AIDS-Related Complex

LOS ANGELES--( BUSINESS WIRE )--In honor of World AIDS Day, AIDS Healthcare Foundation (AHF), the world’s largest HIV/AIDS health care organization, has taken over the largest digital sign on the West Coast. AHF’s message – “1.9 Million Lives in Care” – will show every couple minutes all day Friday on three sides of the building located on Broadway off the I-10 in downtown Los Angeles. Freeway commuters have a clear view of the building’s display. While 29.8 million people living with HIV – of 39 million worldwide – now receive lifesaving treatment, the fight against HIV/AIDS continues. AHF will reach two million lives in care by early 2024. In addition to street level photographs available now, drone images and additional images from the freeway will be available for distribution throughout the day. PJX Media secured the placement for AHF. AIDS Healthcare Foundation (AHF) and more than 40 AHF country teams are holding commemorative events Friday to honor all who have lost their lives to AIDS-related illnesses, support those who carry on the fight, and unite people globally in battling one of the world’s deadliest infectious diseases. AHF mobilizers in the U.S. will host 26 events in 21 cities across the country, promoting testing, education, and open conversation around HIV/AIDS awareness and prevention. AHF is continuing its longstanding tradition of hosting a high-profile World AIDS Day concert and awareness event as global icon Janet Jackson will perform a full-length show at NRG Arena in Houston, TX Friday night. AHF also will honor American actor Blair Underwood with its Lifetime Achievement Award for his efforts as a powerful voice in the fight against HIV/AIDS in the U.S. and abroad for more than three decades. “The global HIV/AIDS response has fallen short over recent years due to COVID-19 and other competing global crises,” said Michael Weinstein , AHF President and Cofounder. “AHF calls on all nations and global public health institutions to ensure the adequate resources and political will are available to fight HIV/AIDS. On World AIDS Day, the world must remember – it’s not over.” AIDS Healthcare Foundation (AHF), the world’s largest HIV/AIDS healthcare organization, provides cutting-edge medicine and advocacy to more than 1.9 million individuals across 45 countries, including the U.S. and in Africa, Latin America/Caribbean, the Asia/Pacific Region, and Eastern Europe. To learn more about AHF, visit us online at AIDShealth.org , find us on Facebook , follow us on Instagram , Twitter , and TikTok , and subscribe to our AHFter Hours podcast.

BAAR, Switzerland--(BUSINESS WIRE)-- Stallergenes Greer, a biopharmaceutical company specialising in the diagnosis and treatment of respiratory allergies, announced today the initiation of a Phase III clinical study (YOBI, YOung patients and BIrch allergy) to confirm the safety and efficacy of Staloral® Birch in children and adolescents with birch pollen-induced allergic rhino-conjunctivitis with or without asthma. The randomised, double-blind placebo-controlled Phase III study will involve approximately 80 sites in 12 European countries. Allergic rhino-conjunctivitis is a worldwide disease and a global health burden affecting more than 500 million people, who are at higher risk of developing rhinitis exacerbation and asthma than the general population1..Birch is among the strongest allergy-producing trees in northern Europe. The allergic potential of other trees belonging to the birch homologous group, such as alder and hazel, is also increasing steadily2. In children and adolescents, allergic rhino-conjunctivitis can lead to sleep problems, fatigue, missed school days and can complicate outdoor activities3. Individuals sensitised at a young age are also more at risk of developing asthma. The younger the children are, the higher their risk of developing asthma, which highlights the relevance of early causal treatment in paediatric patients to slow the worsening of allergy symptoms4. Allergen immunotherapy (AIT) is currently the only available therapeutic treatment that has the potential to uniquely alter the natural course of the disease5. In its liquid form, sublingual AIT can provide a needle-free and flexible treatment for children and adolescents. “Allergic rhino-conjunctivitis induced by birch and related trees can lead to a spiraling of respiratory symptoms and conditions in the paediatric population. The YOBI study will contribute to addressing a global health burden, while deepening our knowledge of AIT with the aim of improving patient outcomes for children and adolescents with birch-induced allergies,” said Professor Oliver Pfaar, International Coordinator of the YOBI study, Head of Rhinology and Allergy, Department of Otorhinolaryngology, Philipps-Universität Marburg, Germany. “Stallergenes Greer’s AIT treatments have proven their efficacy and safety in both clinical trials and the real world,” stated Michele Antonelli, CEO of Stallergenes Greer. “This paediatric Phase III study, illustrates our determination to further develop evidence-based solutions and build on robust datasets and cutting-edge research technologies to advance precision medicine combined with dose adaptation for the benefit of patients with allergies, the medical community, and health systems.” ABOUT STALORAL® Staloral® is a sublingual solution of allergen extracts for AIT. It is indicated in the treatment of seasonal or perennial allergic rhinitis, rhino-conjunctivitis and mild to moderate allergic asthma in adults and, in certain territories, in the paediatric population (children over 5 years of age). Clinical evidence of the efficacy of Staloral® is globally consistent over the clinical studies Stallergenes Greer conducted versus placebo. The effectiveness of Staloral® as a causal treatment for allergic rhino-conjunctivitis beyond clinical trials was also assessed by Stallergenes Greer’s real-world studies EfficAPSI and BREATH (Bringing Real-World Evidence to Allergy Treatment for Health). ABOUT ALLERGIC RHINITIS/ALLERGIC RHINO-CONJUNCTIVITIS Allergic rhinitis/allergic rhino-conjunctivitis (AR/ARC) is a chronic disorder of the upper airways that is caused by allergen exposure and the resulting IgE-mediated inflammation of the nose and, to a less extent, the eyes. Allergic rhinitis can notably include symptoms such as sneezing, a runny nose, wheezing, cough, itching, and watery/itchy eyes. Symptoms may be severe and significantly impact the patient’s quality of life, as well as worsen over time with progression towards asthma4. First intention symptomatic treatments such as antihistamines and nasal corticosteroids provide temporary relief to patients. The primary therapeutic goals of AIT include reducing symptoms, reducing symptomatic medication use, and improving allergy-related quality of life. AIT achieves these goals and can alter the course of the disease, with benefits persisting in many patients for several years after treatment discontinuation6. ABOUT STALLERGENES GREER INTERNATIONAL AG Headquartered in Baar (Switzerland), Stallergenes Greer International AG is a global healthcare company specialising in the diagnosis and treatment of allergies through the research, development and commercialisation of allergen immunotherapy products and services. Stallergenes Greer International AG is the parent company of Greer Laboratories, Inc. (whose registered office is in the United States) and Stallergenes SAS (whose registered office is in France). For more information, visit . 1. Bousquet, J., et al., Allergic Rhinitis and its Impact on Asthma (ARIA) 2008 update (in collaboration with the World Health Organization, GA(2)LEN and AllerGen). Allergy, 2008. 63 Suppl 86: p. 8-160. 2. Biedermann, T., et al., Birch pollen allergy in Europe. Allergy, 2019. 74(7): p. 1237-1248. 3. Canonica GW, Bousquet J, Mullol J, Scadding GK, Virchow JC. A survey of the burden of allergic rhinitis in Europe. Allergy. 2007;62 Suppl 85:17-25. doi:10.1111/j.1398-9995.2007.01549.x 4. Klimek, L., et al., ARIA guideline 2019: treatment of allergic rhinitis in the German health system. Allergo journal international, 2019. 28(7): p. 255-276. 5. Roberts G, Pfaar O, Akdis CA, et al. EAACI Guidelines on Allergen Immunotherapy: Allergic rhinoconjunctivitis. Allergy. 2018;73(4):765-798. doi:10.1111/all.13317 6. Hesse, L., et al., Allergen immunotherapy for allergic airway diseases: Use lessons from the past to design a brighter future. Pharmacology & Therapeutics, 2022: p. 108115.

WILMINGTON, Del. & TOKYO--(BUSINESS WIRE)-- Incyte (Nasdaq:INCY) today announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has approved Pemazyre® (pemigatinib), a selective fibroblast growth factor receptor (FGFR) inhibitor, for the treatment of myeloid/lymphoid neoplasms (MLNs) with FGFR1 fusion (also known as 8p11 myeloproliferative syndrome). MLNs are a rare, aggressive group of cancers characterized by an over-production of myeloid cells, or bone tissue, with the tendency to rapidly progress to an acute myeloid leukemia (AML). “The MHLW approval of Pemazyre in MLNs is an important step toward potentially providing a therapeutic option for Japanese patients with this rare condition,” said Lothar Finke, M.D., Ph.D., Group Vice President and General Manager, Incyte Asia. “Bringing this first and only approved therapy to MLN patients in Japan demonstrates Incyte’s commitment to finding solutions for critical unmet medical needs regardless of the size of the patient population – as is the case with MLNs, an extremely rare disease that is estimated to affect fewer than 100 patients worldwide.” The approval was based on data from the Phase 2 FIGHT-203 study, a multicenter open-label, single-arm trial that evaluated the safety and efficacy of Pemazyre in 41 patients in myeloid or lymphoid neoplasms with FGFR1 fusion gene positive who received Pemazyre 13.5 mg orally once daily continuously or intermittently. The primary endpoint, investigator-assessed complete response rate, was 62.5% (95% CI: 45.8 - 77.3). The complete response rate in the continuous dosing population was 66.7% (95% CI: 46.0 - 83.5). The most common adverse reactions observed in patients receiving Pemazyre were hyperphosphatemia (70.7%), alopecia (56.1%), diarrhea (43.9%) and stomatitis (43.9%). Previously, the MHLW granted Orphan Drug Designation (ODD) for Pemazyre – a designation granted to investigational compounds intended to treat rare diseases that affect fewer than 50,000 people in Japan, and for which there is a high medical need1. Designated orphan drugs are also eligible for priority review for marketing authorizations to ensure supply to clinical settings at the earliest opportunity1. The MLN ODD is the second such designation granted to Pemazyre by the MHLW, having also received ODD for cholangiocarcinoma, a type of biliary tract cancer. MLNs with FGFR1 rearrangement are a form of very rare hematological cancers caused by a chromosomal abnormality (translocation) in which the chromosome breaks where the FGFR1 gene is located (position 11 in the short arm of chromosome 8: location 8p11) and fuses with fragments (genes) of other chromosomes. Various partner genes cause a constitutive activation of the FGFR1 tyrosine kinase, impacting cell proliferation and survival. These cancers are largely divided into two phases according to clinical presentation: the chronic phase, if diagnosed as myeloproliferative disorder or myelodysplastic syndrome, or acute phase, if diagnosed as acute leukemia. The prognosis is unfavorable, and while allogenic hematopoietic stem cell transplant is considered to be the only currently available treatment option that may achieve cure or long-term remission, no standard of care has been established. About FIGHT-203 FIGHT-203 is a Phase 2, multicenter trial that enrolled patients 18 years and older with myeloid/lymphoid neoplasms (MLNs) with a fibroblast growth factor receptor 1 (FGFR1) rearrangement. Sponsored by Incyte, the study evaluated the safety and efficacy of pemigatinib for the treatment of adults with MLNs with FGFR1 rearrangement. Patients received pemigatinib 13.5 mg once daily in 21-day cycles, either on a continuous schedule (the approved recommended starting dosage for use in patients with MLNs with FGFR1 rearrangement) or as an intermittent schedule (14 days on, 7 days off, an unapproved dosage regimen in MLN with FGFR1 rearrangement). Pemigatinib was administered until disease progression or unacceptable toxicity or until patients were able to receive allo-HSCT. For more information about the study, please visit . About Pemigatinib Pemazyre is a kinase inhibitor indicated in the United States for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by an FDA-approved test2. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). Pemazyre is also the first targeted treatment approved for use in the United States for treatment of adults with relapsed or refractory myeloid/lymphoid neoplasms (MLNs) with FGFR1 rearrangement. In Japan, Pemazyre is approved for the treatment of patients with unresectable biliary tract cancer (BTC) with a fibroblast growth factor receptor 2 (FGFR2) fusion gene, worsening after cancer chemotherapy and the treatment of myeloid/lymphoid neoplasms (MLNs) with FGFR1 rearrangement. In Europe, Pemazyre is approved for the treatment of adults with locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement that have progressed after at least one prior line of systemic therapy. Pemazyre is a potent, selective, oral inhibitor of FGFR isoforms 1, 2 and 3 which, in preclinical studies, has demonstrated selective pharmacologic activity against cancer cells with FGFR alterations. Pemazyre is marketed by Incyte in the United States, Europe and Japan. Incyte has granted Innovent Biologics, Inc. rights to develop and commercialize pemigatinib in hematology and oncology in Mainland China, Hong Kong, Macau and Taiwan. Incyte has retained all other rights to develop and commercialize pemigatinib outside of the United States. Pemazyre is a trademark of Incyte Corporation. About Incyte Incyte is a Wilmington, Delaware-based, global biopharmaceutical company focused on finding solutions for serious unmet medical needs through the discovery, development and commercialization of proprietary therapeutics. For additional information on Incyte, please visit Incyte.com and follow @Incyte. For more information on Incyte Biosciences Japan G.K., please visit Incyte.jp. Forward-Looking Statements Except for the historical information set forth herein, the matters set forth in this press release, including whether Pemazyre might provide a successful treatment option for patients with myeloid/lymphoid neoplasms with FGFR1 rearrangement, , 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, MHLW and other regulatory authorities; Incyte’s dependence on its relationships with its collaboration partners; the efficacy or safety of Incyte’s products and the products of Incyte’s collaboration partners; the acceptance of Incyte’s products and the products of Incyte’s collaboration partners in the marketplace; market competition; sales, marketing, manufacturing and distribution requirements; greater than expected expenses; expenses relating to litigation or strategic activities; and other risks detailed from time to time in Incyte’s reports filed with the Securities and Exchange Commission, including its annual report for the year ending December 31, 2022. Incyte disclaims any intent or obligation to update these forward-looking statements. Disclaimer The drug information contained herein is intended for the disclosure of Incyte corporate information and is not intended to advertise or promote any medicinal product, including those under development. ____________________________ 1 Overview of Orphan Drug/Medical Device Designation System. Ministry of Health, Labour and Welfare. Available at: 2 Pemazyre (pemigatinib) [Package Insert]. Wilmington, DE: Incyte; 2020. View source version on businesswire.com: Contacts Media Catalina Loveman +1 302 498 6171 cloveman@incyte.com Investors Christine Chiou +1 302 274 4773 cchiou@incyte.com Cosmo PR +81 3 5561 2915 Incyte@cosmopr.co.jp Source: Incyte View this news release online at: