Fortress Biotech’s Partner Company, Journey Medical Corporation, In-licenses and Launches Accutane® for the Treatment of Severe Recalcitrant Nodular AcneAccutane 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
Accutane® must not be used by patients who are or may become pregnant. There is an extremely high risk that severe birth defects will result if pregnancy occurs while taking Accutane in any amount, even for short periods of time. Potentially any fetus exposed during pregnancy can be affected. There are no accurate means of determining whether an exposed fetus has been affected.
Birth defects which have been documented following Accutane exposure include abnormalities of the face, eyes, ears, skull, central nervous system, cardiovascular system, and thymus and parathyroid glands. Cases of IQ scores less than 85 with or without other abnormalities have been reported. There is an increased risk of spontaneous abortion, and premature births have been reported.
Documented external abnormalities include: skull abnormality; ear abnormalities (including anotia, micropinna, small or absent external auditory canals); eye abnormalities (including microphthalmia); facial dysmorphia; cleft palate. Documented internal abnormalities include: CNS abnormalities (including cerebral abnormalities, cerebellar malformation, hydrocephalus, microcephaly, cranial nerve deficit); cardiovascular abnormalities; thymus gland abnormality; parathyroid hormone deficiency. In some cases death has occurred with certain of the abnormalities previously noted.
If pregnancy does occur during treatment of a patient who is taking Accutane, Accutane must be discontinued immediately and the patient should be referred to an Obstetrician-Gynecologist experienced in reproductive toxicity for further evaluation and counseling.
Special Prescribing Requirements
Because of Accutane's teratogenicity and to minimize fetal exposure, Accutane is approved for marketing only under a special restricted distribution program approved by the Food and Drug Administration. This program is called iPLEDGE®. Accutane must only be prescribed by prescribers who are registered and activated with the iPLEDGE Program. Accutane must only be dispensed by a pharmacy registered and activated with iPLEDGE, and must only be dispensed to patients who are registered and meet all the requirements of iPLEDGE (see PRECAUTIONS).
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:
- for 1 month before starting Accutane
- while taking Accutane
- for 1 month after stopping Accutane
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:
- psychosis (seeing or hearing things that are not real)
- suicide. Some patients taking Accutane have had thoughts about hurting themselves or suicide. Consult your healthcare provider if you have such thoughts.
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:
- start to feel sad or have crying spells
- lose interest in activities you once enjoyed
- sleep too much or have trouble sleeping
- become more irritable, angry, or aggressive than usual (for example, temper outbursts, thoughts of violence)
- have a change in your appetite or body weight
- have trouble concentrating
- withdraw from your friends or family
- feel like you have no energy
- have feelings of worthlessness or guilt
- start having thoughts about hurting yourself or taking your own life (suicidal thoughts)
- start acting on dangerous impulses
- start seeing or hearing things that are not real
After stopping Accutane, you may also need follow-up mental health care if you had any of these symptoms.
Who should not take Accutane?
- Do not take Accutane if you are pregnant, plan to become pregnant, or become pregnant during Accutane treatment. Accutane causes severe birth defects. See “What is the most important information I should know about Accutane?”
- Do not take Accutane if you are allergic to anything in it. See the end of this Medication Guide for a complete list of ingredients in Accutane. Accutane contains parabens as the preservatives.
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:
- mental problems
- liver disease
- heart disease
- bone loss (osteoporosis) or weak bones
- an eating problem called anorexia nervosa (where people eat too little)
- food or medicine allergies
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:
- Vitamin A supplements. Vitamin A in high doses has many of the same side effects as Accutane. Taking both together may increase your chance of getting side effects.
- Tetracycline antibiotics. Tetracycline antibiotics taken with Accutane can increase the chances of getting increased pressure in the brain.
- Progestin-only birth control pills (mini-pills). They may not work while you take Accutane. Ask your doctor or pharmacist if you are not sure what type you are using.
- Dilantin (phenytoin). This medicine taken with Accutane may weaken your bones.
- Corticosteroid medicines. These medicines taken with Accutane may weaken your bones.
- St. John’s Wort. This herbal supplement may make birth control pills work less effectively.
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?
- Do not get pregnant while taking Accutane and for one month after stopping Accutane. See “What is the most important information I should know about Accutane?”
- Do not breast feed while taking Accutane and for one month after stopping Accutane. We do not know if Accutane can pass through your milk and harm the baby.
- Do not give blood while you take Accutane and for one month after stopping Accutane. If someone who is pregnant gets your donated blood, their baby may be exposed to Accutane and may be born with birth defects.
- Do not take other medicines or herbal products with Accutane unless you talk to your doctor. See “What should I tell my doctor before taking Accutane?”
- Do not drive at night until you know if Accutane has affected your vision. Accutane may decrease your ability to see in the dark.
- Do not have cosmetic procedures to smooth your skin, including waxing, dermabrasion, or laser procedures, while you are using Accutane and for at least 6 months after you stop. Accutane can increase your chance of scarring from these procedures. Check with your doctor for advice about when you can have cosmetic procedures.
- Avoid sunlight and ultraviolet lights as much as possible. Tanning machines use ultraviolet lights. Accutane may make your skin more sensitive to light.
- Do not share Accutane with other people. It can cause birth defects and other serious health problems.
What are the possible side effects of Accutane?
- 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.
- Accutane can cause serious mental health problems.
- Serious brain problems. Accutane can increase the pressure in your brain. This can lead to permanent loss of eyesight and, in rare cases, death. Stop taking Accutane and call your healthcare provider right away if you get any of these signs of increased brain pressure:
- bad headache
- blurred vision
- nausea or vomiting
- seizures (convulsions)
- Skin problems. Skin rash can occur in patients taking Accutane. In some patients a rash can be serious. Stop using Accutane and call your healthcare provider immediately if you develop:
- conjunctivitis (red or inflamed eyes, like “pink eye”)
- rash with a fever
- blisters on legs, arms or face and/or sores in your mouth, throat, nose, eyes
- skin begins to peel
- Stomach area (abdomen) problems. Certain symptoms may mean your internal organs are being damaged, such as the liver, pancreas, bowel (intestines), and esophagus (connection between mouth and stomach). If your organs are damaged, they may not get better even after you stop taking Accutane. Stop Accutane and call your healthcare provider if you get:
- severe stomach, chest or bowel pain
- trouble swallowing or painful swallowing
- new or worsening heartburn
- rectal bleeding
- yellowing of your skin or eyes
- dark urine
- Bone or muscle problems. Accutane may affect your bones, muscles, and ligaments and cause pain in your joints and muscles. Tell your healthcare provider if you plan hard physical activity during treatment or get back or joint pain or broken bones. Stop Accutane and call your healthcare provider immediately if you have muscle weakness.Muscle weakness with or without pain can be a sign of serious muscle damage. Accutane may stop long bone growth in teenagers who are still growing.
- Hearing problems. Stop using Accutane and call your healthcare provider if your hearing gets worse or if you have ringing in your ears. Your hearing loss may be permanent.
- Vision problems. Accutane may affect your ability to see in the dark. Stop taking Accutane and call your healthcare provider right away if you have problems with your vision or dryness of the eyes that is painful or constant. If you wear contact lenses, you may have trouble wearing them during and after you stop treatment with Accutane.
- Lipid (fats and cholesterol in blood) problems. Accutane can raise the level of fats and cholesterol in your blood. These problems usually go away when Accutane treatment is finished.
- Serious allergic reactions. Stop taking Accutane and get emergency care right away if you develop hives, a swollen face or mouth, or have trouble breathing. Stop taking Accutane and call your healthcare provider if you get a fever, rash, or red patches or bruises on your legs.
- Blood sugar problems. Accutane may cause blood sugar problems including diabetes. Tell your healthcare professional if you are very thirsty or urinate a lot.
- Decreased red or white blood cells. Call your healthcare professional if you have trouble breathing, faint, or feel weak.
The common, less serious side effects of Accutane include:
- Dry skin
- Chapped lips
- Dry eyes
- Dry nose that may lead to nosebleeds
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.
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.
Jaclyn Jaffe and William Begien
Fortress Biotech, Inc.
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