OSAKA, JAPAN--( / ) February 27, 2020 -- Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) (“Takeda”) announced that it has acquired PvP Biologics, Inc. following the conclusion of a Phase 1 proof-of-mechanism study of investigational medicine TAK-062 (Kuma062) for the treatment of uncontrolled celiac disease. TAK-062 is a potential best-in-class, highly potent super glutenase - a protein that degrades ingested gluten - that was computationally engineered to treat celiac disease, a serious autoimmune disease where the ingestion of gluten leads to inflammation and damage in the small intestine. The Phase 1 study investigated TAK-062’s safety and tolerability in both healthy volunteers and people with celiac disease. The ability of TAK-062 to degrade ingested gluten was studied in healthy volunteers. Takeda plans to submit data from the Phase 1 study for presentation at an upcoming medical congress.
“Many people living with celiac disease manage their symptoms by following a gluten-free diet, but there is no treatment for those who continue to experience severe symptoms,” said Asit Parikh M.D., Ph.D., Head, Gastroenterology Therapeutic Area Unit at Takeda. “PvP Biologics’ work demonstrated that TAK-062 is a highly targeted therapy that could change the standard of care in celiac disease. We are now applying our deep expertise in gastrointestinal diseases to advance the clinical study of TAK-062 and TAK-101, two programs with different modalities that have both demonstrated clinical proof of mechanism.”
TAK-062 enzymatically digests gluten and has demonstrated enhanced catalytic activity compared to other glutenases. It is designed to degrade the immune-reactive parts of gluten before they exit the stomach in order to prevent the immune response to gluten and eliminate the symptoms and intestinal damage caused by celiac disease. Takeda is planning a Phase 2b efficacy and dose-ranging study of TAK-062 in patients with uncontrolled disease who maintain a gluten-free diet.
Takeda exercised its option to acquire PvP Biologics for a pre-negotiated upfront payment as well as development and regulatory milestones totaling up to $330 million. Takeda and PvP Biologics previously entered into a development and option agreement, under which PvP Biologics was responsible for conducting research and development through the Phase 1 proof-of-mechanism study of TAK-062 in exchange for funding by Takeda related to a pre-defined development plan.
“TAK-062 was engineered in 2015 to address the challenges seen by previous glutenases in development for the treatment of celiac disease - their lack of specificity for gluten and activity in the acidic conditions of the stomach. As a result, TAK-062 demonstrated robust gluten degradation in humans, which was anticipated based on the very potent in vitro profile compared with other glutenases,” said Adam Simpson, president and chief executive officer of PvP Biologics. “Takeda has been a great partner and has the expertise, resources, and commitment to people living with celiac disease required to lead the next stage of TAK-062 development.”
In addition to TAK-062, Takeda previously announced data from a Phase 2a study of TAK-101, a potential first-in-class investigational therapy for the treatment of celiac disease. In the study, TAK-101 demonstrated T-cell response suppression, suggesting that it may induce tolerance to gluten in patients with celiac disease by immune uptake of proprietary nanoparticles loaded with gliadin proteins, a disease-specific antigen.
About Celiac Disease
Celiac disease is a genetically driven chronic immune-mediated disorder where abnormal immune responses to gluten peptides lead to small intestinal mucosal damage.[1,2,3] Recent population-based studies in the U.S. indicate that the prevalence of celiac disease is around 1% and approximately 0.5% globally. The threshold of daily gluten that will cause mucosal injury in both adults and children is 10 to 50mg per day - or about 1/100th of a slice of bread.[6,7] Celiac disease can cause symptoms, including abdominal pain, diarrhea, nausea, and vomiting. Long-term complications of celiac disease may include malnutrition, accelerated osteoporosis, nervous system problems and problems related to reproduction. Currently the only available treatment for patients with celiac disease is maintaining a gluten-free diet, which involves strict, lifelong avoidance of exposure to gluten proteins from wheat, barley, and rye, which is not always effective.
Takeda’s Commitment to Gastroenterology
Gastrointestinal (GI) diseases can be complex, debilitating, and life-changing. Recognizing this unmet need, Takeda and our collaboration partners have focused on improving the lives of patients through the delivery of innovative medicines and dedicated patient disease support programs for over 25 years. Takeda aspires to advance how patients manage their disease. Additionally, Takeda is leading in areas of gastroenterology associated with high unmet need, such as inflammatory bowel disease, acid-related diseases, and motility disorders. Our GI Research & Development team is also exploring solutions in celiac disease and liver diseases, as well as scientific advancements through microbiome therapies.
About Takeda Pharmaceutical Company Limited
Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) is a global, values-based, R&D-driven biopharmaceutical leader headquartered in Japan, committed to bringing Better Health and a Brighter Future to patients by translating science into highly-innovative medicines. Takeda focuses its R&D efforts on four therapeutic areas: Oncology, Gastroenterology (GI), Rare Diseases and Neuroscience. We also make targeted R&D investments in Plasma-Derived Therapies and Vaccines. We are focusing on developing highly innovative medicines that contribute to making a difference in people's lives by advancing the frontier of new treatment options and leveraging our enhanced collaborative R&D engine and capabilities to create a robust, modality-diverse pipeline. Our employees are committed to improving quality of life for patients and to working with our partners in health care in approximately 80 countries and regions.
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This press release and any materials distributed in connection with this press release 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. Forward-looking statements in this document are based on Takeda’s estimates and assumptions only as of the date hereof. Such forward-looking statements do not represent any guarantee by Takeda or its management of future performance and involve known and unknown risks, uncertainties and other factors, including but not limited to: 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 timing and impact of post-merger integration efforts with acquired companies; and the ability to divest assets that are not core to Takeda’s operations and the timing of any such divestment(s), any of which may cause Takeda’s actual results, performance, achievements or financial position to be materially different from any future results, performance, achievements or financial position expressed or implied by such forward-looking statements. For more information on these and other factors which may affect Takeda’s results, performance, achievements, or financial position, see “Item 3. Key Information?D. Risk Factors” 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: or at Future results, performance, achievements or financial position of Takeda could differ materially from those expressed in or implied by the forward-looking statements. Persons receiving this press release should not rely unduly on any forward-looking statements. Takeda undertakes no obligation to update any of the forward-looking statements contained in this press release 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 of Takeda in this press release may not be indicative of, and are not an estimate, forecast or projection of Takeda’s future results.
 Jabri B, Sollid LM. T Cells in Celiac Disease. J Immunol 2017;198:3005-3014.
 Molberg O, McAdam S, Lundin KE, et al. T cells from celiac disease lesions recognize gliadin epitopes deamidated in situ by endogenous tissue transglutaminase. Eur J Immunol 2001;31:1317-23.
 Dieterich W, Ehnis T, Bauer M, et al. Identification of tissue transglutaminase as the autoantigen of celiac disease. Nat Med 1997;3:797-801.
 Leonard MM, Sapone A, Catassi C, et al. Celiac Disease and Nonceliac Gluten Sensitivity: A Review. JAMA 2017;318:647-656.
 Lionetti E, Gatti S, Pulvirenti A, et al. Celiac disease from a global perspective. Best Pract Res Clin Gastroenterol 2015;29:365-79.
 Might gluten traces in wheat substitutes pose a risk in patients with celiac disease? A population-based probabilistic approach to risk estimation. Am J Clin Nutr 2013;97:109-16.
 Catassi C, Fabiani E, Iacono G, et al. A prospective, double-blind, placebo-controlled trial to establish a safe gluten threshold for patients with celiac disease. Am J Clin Nutr 2007;85:160-6.
 Symptoms & Causes of Celiac Disease. National Institute of Diabetes and Digestive and Kidney Diseases. Available at: Last updated: June 2016. Last accessed: October 2019
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ISTANBUL--( / ) December 19, 2017 -- The 8th annual Self-Organising Networks (SON) World was held NowGoal 로또투자 in London 다시보다 ISTANBUL--(16-18 October 2017. The event is the foremost gathering for the network optimization industry and mobile operators. In recognition of 다시보다 ISTANBUL--(successful automated network 다시보다 ISTANBUL--(project, Turkcell 콩카페야사 한국연합복권 NowGoal 한국연합복권 and P.I. Works received the “Leading Contribution to NowGoal 미국로또대행 SON” award.
Turkcell deployed P.I. Works uSON, the 베이드라마 Turkcellwinning centralized SON platform, to automate NowGoal the most critical network management activities with significant impact 콩카페야사 가수남지현 on service quality. 23 SON modules have been activated nation-wide in a very short time-frame. P.I. Works solution uses adaptive algorithms and correlates network and customer experience management data to provide the best set of improvement actions.
Turkcell Executive Vice President, Network Technologies Gediz Sezgin 콩카페야사 씨스타다솜왕따 said “This award is a proof of FREESEX Turkcellsuccessful work carried out by both Turkcell and P.I. Works 콩카페야사 teams. By deploying the 이유 Turkcellcomprehensive SON, we are moving towards our goal of becoming a Digital Operator, and use of automation is an instrument for Turkcell’s 5G 콩카페야사 종근당 vision. 먹튀검증먹튀썰전 Turkcellis also one of the first steps for ensuring NowGoal 애들은가라이글루스 participation in standardization studies in the world for 5G”.
P.I. Works CEO Ba?ar Akpınar said “The 삽입비 P.I.used in mobile network 야한것들 P.I.are radically changing to facilitate the evolution towards 5G. This award marks an important milestone 콩카페야사 사이트예스 in the mobile industry, showing how AI-assisted, automated network management empowers 콩카페야사 속옷 Turkcell to proactively solve network NowGoal G스팟 quality problems even 콩카페야사 서우키 before they occur, while 오나홀파는곳자극적인거 P.I.the way NowGoal 서우주식회사 for 5G”.
ADULTS About콩카페야사 유리가면 NowGoal 유리가면 Turkcell 콩카페야사 NowGoal
Turkcell (NYSE: TKC; BIST: TCELL) is a digital operator headquartered in Turkey, serving its customers with its NowGoal 백지영쇼핑몰 unique portfolio of digital services along with voice, messaging, data, IPTV services on its mobile NowGoal 백지영정석원 and fixed networks. Turkcell Group 딜도판매종류 Turkcelloperate in 9 countries - Turkey, Ukraine, Belarus, Turkish Republic 중도동성인게임장 TurkcellNorthern Cyprus, Germany, Azerbaijan, Kazakhstan, Georgia, Moldova. Turkcell has been NowGoal listed on the NYSE and the BIST since 콩카페야사 스타킹각선미 July 2000, and is KPcNo Turkcellonly NYSE-listed company in Turkey. Read more at
About 콩카페야사 이효리노출사진 P.I. 인사동고스톱 About콩카페야사 하하몽쇼이효리노출 NowGoal 하하몽쇼이효리노출
P.I. Works is 콩카페야사 패떳이효리노출 the leading provider of next-generation mobile network planning, management and optimization NowGoal 이효리샤워 solutions. P.I. Works combines field-proven expertise with a commercially available product portfolio and services. NowGoal 섹시몽 These solutions 하사미동화투치기 P.I.operators to lower their costs and improve subscriber experience. P.I. Works has deployed its solutions NowGoal at more 콩카페야사 섹시비키니 than 30 mobile operators in 28 countries.
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