BUSINESS INSIGHTS

GNS Healthcare and Arvinas Enter into Neuroscience Drug Discovery Collaboration

GNS Healthcare | May 10, 2022

GNS Healthcare
GNS Healthcare, the leader in the use of "Virtual Patients", Causal AI and simulation technology for biopharmaceutical companies, today announced a collaboration with Arvinas, Inc. (Nasdaq: ARVN), a clinical-stage biotechnology company creating a new class of drugs based on targeted protein degradation, to generate insights to help accelerate drug development for neurodegenerative diseases.

Every year more than six million patients in the United States alone are diagnosed with Alzheimer's, Parkinson's, and Huntington's diseases. These diseases are chronic, debilitating and there is substantial heterogeneity in the presentation of the symptoms and the rates of their progression among patients. The GNS Gemini Virtual Patient models help discover and unravel the complex biological circuitry of the diseases and predict patient response, which can help biopharmaceutical companies accelerate the discovery and development of new therapeutic options for patients.

Under the terms of the agreement, Arvinas will leverage GNS' Gemini Virtual Patient models to better understand the biology of the underlying disease, how it progresses, and how potential drugs might perform at the individual patient level. This will help Arvinas researchers discover and prioritize novel drug targets and drug candidates, simulate clinical trials to better understand drivers of diseases for various clinical outcomes, better select patients for clinical trials, and help determine which treatments are most effective for given patient types.

"We believe this collaboration will provide novel insights and will help us understand the underlying mechanisms of complex neurodegenerative diseases to inform our discovery and development efforts with the aim of improving patient outcomes."

Angela Cacace, Ph.D., Senior Vice President of Neuroscience & Platform Biology at Arvinas

"We are committed to supporting the critical work Arvinas is doing to discover and develop breakthrough therapies that help patients who suffer from these conditions," said Joseph F. Donahue, Chief Business Officer at GNS Healthcare. "These diseases impact so many families and we are proud to be able to help contribute to potential treatments that lead to better outcomes for them."

About Arvinas
Arvinas is a clinical-stage biotechnology company dedicated to improving the lives of patients suffering from debilitating and life-threatening diseases through the discovery, development, and commercialization of therapies that degrade disease-causing proteins. Arvinas uses its proprietary PROTAC® Discovery Engine platform to engineer proteolysis targeting chimeras, or PROTAC® targeted protein degraders, that are designed to harness the body's own natural protein disposal system to selectively and efficiently degrade and remove disease-causing proteins. In addition to its robust preclinical pipeline of PROTAC® protein degraders against validated and "undruggable" targets, the company has three clinical-stage programs: bavdegalutamide and ARV-766 for the treatment of men with metastatic castration-resistant prostate cancer; and ARV-471 for the treatment of patients with locally advanced or metastatic ER+/HER2- breast cancer.

About GNS Healthcare
GNS Healthcare is the leader in the application of Causal AI and simulation technology to help pharmaceutical and biotech companies discover and develop new medicines faster.  GNS' patented AI uncovers new insights from multi-omic and real-world data leading to the discovery and prioritization of novel biological targets, more efficient clinical trials, and patients who are likely to respond to therapies. The Gemini Virtual Patient models across oncology, auto-immune diseases, and neurology allow researchers and data scientists to simulate clinical trials, disease progression and drug response at the individual patient level in diverse patient cohorts. GNS' partners include seven out of the top ten pharmaceutical companies, leading research centers, medical societies, and patient advocacy groups globally, and our advisory board consists of a renowned group of scientific and medical experts.

Spotlight

INC Research and inVentiv Health merge to become the only fully integrated biopharmaceutical solutions organization, creating better, smarter, faster ways to help clients navigate an increasingly complex marketplace. Creates a Leading Global Biopharmaceutical Solutions Organization with Combined Net Revenue of More Than $3.2 Billion. Combined Company Will Be Second Largest Biopharmaceutical Outsourcing Provider, One of the Top 3 Contract Research Organizations and the Largest Contract Commercial Organization by Net Revenue Comprehensive Suite of End-To-End Solutions to Support Development and Commercialization of Biopharmaceutical Compounds and Biologics Complementary and Diversified Customer Base with Leadership in Large, Mid-Sized and Small Biopharma. Transaction Estimated to Realize Approximately $100 Million in Annual Run-Rate Cost Synergies and Projected to be Accretive to Adjusted EPS.


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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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BUSINESS INSIGHTS

Deargen Annonuces Patent Application for a TNBC Target Novel Drug Candidate Using AI

Deargen Inc. | December 23, 2021

Deargen, a company specializing in the development of novel NCE drugs using artificial intelligence, announced on the 22rd that it had discovered and synthesized a new anticancer target compound using its own AI platform and had already applied for a patent for it. Deargen has the technology to predict candidates for a novel drug without the 3D structure data of proteins. Deargen's technology, which uses amino acid sequence data rather than the structure information of proteins, possesses global-level differentiated artificial intelligence technology that enables the rapid development of novel drugs even for proteins whose 3D structure has not yet been identified. "The new compound for which we have applied for a patent this time is a first-in-class candidate, and we plan to develop a therapeutic agent targeting triple-negative breast cancer. TNBC is an area where there are few novel drugs available and it is difficult to find innovative targets, so it is a disease with a high demand for new therapeutics…Deargen confirmed the efficacy of the new compound discovered through in-vitro experiments." An official from Deargen Also, the substance that Deargen discovered through this study is an NCE. An NCE refers to a new chemically synthesized drug, which requires a great deal of time and money because it is difficult to develop such a drug that has not been previously approved by the FDA. However, it is within an area with high needs by many global pharmaceutical companies as it has the advantage of being able to receive market monopoly rights for 5 years in the U.S. and 10 years in Europe after product approval. In particular, Deargen's achievements are significant in that it discovered the new compound in a shorter time than the existing novel drug discovery process through its collaboration of advanced AI and in-house experts for novel drug development. The target discovery and substance design process, which usually takes about 3 to 4 years in the existing traditional drug development process, was carried out in just 10 weeks, and it took merely 2 weeks for target discovery and 8 weeks for substance design and synthesis. Currently, Deargen is establishing a large-scale R&D center. With this R&D center, the plan is to further shorten the period of the discovery of candidates by efficiently managing the time required for designing and synthesizing substances. The R&D center will be in charge of fast verification of substances by conducting the design and synthesis verification of substances under joint research with Deargen's internal pipeline, along with the production of high-quality data. Daniel Bae, Chief Business Officer of Deargen said : "We plan to continuously derive new substances with patentability through our synthesis research center, which will be established in the first half of next year. We plan to not only build our own pipeline centered on anticancer drugs, but also to introduce various business models with our partners that go beyond the existing joint research contracts." He also said, "Deargen plans to establish its position among global AI drug developers as a company specializing in NCE drug development, from target discovery to compound design and synthesis." About Deargen Inc. Established in December 2016, Deargen is an AI-based drug discovery and development company. In February 2020, the company released study results on predicting the development of COVID-19 treatments. Candidate compounds for treating COVID-19 predicted by Deargen include remdesivir, which was first approved as an emergency therapy. The company conducts research on and owns core AI technologies in-silico, such as 'prediction of bio-markers', 'selection of disease targets', and 'extraction of candidate substances for new drugs', utilizing techniques of meta analysis of genome big data and its unique AI technologies. Building on these outcomes, the company is developing new drugs in collaboration with multiple pharmaceutical companies and research institutions, demonstrating its outstanding technology capabilities as being named as top awardees at the ILSVRC, a world-prominent deep-learning competition, and Dream Challenge, an international AI-based new drug development competition.

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PHARMA TECH

CSL Limited announces tender offer to acquire Vifor Pharma Ltd

Vifor Pharma Group | December 15, 2021

Global biotechnology leader CSL Limited and Vifor Pharma Ltd, a global specialty pharmaceutical company with leadership in iron deficiency, nephrology & cardio-renal therapies, announced that they have entered into a definitive agreement for CSL to acquire Vifor Pharma for an aggregate equity value for Vifor Pharma of US$ 11.7 / CHF 10.9 billion. CSL has offered to acquire Vifor Pharma in an all-cash tender offer of US$179.25 per share, payable in U.S. dollars.1 The offer assumes a dividend of CHF 2 expected to be declared at the AGM of 26 April, consistent with past practice. The tender offer represents an implied premium of approximately 61% to the unaffected closing price of Vifor Pharma on 1 December 2021 and a 47% premium to Vifor Pharma’s unaffected 1-month VWAP as of 1 December 2021.2 Patinex AG, Vifor Pharma’s largest shareholder holding 23.2% has agreed to tender its shares into the offer. The Transaction remains subject to the conditions and further terms including: Minimum acceptance rate of 80% of all Vifor Pharma shares on a fully diluted basis; and further customary offer conditions, including regulatory approvals. The tender is currently expected to commence around 18 January 2022 and the transaction is expected to complete around mid-2022. The Board of Directors of Vifor Pharma considers that the proposed transaction respects the interests of all stakeholders and is unanimously recommending the offer to shareholders. There is committed financing for the deal and a strong commitment to pursue regulatory clearances. “Vifor Pharma's strategy has been to focus towards continuing being a market leader in iron deficiency, nephrology and cardio-renal therapies. The offer provides an excellent strategic opportunity for Vifor Pharma to optimize future market opportunities from a position of strength and to create substantial value for all stakeholders.” Jacques Theurillat, Chairman of the Board of Directors Vifor Pharma Group The transaction will enable Vifor Pharma to leverage CSL’s global reach, balance sheet and capabilities to bring more products to patients within its key categories. The transaction also enables Vifor Pharma to accelerate growth in cardiovascular-metabolic, renal and transplant. Centerview Partners UK LLP is acting as exclusive financial advisor to Vifor Pharma on the transaction. IFBC have been retained as Fairness Opinion providers by the Vifor Pharma Board of Directors. About Vifor Pharma Group Vifor Pharma Group is a global pharmaceuticals company. It aims to become the global leader in iron deficiency, nephrology and cardio-renal therapies. The company is a partner of choice for pharmaceuticals and innovative patient-focused solutions. Vifor Pharma Group strives to help patients around the world with severe and chronic diseases lead better, healthier lives. The company develops, manufactures and markets pharmaceutical products for precision patient care. Vifor Pharma Group holds a leading position in all its core business activities and consists of the following companies: Vifor Pharma and Vifor Fresenius Medical Care Renal Pharma Vifor Pharma Group is headquartered in Switzerland, and listed on the Swiss Stock Exchange About CSL CSL is a leading global biotechnology company with a dynamic portfolio of life-saving medicines, including those that treat hemophilia and immune deficiencies, as well as vaccines to prevent influenza. Since our start in 1916, we have been driven by our promise to save lives using the latest technologies. Today, CSL — including our two businesses, CSL Behring and Seqirus- provides life-saving products to more than 100 countries and employs more than 25,000 people. Our unique combination of commercial strength, R&D focus and operational excellence enables us to identify, develop and deliver innovations so our patients can live life to the fullest.

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BUSINESS INSIGHTS

Adalvo Partners With SK Pharma to Create Arphio, a New Business Entity Dedicated Solely to Orphan and Rare Disease Medicines

Adalvo | March 01, 2022

Adalvo, the leading global B2B pharmaceutical company, is thrilled to announce the recent establishment of a new entity ArphioTM a venture initiated in close collaboration with SK Pharma. Together with our new partner, we are developing a powerhouse, solely dedicated to orphan drugs with the intention of improving accessibility of vital treatments, to patients suffering from rare diseases and unmet medical needs. ArphioTM will operate as an independent entity, focusing on rare disease detection, market access and supply of orphan drugs, targeting the EU and ROW regions. ArphioTM has a unique understanding on orphan products and their epidemiology data and unique characteristics. The aim of this venture is to expand access to vital treatments and continue to develop technological capabilities and expertise, while maintaining a patient-centric approach with the possibility of relying on state-of-the art novel technology including worldwide data, artificial intelligence, and machine learning. Arphio is founded by pharmaceutical professionals with expertise covering all major therapeutic areas and pharmaceutical forms in various parts of the globe. The company is focused on rare disease detection, market access and the supply of orphan drugs internationally. Arphio is powered by DrugsIntel (DI), a data science powerhouse focusing on the aggregation, unleashing, processing, unification and deployment of pharmaceutical data covering over 75 countries, and over 6,000 sources. This intelligence tools ensure the successful launch of orphan drugs in the market of operation, based on DI’s unique methodology of these Six factors and Pillars. This stand-alone market player will cover all services and functions ranging from medical, market access, regulatory, direct sales, and marketing activities. ArphioTM proudly boasts of strictly following ethics, compliance, accessibility, and corporate governance. There are over 300 million people living with one or more of over 7,000 identified rare diseases around the world, each supported by family, friends, and caregivers. Currently, only about 5% of orphan disorders can be managed with an approved treatment. It is estimated that it takes about seven years and visits to 10 different doctors for a patient to receive a proper diagnostic of an orphan condition. At ArphioTM, fueled by our passion to improve people’s lives, we will apply innovative technologies to provide effective treatments for people with orphan diseases. Anil Okay, General Manager at Adalvo comments: “We are thrilled to be partnering with SK Pharma on this exciting new journey. We welcome this opportunity to work in the domain of Orphan drugs, and we are eager to make a valuable contribution to patients across the globe who are living with Rare diseases”. “I’m captivated to have Adalvo as our partner with the important endeavor of helping neglected orphan patients and their caregivers with their unmet medical needs. I’m bullish on the synergistical power that could outcome from this collaboration for the benefit of rare disease patients". Dr. Shlomo Sadoun, CEO at SK Pharma About Adalvo Adalvo is a global pharmaceutical company, and one of the leading B2B pharmaceutical companies in Europe, with commercial partnerships in more than 70 countries and for over 90 commercial partners globally. The company’s declared purpose is to make a difference for patients all over the world, driven by our smart collaboration network and commitment to delivering highest quality differentiated products and services to our partners. With headquarters in Malta, the company has additional offices in more than 15 countries such as Switzerland, UK, Netherlands, Spain, Iceland, Austria, Romania, Hungary, Bulgaria, Portugal, Czech Republic, and India. At Adalvo, we know that our partners like to be bigger, better, and smarter in the dynamic pharmaceutical sector. That’s why our approach is unique, customized to our partners, and is designed to challenge the status quo: together, this helps our partners achieve their business goals. We take pride in our ability to help its partners reach their goals – be those increasing revenues or pushing into new markets. While partners are a high priority, Adalvo is also committed to its purpose and mission to accelerate the growth and development of employees and local communities. Adalvo tirelessly strives for excellence in all of its endeavors, driven by a deep-rooted passion to making a difference for partners. The company’s purpose driven culture is committed to improving the lives of patients around the world. Our dynamic leadership team brings significant experience and industry know-how to Adalvo, which has helped to establish the company as a reliable global partner. About SK Pharma SK-Pharma is a global pharmaceutical company focusing on making drugs accessible to patients in needs. The vison of the company lay in utilizing cutting edge technologies to support smart business decisions that will lead to better healthcare solutions. Taking patient centric approach, the company holistically follow the patient’s journey and understand better their unmet needs. Mimicking the patient journey allow us to come with viable solutions that change the patient treatment paradigm and make it more suitable to their lifestyle and their unique needs. The group is divided to three divisions: First to launch and the introduction of complex hybrid generic products. The second division is focusing on providing technological solutions to enhance smart business decisions. The third division is specialized in orphan drugs market access and distribution worldwide.

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Spotlight

INC Research and inVentiv Health merge to become the only fully integrated biopharmaceutical solutions organization, creating better, smarter, faster ways to help clients navigate an increasingly complex marketplace. Creates a Leading Global Biopharmaceutical Solutions Organization with Combined Net Revenue of More Than $3.2 Billion. Combined Company Will Be Second Largest Biopharmaceutical Outsourcing Provider, One of the Top 3 Contract Research Organizations and the Largest Contract Commercial Organization by Net Revenue Comprehensive Suite of End-To-End Solutions to Support Development and Commercialization of Biopharmaceutical Compounds and Biologics Complementary and Diversified Customer Base with Leadership in Large, Mid-Sized and Small Biopharma. Transaction Estimated to Realize Approximately $100 Million in Annual Run-Rate Cost Synergies and Projected to be Accretive to Adjusted EPS.

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