JAK1

The acquisition expands Organon’s dermatology capabilities with a nonbiologic, non-steroidal topical treatment in the U.S.BASEL, Switzerland and LONDON and NEW YORK, Oct. 28, 2024 (GLOBE NEWSWIRE) -- Organon (NYSE: OGN), a global healthcare company with a mission to improve the health of women throughout their lives, today announced the successful completion of its acquisition of Dermavant Sciences Ltd. from Roivant (NASDAQ: ROIV). Dermavant is a company dedicated to developing and commercializing innovative therapeutic solutions in immuno-dermatology. Please see our prior announcement for a summary of the transaction terms. VTAMA® (tapinarof) cream, 1%, is a novel nonbiologic, non-steroidal topical therapy approved by the U.S. Food and Drug Administration (FDA) for treatment of mild, moderate, and severe plaque psoriasis in adults with no safety label warnings or precautions and without restrictions on location and duration of use or body surface area. The FDA is reviewing a supplemental New Drug Application (sNDA) for VTAMA cream as a potential treatment for atopic dermatitis (AD) in adults and children two years of age and older, with Prescription Drug User Fee Act (PDUFA) action expected in the fourth quarter of calendar year 2024. Plaque psoriasis and atopic dermatitis-commonly known as eczema-are common chronic inflammatory skin diseases affecting millions of people in the U.S. and around the globe.1,2 Psoriasis presents a significant impact to quality of life and atopic dermatitis is associated with a higher disease burden for women compared to men.3,4“The future of dermatology depends on innovative treatments like VTAMA, and Organon’s acquisition of Dermavant allows us to further expand our existing portfolio of established brands and biosimilar dermatology treatments,” said Kevin Ali, Chief Executive Officer of Organon. “Integrating the expertise of Dermavant into Organon’s U.S. organization marks the beginning of a new chapter in dermatology. We are excited to bring this nonbiologic non-steroidal topical option to the millions of patients suffering from a chronic skin condition like plaque psoriasis and, potentially in the future, atopic dermatitis.” “I would like to thank Kevin and the entire Organon team for their partnership in the acquisition of Dermavant,” said Mayukh Sukhatme, MD, President and Chief Investment Officer of Roivant. “This deal represents a true win-win outcome for Organon and Roivant in our mutual goal to address patient needs and is emblematic of Roivant’s ability to form non-traditional, value-enhancing collaborations on important medicines. We believe that Organon’s strong global commercial footprint will maximize the impact of VTAMA for patients globally, and we are excited to continue to share meaningfully in the success of VTAMA along the way.” About VTAMA® (tapinarof) cream, 1%VTAMA cream is a non-steroidal once-daily topical treatment. The safety and effectiveness of VTAMA cream was evaluated in randomized, double-blind, vehicle-controlled trials, PSOARING-1 and 2 for plaque psoriasis. The safety and efficacy of VTAMA for the treatment of atopic dermatitis was also evaluated in ADORING-1 and ADORING-2 Phase III clinical studies and is currently under review with the FDA. Important Safety Information Indication: VTAMA® (tapinarof) cream, 1% is an aryl hydrocarbon receptor agonist indicated for the topical treatment of plaque psoriasis in adults. VTAMA cream is for use on the skin (topical) only. Do not use VTAMA cream in your eyes, mouth, or vagina. Adverse Events: The most common adverse reactions (incidence ≥ 1%) in subjects treated with VTAMA cream were folliculitis (red raised bumps around the hair pores), nasopharyngitis (pain or swelling in the nose and throat), contact dermatitis (skin rash or irritation, including itching and redness, peeling, burning, or stinging), headache, pruritus (itching), and influenza (flu). 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. See full Prescribing Information and Patient Information. About Organon Organon is an independent global healthcare company with a mission to help improve the health of women throughout their lives. Organon’s diverse portfolio offers more than 60 medicines and products in women’s health, biosimilars, and a large franchise of established medicines across a range of therapeutic areas. In addition to Organon’s current products, the company invests in innovative solutions and research to drive future growth opportunities in women’s health and biosimilars. In addition, Organon is pursuing opportunities to collaborate with biopharmaceutical partners and innovators looking to commercialize their products by leveraging its scale and agile presence in fast growing international markets. Organon has geographic scope with significant reach, world-class commercial capabilities, and approximately 10,000 employees with headquarters located in Jersey City, New Jersey. For more information, visit http://www.organon.com and connect with us on LinkedIn, Instagram, X (formerly known as Twitter) and Facebook. Cautionary Note Regarding Forward-Looking StatementsExcept for historical information, this press release includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, including, but not limited to, statements about management’s expectations about Organon’s acquisition of Dermavant (including statements regarding the timing, benefits, and financial impact of such acquisition), potential regulatory approvals and other actions relating to VTAMA (including the expected timeframe thereof), and Organon’s expected financial results and condition. Forward-looking statements may be identified by words such as “pursuing,” “foresees,” “future,” “potential,” “potentially,” “expected,” “expects,” “will” or words of similar meaning. These statements are based upon the current beliefs and expectations of Organon’s management and are subject to significant risks and uncertainties. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward- looking statements. Risks and uncertainties include, but are not limited to, an inability to execute on our business development strategy or realize the benefits of our acquisition of Dermavant or any other planned acquisitions; weakening of economic conditions that could adversely affect the level of demand for Dermavant’s products; the risk that the business will not be integrated successfully; risks related to the ability to realize the anticipated benefits of the acquisition, including the possibility that the expected benefits from the acquisition will not be realized or will not be realized within the expected time period; the ability to retain key personnel; unknown liabilities; the risk of litigation and/or regulatory actions related to the completed acquisition; pricing pressures globally, including rules and practices of managed care groups, judicial decisions and governmental laws and regulations related to Medicare, Medicaid and health care reform, pharmaceutical reimbursement and pricing in general; an inability to fully execute on Organon’s product development and commercialization plans in the United States, Europe, and elsewhere internationally; an inability to adapt to the industry-wide trend toward highly discounted channels; changes in tax laws or other tax guidance which could adversely affect Organon’s cash tax liability, effective tax rates, and results of operations and lead to greater audit scrutiny; expanded brand and class competition in the markets in which Organon operates; and governmental initiatives that adversely impact Organon’s marketing activities. Organon undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in Organon’s filings with the Securities and Exchange Commission (“SEC”), including Organon’s most recent Annual Report on Form 10-K and subsequent SEC filings, available at the SEC’s Internet site www.sec.gov. References and links to websites have been provided for convenience, and the information contained on any such website is not a part of, or incorporated by reference into, this press release. Organon is not responsible for the contents of third-party websites About Roivant Roivant is a biopharmaceutical company that aims to improve the lives of patients by accelerating the development and commercialization of medicines that matter. Roivant’s pipeline includes IMVT-1402 and batoclimab, fully human monoclonal antibodies targeting FcRn in development across several IgG-mediated autoimmune indications; brepocitinib, a potent small molecule inhibitor of TYK2 and JAK1 in development for the treatment of dermatomyositis and non-infectious uveitis; and mosliciguat, an inhaled soluble sGC activator in development for pulmonary hypertension associated with interstitial lung disease, in addition to other clinical stage molecules. We advance our pipeline by creating nimble subsidiaries or “Vants” to develop and commercialize our medicines and technologies. Beyond therapeutics, Roivant also incubates discovery-stage companies and health technology startups complementary to its biopharmaceutical business. For more information, www.roivant.com. Roivant Forward-Looking Statements This press release contains forward-looking statements. Statements in this press release may include statements that are not historical facts and are considered forward-looking within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), which are usually identified by the use of words such as “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intends,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “would” and variations of such words or similar expressions. The words may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. We intend these forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Exchange Act. Our forward-looking statements include, but are not limited to, statements regarding our or our management team’s expectations, hopes, beliefs, intentions or strategies regarding the future, and statements that are not historical facts, including statements about the clinical and therapeutic potential of our product candidates, the availability and success of topline results from our ongoing clinical trials and any commercial potential of our product candidates following applicable regulatory approvals. In addition, any statements that refer to projections, forecasts or other characterizations of future events, results or circumstances, including any underlying assumptions, are forward-looking statements. Actual results may differ materially from those contemplated in these statements due to a variety of risks, uncertainties and other factors, including (i) the possibility that the transaction may involve unexpected costs or liabilities, (ii) the risk that disruptions from the transaction will harm relationships with employees, customers and suppliers and other business partners or (iii) the risk that the achievement of the specified milestones or royalties described in the definitive agreement for the transaction may take longer to achieve than expected or may never be achieved and the resulting contingent milestone payments or royalties may never be realized. Although we believe that our plans, intentions, expectations and strategies as reflected in or suggested by those forward-looking statements are reasonable, we can give no assurance that the plans, intentions, expectations or strategies will be attained or achieved. Furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a number of risks, uncertainties and assumptions, including, but not limited to, those risks set forth in the Risk Factors section of our filings with the U.S. Securities and Exchange Commission. Moreover, we operate in a very competitive and rapidly changing environment in which new risks emerge from time to time. These forward-looking statements are based upon the current expectations and beliefs of our management as of the date of this press release, and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Except as required by applicable law, we assume no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise. Contacts: InvestorsKeyur Parekh keyur.parekh@roivant.com MediaStephanie Leestephanie.lee@roivant.com 1 Armstrong, A., Mehta, M., Schupp, C., Gondo, C., Bell, S., Griffiths, C. Psoriasis Prevalence in Adults in the United States. JAMA Dermatol. 2021 Aug; 157(8):1-7. doi:10.1001/jamadermatol.2021.2007 2 Eczema Prevalence. National Eczema Foundation. Eczema Prevalence, Quality of Life and Economic Impact.3 Carole, G., Corsin, S., Meienberger, N., Valeska Maul, L., Maul, J-T. The Impact of Gender and Sex in Psoriasis: What to be Aware of When Treating Women with Psoriasis. Int J Women’s Dermatol. 2022 Jun; 8(2): e010. doi: 10.1097/JW9.0000000000000010. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9112394/ 4 Urban, K., Chu, S., Giesey, RL., Mehrmal, S., Uppal, P., Nedley, N., Delost, GR. The Global, Regional, and National Burden of Atopic Dermatitis in 195 Countries and Territories: An ecological study from the Global Burden of Disease Study 2017. 2021 Mar; 2: 12-18. JAAD International. doi: https://doi.org/10.1016%2Fj.jdin.2020.10.002. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8362298/

Data at 68 weeks of treatment with LEQSELVI showed ongoing and clinically meaningful improvement in scalp hair regrowth Study finds that doctors and patients prefer fast time to onset and proven efficacy in JAK inhibitor options, regardless of dosing schedule MUMBAI, India and PRINCETON, N.J., Oct. 25, 2024 /PRNewswire/ -- Sun Pharmaceutical Industries Limited (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715, together with its subsidiaries and/or affiliated companies, "Sun Pharma") today presented new data highlighting the clinical efficacy and safety of LEQSELVI™ (deuruxolitinib) 8 mg tablets at the 44th Annual Fall Clinical Dermatology Conference, being held October 24-27, 2024, in Las Vegas, Nevada. LEQSELVI 8 mg tablets was approved by the U.S. Food and Drug Administration for the treatment of adults with severe alopecia areata (AA) earlier this year. LEQSELVI, a JAK inhibitor, treats alopecia areata at the source and is clinically proven to deliver statistically significant efficacy. LEQSELVI data presented at Fall Clinical includes pooled long-term results from open-label extension (OLE) studies showing ongoing and clinically meaningful improvements in scalp hair regrowth in adults with AA taking LEQSELVI for up to 68 weeks. To determine long-term efficacy, the Severity of Alopecia Tool (SALT) scores were analyzed using two methods: Last Observation Carried Forward (LOCF) and As Observed (AO). At the end of the qualifying trial period at Week 24, 32.6% of patients receiving LEQSELVI 8 mg BID (twice daily) achieved a SALT ≤20 score; the percentage of SALT 20 responders increased to 48.8% (LOCF analysis) and 76.6% (AO analysis) at Week 68 of the OLE studies. Additionally, 99.6% (282 patients) maintained their response to LEQSELVI 8 mg BID (as defined by sustaining a SALT ≤50 after achieving SALT ≤20 during the OLE studies as of the cutoff date). "This research provides insight into the durability of response experienced with LEQSELVI 8 mg twice daily, adding to a growing body of evidence highlighting the benefits of this treatment for those living with severe alopecia areata," said Brett King, MD, PhD. "These data highlight an important role for deuruxolitinib in the care of patients living with this disease." In addition to the OLE study, two posters presented at Fall Clinical capture patient and clinician feedback for the treatment of AA which confirm the preference for treatment options with fast time to onset and proven efficacy, irrespective of dosing schedules. In the blinded treatment scenario displaying profiles of LEQSELVI, baricitinib and ritlecitinib, patients and clinicians chose the profile of LEQSELVI as the preferred therapeutic option. "As we continue to grow the Sun Pharma dermatology portfolio, the data presented at Fall Clinical support a growing body of clinical evidence, which show LEQSELVI is an effective treatment option for those living with severe alopecia areata," said Marek Honczarenko, MD, PhD, Senior Vice President and Head of Global Development at Sun Pharma. "We're excited to share these important data with the dermatology community and look forward to seeing patients living with alopecia areata access this innovative treatment option." LEQSELVI may cause serious side effects including serious infections, malignancies, thrombosis, gastrointestinal perforations, and certain laboratory abnormalities. There also may be an increased risk of mortality and major cardiovascular events. LEQSELVI should not be used in patients who are CYP2C9 poor metabolizers or who are taking moderate or strong CYP2C9 inhibitors. In placebo-controlled trials, the three most common adverse events were headache (12.4% as compared to 9.4% with placebo), acne (10% as compared to 4.3% with placebo), and nasopharyngitis (8.1% as compared to 6.7% with placebo). Please see full Prescribing Information, including BOXED WARNING and Medication Guide, and see below for Important Safety Information. For more information about LEQSELVI, visit LEQSELVI.com. About LEQSELVI™ and alopecia areata LEQSELVI (deuruxolitinib) 8 mg tablets is an oral selective inhibitor of Janus kinases JAK1 and JAK2 approved for the treatment of adult patients with severe alopecia areata. Alopecia areata is an autoimmune disease in which the immune system attacks hair follicles, resulting in partial or complete loss of hair on the scalp and body. Alopecia areata may affect up to 2.5% of the United States and global population during their lifetime.1,2,3 The scalp is the most commonly affected area, but any hair-bearing site can be affected alone or together with the scalp. Onset of the disease can occur throughout life and affects both women and men. Alopecia areata can be associated with serious psychological consequences, including anxiety and depression. There are currently limited approved treatment options available for alopecia areata. LEQSELVI Important Safety Information Please click here for full Prescribing Information Including BOXED WARNING and Medication Guide. Indications and Usage LEQSELVI (deuruxolitinib) is a Janus kinase (JAK) inhibitor indicated for the treatment of adults with severe alopecia areata. Limitations of Use LEQSELVI is not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, cyclosporine or other potent immunosuppressants. Contraindications LEQSELVI is contraindicated in patients who are CYP2C9 poor metabolizers or who are using moderate or strong CYP2C9 inhibitors. Warnings Serious Infections Increased risk of serious bacterial, fungal, viral and opportunistic infections including tuberculosis (TB) that may lead to hospitalization or death. Interrupt treatment with LEQSELVI if a serious infection occurs until the infection is controlled. Test for latent TB before and during therapy; treat latent TB prior to use. Monitor all patients for active TB during treatment, even patients with initial negative, latent TB test. Mortality Higher rate of all-cause mortality, including sudden cardiovascular death with another Janus kinase inhibitor (JAK) vs. TNF blockers in rheumatoid arthritis (RA) patients. LEQSELVI is not approved for use in RA patients. Malignancy Malignancies have occurred in patients treated with LEQSELVI. Higher rate of lymphomas and lung cancers with another JAK inhibitor vs. TNF blockers in RA patients. Major Adverse Cardiovascular Events Higher rate of MACE (defined as cardiovascular death, myocardial infarction, and stroke) with another Janus kinase inhibitor (JAK) vs. TNF blockers in rheumatoid arthritis (RA) patients. Thrombosis Thrombosis, including PE, DVT & CVT, has occurred in patients treated with LEQSELVI. Increased incidence of pulmonary embolism, venous and arterial thrombosis with another JAK inhibitor vs. TNF blockers. Increased risk of serious adverse reactions in CYP2C9 poor metabolizers or with concomitant use of moderate or strong CYP2C9 inhibitors Do not treat patients who are CYP2C9 poor metabolizers or patients taking a moderate or strong CYP2C9 inhibitor with LEQSELVI. Gastrointestinal Perforations GI perforations have occurred in patients treated with LEQSELVI. Monitor patients who may be at increased risk for gastrointestinal perforation. Evaluate promptly patients presenting with new onset abdominal symptoms. Lipid elevations, anemia, neutropenia, and lymphopenia Monitor for changes in lipids, hemoglobin, neutrophils, and lymphocytes. Immunizations Avoid use of live vaccines during or immediately prior to LEQSELVI treatment. Prior to initiating LEQSELVI, it is recommended that patients be brought up to date with all immunizations. Dosage The recommended dosage of LEQSELVI for the treatment of severe alopecia areata is 8 mg orally twice daily, with or without food. Before treatment with LEQSELVI, perform the following evaluations: CYP2C9 genotype & use of moderate or strong CYP2C9 inhibitors; Active and latent tuberculosis evaluation; Viral hepatitis screening; Complete blood count (LEQSELVI treatment is not recommended in patients with an absolute lymphocyte count (ALC) <500 cells/mm3 absolute neutrophil count (ANC) <1,000 cells/mm3, or hemoglobin level <8 g/dl). Adverse Reactions Most common adverse reactions (≥1%) are headache, acne, nasopharyngitis, blood creatine phosphokinase increased, hyperlipidemia, fatigue, weight increased, lymphopenia, thrombocytosis, anemia, skin and soft tissue infections, neutropenia, and herpes. Use in Specific Populations Based on animal studies, LEQSELVI may cause fetal harm during pregnancy. Pregnant women should be advised of a risk to the fetus. Consider pregnancy planning and prevention for women of reproductive potential. LEQSELVI should not be used by women who are breastfeeding until one day after the last dose. LEQSELVI should not be used by patients with severe renal impairment or severe hepatic impairment. References Benigno M. A Large Cross-Sectional Survey Study of the Prevalence of alopecia areata in the United States, Clinical, Cosmetic and Investigational Dermatology 2020. Lee HH et al. Epidemiology of alopecia areata, ophiasis, totalis, and universalis: A systematic review and meta-analysis, J Am Acad Dermatol. 2020 Mar; 82(3): 675-682. Fricke et al. Epidemiology and burden of alopecia areata: a systematic review, Clin Cosmet Investig Dermatol. 2015 Jul 24;8: 397-403. About Sun Pharmaceutical Industries Limited. (CIN – L24230GJ1993PLC019050) Sun Pharma is the world's leading specialty generics company with a presence in Specialty, Generics and Consumer Healthcare products. It is the largest pharmaceutical company in India and is a leading generic company in the US as well as Global Emerging Markets. Sun's high growth Global Specialty portfolio spans innovative products in dermatology, ophthalmology, and onco-dermatology and accounts for over 18% of company sales. The company's vertically integrated operations deliver high-quality medicines, trusted by physicians and consumers in over 100 countries. Its manufacturing facilities are spread across six continents. Sun Pharma is proud of its multi-cultural workforce drawn from over 50 nations. For further information, please visit and follow us on LinkedIn & X (Formerly Twitter). Disclaimer: Statements in this "document" describing the Company's objectives, projections, estimates, expectations, plans or predictions, industry conditions, or events may be "forward-looking statements" within the meaning of applicable securities laws and regulations. Actual results, performance, or achievements could differ materially from those expressed or implied. The Company undertakes any obligation to update or revise forward-looking statements to reflect developments or circumstances that arise or to reflect the occurrence of unanticipated developments/circumstances after the date hereof. Contacts: Sun Pharma SOURCE Sun Pharma WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Board-certified dermatologist, Dr. Sandra Lee , widely known as Dr. Pimple Popper , among others, details her journey with mild-moderate atopic dermatitis, the most common form of eczema, and her experience on Opzelura® (ruxolitinib) cream 1.5% WILMINGTON, Del. --(BUSINESS WIRE)--Oct. 10, 2024-- Incyte (Nasdaq:INCY) announced today the expansion of its Moments of Clarity program, an educational initiative highlighting stories of people living with mild to moderate atopic dermatitis (AD) and their paths to finding relief. Building on last year’s program launch in partnership with Mandy Moore , the Moments of Clarity program will now feature several additional real-life patient perspectives, including that of Dr. Sandra Lee and Emily, a mom of three, who share their emotional experiences and the impact AD has had on their lives. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20241009443934/en/ In the new program content, each patient shares defining moments throughout their journeys including how they finally found relief with Opzelura® (ruxolitinib) cream 1.5%. Opzelura is a nonsteroidal, twice-daily cream that is indicated for the short-term and non-continuous treatment of mild to moderate eczema in certain people 12 and older whose disease is not well-controlled with topical prescription therapies or when those therapies are not recommended. Use of Opzelura in combination with biologics, other JAK inhibitors or potent immunosuppressants is not recommended. “While many people know me as a dermatologist from my TV show, most probably don’t know that I live with eczema and have struggled with symptoms like persistent itch and skin inflammation throughout my life,” said Dr. Lee . “I started using Opzelura, a non-steroidal topical option, to treat my eczema flares, which helped alleviate some of my worst symptoms like itch. In the pivotal clinical trial for mild to moderate AD, 54% of patients had clear to almost clear skin at 8 weeks and 52% of patients had a significant reduction in their itch, compared to 15% of patients who used a cream that did not contain medication. I partnered with Incyte on their Moments of Clarity program to share my story and to empower others to seek out a treatment that is right for them.” AD – the most common type of eczema – is a chronic condition characterized by inflammation of the skin, which can manifest as persistent itch, dry and scaly patches or red lesions on the body1. AD affects more than 21 million people aged 12 years and older in the U.S. Signs and symptoms include irritated and itchy skin that can cause red lesions that may ooze and crust. “We understand the impact eczema can have on daily life, which furthers the need for patients to find a treatment to address their individual symptoms,” said Matteo Trotta , Executive Vice President, General Manager, U.S. Dermatology, Incyte . “We are proud to elevate the patient voice and share the real, lived experience with Opzelura as part of our commitment to patients and to providing a treatment that can help address some of the most burdensome symptoms of AD. Our hope is that the Moments of Clarity program helps those living with eczema connect with others and inspires them to have conversations with their doctor.” OPZELURA is not for everyone. See below for IMPORTANT SAFETY INFORMATION including boxed Warning for Serious Infections, Increased Risk of Death, Lymphoma and other Cancers, Major Cardiovascular Events and Blood Clots. To hear more visit MyMomentsofClarity.com. All individuals were compensated for their participation. About Opzelura® (ruxolitinib) Cream Opzelura® (ruxolitinib) cream, a novel cream formulation of Incyte’s selective JAK1/JAK2 inhibitor ruxolitinib, approved by the U.S. Food & Drug Administration for the topical treatment of nonsegmental vitiligo in patients 12 years of age and older, is the first and only treatment for repigmentation approved for use in the United States . Opzelura is also approved in the U.S. for the topical short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis (AD) in non-immunocompromised patients 12 years of age and older whose disease is not adequately controlled with topical prescription therapies, or when those therapies are not advisable. Use of Opzelura in combination with therapeutic biologics, other JAK inhibitors, or potent immunosuppressants, such as azathioprine or cyclosporine, is not recommended. Incyte has worldwide rights for the development and commercialization of ruxolitinib cream, marketed in the United States as Opzelura. In April 2022 , Incyte entered into a strategic alliance agreement with Maruho Co., Ltd. for the development, manufacturing and exclusive commercialization of ruxolitinib cream for treatment of autoimmune and inflammatory dermatology indications in Japan . Opzelura is a registered trademark of Incyte . IMPORTANT SAFETY INFORMATION OPZELURA is for use on the skin only. Do not use OPZELURA in your eyes, mouth, or vagina. OPZELURA may cause serious side effects, including: Serious Infections: OPZELURA contains ruxolitinib. Ruxolitinib belongs to a class of medicines called Janus kinase (JAK) inhibitors. JAK inhibitors are medicines that affect your immune system. JAK inhibitors can lower the ability of your immune system to fight infections. Some people have had serious infections while taking JAK inhibitors by mouth, including tuberculosis (TB), and infections caused by bacteria, fungi, or viruses that can spread throughout the body. Some people have been hospitalized or died from these infections. Some people have had serious infections of their lungs while taking OPZELURA. Your healthcare provider should watch you closely for signs and symptoms of TB during treatment with OPZELURA. OPZELURA should not be used in people with an active, serious infection, including localized infections. You should not start using OPZELURA if you have any kind of infection unless your healthcare provider tells you it is okay. You may be at a higher risk of developing shingles (herpes zoster) while using OPZELURA. Increased risk of death due to any reason (all causes): Increased risk of death has happened in people 50 years of age and older who have at least 1 heart disease (cardiovascular) risk factor and are taking a medicine in the class of medicines called JAK inhibitors by mouth. Cancer and immune system problems: OPZELURA may increase your risk of certain cancers by changing the way your immune system works. Lymphoma and other cancers have happened in people taking a medicine in the class of medicines called JAK inhibitors by mouth. People taking JAK inhibitors by mouth have a higher risk of certain cancers including lymphoma and lung cancer, especially if they are a current or past smoker. Some people have had skin cancers while using OPZELURA. Your healthcare provider will regularly check your skin during your treatment with OPZELURA. Limit the amount of time you spend in the sunlight. Wear protective clothing when you are in the sun and use a broad-spectrum sunscreen. Increased risk of major cardiovascular events: Increased risk of major cardiovascular events such as heart attack, stroke, or death have happened in people 50 years of age and older who have at least 1 heart disease (cardiovascular) risk factor and taking a medicine in the class of medicines called JAK inhibitors by mouth, especially in current or past smokers. Blood clots: Blood clots in the veins of your legs (deep vein thrombosis, DVT) or lungs (pulmonary embolism, PE) can happen in some people taking OPZELURA. This may be life-threatening. Blood clots in the vein of the legs (deep vein thrombosis, DVT) and lungs (pulmonary embolism, PE) have happened more often in people who are 50 years of age and older and with at least 1 heart disease (cardiovascular) risk factor taking a medicine in the class of medicines called JAK inhibitors by mouth. Low blood cell counts: OPZELURA may cause low platelet counts (thrombocytopenia), low red blood cell counts (anemia), and low white blood cell counts (neutropenia). If needed, your healthcare provider will do a blood test to check your blood cell counts during your treatment with OPZELURA and may stop your treatment if signs or symptoms of low blood cell counts happen. Cholesterol increases: Cholesterol increase has happened in people when ruxolitinib is taken by mouth. Tell your healthcare provider if you have high cholesterol or triglycerides. Before starting OPZELURA, tell your healthcare provider if you: After starting OPZELURA: Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. The most common side effects of OPZELURA in people treated for atopic dermatitis include: common cold (nasopharyngitis), diarrhea, bronchitis, ear infection, increase in a type of white blood cell (eosinophil) count, hives, inflamed hair pores (folliculitis), swelling of the tonsils (tonsillitis), and runny nose (rhinorrhea). The most common side effects of OPZELURA in people treated for nonsegmental vitiligo include: acne at the application site, itching at the application site, common cold (nasopharyngitis), headache, urinary tract infection, redness at the application site, and fever. These are not all of the possible side effects of OPZELURA. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to Incyte Corporation at 1-855-463-3463. INDICATIONS AND USAGE OPZELURA is a prescription medicine used on the skin (topical) for: The use of OPZELURA along with therapeutic biologics, other JAK inhibitors, or strong immunosuppressants such as azathioprine or cyclosporine is not recommended. It is not known if OPZELURA is safe and effective in children less than 12 years of age with atopic dermatitis or nonsegmental vitiligo. Please see the Full Prescribing Information, including Boxed Warning, and Medication Guide for OPZELURA. About Incyte Dermatology Incyte’s science-first approach and expertise in immunology has formed the foundation of the company. Today, we are building on this legacy as we discover and develop innovative dermatology treatments to bring solutions to patients in need. We strive to identify and develop therapies to modulate immune pathways driving uncontrolled inflammation to help restore normal immune function and bring the body closer to homeostasis. Specifically, our efforts in dermatology are focused on a number of immune-mediated dermatologic conditions with a high unmet medical need, including atopic dermatitis, vitiligo, hidradenitis suppurativa, lichen planus, lichen sclerosus and prurigo nodularis To learn more, visit the Dermatology section of Incyte.com. About Incyte A global biopharmaceutical company on a mission to Solve On., Incyte follows the science to find solutions for patients with unmet medical needs. Through the discovery, development and commercialization of proprietary therapeutics, Incyte has established a portfolio of first-in-class medicines for patients and a strong pipeline of products in Oncology and Inflammation & Autoimmunity. Headquartered in Wilmington, Delaware , Incyte has operations in North America , Europe and Asia . For additional information on Incyte , please visit Incyte.com or follow us on social media: LinkedIn, X, Instagram, Facebook, YouTube. Forward-Looking Statements Except for the historical information set forth herein, the matters set forth in this press release, including statements regarding the partnership between Incyte and Dr. Sandra Lee Incyte’s goal of improving the lives of patients, whether and when Opzelura might provide a successful treatment option for patients with atopic dermatitis, and Incyte’s dermatology program generally, contain predictions, estimates and other forward-looking statements. These forward-looking statements are based on Incyte’s current expectations and subject to risks and uncertainties that may cause actual results to differ materially, including unanticipated developments in and risks related to: unanticipated delays; further research and development and the results of clinical trials possibly being unsuccessful or insufficient to meet applicable regulatory standards or warrant continued development; the ability to enroll sufficient numbers of subjects in clinical trials; determinations made by the FDA and other regulatory authorities outside of the United States ; the efficacy or safety of Incyte’s products; the acceptance of Incyte’s products in the marketplace; market competition; sales, marketing, manufacturing and distribution requirements; and other risks detailed from time to time in Incyte’s reports filed with the Securities and Exchange Commission , including its annual report and its quarterly report on Form 10-Q for the quarter ended June 30, 2024 . Incyte disclaims any intent or obligation to update these forward-looking statements. 1 National Eczema Association . What is atopic dermatitis? https://nationaleczema.org/eczema/types-of-eczema/atopic-dermatitis/ View source version on businesswire.com: https://www.businesswire.com/news/home/20241009443934/en/ Media media@incyte.com Investors ir@incyte.com Source: Incyte