Kowa Pharmaceuticals America, Inc.

Over 200-person sales force to promote ZORYVE (roflumilast) in primary care and pediatric practicesProvides access to a large portion of the 7.4 million individuals treated for plaque psoriasis, seborrheic dermatitis, and atopic dermatitis outside of dermatology officesZORYVE will be promoted in the primary position to maximize prescriber education WESTLAKE VILLAGE, Calif. and MONTGOMERY, Ala., July 29, 2024 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced the signing of a co-promotion agreement with Kowa Pharmaceuticals America, Inc., a company committed to the development and commercialization of safe and effective healthcare solutions. Under the agreement, Kowa will leverage its primary care sales force to market and promote ZORYVE (roflumilast) cream and ZORYVE (roflumilast) foam to primary care practitioners and pediatricians for all FDA approved indications. Arcutis will maintain responsibility for the marketing and sales of ZORYVE to dermatologists, other dermatology clinicians, and related specialists. This partnership is expected to expand the total addressable market for ZORYVE, providing access to a large portion of the 7.4 million patients treated outside of dermatology offices. “This partnership is aligned with our strategy and significantly extends the reach of ZORYVE to primary care practitioners and pediatricians who treat millions of individuals each year suffering from atopic dermatitis, seborrheic dermatitis, and plaque psoriasis. ZORYVE is well-suited to fit into the daily practice of these offices, as it simplifies disease management with a once-daily, steroid-free treatment option,” said Frank Watanabe, president and CEO of Arcutis. “Sales of ZORYVE continue to grow because it provides reliable efficacy and a safe and well-tolerated product profile, as well as Arcutis’ broad market access. With the new expansion into primary care and pediatrics through this partnership with Kowa, we will drive incremental revenue, while maintaining the focus of Arcutis’ sales force and its marketing efforts on dermatology clinicians and driving patient demand in the dermatology offices. Importantly, Kowa has established relationships in primary care and will promote ZORYVE as a core product throughout the term of the agreement.” “Kowa Pharmaceuticals America, Inc. has a long history of successfully co-promoting products within primary care, and this new partnership with Arcutis aligns closely with our focus and expertise in the primary care setting,” said Ben Stakely, chairman, CEO, and president of Kowa Pharmaceuticals America, Inc. “We remain committed to patients and healthcare professionals and to providing therapies that help address unmet needs. Adding ZORYVE to our product portfolio expands our offering and will enhance our ability to support patients.” Arcutis will recognize all revenue and will have sole responsibility for the manufacturing of ZORYVE during the 5-year term of the partnership. Kowa will have an exclusive agreement to promote ZORYVE in all approved formulations and dosage forms as commercialized by Arcutis to primary care clinicians, pediatricians, and certain collocated healthcare providers in the United States throughout the term of the agreement. Kowa will promote ZORYVE in priority position throughout the term of the partnership, and receive a commission on their sales. Financial terms of the agreement were not disclosed. INDICATIONSZORYVE cream, 0.3%, is indicated for topical treatment of plaque psoriasis, including intertriginous areas, in adult and pediatric patients 6 years of age and older. ZORYVE cream, 0.15%, is indicated for topical treatment of mild to moderate atopic dermatitis in adult and pediatric patients 6 years of age and older. ZORYVE foam, 0.3%, is indicated for the treatment of seborrheic dermatitis in adult and pediatric patients 9 years of age and older. IMPORTANT SAFETY INFORMATION ZORYVE is contraindicated in patients with moderate to severe liver impairment (Child-Pugh B or C). Flammability: The propellants in ZORYVE foam are flammable. Avoid fire, flame, and smoking during and immediately following application. The most common adverse reactions (≥1%) for ZORYVE cream 0.3% for plaque psoriasis include diarrhea (3.1%), headache (2.4%), insomnia (1.4%), nausea (1.2%), application site pain (1.0%), upper respiratory tract infection (1.0%), and urinary tract infection (1.0%). The most common adverse reactions (≥1%) for ZORYVE cream 0.15% for atopic dermatitis include headache (2.9%), nausea (1.9%), application site pain (1.5%), diarrhea (1.5%), and vomiting (1.5%). The most common adverse reactions (≥1%) for ZORYVE foam 0.3% for seborrheic dermatitis include nasopharyngitis (1.5%), nausea (1.3%), and headache (1.1%). Please see full Prescribing Information for ZORYVE foam and full Prescribing Information for ZORYVE cream. About ArcutisArcutis Biotherapeutics, Inc. (Nasdaq: ARQT) is a commercial-stage medical dermatology company that champions meaningful innovation to address the urgent needs of individuals living with immune-mediated dermatological diseases and conditions. With a commitment to solving the most persistent patient challenges in dermatology, Arcutis has a growing portfolio including three FDA approved products that harness our unique dermatology development platform coupled with our dermatology expertise to build differentiated therapies against biologically validated targets. Arcutis’ dermatology development platform includes a robust pipeline with multiple clinical programs for a range of inflammatory dermatological conditions including scalp and body psoriasis, atopic dermatitis, and alopecia areata. For more information, visit www.arcutis.com or follow Arcutis on LinkedIn, Facebook, Instagram and X. About Kowa Company, Ltd. Kowa Company, Ltd. (Kowa) is a privately held, multinational company headquartered in Nagoya, Japan. Established in 1894, Kowa is actively engaged in various business fields, including the trading of textiles, machinery, and construction materials, in addition to the manufacturing and sales of pharmaceuticals, medical devices, vison units, energy-saving and energy-creating products. Kowa's pharmaceutical business is focused on research and development for three main activities in lifestyle-related diseases (dyslipidemia, type 2 diabetes, and atherosclerosis), ophthalmology, and anti-inflammatory agents. For more information, please see https://www.kowa.co.jp/eng/. About Kowa Pharmaceuticals America, Inc.Kowa Pharmaceuticals America, Inc., headquartered in Montgomery, AL, is focused primarily in the area of primary care diseases. Established in September 2008, Kowa Pharmaceuticals America, Inc. focuses its efforts on the successful commercialization of its current and near-term portfolio of pharmaceutical products, and business development activities. For more information about Kowa Pharmaceuticals America, visit https://www.kowapharma.com/. Forward-Looking StatementsArcutis cautions you that statements contained in this press release regarding matters that are not historical facts are forward-looking statements. These statements are based on the Company’s current beliefs and expectations. Such forward-looking statements include, but are not limited to, statements regarding the potential for ZORYVE to simplify disease management for care of plaque psoriasis, atopic dermatitis and seborrheic dermatitis; the potential of real-world use results of roflumilast cream, the potential success of the co-promotion agreement with Kowa, the potential for and general ability to access patients treated outside of dermatology offices, as well as the commercial strategy and launches of ZORYVE. These statements are subject to substantial known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance, or achievements to be materially different from the information expressed or implied by these forward-looking statements. Risks and uncertainties that may cause our actual results to differ include risks inherent in our business, reimbursement and access to our products, and the impact of competition and other important factors discussed in the “Risk Factors” section of our Form 10-K filed with the U.S. Securities and Exchange Commission (SEC) on February 27, 2024, as well as any subsequent filings with the SEC. You should not place undue reliance on any forward-looking statements in this press release. We undertake no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes available. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Contacts:MediaAmanda Sheldon, Head of Corporate Communicationsmedia@arcutis.com InvestorsLatha Vairavan, Vice President, Finance and Investor Relationsir@arcutis.com

Additional ACTG Presentations Address Muscle Density and Area among People Living with HIV and COVID-19 TreatmentLOS ANGELES, July 23, 2024 (GLOBE NEWSWIRE) -- ACTG, a global clinical trials network focused on HIV and other infectious diseases, will present an exploratory analysis from the REPRIEVE trial demonstrating that former and current use of abacavir was associated with a higher incidence of major adverse cardiovascular events at AIDS 2024 in Munich, Germany. The oral presentation will take place on July 26, 2024, as part of the session Comorbidities: The Heart of the Matter, from 10:30-11:30 am CEST at Hall B0b/Channel 5 and virtually. “This carefully constructed analysis adds to the body of evidence that abacavir use is associated with a higher risk of cardiovascular events like heart attacks and strokes,” said ACTG Chair Judith Currier, M.D., M.Sc., University of California Los Angeles. “These data align with prior studies that had been considered somewhat controversial because no exact mechanism was clearly demonstrated and should be taken into account by clinicians when they evaluate treatment options for people living with HIV.” These are the latest findings from REPRIEVE, the first large-scale clinical trial to test a primary prevention strategy to reduce the increased risk of cardiovascular disease among people living with HIV. It found that participants who took pitavastatin calcium (a daily statin pill that lowers cholesterol) reduced their risk of major adverse cardiovascular events by 36 percent compared with those receiving a placebo over a median duration of five years of follow up. The analysis being presented at AIDS 2024 evaluated the role of prior and current use of select antiretroviral treatments (including abacavir, tenofovir, thymidine analogs, and protease inhibitors) on the development of major cardiovascular events. These antiretrovirals were selected based upon prior association with cardiovascular risk and kidney impairment (future analyses are planned to examine the role of other antiretrovirals). Among 7,769 participants, 31.3 percent were born female and 65.2 percent were not white. The median age was 50, LDL (low-density lipoprotein, a kind of cholesterol) was 108 mg/dL, CD4 count was 621 cell/mm3, and 88 percent had a viral load under 400 copies/mL. Participants had been taking HIV treatment for a median of 9.5 years. Researchers found that current or past use of abacavir increased the risk of major adverse cardiovascular events by 42 and 50 percent, respectively, while current or past use of other antiretroviral treatments caused no such increase. “This analysis is important as we seek to tease out the various factors that may help reduce cardiovascular risk in people living with HIV,” said lead study author Carl Fichtenbaum, M.D., University of Cincinnati. “While the association between abacavir and cardiovascular risk is disappointing, it is not a surprise. It is, however, reassuring that the other HIV therapies included in the analysis like tenofovir were not associated with a higher risk.” REPRIEVE had a number of unique aspects: study participants had no known prior history of cardiovascular disease, the global cohort from 12 countries had low-to-moderate risk for cardiovascular disease, and all study endpoints were independently vetted by the national study Thrombolysis in Myocardial Infarction (TIMI). REPRIEVE began in 2015 as cooperative agreements (HL12339, HL123336, HL164284, and HL164285) and was a collaborative effort between the National Institutes of Health’s National Heart, Lung, and Blood Institute (NHLBI) and the National Institute of Allergy and Infectious Diseases (NIAID), two of the largest NIH institutes. It received additional funding from the NIH Office of AIDS Research, Kowa Pharmaceuticals America, Inc. (providers of pitavastatin calcium and placebo), Gilead Sciences, Inc., and ViiV HealthCare. The trial is led by Steven Grinspoon, M.D. (Chair) and Pamela S. Douglas, M.D. (Co-chair), who led the Clinical Coordinating Center and Heather Ribaudo, Ph.D. (Lead Statistician) and Michael Lu, M.D., M.P.H. (Protocol Chair, Mechanistic Substudy of REPRIEVE), who led the Data Coordinating Center. To learn more, please visit www.reprievetrial.org. In addition to these data from REPRIEVE, ACTG will also make the following presentations at AIDS 2024: No Evidence of Pitavastatin Effect on Muscle Density or Area Among People with HIV (REPRIEVE; Poster Presentation: Tuesday, July 23rd, 12:00-1:00 pm CEST, Poster Exhibition Hall) Kristine Erlandson, et al. This analysis from the REPRIEVE mechanistic substudy found that statins did not reduce muscle density or area. This two-year study of middle-aged people living with HIV at low-to-moderate risk of cardiovascular disease, confirmed through imaging that statins were safe and did not cause significant muscle damage. This is reassuring to people who want to use statins to lower their risk of cardiovascular events like heart attacks and strokes. Efficacy and Safety of Ensitrelvir in Non-Hospitalized Adults at Standard or High-Risk of Progression to Severe COVID-19: the SCORPIO-HR Phase 3, Randomized, Double-Blind Placebo-Controlled Trial (ACTG 5407; Poster Presentation: Tuesday, July 23rd, 12:00-1:00 pm CEST, Poster Exhibition Hall) Kara Chew, et al. While the oral protease inhibitor ensitrelvir demonstrated anti-viral activity, safety, and a trend toward shorter time to symptom resolution compared to placebo, SCORPIO-HR (ACTG 5407) did not meet its primary endpoint of time to two or more days sustained resolution of 15 COVID-19 symptoms in outpatient participants at standard and higher risk for severe disease. About ACTG ACTG is the world’s largest and longest running clinical trials network focused on HIV and other infectious diseases and the people living with them. It is funded by NIAID and collaborating NIH Institutes under award numbers UM1 AI068636, UM1 AI107716, and UM1 AI068634. Founded in 1987, ACTG conducts research to improve the management of HIV and its comorbidities; develop a cure for HIV; and innovate treatments for tuberculosis, hepatitis B, and emerging infectious diseases. It comprises thousands of dedicated researchers, staff, and community members who are pursuing research into novel treatments and cures for infectious diseases at 65 locations across four continents, with the ultimate goal of advancing science that meaningfully impacts the lives of the people we serve. Disclaimer: This content is solely the responsibility of ACTG and does not necessarily represent the official views of the NIH. Media Contact:Jenna Conley, ACTGjenna@conleycommunications.net

The construction project will be financed until 2026 by a €100 million ($108 million) investment by the company. The facilities, slated to begin operations in early 2026, will involve production and service buildings in addition to up to 150 cubic meters of reaction volume. With the new manufacturing facility, Esteve expects its production capacity in the plant to increase by 45%, with an additional 15% growth in its global capacity. Esteve’s API manufacturing and development activity has seen “notable growth” in recent years, said Pere Mañé, General Manager of Esteve Química, in a public statement ​. “The expansion of our main industrial center will allow us to satisfy a growing global demand and expand our activity, advancing our mission of improving people's lives," he added. The facility will see Esteve take on 100 new staff to add to its current headcount of 370 employees. In addition, the project will deploy unspecified innovations in digitalization and use of data to help the company produce new products for its portfolio for distribution in the United States, Europe, and Japan. Services and R&D Esteve was founded in 1929 and has a chemical R&D center in Barcelona along with three production plants in Catalonia. The company also has manufacturing centers in Mexico and China, with a global total reaction volume capacity of 875 cubic meters. In addition to its contract manufacturing activities, Esteve is developing its own pipeline of treatments with one candidate, Seglenta, approved for the treatment of management of acute pain in the US and Spain. Commercialized in collaboration with Kowa Pharmaceuticals America, Seglenta consists of a co-crystal entity combining the anti-inflammatory compound celecoxib and the analgesic drug tramadol. Other candidates in Esteve’s pipeline include small molecule and gene therapies for pain and rare diseases. googletag.cmd.push(function () { googletag.display('text-ad1'); }); Esteve’s 2023 earnings totaled €710 million, a 10% increase from 2022, according to a recent company announcement ​. Its revenues in Spain contributed 25% of the total while the rest of the EU and the rest of the world accounted for 49% and 26% respectively. The growth in Esteve’s API activities is linked to customers seeking tailored manufacturing solutions with capacity, flexibility and expertise, in addition to state-of-the-art facilities, Mañé told Outsourcing Pharma. Some of the advantages of hosting API facilities in Spain, and particularly Catalonia, over other European countries include a robust supply network for materials and equipment, a rich tradition of healthcare companies and a substantial talent pool, he added. APIs in growth The global API market was worth $197 billion in 2023 and is expected to rise to $359 billion by 2032, according to Fortune Business Insights ​. This growth is partly driven by the rising prevalence of chronic diseases with ageing populations, leading to a higher demand for treatments. Other players funneling cash into their API facilities in recent times include Eli Lilly, which pumped $9 billion into its US API site in May, and Novo Nordisk, which invested $6 billion into its API capacity in Denmark last year. “Over the next decade, API manufacturing will see significant changes. Digitalization, environmental sustainability, and technological adaptation will drive these transformations,” Mañé said. “Efficient data management, AI, and cybersecurity will optimize processes. Additionally, there will be a focus on reducing environmental impact and handling molecules with higher pharmacological activity,” he concluded.