BUSINESS INSIGHTS

Breckenridge Signs New-Product Agreement with PTS Pharma

Breckenridge Pharmaceutical, Inc. | April 23, 2022

Breckenridge Signs
Breckenridge Pharmaceutical, Inc. announces today that it has signed a new-product agreement with PTS Pharma, LLC. under which PTS will support a technology transfer to Towa Pharmaceutical Europe, S.L. of a complex "For Suspension" product developed by PTS.  The remainder of development and commercialization will be performed at the Towa facility.  According to industry sales data, the product and its generics had annual sales of approximately $75 million during the twelve months ending February 2022. The companies are actively negotiating and look forward to collaborating on additional complex formulations under the same business model.

About Breckenridge
Breckenridge Pharmaceutical, Inc., a subsidiary of Towa Pharmaceutical, partners with manufacturers nationwide and around the world to bring quality, cost-effective generic pharmaceuticals to U.S. patients.  With our dedication to customer service, on-time delivery, reliable supply and quality manufacturing, we improve the health and quality of life of the patients we and our customers serve.

About PTS Pharma, LLC
PTS Consulting, LLC and PTS Pharma LLC., is a formulation development, clinical trial production, regulatory services and analytical control laboratory based in Kansas.  PTS Consulting is actively involved in regulatory consulting services. PTS Pharma operations include the capability and expertise to develop complex formulations of tablets, capsules, granules, modified dosage forms, topical dosage forms, suppositories, film products, solution, and suspension formulations and sterile injectables, with involvement in multiple aNDA and NDA filings over the years.   The activities are housed in dedicated GMP suites in the facility in Kansas City, USA. PTS Pharma is also involved in active raw material clinical production by fermentation technology processes. The firm was founded in 2003 by Paul Sudhakar, an industry veteran who is the Owner, President, and CEO of the firm.

Spotlight

AstraZeneca’s Global Medicines Development unit transforms clinical concepts into medicines that deliver patient health benefits. Here’s how they do it. Each patient battling a disease or managing a chronic condition lives in the hope that tomorrow will bring a new medicine that delivers better health. America’s biopharmaceutical research companies share the same goal, constantly developing new medicines that can prevent diseases, improve patients’ health, and save lives.


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BUSINESS INSIGHTS

NextRNA Launches with $56 Million in Funding to Bring Transformative Non-Coding RNA-Directed Medicines to Patients

NextRNA Therapeutics | March 02, 2022

NextRNA Therapeutics, a biotechnology company unlocking the potential of non-coding RNAs to develop transformative therapeutics, announces its launch with $9.3 million in seed financing and a $46.8 million Series A led by Cobro Ventures and Lightchain Capital, with additional participation from Circle Alternative Investments, Evans Capital, Jefferies, Rivas Capital, and Willett Advisors. Proceeds will be used by the company to augment its target and drug discovery engine, expand its pipeline, and advance lead programs. The vast majority of DNA is copied into RNAs that do not make proteins. These RNA molecules, called “non-coding RNAs,” play essential roles in cells by interacting with and modulating the activities of proteins. These interactions can drive pathogenic processes in multiple disease areas, including oncology, immunology, and neurology. Non-coding RNAs, in particular long non-coding RNAs, and their interacting proteins therefore represent a vast and untapped class of novel therapeutic targets. “NextRNA is uniquely positioned to be the leader in non-coding RNA-directed medicines. We have established a robust target and drug discovery engine to systematically identify disease-relevant long non-coding RNAs and their interacting proteins. By developing selective small molecules to drug these interactions, we plan to translate discoveries of non-coding RNA targets into a robust pipeline of transformative therapies across multiple disease areas.” Dominique Verhelle, Ph.D., MBA, co-founder, chief scientific officer, and interim chief executive officer, NextRNA NextRNA was established based on pioneering work by Carl Novina, M.D., Ph.D., at Dana-Farber Cancer Institute. “By understanding the interactions between long non-coding RNAs and specific proteins, we can decode the function of long non-coding RNAs and apply it to create medicines,” said Dr. Novina, co-founder of NextRNA. Since its founding in January of 2021, NextRNA has established its initial team, built out the target and drug discovery engine, and advanced two small molecule programs in oncology and immunology. “NextRNA is at the forefront of innovation in the field of non-coding RNAs,” said Todd Kaloudis, Managing Director at Cobro Ventures. “There is growing excitement around the potential of non-coding RNA-directed medicines, and we are pleased to have such an experienced team focused on NextRNA’s vision of bringing transformative therapies to patients.” About NextRNA Therapeutics NextRNA is a biotechnology company with a mission to translate pioneering science into transformative therapeutics for the benefit of patients. The company is leveraging its proprietary technology platform to systematically identify disease-relevant non-coding RNAs and their interacting proteins, and to develop selective small molecules to drug these interactions. NextRNA investors include Cobro Ventures, Lightchain Capital, Circle Alternative Investments, Evans Capital, Jefferies, Rivas Capital, and Willett Advisors.

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The Danish National Genome Center Partners with Lifebit to Deliver Nationwide Personalised Medicine

Lifebit Biotech | April 29, 2022

Lifebit, whose leading technology enables secure analysis over sensitive datasets for researchers and interconnects such large patient cohorts worldwide, today announces a long-term partnership with the Danish National Genome Center (NGC). Lifebit will deploy Lifebit CloudOS to create a Federated Trusted Research Environment within the Danish NGC's supercomputing cluster to serve as the scalable and secure data management and analysis platform for Denmark's national researchers, clinical scientists and international collaborators. The Danish NGC, a government agency and authority within the Danish Healthcare system, was created to implement the Danish Government's National Personalised Medicine Strategy. The core vision of the NGC is to develop more precise diagnosis, targeted treatment and strengthen research within the Danish healthcare system. During the first phase of the strategy, the Danish National Genome Center and its collaborators will recruit and sequence whole genomes of 60,000 patients diagnosed with cancer, autoimmune disorders and rare diseases by 2024. The platform will deliver a next-generation computational infrastructure within Denmark's on-premise supercomputing center, allowing the NGC to meet its vision of establishing and operating a state-of-the-art national infrastructure for personalised medicine while keeping the data at all times in the secure national infrastructure. Only Lifebit with both its genomic data expertise as well as its internationally proven ability of managing such complex Government environments through its patented operating system Lifebit CloudOS was deemed capable to deliver this project. The platform will thus enable researchers with secure access, querying and analysis of this sensitive clinico-genomic data in a fully scalable and flexible way; also allowing for them to collaborate at a global scale. Federation will play a crucial role in enabling the future possibility to collaborate with international partners such as Genomics England, France Genomique, Genomic Medicine Sweden and other biobanks from around the world. Virtually connecting these sensitive datasets, enabling joint analysis that is however performed in situ without moving data, can lead to exponentially higher research findings. In some cases, it can be observed that increasing the number of patients in a study by 10x led to ~100x the number of scientific findings and genomic associations making clear how important real connectivity of these datasets is. "Lifebit continues to guide and power the world's largest national and private precision medicine programmes. We are extremely proud to be delivering this flagship programme for the nation of Denmark. This Federated Trusted Research Environment will enable researchers to more effectively collaborate over this rich dataset at scale and drive international collaboration between other government initiatives - many of which already leverage Lifebit's federated technology." Thorben Seeger, Chief Business Development Officer at Lifebit Other examples of Lifebit's data platform at work include Genomics England, NIHR Cambridge and the Hong Kong Genome Institute. About Lifebit Biotech, Ltd. Lifebit builds enterprise data platforms for use by organisations with complex and sensitive biomedical datasets. Lifebit's patented federated technology securely unlocks access to biomedical data. From providing Trusted Research Environments for national precision medicine programmes to enabling pharmaceutical companies to discover new drug targets faster, Lifebit empowers customers to transform how they leverage sensitive biomedical data.

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BUSINESS INSIGHTS

GNS Healthcare and Arvinas Enter into Neuroscience Drug Discovery Collaboration

GNS Healthcare | May 10, 2022

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.

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MEDITECH Wins Google Cloud Industry Solution Partner of the Year Award for Healthcare

MEDITECH | June 15, 2022

MEDITECH announced that it has received the 2021 Google Cloud Industry Solution Partner of the Year award for Healthcare. MEDITECH was recognized for its achievements in the Google Cloud ecosystem, helping joint customers to develop systems that complement their EHR with scalable, secure data storage and access. Built to harness Google Cloud for patient data storage and access, provider mobility, and organizational efficiency, MEDITECH Expanse encompasses a growing suite of solutions that deliver innovative, cost-effective healthcare technology. The company also deployed MEDITECH Cloud Platform, a set of new applications including Expanse Patient Connect, Expanse Now, Virtual Care, and High Availability SnapShot that provide providers and patients with a better, more mobile healthcare experience. “We’re proud to recognize MEDITECH as our Industry Partner of the Year for Healthcare, based on their deep knowledge and evident experience in helping customers across the healthcare industry succeed,” said Bronwyn Hastings, VP of Global ISV Partnerships and Channels, Google Cloud. “MEDITECH has demonstrated strong technical and service capabilities over this past year, and we look forward to expanding our work together to help healthcare organizations digitally transform their businesses.” Most recently, MEDITECH released Expanse Ambulatory for independent physician practices, representing its entry into a new segment of the healthcare market and leveraging Google Cloud to deliver an intuitive cloud-based practice management solution to more organizations. MEDITECH maintained a strong pace of new customer signings and solution deployments that further expanded its reach and bolstered the company’s reputation as a proven partner for health systems of all sizes. Propelled by the deployment of new solutions such as Ambulatory and impressive sales of the cloud-based MEDITECH as a Service (MaaS) deployment model, MEDITECH secured the second-largest market share growth in the EHR space in 2021. The company’s continued market growth in the large hospital segment again earned plaudits from the global healthcare research firm KLAS, which ranked MEDITECH Expanse #1 in Acute Care EMR (Community Hospital), Patient Accounting & Patient Management, and Home Health EHR. “Our embrace of Google Cloud-powered solutions is a further evolution of MEDITECH’s stance that the time for incremental change is over. We have set out to redefine what an EHR can be,” said MEDITECH Vice President Scott Radner. “We are honored to be recognized by Google Cloud for creating healthcare solutions that ensure faster development, lower costs, and better health outcomes. Our goal is to help healthcare organizations realize tomorrow’s possibilities, today.” About MEDITECH MEDITECH empowers healthcare organizations around the world to expand their vision of what’s possible with Expanse, the intuitive EHR setting new standards for usability, efficiency, and personalization. Our agile innovation is advancing the productivity of busy clinicians in 23 countries, driving positive clinical outcomes and patient experiences. MEDITECH solutions span every care setting, from acute centers and ambulatory practices, to home health and hospice, long-term care and behavioral health facilities, outpatient services, patients’ homes and beyond. Expand your possibilities.

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Spotlight

AstraZeneca’s Global Medicines Development unit transforms clinical concepts into medicines that deliver patient health benefits. Here’s how they do it. Each patient battling a disease or managing a chronic condition lives in the hope that tomorrow will bring a new medicine that delivers better health. America’s biopharmaceutical research companies share the same goal, constantly developing new medicines that can prevent diseases, improve patients’ health, and save lives.

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