Minocycline Hydrochloride

SCOTTSDALE, Ariz., Nov. 04, 2024 (GLOBE NEWSWIRE) -- Journey Medical Corporation (Nasdaq: DERM) (“Journey Medical”), a commercial-stage pharmaceutical company that primarily focuses on selling and marketing U.S. Food and Drug Administration (“FDA”)-approved prescription pharmaceutical products for the treatment of dermatological conditions, today announced that the FDA has approved Emrosi™ (Minocycline Hydrochloride Extended Release Capsules, 40 mg), formerly referred to as DFD-29, for the treatment of inflammatory lesions of rosacea in adults. Emrosi was developed in collaboration with Dr. Reddy’s Laboratories Ltd. Claude Maraoui, Co-Founder, President, and Chief Executive Officer of Journey Medical, said, “With approval from the FDA, Journey Medical is proud to deliver Emrosi, a unique treatment option for the millions of patients in the U.S. suffering from rosacea. Rosacea is a difficult to treat skin condition and based on the favorable results from our Phase 3 clinical trials, Emrosi has potential to become the best-in-class oral medication to treat the condition. Our seasoned dermatology-focused sales force is now preparing for a successful launch and to establish Emrosi as a new standard of care in the treatment of rosacea. Journey Medical is committed to bringing cutting-edge innovation to patients with dermatological conditions and the healthcare professionals who treat them.” The approval of Emrosi is supported by positive data from Journey Medical’s two Phase 3 clinical trials for the treatment of rosacea. The Phase 3 clinical trials met all co-primary and secondary endpoints, and subjects completed the 16-week treatment with no significant safety issues. Emrosi demonstrated statistically significant superiority over both the current standard-of-care treatment, Oracea® 40 mg capsules, and placebo for Investigator’s Global Assessment treatment success as well as the reduction in total inflammatory lesion count in both studies. Journey Medical is completing the manufacturing of Emrosi for the U.S. market and anticipates that initial supply will be available late in the first quarter or early in the second quarter of 2025. Journey Medical intends to commercialize Emrosi in the U.S. with its dermatology-focused commercial organization. In line with the approved label, Journey Medical will execute a launch strategy to drive Emrosi toward becoming a new oral standard of care for adult rosacea patients. Srinivas Sidgiddi, M.D., Vice President, Research & Development at Journey Medical, added, “Emrosi showed great efficacy and tolerability in the pivotal clinical trials, and we are tremendously grateful to the patients, physicians, investigators, and site coordinators who participated and contributed to this important approval milestone.” Conference Call and Replay Information Journey Medical management will host a conference call to review the FDA approval on Monday, November 4, 2024, at 8:30 a.m. Eastern Time. To listen to the conference call, interested parties within the U.S. should dial 1-866-777-2509 (domestic) or 1-412-317-5413 for international callers. All callers should dial in approximately 10 minutes prior to the scheduled start time and ask to be joined into the Journey Medical conference call. Participants can register for the conference call online by clicking the following link: https://dpregister.com/sreg/10193869/fdcd4e50be. Please note that registered participants will receive their dial-in number upon registration. A replay of the conference call will be available shortly after the call concludes for approximately two weeks, and can be accessed by dialing 1-877-344-7529 (domestic) or 1-412-317-0088 (international), and providing the replay access code: 8833884. Participants will be required to state their name and company upon registering for the replay. Important Safety Information Indication: EMROSI™ is indicated for the treatment of inflammatory lesions (papules and pustules) of rosacea in adults. Adverse Events: The most common adverse reaction reported by ≥1% of subjects treated with EMROSI and more frequently than in subjects receiving placebo was dyspepsia. Contraindications: EMROSI should not be taken by patients who have a history of hypersensitivity to any of the tetracyclines. Warnings/Precautions: Cases of anaphylaxis, serious skin reactions (e.g., Stevens-Johnson syndrome), erythema multiforme, and drug rash with eosinophilia and systemic symptoms (DRESS) syndrome have been reported postmarketing with minocycline use in patients with acne. If DRESS syndrome is recognized, discontinue EMROSI immediately. Use during the second and third trimesters of pregnancy, infancy and childhood up to the age of 8 years may cause permanent discoloration of the teeth and reversible inhibition of bone growth. Discontinue EMROSI use if Antibiotic-Associated Colitis occurs. Discontinue EMROSI if liver injury is suspected. Patients experiencing light-headedness, dizziness or vertigo should be cautioned about driving vehicles or operating heavy machinery. Clinical manifestations include headache, blurred vision, diplopia, and vision loss. Discontinue EMROSI immediately if symptoms occur. Symptoms may be manifested by fever, rash, arthralgia, and malaise. Discontinue EMROSI immediately if symptoms occur. Patients should minimize or avoid exposure to natural or artificial sunlight while using EMROSI. Tetracycline-class antibiotics are known to cause hyperpigmentation. EMROSI may induce hyperpigmentation in many organs, including nails, bone, skin, eyes, thyroid, visceral tissue, oral cavity, sclerae and heart valves. Because of the potential for drug-resistant bacteria to develop during the use of EMROSI, use EMROSI only as indicated. If superinfection occurs, discontinue EMROSI and institute appropriate therapy. Perform periodic laboratory evaluations of organ systems, including hematopoietic, renal and hepatic studies. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. For full prescribing information, please visit www.emrosi.com. About Rosacea Rosacea is a chronic, relapsing, inflammatory skin condition that most commonly presents with symptoms such as deep facial redness, acne-like inflammatory lesions (papules and pustules) and spider veins (telangiectasia). According to The National Rosacea Society, it is estimated that rosacea affects over 16 million Americans and as many as 415 million people worldwide. Rosacea is most frequently seen in adults between 30 and 50 years of age. Surveys conducted by The National Rosacea Society report that more than 90 percent of rosacea patients said their condition had lowered their self-confidence and self-esteem, and 41 percent stated that it had caused them to avoid public contact or cancel social engagements. Among rosacea patients with severe symptoms, 88 percent said the disorder had adversely affected their professional interactions, and 51 percent said they had missed work because of their condition. About Journey Medical Corporation Journey Medical Corporation (Nasdaq: DERM) (“Journey Medical”) is a commercial-stage pharmaceutical company that primarily focuses on the selling and marketing of FDA-approved prescription pharmaceutical products for the treatment of dermatological conditions through its efficient sales and marketing model. The Company currently markets seven branded and two generic products that help treat and heal common skin conditions. The Journey Medical team comprises industry experts with extensive experience in developing and commercializing some of dermatology’s most successful prescription brands. Journey Medical is located in Scottsdale, Arizona and was founded by Fortress Biotech, Inc. (Nasdaq: FBIO). Journey Medical’s common stock is registered under the Securities Exchange Act of 1934, as amended, and it files periodic reports with the U.S. Securities and Exchange Commission (“SEC”). For additional information about Journey Medical, visit www.journeymedicalcorp.com. Forward-Looking Statements This press release may contain “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. As used below and throughout this press release, the words “the Company”, “we”, “us” and “our” may refer to Journey Medical. 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. The words “anticipate,” “believe,” “estimate,” “may,” “expect,” “will,” “could,” “project,” “intend,” “potential” and similar expressions are generally intended to identify forward-looking statements. 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: the fact that our products and product candidates are subject to time and cost intensive regulation and clinical testing and as a result, may never be successfully developed or commercialized; a substantial portion of our sales derive from products that may become subject to third-party generic competition, the introduction of new competitor products, or an increase in market share of existing competitor products, any of which could have a significant adverse impact on our operating income; we operate in a heavily regulated industry, and we cannot predict the impact that any future legislation or administrative or executive action may have on our operations; our revenue is dependent mainly upon sales of our dermatology products and any setback relating to the sale of such products could impair our operating results; competition could limit our products’ commercial opportunity and profitability, including competition from manufacturers of generic versions of our products; the risk that our products do not achieve broad market acceptance, including by government and third-party payors; our reliance third parties for several aspects of our operations; our dependence on our ability to identify, develop, and acquire or in-license products and integrate them into our operations, at which we may be unsuccessful; the dependence of the success of our business, including our ability to finance our company and generate additional revenue, on the successful commercialization of our recently approved product, EmrosiTM, and any future product candidates that we may develop, in-license or acquire; clinical drug development is very expensive, time consuming, and uncertain and our clinical trials may fail to adequately demonstrate the safety and efficacy of our current or any future product candidates; our competitors could develop and commercialize products similar or identical to ours; risks related to the protection of our intellectual property and our potential inability to maintain sufficient patent protection for our technology and products; our business and operations would suffer in the event of computer system failures, cyber-attacks, or deficiencies in our or our third parties’ cybersecurity; the substantial doubt about our ability to continue as a going concern; the effects of major public health issues, epidemics or pandemics on our product revenues and any future clinical trials; our potential need to raise additional capital; Fortress controls a voting majority of our common stock, which could be detrimental to our other shareholders; as well as other risks described in Part I, Item 1A, “Risk Factors,” in our Annual Report on Form 10-K for the year ended December 31, 2023, subsequent Reports on Form 10-Q, and our other filings we make with the SEC. 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. Company Contact: Jaclyn Jaffe (781) 652-4500 ir@jmcderm.com Media Relations Contact: Tony Plohoros 6 Degrees (908) 591-2839 tplohoros@6degreespr.com Released November 4, 2024

Taylor Tieden for BioSpace The FDA is set to decide on four promising therapies in the next two weeks, including a CAR T for acute lymphoblastic leukemia. In the coming weeks, the FDA has four big decisions lined up. Among these are verdicts for a gene therapy for a rare disease and another for a lung cancer biologic therapy under Priority Review. Read below for more. Journey’s Rosacea Drug Awaits FDA Verdict By November 4, the FDA will release its decision on Journey Medical Corporation’s DFD-29 (minocycline hydrochloride modified release capsules), which the company is proposing as an oral treatment for inflammatory lesions and erythema in adults with rosacea. Journey is backing its New Drug Application (NDA) with data from two Phase III studies, both of which hit all co-primary and secondary endpoints . Compared with the current standard of care—40-mg Oracea (doxycycline) capsules—DFD-29 showed significant superiority in treatment success, as per the Investigator’s Global Assessment. DFD-29 was likewise better than Oracea at reducing total inflammatory lesion count and erythema in rosacea patients. Both trials also found that DFD-29 significantly outperformed placebo. If approved, DFD-29 would be “the only oral medication to address both inflammatory lesions and erythema” in rosacea “and will be a preferred treatment option by physicians and their patients,” Journey president and CEO Claude Maraoui said in a company statement alongside the FDA’s acceptance of its NDA. Rosacea is an inflammatory dermatologic condition that affects around 16 million people in the U.S. The disease manifests as red, pus-filled bumps on the skin, alongside redness in the face. Merus Seeks Approval for Bispecific Antibody in NSCLC, Pancreatic Cancer Netherlands-based Merus is advancing the investigational bispecific antibody zenocutuzumab for the treatment of non-small cell lung cancer (NSCLC) and pancreatic ductal adenocarcinoma (PDAC) patients positive for fusions of the NRG1 gene. The FDA accepted Merus’ Biologics License Application (BLA) on May 6, 2024, and granted it Priority Review, which shortens the usual review period from 10 months to six months. In keeping with this schedule, the regulator is expected to release its decision no later than November 6. The NRG1 gene encodes for the HER3 ligand neuregulin. Though rare, fusion mutations between NRG1 and partner genes result in cancer-causing genomic events that are typically observed in certain malignancies, such as NSCLC and PDAC. Zenocutuzumab utilizes Merus’ proprietary Dock & Block technology to bind to HER2 and disrupt the interaction between the HER3 receptor and neuregulin or NRG1-fusion proteins. Preclinical studies have confirmed that zenocutuzumab effectively blocks the formation of HER2/HER3 heterodimers, in turn preventing cancer cell proliferation and survival. Merus’ data package for zenocutuzumab includes results from the Phase I/II eNRGy study, an October 2023 readout from which demonstrated a 37% objective response rate in NSCLC patients positive for NRG1 fusions. In PDAC patients carrying the same biomarker status, zenocutuzumab elicited a 42% objective response rate. Will FDA Follow Europe in Approving PTC’s Gene Therapy for AADC Deficiency? PTC Therapeutics is seeking U.S. approval for its gene therapy Upstaza (eladocagene exuparvovec) for the treatment of the ultrarare disease aromatic L-amino acid decarboxylase (AADC) deficiency in pediatric patients aged 18 months and up. The FDA’s decision is due on November 13. AADC deficiency is a genetic disorder caused by a mutation in the DDC gene, which leads to insufficient levels of the AADC protein. In turn, AADC deficiency is characterized by compromised production of dopamine, serotonin and other neurotransmitters, resulting in its key symptoms of developmental delays, muscle stiffness, movement problems and lethargy. Most patients with AADC deficiency need lifelong care, and the disease can be fatal. AADC deficiency affects between 1 in 64,000 and 1 in 90,000 births in the U.S. Upstaza targets the underlying cause of AADC deficiency by delivering a functional copy of the DDC gene. The gene therapy is delivered straight into the brain through a minimally invasive procedure and is meant to be a one-time treatment. In July 2022, the European Commission granted the gene therapy is Marketing Authorization, allowing its use in all 27 European Union member states, plus Iceland, Norway and Liechtenstein. The U.K.’s Medicines and Healthcare Products Regulatory Agency followed suit in November 2022. In March 2023, England’s National Institute for Health and Care Excellence recommended the use of Upstaza for the treatment of AADC deficiency, ensuring that the National Health Service will make the gene therapy available for patients who need it. FDA to Decide on Autolus’ CAR T Therapy for Acute Lymphoblastic Leukemia By November 16, the FDA will release its verdict for Autolus Therapeutics’ investigational CAR T therapy obecabtagene autoleucel (obe-cel) for the treatment for adult patients with relapsed or refractory B cell acute lymphoblastic leukemia (ALL). The London-based biotech is backing its BLA, which the FDA accepted in January 2024, with data from the pivotal Phase II FELIX study. An interim readout in December 2022 showed that the next-generation CAR T therapy could induce a 70% overall remission rate, alongside promising expansion and initial persistence at a median follow-up of 6.4 months. Obe-cel was also well-tolerated overall, with 3% of patients developing grade 3 or higher cytokine release syndrome, and 8% experiencing grade 3 or higher immune effector cell-associated neurotoxicity syndrome. If approved, obe-cel will join the limited roster of approved CAR T therapies alongside others such as Bristol Myers Squibb’s Abecma and Breyanzi and Gilead’s Tecartus and Yescarta. Obe-cel previously won the FDA’s Orphan Drug and Regenerative Medicine Advanced Therapy designations.