira, with net proceeds to Journey of $2.5 million. In accordance with the terms of the agreement with Maruho, the milestone payment is due by Maruho within 30 days. Journey Medical Acquired Worldwide Rights to QBREXZA® of Dermira in 2021.
Claude Maraoui, President and CEO of Journey Medical, said: “Approval to manufacture and market Rapifort 2.5% wipes in Japan activates a milestone payment to Journey Medical, which adds source of revenue beyond product sales in the United States for the company. We are very pleased that Rapifort 2.5% wipes are released in Japan, allowing more people to access this beneficial prescription tissue wipe for the treatment of primary axillary hyperhidrosis.
QBREXZA is a topical product approved by the United States Food and Drug Administration for the treatment of primary axillary hyperhidrosis in adult and pediatric populations (nine years of age and older) and is self-administered by patients. Additionally, QBREXZA is considered a first-line treatment for primary axillary hyperhidrosis by the International Hyperhidrosis Society.
Hyperhidrosis is a condition of sweating beyond what is physiologically required for normal thermal regulation and affects approximately 4.8% of the US population, or about 15 million people.1 Of these, 65%, or almost 10 million people, suffer from localized sweating in the armpits (axillary disease). Studies have shown that excessive sweating often interferes with normal daily activities and can also lead to occupational, emotional, psychological, social and physical disorders.1.2
For more information on QBREXZA, please visit https://www.QBREXZA.com/.
About QBREXZA® (glycopyrronium) fabric
QBREXZA (pronounced kew brex’ zah) is an anticholinergic indicated for the 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 may be exacerbated by the anticholinergic effect of QBREXZA (e.g., glaucoma, paralytic ileus, unstable cardiovascular status in acute bleeding, severe ulcerative colitis, toxic megacolon complicating ulcerative colitis, myasthenia gravis, Sjögren’s syndrome) .
Warnings and Precautions
Aggravation of urinary retention: QBREXZA should be used with caution in patients with a history or documented presence of urinary retention. Prescribers and patients should be alert to signs and symptoms of urinary retention (eg, difficulty urinating, distended bladder), especially in patients with prostatic hypertrophy or bladder neck obstruction. Instruct patients to discontinue use immediately and seek medical attention if any of these signs or symptoms develop. Patients with a history of urinary retention were not included in clinical studies.
Body temperature check: In the presence of high ambient temperature, heat illness (hyperpyrexia and heat stroke due to decreased sweating) may occur with the use of anticholinergic medicines such as QBREXZA. Advise patients using QBREXZA to monitor for a generalized absence of sweating when in warm or very hot ambient temperatures and to avoid use if they do not sweat under these conditions.
Driving machinery or a car: Transient blurred vision may occur with the use of QBREXZA. If vision is blurred, the patient should discontinue use until symptoms subside. Patients should be warned not to engage in activities that require clear vision such as driving a motor vehicle or other machinery or performing hazardous work until symptoms have resolved ..
The most common adverse reactions observed in ≥ 2% of QBREXZA-treated subjects were dry mouth (24.2%), mydriasis (6.8%), oropharyngeal pain (5.7%), headache (5.0%), urinary hesitation (3.5%), blurred vision (3.5%), nasal dryness (2.6%), throat dryness (2.6%), eye dryness (2.4%), dry skin (2.2%) and constipation (2.0%). Local skin reactions including erythema (17.0%), burning/stinging sensation (14.1%) and pruritus (8.1%) were also common.
Anticholinergics: Concomitant administration of QBREXZA with anticholinergic medicinal products may result in an additive interaction resulting in increased anticholinergic adverse reactions. Avoid co-administration of QBREXZA with other medicinal products containing anticholinergics.
Instructions for administration of QBREXZA
Instruct patients to use a cloth to apply QBREXZA to both armpits by wiping the cloth over one armpit ONCE. Using the same cloth, apply the medicine to the other armpit ONCE. Advise patients that QBREXZA may cause temporary dilation of the pupils and blurred vision if it comes into contact with the eyes.
Instruct patients to wash their hands with soap and water immediately after disposing of the used cloth.
Use in Specific Populations
Pregnancy: There are no data available from the use of QBREXZA in pregnant women to inform a drug-associated risk of developmental adverse effects.
Lactation: There are no data on the presence of glycopyrrolate or its metabolites in breast milk, effects on the nursing infant or effects on milk production. The developmental and health benefits of breastfeeding should be considered, as well as the clinical need for QBREXZA for the mother and any potential adverse effects on the breastfed infant due to QBREXZA or the underlying maternal condition. .
Renal failure: The elimination of glycopyrronium is severely impaired in patients with renal insufficiency.
please look Full Prescribing Information
About Journey Medical Corporation
Journey Medical Corporation (NASDAQ:DERM) (“Journey Medical”) is focused on the identification, acquisition, development and strategic commercialization of innovative and differentiated dermatology products through its effective sales and marketing model. The company currently markets nine products that help treat and cure common skin conditions. The Journey Medical team is comprised of industry experts with extensive experience marketing some of the most successful prescription dermatology brands. Journey Medical is located in Scottsdale, Arizona and was founded by Fortress Biotech, Inc. (NASDAQ: FBIO). Journey is registered under the Securities Exchange Act of 1934, as amended, and files periodic reports with the United States Securities and Exchange Commission (“SEC”). For more information about Journey Medical, visit www.journeymedicalcorp.com.
This press release may contain “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, as amended. As used below and throughout this press release, the words “we”, “us” and “our” may refer to Journey Medical. These statements include, but are not limited to, any statements relating to our growth strategy and product development programs and any other statements that are not historical facts. Forward-looking statements are based on management’s current expectations and are subject to risks and uncertainties that could adversely affect our business, results of operations, financial condition and stock price. Factors that could cause actual results to differ materially from those currently anticipated include: risks relating to our growth strategy; our ability to obtain, execute and maintain financing and strategic agreements and relationships; risks related to the results of research and development activities; uncertainties related to preclinical and clinical trials; risks relating to the timing of the start and completion of clinical trials; our reliance on third-party vendors; risks related to the COVID-19 outbreak and its potential impact on the ability of our employees and consultants to complete work in a timely manner and on our ability to obtain additional financing on favorable terms or not at all; our ability to attract, integrate and retain key personnel; the early stage of products under development; our need for substantial additional funds; government regulations; patents and intellectual property; competetion; and other risks described in our filings with the SEC. We expressly disclaim any obligation or undertaking to publicly release any updates or revisions to any forward-looking statement contained herein to reflect any change in our expectations or any change in events, conditions or circumstances on which any such statement is based, except where possible. required by law, and we claim safe harbor protection for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. The information contained herein is intended to be considered in its entirety, and all stipulations , conditions or covenants that apply to information given in any part of this press release should be read as applying mutatis mutandis to any other instance of such information appearing here.
Company details :
Jaclyn Jaffe and Bill Begien
Fortress Biotech, Inc.
Contact person for media relations:
- Doolittle and. al., Hyperhidrosis: an update on prevalence and severity in the United States. Arch Dermatol Res. 308:743-749, 2016.
- Kamudoni, et al., The impact of hyperhidrosis on patients’ daily life and quality of life: a qualitative survey. Health and Quality of Life Outcomes, 15(1). 2017.