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    Addressing the urgent need for novel therapeutics in liver disease

    The global outlook in liver disease

    Although there has been significant progress in the field of hepatology – the branch of medicine that incorporates the study and management of liver disease – over the last decade, the number of people who require a liver transplant continues to rise.1 This is largely due to the emerging global epidemic of non-alcoholic steatohepatitis (NASH),2 a progressive liver disease that currently has no approved therapies.3 The overall prevalence of liver disease is also increasing, with approximately two million people dying from liver disease globally every year.1 There is a clear need for innovative therapeutic approaches to help address a wide variety of patient needs in hepatology, including reducing morbidity, mortality, and global transplant requirements.

    Other less common – but no less devastating – liver diseases remain unaddressed. Alpha-1 antitrypsin deficiency (A1ATD) disease is a genetic disease estimated to affect 1 per 3,000-5,000 people in North America and 1 per 2,500 in Europe.4,5 Patients with A1ATD disease are at risk of developing liver cirrhosis and progressing to liver failure and its complications, including hepatic encephalopathy, a debilitating complication of end-stage liver disease that reduces patient quality of life and accounts for a significant number of hospitalizations.6,7 Liver transplantation remains the only treatment option once A1ATD disease progresses to end-stage liver disease, as no therapeutic options currently exist.6

    Liver disease: A natural fit for Takeda

    Historically, hepatology did not exist as a subspecialty but was considered part of gastroenterology because of the liver’s role in the digestive process. As such, developing medicines for liver diseases is a natural extension of Takeda’s 30-year heritage in gastrointestinal disease.

    Through exploring treatment options in liver disease, patient outcomes and quality of life can be improved; this goal lies at the core of Takeda’s values. We also have the right qualities to aim to meet this challenge: a collection of talented drug development professionals who have training and experience in liver disease, a global footprint in gastroenterology that aligns well with liver disease therapeutics, and a drive to innovate patient care and improve patient outcomes.

    “Liver disease represents an area of great medical need. It is exciting for Takeda to enter this space and use our gastroenterology expertise to help patients with liver disorders. I trained as a gastroenterologist and hepatologist but practised almost exclusively as a hepatologist for almost two decades. It is gratifying to spend my time working on therapies for my patients with liver diseases.” Chinwe Ukomadu, Head GI Therapeutic Area Unit at Takeda

    The importance of collaboration

    By taking a collaborative approach, we are open to partnering with other experts in the liver disease space to produce innovative products and programs. We strongly believe in working with both internal and external talent to expedite the development of new therapies for patients.

    For this reason, Takeda is working with Arrowhead Pharmaceuticals and its RNA interference technology to develop a therapy for the treatment of A1ATD disease, exploring an asset to complement our growing portfolio of research and development programs focused on advanced liver disease.8 Takeda has also partnered with NuBiyota to conduct further research around the treatment of hepatic encephalopathy, a serious complication of late-stage liver disease.9

    Furthermore, we are in the preclinical stages of research around several anti-fibrotic assets targeting liver fibrosis and continue to collaborate with Ambys Medicines to evaluate cell therapies for liver diseases.10 Also, Takeda has an ongoing collaboration with HemoShear Therapeutics around the development of treatments for NASH, a major global treatment priority in hepatology.11

    Together with our partners, we strive towards better health and a brighter future for people living with liver disease.

    “The assets targeting liver disease that we currently have in clinical trials come from modalities in which we are building expertise and target a high unmet medical need segment of liver patients. Succeeding here would mean that the team could expand into other areas within liver disease, addressing other important therapeutic questions in hepatology.” Graham Heap, Global Program Leader at Takeda.

    Disclaimers:

    Forward-Looking Statements

    This article and any materials distributed in connection with this article  may contain forward-looking statements, beliefs or opinions regarding Takeda’s future business, future position and results of operations, including estimates, forecasts, targets and plans for Takeda. Without limitation, forward-looking statements often include words such as “targets”, “plans”, “believes”, “hopes”, “continues”, “expects”, “aims”, “intends”, “ensures”, “will”, “may”, “should”, “would”, “could” “anticipates”, “estimates”, “projects” or similar expressions or the negative thereof. These forward-looking statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those expressed or implied by the forward-looking statements: the economic circumstances surrounding Takeda’s global business, including general economic conditions in Japan and the United States; competitive pressures and developments; changes to applicable laws and regulations; the success of or failure of product development programs; decisions of regulatory authorities and the timing thereof; fluctuations in interest and currency exchange rates; claims or concerns regarding the safety or efficacy of marketed products or product candidates; the impact of health crises, like the novel coronavirus pandemic, on Takeda and its customers and suppliers, including foreign governments in countries in which Takeda operates, or on other facets of its business; the timing and impact of post-merger integration efforts with acquired companies; the ability to divest assets that are not core to Takeda’s operations and the timing of any such divestment(s); and other factors identified in Takeda’s most recent Annual Report on Form 20-F and Takeda’s other reports filed with the U.S. Securities and Exchange Commission, available on Takeda’s website at: http://www.asiamerlion.cn/investors/reports/sec-filings/ or at www.sec.gov. Takeda does not undertake to update any of the forward-looking statements contained in this article or any other forward-looking statements it may make, except as required by law or stock exchange rule. Past performance is not an indicator of future results and the results or statements of Takeda in this article may not be indicative of, and are not an estimate, forecast, guarantee or projection of Takeda’s future results.

    Regulatory disclaimer

    Efficacy and safety of these products are currently under investigation. Regulatory approval of any of these products or uses is dependent on the completion of the study programs and review by regulatory authorities.


    References

    1 Asrani SK, Devarbhavi H, Eaton J, Kamath, PS. Burden of liver diseases in the world. J. Hepatol. 2019;70(1):151-171

    2 Haldar D, Kern B, Hodson J, et al. Outcomes of liver transplantation for non-alcoholic steatohepatitis: A European Liver Transplant Registry study. J Hepatol. 2019;71(2):313-322.

    3 Dufour J, Caussy C, Loomba R. Combination therapy for non-alcoholic steatohepatitis: rationale, opportunities and challenges. Gut. 2020;69:1877-1884.

    4 Brode SK, Ling SC, Chapman KR. Alpha-1 antitrypsin deficiency: a commonly overlooked cause of lung disease. Can. Med. Assoc. J. 2012; 184(12): 1365–1371

    5 Fregonese L, Stolk J. Hereditary alpha-1-antitrypsin deficiency and its clinical consequences. Orphanet J. Rare Dis. 2008;3:16

    6 Mitchell EL, Khan Z. Liver Disease in Alpha-1 Antitrypsin Deficiency: Current Approaches and Future Directions. Curr Pathobiol Rep. 2017;5(3):243-252.

    7 Kima LCD, Miranda AS, Ferreira RN, et al. Hepatic encephalopathy: Lessons from preclinical studies. World J Hepatol. 2019;11(2):173-185.

    8 Takeda and Arrowhead Collaborate to Co-Develop and Co-Commercialize ARO-AAT for Alpha-1 Antitrypsin-Associated Liver Disease. Available at: http://www.asiamerlion.cn/newsroom/newsreleases/2020/takeda-and-arrowhead-collaborate-to-co-develop-and-co-commercialize-aro-aat-foralpha-1-antitrypsin-associated-liver-disease/. Last updated: 8 October 2020. Last accessed: April 2021.

    9 Takeda Enters into Strategic Collaboration with NuBiyota for Microbiome Therapeutics. Available at: http://www.asiamerlion.cn/newsroom/newsreleases/2017/takeda-enters-into-strategic-collaboration-with-nubiyota-for-microbiome-therapeutics/. Last updated: 11 April 2017. Last accessed: April 2021.

    10 Ambys Medicines and Takeda Announce Partnership to Pioneer First-In-Class Therapies for the Treatment of Serious Liver Diseases. Available at: http://www.asiamerlion.cn/newsroom/newsreleases/2018/ambys-medicines-and-takeda-announce-partnership-to-pioneer-first-in-class-therapies-for-the-treatment-of-serious-liver-diseases/. Last updated: 9 August 2018. Last accessed: April 2021.

    11 Takeda and HemoShear Therapeutics Enter into Exclusive Drug Discovery Partnership in Liver Diseases. Available at: http://www.asiamerlion.cn/newsroom/newsreleases/2017/hemoshear2/. Last updated: 17 October 2017. Last accessed: April 2021.

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