Accutane is Journey Medical’s sixth marketed dermatology product
NEW YORK and SCOTTSDALE, Ariz., March 22, 2021 (GLOBE NEWSWIRE) — Fortress Biotech, Inc. (NASDAQ: FBIO) (“Fortress”), today announced that Journey Medical Corporation (“Journey Medical”), a partner company of Fortress, in-licensed and launched an oral isotretinoin under the brand name Accutane® (isotretinoin capsules USP) in the U.S. Accutane is an oral medication that is indicated for the treatment of severe recalcitrant nodular acne. It is only available by prescription at major U.S. retail and specialty pharmacy chains.
Claude Maraoui, President and Chief Executive Officer of Journey Medical, stated, “We are proud to add Accutane to our growing portfolio of dermatology products, which also includes Targadox® (doxycycline hyclate tablets USP) and Ximino® (minocycline hydrochloride extended-release capsules). Licensing and launching Accutane allows us to leverage the strength of its brand name with our experienced acne sales team. We are poised for an exciting year as we launch this brand under the Journey Medical umbrella.”
Acne is one of the most commonly treated disease states in dermatology. Acne is most common among teenagers, though it affects people of all ages. Accutane belongs to a class of drugs that may affect all four major pathogenic processes in acne: increased sebum production, irregular follicular desquamation, propionibacterium acnes proliferation and inflammation. Over 1.8 million prescriptions were written for all isotretinoin products in 2020, according to Symphony Health.
Lindsay A. Rosenwald, M.D., Chairman, President and Chief Executive Officer of Fortress, added, “The in-licensing of Accutane and expansion of Journey Medical’s portfolio of branded dermatology products showcases Fortress’ unique business model designed to acquire and rapidly advance overlooked yet potentially transformative assets to patients. We are excited about the growth potential that this newly acquired product will bring to our revenue-generating partner company.”
For full prescribing information about Accutane, please visit www.rxaccutane.com.
IMPORTANT SAFETY INFORMATION FOR ACCUTANE® (ISOTRETINOIN)
CAUSES BIRTH DEFECTS – DO NOT GET PREGNANT
CONTRAINDICATIONS AND WARNINGS |
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Important Safety Information for Accutane® (isotretinoin)
What is the most important information I should know about Accutane?
Accutane is used to treat a type of severe acne (nodular acne) that has not been helped by other treatments, including antibiotics.
Accutane can harm your unborn baby, including birth defects (deformed babies), loss of a baby before birth (miscarriage), death of the baby, and early (premature) births. Patients who are pregnant or who plan to become pregnant must not take Accutane.
Patients must not get pregnant:
If you get pregnant while taking Accutane, stop taking it right away and call your healthcare provider.
Accutane is only for patients who can understand and agree to follow all the instructions in the iPLEDGE® Program. Patients taking Accutane must register in the iPLEDGE® Pregnancy Registry at 1-866-495-0654 or www.ipledgeprogram.com. See your healthcare provider for further information.
Accutane can cause serious mental health problems, including:
Stop Accutane and call your healthcare provider right away if you or a family member notices that you have any signs and symptoms of depression or psychosis:
After stopping Accutane, you may also need follow-up mental health care if you had any of these symptoms.
Who should not take Accutane?
What should I tell my doctor before taking Accutane?
Tell your doctor if you or a family member has any of the following health conditions:
Tell your doctor if you are pregnant or breastfeeding. Accutane must not be used by women who are pregnant or breastfeeding.
Tell your doctor about all of the medicines you take including prescription and nonprescription medicines, vitamins and herbal supplements. Accutane and certain other medicines can interact with each other, sometimes causing serious side effects. Especially tell your doctor if you take:
These medicines should not be used with Accutane unless your doctor tells you it is okay.
Know the medicines you take. Keep a list of them to show to your doctor and pharmacist. Do not take any new medicine without talking with your doctor.
What should I avoid while taking Accutane?
What are the possible side effects of Accutane?
The common, less serious side effects of Accutane include:
These are not all of the possible side effects of Accutane. Call your healthcare professional for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or JG Pharma, Inc. at 1-844-325-3350.
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 six 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). Accutane is being launched by JG Pharma, Inc., a wholly owned subsidiary of Journey Medical. 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 six 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. For more information, visit www.fortressbiotech.com.
Forward-Looking Statements
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 Fortress individually or together with one or more partner companies, as dictated by context. Such 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 negatively affect our business, operating results, 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, perform under and maintain financing and strategic agreements and relationships; risks relating to the results of research and development activities; uncertainties relating to preclinical and clinical testing; risks relating to the timing of starting and completing clinical trials; our dependence on third-party suppliers; risks relating to the COVID-19 outbreak and its potential impact on our employees’ and consultants’ ability to complete work in a timely manner and on our ability to obtain additional financing on favorable terms or at all; our ability to attract, integrate and retain key personnel; the early stage of products under development; our need for substantial additional funds; risks pertaining to bodily injury or death from Accutane and/or isotretinoin products (and resultant litigation); government regulation; patent and intellectual property matters; competition; as well as other risks described in our Securities and Exchange Commission filings. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as may be required by law, and we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. The information contained herein is intended to be reviewed in its totality, and any stipulations, conditions or provisos that apply to a given piece of information in one part of this press release should be read as applying mutatis mutandis to every other instance of such information appearing herein.
Company Contacts:
Jaclyn Jaffe and William Begien
Fortress Biotech, Inc.
(781) 652-4500
ir@fortressbiotech.com
Investor Relations Contact:
Daniel Ferry
LifeSci Advisors, LLC
(617) 430-7576
daniel@lifesciadvisors.com
Media Relations Contact:
Tony Plohoros
6 Degrees
(908) 591-2839
tplohoros@6degreespr.com
A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/d2ab8b95-29cc-46e9-a41c-851575f07e64
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