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WEST CHESTER, Ohio, March 5, 2024 /PRNewswire/ -- Technoclone Herstellung von Diagnostika und Arzneimitteln GmbH, world-leading producer of diagnostic tests, equipment, and research products in the field of blood clotting and its exclusive distributor in the USA, DiaPharma Group, Inc., are pleased to announce that the US Food and Drug Administration (FDA) granted De Novo marketing authorization for Technozym ADAMTS13 Activity ELISA. This is the first ADAMTS13 activity test authorized by the FDA. The Technozym ADAMTS13 Activity assay is an enzyme-linked immunosorbent assay (ELISA) intended for the qualitative determination of ADAMTS13 activity in platelet poor human citrated plasma. The assay is intended to be used in conjunction with other clinical and laboratory findings as an aid in the diagnosis of thrombotic thrombocytopenic purpura (TTP) in adult and pediatric patients being evaluated for thrombotic microangiopathy (TMA). "In line with our commitment to provide ADAMTS13 diagnostics globally, we are excited about this milestone, having the first ADAMTS13 activity test granted with marketing authorization by the FDA", says Nikolaus Binder, MD, PhD, CSO of Technoclone. "And today we are honored to address this unmet need for laboratories and patients across the U.S." "We are proud to partner with Technoclone to provide the first in vitro diagnostic assay for ADAMTS13 Activity in the U.S., leading the way for better access to this important parameter", says Madeleine Burmester, President & CEO of DiaPharma. About TTP TTP is a very rare, life-threatening blood clotting disorder caused from either a congenital or acquired absence/decrease of the von Willebrand factor-cleaving protease ADAMTS13. About Technoclone Technoclone is committed to delivering high-quality test systems for in vitro diagnostics in hemostasis to its worldwide clientele. At Technoclone innovation is seen as its responsibility to address emerging complexities in the diagnosis of hematological and cardiovascular disorders. Since 1987, Technoclone has fostered close collaborations with global partners from academia, clinical laboratories, and industry, positioning itself at the forefront of anticipated diagnostic challenges in the years to come. About DiaPharma DiaPharma Group, Inc. sells assay kits, reagents, and instrumentation for laboratory research and clinical applications in the fields of Bleeding and Clotting Disorders and Liver Injury. DiaPharma provides strong personal support and technical competence and experience to ensure customer expectations will be met or exceeded. SOURCE DiaPharma

Takeda Will Be Protagonist's Co-Development, U.S. Co-Commercialization Partner With 50:50 Profit Share, and With Exclusive Ex-U.S. Global Rights to Commercialize Rusfertide, Protagonist's Investigational Injectable Hepcidin Mimetic Currently in Development for the Treatment of Polycythemia Vera (PV) Takeda Will Make an Upfront Payment of $300 Million at Closing Partnership Combines Protagonist's Leadership in Pharmaceutical Peptide Drug Development With Takeda's Commercial Expertise and 70-Plus Year Legacy of Driving Innovation Within the Rare Hematology Community Protagonist to Host Conference Call and Webcast Today at 4:30 PM ET OSAKA, JAPAN, CAMBRIDGE, MA, and NEWARK, CA / ACCESSWIRE / January 31, 2024 / Takeda (TSE:4502/NYSE:TAK) and Protagonist Therapeutics, Inc., (Nasdaq:PTGX) today announced the signing of a worldwide license and collaboration agreement for the development and commercialization of rusfertide, an investigational injectable hepcidin mimetic peptide of the natural hormone hepcidin, currently in a pivotal Phase 3 trial, VERIFY, for the treatment of Polycythemia Vera (PV). PV is a rare chronic blood disorder characterized by excessive production of red blood cells that affects as many as 160,000 patients in the U.S.[i], with a similar prevalence in Europe[ii][iii]. The hallmark manifestations of PV are increased red blood cell count and iron deficiency[iv], putting patients at higher risk of cardiovascular and thrombotic events, such as heart attack and stroke[v][vi], often impacting quality-of-life with symptoms such as fatigue and confusion[vii]. Under the terms of the agreement, Protagonist will receive an upfront payment of $300 million and is eligible to receive additional worldwide development and regulatory milestone payments, as well as commercial milestones and tiered royalties on ex-U.S. net sales. Protagonist will remain responsible for research and development through the completion of the Phase 3 clinical trial and U.S. regulatory approval. Takeda has rights for ex-U.S. development and is responsible for leading global commercialization activities. "As pioneers in the field of pharmaceutical peptide drug discovery and development, we believe that the maximum impact from our innovation and development acumen can be best achieved with the right partner at the right time," said Dinesh V. Patel, Ph.D., President and CEO of Protagonist Therapeutics. "This transformational deal allows Protagonist to focus on completion of Phase 3, while leveraging Takeda's exceptional global commercialization capabilities to immediately commence pre-commercial activities with a first-in-class new chemical entity. As we progress towards a fully integrated pharmaceutical company, this deal mitigates the inherent execution risks of a first-time commercial launch, optimizes the timing and enhances the scope for peak potential sales of rusfertide, while still allowing us to actively participate in the commercial experience and economics with a 50:50 profit split in the U.S. market." "The agreement with Protagonist represents an important step forward in our strategy of acquiring late-stage assets in the rare disease space to leverage our existing infrastructure and expertise. It combines the strength of their science with the reach of our commercial organization, understanding of rare diseases, and most importantly, our focus on supporting patients through their journey," said Julie Kim, president, U.S. Business Unit and U.S. country head, Takeda. "This is an exciting opportunity to leverage our more than 70 years of innovation and commitment to rare diseases and hematology to deliver a first-in-class therapy to Polycythemia Vera patients, helping to address significant needs in the community. We look forward to working closely with Protagonist as rusfertide completes its registrational clinical program." Discovered through Protagonist's peptide technology platform, rusfertide's mechanism of action is thought to regulate iron homeostasis and control the absorption, storage and distribution of iron in the body. The randomized portion of the Phase 2 REVIVE study of rusfertide in Polycythemia Vera achieved its primary endpoint. The long-term follow-up data from the 2-year open label extension were presented at the American Society of Hematology 2023 Annual Meeting in early December, which showed durable hematocrit control, decreased phlebotomy use, long-term tolerability and no new safety signals in patients with PV. Today's announcement builds upon Takeda's heritage in Rare Hematology and follows the recent U.S. Food and Drug Administration (FDA) approval of ADZYNMA, Takeda's treatment for congenital thrombotic thrombocytopenic purpura (cTTP), an ultra-rare blood clotting disorder. Following U.S. regulatory filing, Takeda will lead commercialization of rusfertide with Protagonist holding an option to co-detail in the U.S. Under the terms of the agreement, Protagonist has the right to opt-out of the 50:50 profit share. In that event, Protagonist would be eligible to receive opt-out payments and enhanced milestone and royalty payments. Takeda would maintain full ex-U.S. rights under either scenario. Further details related to the agreement are available on the Form 8-K filed today by Protagonist Therapeutics with the U.S. Securities and Exchange Commission. The effectiveness of the agreement is subject to the termination or expiration of any applicable waiting periods under the Hart-Scott-Rodino Act. PJT Partners acted as the exclusive financial advisor to Protagonist. Conference Call and Webcast Information Protagonist management will host a conference call and webcast today at 4:30 p.m. ET to provide a brief overview of the co-commercialization agreement. Wednesday, January 31 at 4:30 PM ET Domestic: (877) 704-4390 (U.S./Canada) International: (201) 389-0920 Conference ID: 13744228 Participants can use Guest dial-in #s above and be answered by an operator OR click the Call me™ link for instant telephone access to the event. Call me™ link will be made active 15 minutes prior to scheduled start time. Call me™: Webcast: A live and archived webcast will also be accessible in the Investors section of the Company's website at . ABOUT ADZYNMA ADZYNMA (ADAMTS13, recombinant-krhn) is a human recombinant "A disintegrin and metalloproteinase with thrombospondin motifs 13" ADAMTS13 (rADAMTS13) indicated for prophylactic or on-demand enzyme replacement therapy (ERT) in adult and pediatric patients with congenital thrombotic thrombocytopenic purpura (cTTP). ADZYNMA was previously granted Orphan Drug Designation (ODD) and by the U.S. FDA for the treatment and prevention of TTP, including its acquired idiopathic and secondary forms, as well as Fast Track and Rare Pediatric Disease Designation. The U.S. FDA granted Takeda a Rare Pediatric Disease Voucher for the approval of ADZYNMA. ADZYNMA has also been granted ODD by the European Medicines Agency (EMA) and Japan's Ministry of Health, Labour and Welfare (MHLW) for the treatment of TTP. Important Safety Information ADZYNMA is contraindicated in patients who have experienced life-threatening hypersensitivity reactions to ADZYNMA or its components. Hypersensitivity Reactions: Allergic-type hypersensitivity, including anaphylactic reactions, may occur with ADZYNMA. Patients should be educated about early signs of hypersensitivity such as tachycardia, chest tightness, wheezing and/or acute respiratory distress, hypotension, generalized urticaria, pruritus, rhinoconjunctivitis, angioedema, lethargy, nausea, vomiting, paresthesia, and restlessness. If signs and symptoms of severe allergic reactions occur, immediately discontinue administration of ADZYNMA and provide appropriate supportive care. Immunogenicity: There is a potential for immunogenicity with ADZYNMA. Patients may develop neutralizing antibodies to ADAMTS13, which could potentially result in a decreased or lack of response to ADAMTS13. Patients may develop antibodies to host cell proteins which could potentially result in adverse reactions. There are no data on immunogenicity with ADZYNMA or to host cell proteins in previously untreated patients (subjects naïve to plasma-based products). Adverse Reactions: The most commonly observed adverse reactions (>5% of subjects) associated with ADZYNMA are headache, diarrhea, migraine, abdominal pain, nausea, upper respiratory tract infection, dizziness and vomiting. Use in Specific Populations: The safety of ADZYNMA for use during pregnancy has not been established in controlled clinical trials. Limited data are insufficient to inform a drug associated risk of adverse developmental outcomes. There is no information regarding the presence of ADZYNMA in human milk, its effects on milk production, or the breastfed infant. To report SUSPECTED ADVERSE REACTIONS, contact Takeda Pharmaceuticals U.S.A, Inc. at 1-877-TAKEDA-7 (1-877-825-3327) or FDA at 1-800-FDA-1088 or . Please see full Prescribing Information, including information for patients. About Takeda Takeda is focused on creating better health for people and a brighter future for the world. We aim to discover and deliver life-transforming treatments in our core therapeutic and business areas, including gastrointestinal and inflammation, rare diseases, plasma-derived therapies, oncology, neuroscience and vaccines. Together with our partners, we aim to improve the patient experience and advance a new frontier of treatment options through our dynamic and diverse pipeline. As a leading values-based, R&D-driven biopharmaceutical company headquartered in Japan, we are guided by our commitment to patients, our people and the planet. Our employees in approximately 80 countries and regions are driven by our purpose and are grounded in the values that have defined us for more than two centuries. For more information, visit . About Protagonist Protagonist Therapeutics is a biopharmaceutical company with peptide-based new chemical entities (NCEs) rusfertide and JNJ-2113 (formerly PN-235) in advanced stages of clinical development, both derived from the Company's proprietary peptide technology platform. Protagonist and Janssen scientists jointly discovered oral peptide PN-235 (now known as JNJ-2113) as part of Protagonist's Interleukin-23 receptor (IL-23R) collaboration with Janssen and followed it through IND-enabling pre-clinical and Phase 1 studies, with Janssen assuming responsibility for further clinical development. Rusfertide, a peptide-mimetic of the natural hormone hepcidin, is currently in a global Phase 3 development program. More information on Protagonist, its pipeline drug candidates and clinical studies can be found on the Company's website at . [i] Mehta J, Wang H, Iqbal SU, Mesa R. Epidemiology of myeloproliferative neoplasms in the United States. Leuk Lymphoma 2014; 55:595-600. [ii] Orphanet: (s)/group%20of%20diseases=Polycythemia-vera&title=Polycythemia%20vera&search=Disease_Search_Simple [iii] RareCare EU: [iv] Verstovsek S, et al. Leuk Res. 2017;56:52-59. doi:10.1016/j.leukres.2017.01.032 [v] Marchioli R, et al. N Engl J Med 2013; 368:22-33 [vi] Spivak JL. Ann Hematol 2018; 19(2):1-14. [vii] Mesa R, et al. BMC Cancer. 2016;16,167. Takeda Media Contacts: Protagonist Therapeutics Investor and Media Contacts: Japanese Media Investors Jun Saito Corey Davis, Ph.D. jun.saito@takeda.com LifeSci Advisors cdavis@lifesciadvisors.com U.S. and International Media +1 212-915-2577 Megan Ostrower megan.ostrower@takeda.com Media +1 772-559-4924 Virginia Amann ENTENTE Network of Companies virginiaamann@ententeinc.com +1 833-500-0061 Important Notice For the purposes of this notice, "press release" means this document, any oral presentation, any question-and-answer session and any written or oral material discussed or distributed by Takeda Pharmaceutical Company Limited ("Takeda") regarding this release. This press release (including any oral briefing and any question-and-answer in connection with it) is not intended to, and does not constitute, represent or form part of any offer, invitation or solicitation of any offer to purchase, otherwise acquire, subscribe for, exchange, sell or otherwise dispose of, any securities or the solicitation of any vote or approval in any jurisdiction. No shares or other securities are being offered to the public by means of this press release. No offering of securities shall be made in the United States except pursuant to registration under the U.S. Securities Act of 1933, as amended, or an exemption therefrom. This press release is being given (together with any further information which may be provided to the recipient) on the condition that it is for use by the recipient for information purposes only (and not for the evaluation of any investment, acquisition, disposal or any other transaction). Any failure to comply with these restrictions may constitute a violation of applicable securities laws. The companies in which Takeda directly and indirectly owns investments are separate entities. In this press release, "Takeda" is sometimes used for convenience where references are made to Takeda and its subsidiaries in general. Likewise, the words "we", "us" and "our" are also used to refer to subsidiaries in general or to those who work for them. These expressions are also used where no useful purpose is served by identifying the particular company or companies. Takeda Forward-Looking Statements 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. 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, including global health care reforms; challenges inherent in new product development, including uncertainty of clinical success and decisions of regulatory authorities and the timing thereof; uncertainty of commercial success for new and existing products; manufacturing difficulties or delays; 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: or at Takeda does not undertake 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 or statements of Takeda in this press release may not be indicative of, and are not an estimate, forecast, guarantee or projection of Takeda's future results. Medical Information This press release contains information about products that may not be available in all countries, or may be available under different trademarks, for different indications, in different dosages, or in different strengths. Nothing contained herein should be considered a solicitation, promotion or advertisement for any prescription drugs including the ones under development. Protagonist Therapeutics Cautionary Note on Forward-Looking Statements This press release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements regarding the potential benefits of JNJ-2113, our expectations regarding the anticipated benefits of rusfertide, the Agreement and our collaboration with Takeda. In some cases, you can identify these statements by forward-looking words such as "anticipate," "believe," "may," "will," "expect," or the negative or plural of these words or similar expressions. Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that could cause actual results and events to differ materially from those anticipated, including, but not limited to, our ability to develop and commercialize our product candidates, our ability to earn milestone payments under our collaboration agreements with Janssen and Takeda, our ability to use and expand our programs to build a pipeline of product candidates, our ability to obtain and maintain regulatory approval of our product candidates, our ability to operate in a competitive industry and compete successfully against competitors that have greater resources than we do, and our ability to obtain and adequately protect intellectual property rights for our product candidates. Additional information concerning these and other risk factors affecting our business can be found in our periodic filings with the Securities and Exchange Commission, including under the heading "Risk Factors" contained in our most recently filed periodic reports on Form 10-K and Form 10-Q filed with the Securities and Exchange Commission. Forward-looking statements are not guarantees of future performance, and our actual results of operations, financial condition and liquidity, and the development of the industry in which we operate, may differ materially from the forward-looking statements contained in this press release. Any forward-looking statements that we make in this press release speak only as of the date of this press release. We assume no obligation to update our forward-looking statements, whether as a result of new information, future events or otherwise, after the date SOURCE: Protagonist Therapeutics, Inc. View the original press release on accesswire.com

Takeda announced at the end of last month (November 2023) that it had been approved by the US Food and Drug Administration (FDA) on November 9, 2023. cTTP is a very rare, complex condition that can present as an acute life-threatening disorder requiring prompt diagnosis, early referral, and effective immediate and ongoing management in a center with comprehensive provision and a multi-discipline approach. Adzynma is the first and only recombinant ADAMTS13 enzyme replacement therapy for people with cTTP designed to address the root cause of the condition, an ADAMTS13 enzyme deficiency. On-demand treatment for cTTP Adults and children in the US with cTTP can now access Adzynma for prophylactic and on-demand treatment. “For nearly a century, people impacted by this debilitating, ultra-rare condition have been without a treatment option specifically indicated for their disease,” said Cheryl Schwartz, senior vice president of, Rare Disease Business Unit at Takeda. “Patients have waited too long, and so it is with great pride that we announce the availability of the first and only FDA-approved treatment for patients with cTTP to directly address their ADAMTS13 enzyme deficiency.” Significant milestone for cTTP community The ultra-rare, chronic blood clotting disorder caused by a deficiency in the ADAMTS13 enzyme is associated with acute events and debilitating chronic symptoms or thrombotic thrombocytopenic purpura (TTP) manifestations. These can include thrombocytopenia, microangiopathic hemolytic anemia, headache, and abdominal pain. When left untreated, acute TTP events have a mortality rate of more than 90%. googletag.cmd.push(function () { googletag.display('text-ad1'); }); “The availability of this treatment marks a significant milestone for the cTTP community,” said James Wynn, president and co-founder, The Ree Wynn Foundation. “It is an honor to stand with the community as we recognize this turning point for the treatment of cTTP, and ultimately, work to improve outcomes for patients.” cTTP - idiopathic and secondary forms The treatment was previously granted Orphan Drug Designation (ODD) by the US FDA for the treatment and prevention of TTP, including its acquired idiopathic and secondary forms, as well as Fast Track and Rare Pediatric Disease Designation. The FDA granted Takeda a Rare Pediatric Disease Priority Review Voucher for the approval of Adyznmz. It has also been granted ODD by the European Medicines Agency (EMA) and Japan’s Ministry of Health, Labour and Welfare (MHLW) for the treatment of TTP. In its research, Takeda found that TTP has an estimated prevalence of 2-6 cases per million. The inherited form of the disease, cTTP, accounts for the same as or more than 5% of TTP patients. It develops due to deficiency in ADAMTS13, a von Willebrand factor (VWF) cleaving protease, which results in the accumulation of ultra-large VWF multimers in the blood. Uncontrolled platelet manifestations The accumulation of ultra-large VWF multimers leads to uncontrolled platelet aggregation and adhesion. This can lead to abnormal clotting in the small blood vessels of the body and is associated with microangiopathic hemolytic anemia and low platelet levels known as thrombocytopenia. Takeda says cTTP has both acute and chronic manifestations including stroke and cardiovascular disease and can also cause ongoing widespread organ damage and other co-morbidities resulting from an ADAMTS13-deficient state if left untreated. Takeda says it is focused on ‘creating better health for people and a brighter future for the world’. The company said: “We aim to discover and deliver life-transforming treatments in our core therapeutic and business areas, including gastrointestinal and inflammation, rare diseases, plasma-derived therapies, oncology, neuroscience and vaccines.”