AstraZenecas Farxiga follows rival Zynquista to FDA rejection in Type 1 diabetes.

fiercepharma | July 15, 2019

Turns out, the FDAs March rejection of Sanofi and Lexicon Pharmaceuticals Zynquista was just a preview of what would come for the SGLT class in Type 1 diabetes. The agency shot down a second drug from the group, AstraZeneca’s Farxiga, the British drugmaker said Monday. Regulators issued a complete response letter for the drug as an add-on to insulin in Type 1 adults whose insulin therapy isn't enough to control their blood sugar levels. AstraZeneca didn’t provide any details about the denial or a timeline for resubmitting its application, saying only that it would work closely with the FDA to discuss next steps. The FDA’s decision is hardly a shocking one, despite a thumbs-up for Farxiga—called Forxiga in Europe—from regulators across the pond earlier this year. The European Commission greenlighted the drug in overweight Type 1 patients, and an AstraZeneca spokesperson said at the time that “We remain confident in the positive benefit-risk profile of dapagliflozin and dapagliflozin-containing products, as outlined in the prescribing information.” The thing is, the European watchdogs also waved through SGLT 1/2 Zynquista, which the FDA nixed on safety concerns. An increased incidence of diabetic ketoacidosis—a potentially life-threatening complication when the body produces high levels of blood acids—seen among trial patients was enough to turn off some expert panelists at an advisory committee meeting. Farxiga—as well as the rest of its SGLT2 brethren—also bears that risk.

Spotlight

According to UPI, a new study found that a vegan diet can help reduce blood sugar and body weight. Men who ate vegan meals saw a boost in their gastrointestinal hormones, which help manage weight. The beneficial gut hormones also enhance insulin secretion, regulate blood sugar, and keep us feeling full longer. The study's lead author said this research "has important implications for those with type 2 diabetes or weight problems." According to the National Institutes of Health, approximately 30 million people in the U.S. have diabetes.


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PHARMACY MARKET

KromaTiD Announces Launch of KromaTiD Pinpoint FISH TP53/CEP17 Kit for Synthetic Oligonucleotide-Based FISH Assay

KromaTiD Inc | January 14, 2022

KromaTiD is excited to announce early access to our KromaTiD Pinpoint FISH TP53/CEP17 Kit, our new product designed to supply the highest resolution, lowest background, and lowest limit of detection available. KromaTiD's Pinpoint FISH™ Kit, allows for better hybridization conditions and eliminating strand degradation steps. Pinpoint FISH™ allows researchers to expand beyond the capabilities of conventional FISH probes to detect smaller targets and design ultra-high specificity tests. Our technology is fully compatible with your standard FISH equipment/conditions and BAC probes and works with your established samples, workflow, and imaging system. "Single-cell genomic measurements from KromaTiD have unique capabilities to analyze and understand the underlying genomic drivers of human disease. Pinpoint FISH has an unmatched resolution, extraordinary ease of use, consistency from analysis to analysis, and an unprecedented ability to distinguish fine genomic structural variation" Dr. Tompkins continues, "While this is the first catalog product from KromaTiD, we have a ten-year history of building a custom assay for Pharma and Biotech companies based on the PPF and dGH platforms. As we begin to build out a comprehensive line of blood cancer measurement kits, we are delighted to bring Pinpoint FISH to a worldwide market". Pinpoint FISH™ is available now from KromaTiD for researchers' use in oligonucleotide-based FISH assays. Christopher Tompkins, KromaTiD's Chief Technology Officer About KromaTiD, Inc. KromaTiD is transforming the fields of genome engineering through the discovery and characterization of genomic structural changes that help leading gene editing and pharmaceutical companies advance therapies to market. KromaTiD offers a powerful suite of products and services for studying genomic rearrangements, custom assay development services and preclinical research support. KromaTiD's proprietary Pinpoint FISH™ and directional Genomic Hybridization platforms (dGHTM) have applications throughout genomics, supplying direct, definitive data on structural variations that no other technologies can provide. We provide the essential genomic structural context to sequence.

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PHARMACY MARKET

Sunovion and Otsuka Initiate Phase 3 Clinical Development of Non-Racemic Amisulpride for the Treatment of People with Bipolar Depression

Sunovion Pharmaceuticals Inc. | February 10, 2022

Sunovion Pharmaceuticals Inc. and Otsuka Pharmaceutical Development And Commercialization, Inc. announced that the first patient has been randomized in SEP380-301, a Phase 3 clinical study evaluating non-racemic amisulpride for the treatment of major depressive episodes associated with bipolar I disorder (bipolar depression). Non-racemic amisulpride is being jointly developed and commercialized as part of a collaboration between Sunovion, its parent company Sumitomo Dainippon Pharma and Otsuka Pharmaceutical Co., Ltd. SEP380-301, named RELEASE 1 is a six-week, global, multicenter, randomized, double-blind, placebo-controlled, parallel-group study examining the efficacy, safety and tolerability of non-racemic amisulpride in adults with bipolar depression. Patients will be randomized to receive fixed-dose, non-racemic amisulpride or placebo. The primary endpoint for RELEASE 1 is the reduction of depressive symptoms, as measured by the change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) total score, compared to placebo, after six weeks of treatment. Following participation in the six-week study period, patients who complete RELEASE 1 may enroll in RELEASE 3, a 12-month, open-label extension study assessing the long-term safety, tolerability and effectiveness of non-racemic amisulpride. “Major depressive episodes associated with bipolar I disorder have a profound impact on those living with the condition. Depressive episodes are associated with mood impairment, fatigue, loss of interest in activities or social situations and, in some cases, suicidality. We are encouraged by our Phase 2 clinical results and look forward to enhancing our understanding of non-racemic amisulpride and its potential to help address unmet needs in the treatment of bipolar depression.” Armin Szegedi, M.D., Ph.D., Senior Vice President, Chief Medical Officer at Sunovion “Randomizing the first patient in the RELEASE Phase 3 clinical development program is a significant step in our collaboration with Sunovion and our shared goal of expanding neuropsychiatric treatment options to patients living with serious mental conditions,” said John Kraus, M.D., Ph.D., Vice President, Clinical Development Therapeutic Head, CNS, Otsuka Pharmaceutical Development & Commercialization, Inc. “Through our collaboration with Sunovion, we hope to advance SEP-4199, which we believe shows promise for the treatment of people with bipolar depression.” About Non-Racemic Amisulpride (SEP-4199) Non-racemic amisulpride is in Phase 3 clinical development for the treatment of major depressive episodes associated with bipolar I disorder (bipolar depression). Non-racemic amisulpride was designed to enhance 5-HT7 receptor antagonist activity and reduce dopamine D2 receptor antagonist activity compared to racemic amisulpride. Lower D2 receptor occupancy associated with non-racemic amisulpride is intended to maintain overall effectiveness for patients with mood disorders, including bipolar depression, while reducing the burden of D2-related side effects, including movement-related symptoms, such as extrapyramidal symptoms and akathisia.1 About Bipolar Disorder Bipolar disorder affects approximately 12.6 million individuals in the United States and an estimated 29 million people worldwide.2,3 A person is usually diagnosed with bipolar disorder after experiencing at least one manic/hypomanic episode, with symptoms that are not better explained by another mental health condition, such as schizophrenia.4 Bipolar disorder is characterized by debilitating mood swings, interspersed with periods of stable mood and behavior.5 When individuals with bipolar disorder are experiencing symptoms, most tend to be depressed rather than manic.4 Bipolar disorder is associated with significant impairment in personal and professional relationships, quality of life and ability to function. About Sunovion Pharmaceuticals Inc. (Sunovion) Sunovion is a global biopharmaceutical company focused on the innovative application of science and medicine to help people with serious medical conditions. Sunovion’s vision is to lead the way to a healthier world. The company’s spirit of innovation is driven by the conviction that scientific excellence paired with meaningful advocacy and relevant education can improve lives. With patients at the center of everything it does, Sunovion has charted new paths to life-transforming treatments that reflect ongoing investments in research and development and an unwavering commitment to support people with psychiatric, neurological and respiratory conditions. Headquartered in Marlborough, Mass., Sunovion is an indirect, wholly-owned subsidiary of Sumitomo Dainippon Pharma Co., Ltd. Sunovion Pharmaceuticals Canada Inc., based in Mississauga, Ontario, is a wholly-owned direct subsidiary of Sunovion Pharmaceuticals Inc. About Otsuka Otsuka Pharmaceutical Co., Ltd. is a global healthcare company with the corporate philosophy: “Otsuka–people creating new products for better health worldwide.” Otsuka researches, develops, manufactures, and markets innovative products, with a focus on pharmaceutical products to meet unmet medical needs and nutraceutical products for the maintenance of everyday health. In pharmaceuticals, Otsuka is a leader in the challenging areas of mental, renal, and cardiovascular health and has additional research programs in oncology and on several under-addressed diseases including tuberculosis, a significant global public health issue. These commitments illustrate how Otsuka is a “big venture” company at heart, applying a youthful spirit of creativity in everything it does. Otsuka established a presence in the U.S. in 1973 and today its U.S. affiliates include Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC) and Otsuka America Pharmaceutical, Inc. (OAPI). These two companies’ 1,700 employees in the U.S. develop and commercialize medicines in the areas of mental health, nephrology, and cardiology, using cutting-edge technology to address unmet healthcare needs. OPDC and OAPI are indirect subsidiaries of Otsuka Pharmaceutical Company, Ltd., which is a subsidiary of Otsuka Holdings Co., Ltd. headquartered in Tokyo, Japan. The Otsuka group of companies employed 47,000 people worldwide and had consolidated sales of approximately USD 13.3 billion in 2020. About Sumitomo Dainippon Pharma Co., Ltd. Sumitomo Dainippon Pharma is among the top-10 listed pharmaceutical companies in Japan, operating globally in major pharmaceutical markets, including Japan, the U.S., China, and other Asian countries. Sumitomo Dainippon Pharma aims to create innovative pharmaceutical products in the Psychiatry & Neurology area, the Oncology area and Regenerative medicine/Cell therapy field, which have been designated as the focus therapeutic areas. Sumitomo Dainippon Pharma is based on the merger in 2005 between Dainippon Pharmaceutical Co., Ltd., and Sumitomo Pharmaceuticals Co., Ltd. Today, Sumitomo Dainippon Pharma has more than 7,000 employees worldwide. Additional information about Sumitomo Dainippon Pharma is available through its corporate

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PHARMA TECH

Therorna completes Series A financing to accelerate pipeline development and clinical transformation of circRNA-based platform

Therorna Inc. | June 21, 2022

Therorna Inc., a China-based biotech company specialized in the development of cutting-edge circular RNA technology-based new vaccines and therapies, announced the completion of a US$42 million Series A financing round. The round was co-led by a well-known industrial investment firm and MSA Capital, with participation from Sherpa Healthcare Partners, 3H Health Investment, and existing investors Quan Capital and Cenova Capital, demonstrating their continuous commitment to supporting Therorna's growth. With the new funding, Therorna plans to accelerate the build-out of its technology platform and the development of its product pipeline, as well as the clinical trials, regulatory applications, and international collaborations. Therorna was founded in Beijing in April 2021. The company focuses on leveraging its proprietary circRNA technology platform to develop next-generation vaccines and innovative therapies. The company has established a strong pipeline of novel prophylactic and therapeutic drugs aiming to address high unmet medical needs. When combined with the previously completed angel and pre-A rounds, the company has to date raised over US$60 million. "We really appreciate the support of our investors. As the world continues to suffer from the COVID-19, scientists are obliged to shoulder the responsibility to provide scientific solutions to end this pandemic. We are devoted to accelerating the clinical application of our circRNA-based vaccines against SARS-CoV-2 and its variants." The scientific founder of Therorna, Professor Wensheng Wei Therorna Chief Executive Officer, Dr. Daniel Tang commented, "I am very grateful for the support of our new and existing investors in this financing round. The successful completion of this round will play a key role in helping Therorna accelerate the development of a new broad-spectrum COVID-19 vaccine and the discovery of additional novel therapies for a variety of diseases. Our team will continue to spare no effort to advance the circRNA platform technology to develop the next-generation of breakthrough therapies and quickly deliver meaningful social benefits." MSA Capital founder and managing partner Yu Zeng added, "We are confident in the potential of circRNA technology for drug development in the area of protein expression and regulation. Compared with linear RNA, circRNA boasts breakthroughs in expression, stability, immunogenicity, and production. In terms of the technology, Chinese scientists have proven their internationally recognized capabilities at innovation and efficient transformation. MSA Capital is impressed by Therorna's strong team of scientists and entrepreneurs. As a serial entrepreneur, Professor Wei has deep expertise in gene editing and circRNA technology application, and Therorna's management team has rich experience in drug R&D and industrial management. MSA Capital will make use of its resources to support the expansion of Therorna in international markets." Sherpa Healthcare Partners investment VP Dr. Changzu Cai said, "mRNA drugs have achieved notable success in the application of COVID-19 vaccines, but challenges in terms of side effects remain to be addressed. Linear RNA is easily degraded and its application beyond vaccines is still under exploration. Thanks to its unique structure, the circRNA as a tool for protein expression has been proven to maintain a relatively stable protein expression level in vivo for a longer time, which is expected to further expand the application scenarios of RNA therapy. The team led by Professor Wei is leveraging their experience in applying circRNA as a gene editing tool to support the development of the circRNA expression tool. The proprietary circularization method developed by Therorna has demonstrated its advantages in terms of dosage, and activation of cellular immunity by being first applied in COVID-19 vaccines. We are pleased to continue supporting the efforts of Wei Lab in converting innovations into benefits for patients and communities, while looking forward to transforming Therorna into a platform-based circRNA technology-focused company with an international presence." 3H Health partner Dr. Minchuan Wang said, "circRNA has better stability and long-lasting expression with a potential for creating a new RNA therapy platform. The combination of Professor Wei's team with strong technical expertise in circRNA and the management team established at an earlier stage of the company with members having rich experience in promoting the adoption of new technologies will help accelerate the clinical transformation of circRNA. We are honored to support Therorna in this financing round, and we will work with the company's team, and their new and existing investors, to help the company assume a leadership role in the realm of circRNA, providing patients with pioneering therapies and addressing unmet clinical needs." Exclusive financial advisor for this transaction and CEC Capital Managing Director, Echo Zhang commented, "circRNA has attracted widespread attention as an emerging technology for RNA drugs. Therorna is expected to take the lead in advancing the technology into clinical applications. We are honored to help Therorna complete this round of financing, and we believe that Therorna will lead the development of the global circRNA sector." About MSA Capital Founded in 2014, MSA Capital is an independent global private equity and venture capital firm with over $2.0 billion under management. The firm manages capital from the world's top sovereign wealth funds, international asset managers, pension funds, university endowments, fund of funds and family offices, as well as China's leading new economy entrepreneurs. MSA actively partners with outstanding entrepreneurs in China and other technology markets to build leading, innovative companies that aim to deliver strong financial returns and meaningful, positive impact. The firm is headquartered in Beijing, with resident teams in Shanghai, Hong Kong, Singapore, Middle East, North Africa and the United States. About Sherpa Healthcare Partners Sherpa Healthcare Partners ("Sherpa") was founded in 2018, the founders previously worked together in one of China's leading venture capital firms, built and led its professional medical investment team since 2011, set up the dedicated healthcare investment fund and responsible for healthcare investment. The founders have been teamed together in close co-operation, built on shared values, mutual trust, and complementary capabilities. Sherpa has now become an influential healthcare VC firm in the industry. Sherpa has invested in leading companies in many key areas, such as Pharma, GeneTech, MedTech and Medical services. From 2011 to 2020, the team has gone through 4 vintage year cycles of multiple U.S dollar funds and RMB funds and made 100 investments. Sherpa has the honor to work with many outstanding entrepreneurs and grow together with them. About 3H Health Investment 3H Health Investment is a Hong Kong and Shanghai based healthcare venture capital firm. It focuses on unmet medical needs and invests in emerging fields of science and medicine to deliver breakthroughs to patients. Leveraging its extensive resources with clinical institutions, industry partners and policy institutes, 3H builds leading innovative healthcare companies together with its partners. About Quan Capital Quan capital is a life sciences venture capital firm with strong China expertise and global capabilities. We discover, incubate, and grow next-generation life science companies in early and growth stage, worldwide. Our portfolio companies pioneer differentiated therapies and enabling technologies to address major human diseases with high unmet medical needs. Quan has offices in Shanghai, Menlo Park and Boston. Our investment professionals combine their strong expertise in both science and business with their diverse experiences in global drug development and healthcare investments, and they leverage their broad network worldwide to help maximize the company's value across geographies and development stages. Visit www.quancapital.com to learn more about us. About Cenova Capital Cenova Capital is one of the earliest healthcare funds dedicated to early and growth-stage investments in the life sciences and healthcare sectors in China. Since inception in 2010, Cenova Capital now has six funds under management with investments in over 80 companies in pharmaceuticals, medical devices,healthcare services and digital heath. Cenova Capital's investors are mainly large domestic and international institutional investors including Asian sovereign wealth investors, government institutions, insurance companies, financial institutions and multinational companies. About CEC Capital CEC Capital is a leading Chinese FA with a focus on the global TMT, consumption and health sectors. In addition to investment banking, CEC Capital is managing a RMB fund and a dollar fund with offices in Beijing, Shanghai, Los Angeles and San Francisco, and it also has a license to the US securities market. The healthcare industry is an advantageous industry that CEC Capital is concerned about. Meanwhile, CEC Capital has the largest and most professional health investment banking team in China with the most complete industry chain.

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BUSINESS INSIGHTS

Agilent Announces the Innovative Seahorse XF Pro Analyzer

Agilent Technologies Inc. | January 25, 2022

Agilent Technologies Inc. announced the release of the Agilent Seahorse XF Pro Analyzer, featuring new pharma-oriented workflow solutions incorporating advanced experimental design and analysis tools. With enhanced performance, more robust and efficient workflows, and an optimized user experience, the XF Pro enables operators at any skill level to access the most advanced cellular metabolism analysis technology for understanding cellular fate, fitness, and function. Preclinical therapeutic discovery workflows place high demands on cellular analysis, with immunology and disease researchers increasingly using rare, ex vivo, and genetically engineered cells to build better disease models. To address the increasing interest in monitoring live cells in real-time, the new XF Pro Analyzer incorporates a suite of hardware and software enhancements that improve measurement performance and data interpretation. These enhancements will make it easier to identify novel drug targets, validate target effect on cellular function, optimize disease models, and determine drug safety and antitumor potential of T cell therapies. “With dedicated workflow solutions the XF Pro provides enhanced performance and customer experience, particularly within pharma and biopharma therapeutic development, and toxicity programs. This underlines Agilent’s commitment towards developing intentional end-to-end solution-focused innovations that continue to lead the way for applied analytical and research applications, including direct metabolic analysis.” Richard Fernandes, associate vice president and general manager of Agilent’s Cell Analysis, Seahorse, Luxcel, and microplates businesses "The launch of the XF Pro is very much a customer-driven event. Through collaboration and intentional conversations with our customers and key opinion leaders, we recognized the need for a live-cell metabolic analysis platform which makes sophisticated analysis even more accessible for both experienced users as well as novices,” added Chris Braun, associate vice president of Marketing for Agilent’s Cell Analysis Division. “Primarily targeting the pharma/biopharma sector, but beneficial to all our customers, the XF Pro incorporates critical metabolic insights into researchers’ discovery workflows to facilitate even higher quality data where it matters most.” The XF Pro Analyzer is expected to enhance critical aspects of live-cell analysis, particularly for researchers working in immunotherapy, early drug discovery, and preclinical safety assessment. By delivering better precision at a low oxygen consumption rate (OCR), the XF Pro Analyzer allows analysts to confidently interrogate more immune cell types, as well as cell types that are bioenergetically compromised. The instrument also features pharma-tailored workflows for harnessing robust cellular metabolism measurements while handling suspension cell types, along with simplified automation enablement and analytical instrument qualification (AIQ). About Agilent Technologies Agilent Technologies Inc. is a global leader in the life sciences, diagnostics, and applied chemical markets, delivering insight and innovation that advance the quality of life. Agilent’s full range of solutions includes instruments, software, services, and expertise that provide trusted answers to our customers' most challenging questions. The company generated revenue of $6.32 billion in fiscal 2021 and employs 17,000 people worldwide.

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Spotlight

According to UPI, a new study found that a vegan diet can help reduce blood sugar and body weight. Men who ate vegan meals saw a boost in their gastrointestinal hormones, which help manage weight. The beneficial gut hormones also enhance insulin secretion, regulate blood sugar, and keep us feeling full longer. The study's lead author said this research "has important implications for those with type 2 diabetes or weight problems." According to the National Institutes of Health, approximately 30 million people in the U.S. have diabetes.

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