Kissei Pharmaceutical Co., Ltd.

The demand for heparin is mainly increasing due to the growing incidence of cardiovascular diseases, the expanding range of cancer risk factors such as smoking, radiation exposure, unhealthy lifestyles, and other factors, as well as the rising research and development activities by global market players throughout the forecast period from 2024 to 2030. LAS VEGAS, Sept. 4, 2024 /PRNewswire/ -- DelveInsight's Heparin Market Insights report provides the current and forecast market analysis, individual leading heparin companies' market shares, challenges, heparin market drivers, barriers, trends, and key market heparin companies in the market. Key Takeaways from the Heparin Market Report As per DelveInsight estimates, North America is anticipated to dominate the global heparin market during the forecast period. In the application segment of the heparin market, the coronary artery disease category had a significant revenue share in the Heparin market in 2023. Notable heparin companies such as Pfizer Inc., Leo Pharma A/S, Dr. Reddy's Laboratories Ltd., GSK plc., Sanofi, B. Braun Melsungen AG, Aspen Holdings, Fresenius SE & Co. KGaA, Novartis AG, Baxter, and several others, are currently operating in the heparin market. In November 2023, the FDA approved a taurolidine plus heparin (DefenCath®) catheter lock solution to reduce catheter-related bloodstream infections in patients receiving maintenance hemodialysis via a central venous catheter (CVC). In February 2022, Techdow USA Inc. announced the launch of its Heparin Sodium Injection, USP in the US market. In January 2022, the Ohio biotechnology firm Optimvia Pharmaceuticals developed a cost-effective synthetic method to produce large quantities of heparin, used to make common blood thinner, also striking a deal with the synthetic biology firm Ginkgo Bioworks to scale the process up. To read more about the latest highlights related to the heparin market, get a snapshot of the key highlights entailed in the Global Heparin Market Report Heparin Overview Heparin is a widely used anticoagulant medication that helps prevent and treat blood clots. It works by enhancing the activity of antithrombin III, a protein in the blood that inhibits blood clotting factors such as thrombin and factor Xa. Heparin is administered either intravenously or subcutaneously and is commonly used in medical settings such as during surgeries, dialysis, and for patients with certain types of heart disease. Its rapid onset and short duration of action make it particularly useful in acute settings where quick and reversible anticoagulation is needed. Despite its effectiveness, heparin therapy requires careful monitoring due to the risk of bleeding complications. One of the most significant side effects is heparin-induced thrombocytopenia (HIT), a condition where the patient's platelet count drops dramatically, which paradoxically increases the risk of thrombosis. To manage these risks, healthcare providers regularly monitor blood clotting parameters, such as activated partial thromboplastin time (aPTT), to ensure that the patient remains within a therapeutic range. In cases where heparin use is contraindicated or needs to be discontinued, alternative anticoagulants, such as low molecular weight heparins or direct oral anticoagulants, may be considered. Heparin Market Insights In 2023, North America held the largest share of the heparin market compared to other regions. This is attributed to the rising incidence of cardiovascular disorders in the area. Contributing factors include the increasing risk factors related to cardiovascular issues, strong research and development efforts, and a highly promising market for product development and launches, all of which are driving the growth of the heparin market in North America. Additionally, the growing number of heparin product launches is anticipated to drive the heparin market in North America. For instance, in February 2024, B. Braun Medical Inc. introduced its new Heparin Sodium 2,000 units in 0.9% Sodium Chloride Injection, 1,000 mL (2 units/mL), marking the fifth addition to its range of Heparin premixed bags. This launch underscores B. Braun's dedication to enhancing supply security by producing pharmaceuticals in the U.S. at its Irvine, CA facility. Given the substantial patient population in North America, the use of heparin for treatment is expected to boost market demand in the coming years. Consequently, these factors combined are projected to contribute to the growth of the heparin market in North America during the forecast period from 2024 to 2030. To know more about why North America is leading the market growth in the heparin market, get a snapshot of the Heparin Market Outlook Heparin Market Dynamics The heparin market is a critical segment within the global pharmaceutical industry, primarily driven by its essential role in anticoagulant therapy. The market dynamics are influenced by a variety of factors including technological advancements, regulatory changes, and shifts in healthcare practices. One significant driver in the heparin market is the ongoing innovation in drug delivery systems and formulations. Advances such as low molecular weight heparins (LMWHs) have improved the efficacy and safety profiles of heparin therapy, leading to increased adoption. Additionally, the development of more efficient manufacturing processes, such as recombinant heparins, has helped meet the growing demand and reduce dependency on animal sources, which can be susceptible to supply chain disruptions. Regulatory factors also play a crucial role in shaping the heparin market. Regulatory agencies, such as the FDA and the EMA, impose stringent standards on the production and quality of heparin products. These regulations are designed to ensure the safety and efficacy of heparin, which can impact market dynamics through compliance costs and potential market entry barriers for new players. Moreover, market dynamics are influenced by global healthcare trends and economic factors. Rising incidences of cardiovascular diseases and an aging population contribute to the increased demand for heparin. However, economic pressures and healthcare cost containment strategies may impact market growth. Furthermore, competition from alternative anticoagulants and biosimilars can also affect the heparin market by offering patients and healthcare providers additional options. Get a sneak peek at the heparin market dynamics @ Heparin Market Dynamics Analysis Heparin Market Assessment Heparin Market Segmentation Heparin Market Segmentation By Source: Bovine, Porcine, and Others Heparin Market Segmentation By Route of Administration: Subcutaneous and Intravenous Heparin Market Segmentation By Application: Coronary Artery Disease, Atrial Fibrillation, Venous Thromboembolism, Renal Impairment, and Others Heparin Market Segmentation By Geography: North America, Europe, Asia-Pacific, and Rest of World Porter's Five Forces Analysis, Product Profiles, Case Studies, KOL's Views, Analyst's View Which MedTech key players in the heparin market are set to emerge as the trendsetter explore @ Heparin Companies Table of Contents Interested in knowing the heparin market by 2030? Click to get a snapshot of the Heparin Market Trends Related Reports Heparin-induced Thrombocytopenia Market Heparin-induced Thrombocytopenia Market Insight, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of market trends, market drivers, market barriers, and key heparin-induced thrombocytopenia companies, including Sandoz, Fresenius Kabi, Hikma Pharm, Veralox Therapeutics, among others. Thrombocytopenia Market Thrombocytopenia Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key thrombocytopenia companies, including Sanofi, Principia Biopharma, Baxalta, Takeda, Argenx, Millennium Pharmaceuticals, Biotest, GC Pharma, Genosco (Subsidiary of Oscotec), Rigel Pharmaceuticals, Kissei Pharmaceutical, Shionogi & Co., Ltd, Amgen, Novartis, Zenyaku Kogyo, among others. Thrombocytopenia Pipeline Thrombocytopenia Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, including clinical and non-clinical stage products, and the key thrombocytopenia companies, including Takeda, Argenx, Keros Therapeutics, Principia Biopharma, Momenta Pharmaceuticals, Veralox Therapeutics, Novartis Pharmaceuticals, Pfizer, HUTCHMED, Principia Biopharma, Genosco, UCB, among others. Immune Thrombocytopenia Immune Thrombocytopenia Market Insights, Epidemiology, and Market Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key immune thrombocytopenia companies, including UCB Biopharma, Sanofi, Principia Biopharma, Argenx, Millennium Pharmaceuticals, Takeda, Biotest, GC Pharma, UCB, HanAll Biopharma, Immunovant, Momenta Pharmaceuticals, Hutchison MediPharma, Cour Pharmaceutical Development, among others. About DelveInsight DelveInsight is a leading Business Consultant, and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP

Kissei gains exclusive rights to develop and commercialize olutasidenib in all current and potential indications in Japan, the Republic of Korea and Taiwan Rigel will receive an upfront cash payment of $10.0 million with the potential for up to $152.5 million in future development, regulatory, and commercial milestone payments Rigel to receive product transfer price payments in the mid-twenty to lower-thirty percent range based on tiered net sales for exclusive supply of REZLIDHIA SOUTH SAN FRANCISCO, Calif., Sept. 3, 2024 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL), a commercial stage biotechnology company focused on hematologic disorders and cancer, today announced it has entered into an exclusive license and supply agreement with Kissei Pharmaceutical Co., Ltd. ("Kissei") to develop and commercialize REZLIDHIA® (olutasidenib) in all current and potential indications in Japan, the Republic of Korea (Korea) and Taiwan. REZLIDHIA is commercially available to patients in the U.S. for the treatment of relapsed or refractory (R/R) mutated isocitrate dehydrogenase-1 (mIDH1) acute myeloid leukemia (AML). Rigel has an existing agreement with Kissei to develop and commercialize TAVALISSE® (fostamatinib disodium hexahydrate) for the treatment of chronic immune thrombocytopenia (ITP) and in all other potential indications in Japan, China, Taiwan and the Republic of Korea. "Kissei has an excellent track record of development and commercial success with in-licensed products for the Asian market, including with Rigel's TAVALISSE. The approval and launch of TAVALISSE in Japan, combined with the strong relationship we have built with Kissei, made expanding our partnership to include REZLIDHIA a natural next step," said Raul Rodriguez, Rigel's president and CEO. "From our experience, we are confident in Kissei's ability and commitment to bring REZLIDHIA to patients in their territories." Under the terms of the agreement, Rigel will receive an upfront cash payment of $10.0 million from Kissei, with the potential for up to an additional $152.5 million in development, regulatory and commercial milestone payments. Rigel will receive product transfer price payments in the mid-twenty to lower-thirty percent range based on tiered net sales for the exclusive supply of REZLIDHIA. Kissei receives exclusive rights to REZLIDHIA in AML and all future indications in Japan, Korea and Taiwan. Kissei will initially seek approval for REZLIDHIA in Japan for R/R mIDH1 AML and will be responsible for conducting clinical studies as required by the Japanese regulatory agency, Pharmaceuticals and Medical Devices Agency (PMDA). "We are pleased to expand our relationship with Rigel to develop and commercialize olutasidenib in Japan, Korea and Taiwan, leveraging our extensive infrastructure and our expertise in the hematology-oncology space," said Mutsuo Kanzawa, Chairman and CEO of Kissei. "In Japan, there are estimated to be 11,000 AML patients, with a higher incidence than any other subtypes of leukemia. Despite the current treatment options available, there are still clear unmet medical needs in the AML treatment landscape." Kissei is a Japanese pharmaceutical company with approximately 80 years of history, specialized in the field of urology, kidney-dialysis and unmet medical needs. Kissei aims to develop innovative pharmaceutical products that contribute to the improvement of medicine and the health of people around the world by aggressive incorporation of leading-edge technology and joint research and collaborations with its foreign and domestic partners. Rigel retains the global rights, excluding these Asian countries, to develop and commercialize REZLIDHIA for all indications, and is currently exploring other ex-US partnership opportunities. In August 2022, Rigel and Forma Therapeutics, Inc., now Novo Nordisk (Forma), announced an exclusive, worldwide license agreement to develop, manufacture and commercialize REZLIDHIA. Pursuant to the agreement, Forma is entitled to a certain portion of Rigel's sublicensing revenue from olutasidenib. About AML Acute myeloid leukemia (AML) is a rapidly progressing cancer of the blood and bone marrow that affects myeloid cells, which normally develop into various types of mature blood cells. AML occurs primarily in adults and accounts for about 1 percent of all adult cancers. The American Cancer Society estimates that there will be about 20,800 new cases in the United States, most in adults, in 2024.1 Relapsed AML affects about half of all patients who, following treatment and remission, experience a return of leukemia cells in the bone marrow.2 Refractory AML, which affects between 10 and 40 percent of newly diagnosed patients, occurs when a patient fails to achieve remission even after intensive treatment.3 Quality of life declines for patients with each successive line of treatment for AML, and well-tolerated treatments in relapsed or refractory disease remain an unmet need. About ITP In patients with ITP (immune thrombocytopenia), the immune system attacks and destroys the body's own blood platelets, which play an active role in blood clotting and healing. Common symptoms of ITP are excessive bruising and bleeding. People suffering with chronic ITP may live with an increased risk of severe bleeding events that can result in serious medical complications or even death. Current therapies for ITP include steroids, blood platelet production boosters (TPO-RAs), and splenectomy. However, not all patients respond to existing therapies. As a result, there remains a significant medical need for additional treatment options for patients with ITP. About REZLIDHIA® REZLIDHIA is indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA-approved test. Please click here for Important Safety Information and Full Prescribing Information, including Boxed WARNING, for REZLIDHIA. About TAVALISSE® TAVALISSE (fostamatinib disodium hexahydrate) tablets is indicated for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment. Please click here for Important Safety Information and Full Prescribing Information for TAVALISSE. To report side effects of prescription drugs to the FDA, visit or call 1-800-FDA-1088 (800-332-1088). TAVALISSE and REZLIDHIA are registered trademarks of Rigel Pharmaceuticals, Inc. About Rigel Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) is a biotechnology company dedicated to discovering, developing and providing novel therapies that significantly improve the lives of patients with hematologic disorders and cancer. Founded in 1996, Rigel is based in South San Francisco, California. For more information on Rigel, the Company's marketed products and pipeline of potential products, visit . The American Cancer Society. Key Statistics for Acute Myeloid Leukemia (AML). Revised June 5, 2024. Accessed June 30, 2024: Leukaemia Care. Relapse in Acute Myeloid Leukaemia (AML). Version 3. Reviewed October 2021. Accessed June 30, 2024: Thol F, Schlenk RF, Heuser M, Ganser A. How I treat refractory and early relapsed acute myeloid leukemia. Blood (2015) 126 (3): 319-27. Accessed June 30, 2024. doi: Forward-Looking Statements This press release contains forward-looking statements relating to, among other things, Rigel's receipt of payments from Kissei under the License Agreement and the Supply Agreement, and the success of Rigel's collaboration with Kissei. Any statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Forward-looking statements can be identified by words such as "plan", "potential", "may", "look to", "expects", "will", "intends" and similar expressions in reference to future periods. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based on Rigel's current beliefs, expectations, and assumptions and hence they inherently involve significant risks, uncertainties and changes in circumstances that are difficult to predict and many of which are outside of our control. Therefore, you should not rely on any of these forward-looking statements. Actual results and the timing of events could differ materially from those anticipated in such forward looking statements as a result of these risks and uncertainties, which include, without limitation, risks and uncertainties associated with the commercialization and marketing of olutasidenib; risks that the FDA, European Medicines Agency, PMDA or other regulatory authorities may make adverse decisions regarding olutasidenib; risks that clinical trials may not be predictive of real-world results or of results in subsequent clinical trials; risks that olutasidenib may have unintended side effects, adverse reactions or incidents of misuses; market competition; as well as other risks detailed from time to time in Rigel's reports filed with the Securities and Exchange Commission, including its Annual Report on Form 10-K for the year ended December 31, 2023 and Quarterly Report on Form 10-Q for the quarter ended June 30, 2024 and subsequent filings. Any forward-looking statement made by us in this press release is based only on information currently available to us and speaks only as of the date on which it is made. Rigel does not undertake any obligation to update forward-looking statements, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise, and expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein, except as required by law. Contact for Investors & Media: Investors: Rigel Pharmaceuticals, Inc. 650.624.1232 [email protected] Media: David Rosen Argot Partners 212.600.1902 [email protected] SOURCE Rigel Pharmaceuticals, Inc.

The UK's National Institute for Health and Care Excellence (NICE) recommended Theramex’s Yselty (linzagolix) as a treatment option for moderate-to-severe symptoms of uterine fibroids in adult women of reproductive age. Subsequent to the decision, the oral gonadotropin-releasing hormone (GnRH) receptor antagonist can now be routinely prescribed to eligible patients through the NHS in England and Wales.Backed by the two Phase III PRIMROSE trials, Yselty was approved in the EU and UK in 2022, making it the first GnRH antagonist offering a non-hormonal option for women with uterine fibroids. “Linzagolix offers greater flexibility as it can be taken either with or without hormone therapy and means clinicians can provide more personalised care,” said Jonathan Benger, NICE chief medical officer. Longer-term use onlyNICE noted that the drug is only recommended for longer-term use of over 6 months and is unsuitable for those requiring short-term treatment, such as before uterine fibroid surgery. Yselty carries an annual list price of £1097.20 ($1410) and £1040.00 ($1336) with and without hormonal add-back therapy, respectively.According to NICE, around a third of women are likely to develop symptomatic uterine fibroids during their lifetime and up to 30,000 women in England and Wales could benefit from the new treatment option. “We are continuing to work with NICE and the NHS in the hope that we can provide as many women as possible the opportunity to access this treatment, wherever they live,” remarked Tina Backhouse, UK general manager at Theramex.Originally an asset of Kissei Pharmaceutical, the GnRH antagonist was licensed to ObsEva in 2015 for commercialisation outside Asia. In 2022, ObsEva struck a deal with Theramex to support the drug’s commercialisation in markets excluding the US, Canada and Asia. However, ObsEva soon ran into trouble with the FDA regarding the drug’s US filing, resulting in a strategic restructuring and Theramex being assigned as Kissei’s ex-Asia licensing partner.