GSK launches PhIII programme for otilimab in RA

pharmatimes | July 04, 2019

GSK has kicked off a Phase III clinical development programme testing otilimab in patients with moderate to severe rheumatoid arthritis (RA) who have had an inadequate response to disease modifying antirheumatic drugs (DMARD) or targeted therapies. The move follows a successful Phase II study with the investigational anti-granulocyte macrophage colony-stimulating factor (anti GM-CSF) monoclonal antibody last year. The data, said Dr Hal Barron, chief scientific officer and president of R&D at GSK, showed “encouraging clinical benefits” in patients treated with the drug. “The unique Phase III studies, designed in consultation with regulators, will help us understand how this potential new medicine could benefit appropriate patients living with rheumatoid arthritis.” The Phase III clinical programme (ContRAst) is the first in RA to include head-to-head comparisons of otilimab with current treatments across all pivotal studies. It compares the drug against two treatments with different modes of actions: tofacitinib (a Janus Kinase (JAK) inhibitor) and sarilumab (an anti-IL6). The programme – which comprises three pivotal studies and a long-term extension once – will also include a broad range of difficult-to-treat patients who have had an inadequate response to or have been unable to tolerate currently available treatments. Dosing of the first patient will trigger a milestone payment of 22 million Euros to MorphoSys, from which GSK licensed rights to the drug in 2013.

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Data integrity is a fundamental element of ensuring compliance in a regulated laboratory and is not a new concept - it dates back decades. However, with computerized laboratory systems now taking the place of paper systems, your compliance strategy must adapt, or you risk difficult regulatory inspections.


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Breckenridge Signs New-Product Agreement with PTS Pharma

Breckenridge Pharmaceutical, Inc. | April 23, 2022

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.

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Oramed Completes Patient Enrollment in Phase 2 Oral Insulin NASH Trial

Oramed Pharmaceuticals Inc. | March 17, 2022

Oramed Pharmaceuticals Inc. a clinical-stage pharmaceutical company focused on the development of oral drug delivery platforms, announced it has completed enrollment of all patients in a Phase 2 trial of its oral insulin capsule ORMD-0801 for the treatment of non-alcoholic steatohepatitis. An estimated 1.5% to 6.5% of adults in the U.S., or between 4 million and 17 million people, have NASH and about half of these also have diabetes, according to the National Institute of Diabetes and Digestive and Kidney Diseases. The double-blind, multi-center trial with clinical sites in the U.S. and Israel is assessing the safety and potential efficacy of ORMD-0801 in Type 2 diabetes patients with NASH. Efficacy endpoints including safety and percentage change in liver fat content, liver fibrosis, and liver steatosis from baseline are measured via MRI-PDFF following 12 weeks of dosing. "There is currently no drug approved to treat this disease, leaving NASH with a serious unmet medical need. With direct action on the liver, we believe that ORMD-0801 has the potential to address over 50% of people with diabetes who also suffer from NASH, a population with unfortunately increased mortality. We look forward to analyzing and reporting topline data, which we expect will confirm our prior pilot study's efficacy and safety results," Oramed Chief Executive Officer, Nadav Kidron The global market for drugs to treat NASH is expected to reach $84 billion by 2029, according to a publication by Research and Markets on the Global Non-Alcoholic Steatohepatitis (NASH) Drugs Market. About NASH Non-alcoholic steatohepatitis is a serious, progressive liver disease caused by a buildup of fat in the liver and accompanied by inflammation, liver cell damage, and in some cases, scarring of the liver. Over time, NASH may progress to cirrhosis, liver cancer, liver failure, and even death. Currently, no pharmacotherapy is globally approved for the treatment of NASH, and people with NASH are left with very few treatment options. About Oramed Pharmaceuticals Oramed Pharmaceuticals is a platform technology pioneer in the field of oral delivery solutions for drugs currently delivered via injection. Established in 2006, with offices in the United States and Israel, Oramed has developed a novel Protein Oral Delivery (POD™) technology. Oramed is seeking to transform the treatment of diabetes through its proprietary lead candidate, ORMD-0801, which is being evaluated in two pivotal Phase 3 trials and has the potential to be the first commercial oral insulin capsule for the treatment of diabetes. In addition, Oramed is developing an oral GLP-1.

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Basetwo Launches No-Code Artificial Intelligence Platform for Pharmaceutical Manufacturing, Raises $3.8 Million

Basetwo | May 27, 2022

Basetwo, a SaaS AI platform for manufacturers, announced it secured a $3.8M seed round led by Glasswing Ventures and Argon Ventures with additional funding from Caffeinated Capital, Graphite Ventures, MaRs IAF, Pareto Holdings, Plug and Play, and Quiet Capital. The funding supports the launch of the category-making Basetwo AI platform, a first-of-its-kind solution that enables process engineers to rapidly build digital twins of their manufacturing plants leveraging a familiar no-code interface. Basetwo promotes the digitalization of manufacturing systems to foster intelligent manufacturing across the global supply chain. Basetwo intends to be the default platform for continuous improvement in the current Good Manufacturing Process (cGMP), beginning with the pharmaceutical market and expanding to the food and beverage and chemical markets. The pharmaceutical manufacturing market has been challenged in the past two years due to the pandemic and associated supply chain issues. In addition, the rate of drug development and demand for pharmaceuticals has increased at an unprecedented rate, fueled by technological and economic advancement globally. However, manufacturing optimization to meet this demand is still rudimentary and inadequate to meet today’s and future needs. According to ABI Research the pharma industry is predicted to spend over $4.5 billion on digital transformation by 2030, growing at a CAGR of 27%. In addition, the market for digital twins is forecasted to reach $35.5 billion by 2026, a 37% CAGR, according to a recent ResearchandMarkets report, primarily driven by the growing applications of digital twin technology in the pharmaceutical and healthcare industries. Basetwo’s platform powered by “physics-informed machine learning” is well suited for pharmaceutical manufacturing. The Company’s no-code approach brings highly sophisticated capabilities from pre-built models to data pipelines and integrations within a complex manufacturing process to a format familiar to process engineers. Basetwo's ability to predict and understand manufacturing processes improves as more data is gathered, improving return on investment over time. “The introduction of our no-code AI platform lets manufacturers of any size leverage the power of the Internet of Things (IoT) and machine learning (ML) to develop digital twins easily, quickly, and economically. We are excited to have the backing and the expertise from Glasswing Ventures, Argon Ventures, and all our investors as we scale the business.” Thouheed Abdul Gaffoor, Co-Founder and CEO of Basetwo Having previously co-founded and exited Emagin, an AI startup in the heavy industry, Thouheed has seen first-hand the challenges that manufacturers face with maximizing value from machine learning initiatives. To address this challenge, Thouheed left his previous role as Head of AI at Autodesk, and partnered with Thamjeeth Abdul Gaffoor, who co-founded and served as the CFO at Emagin, Tawfeeq Abdul Gaffoor, former Software Engineer at Lyft and Databricks, and Kiefer Eaton, a pharmaceutical industry specialist from Johnson & Johnson. Together, the Basetwo founding team brings deep domain expertise in manufacturing, technology, and pharmaceuticals. “The pharmaceutical manufacturing market is at a critical point, having been heavily challenged by the pandemic and supply chain issues. By creating a digital duplicate of a pharmaceutical manufacturing plant, the Basetwo AI platform allows process engineers to analyze where things might break down — or run more efficiently, and increase resilience,” said Rudina Seseri, Founder and Managing Partner of Glasswing Ventures. “As a category maker, Basetwo has delivered a revolutionary AI-based no-code solution that enables manufacturers to use digital twins for optimization. We anticipate that Thouheed and his team will disrupt the status quo in manufacturing and affect significant change in the industry.” About Basetwo Basetwo is the first no-code AI platform that enables process engineers to rapidly build and operationalize digital twins of their manufacturing plants. From process development to commercial manufacturing, manufacturers use the digital twins they build with Basetwo AI to improve process efficiencies across the value chain. About Glasswing Ventures Glasswing Ventures is an early-stage venture capital firm dedicated to investing in the next generation of AI and frontier technology startups that enable the rise of the intelligent enterprise. The firm was founded by visionary partners with decades of experience in these markets, a disciplined investment approach, and a strong track record of industry-leading returns. Glasswing leverages its deep domain expertise and world-leading advisory councils to invest in exceptional founders who transform markets and revolutionize industries. About Argon Ventures Argon Ventures is a venture fund with a mission to amplify the energy of founders to launch breakthrough products to build impactful, global businesses. The firm’s Intelligent Industry Solutions investment thesis is centered on cutting-edge software platforms that accelerate productivity & drive top-line revenue, transform markets through radical efficiency and create enterprise value through data at scale. Argon’s portfolio spans a number of markets, including digital health, future of work, manufacturing, and others. The founding General Partners collectively bring over four decades of experience as successful operators, investors, advisors, founders and C-level executives of global companies.

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LexisNexis® Reed Tech™ and Schlafender Hase® Alliance Provides Mutual Customer Benefits for Pharmaceutical and Medical Device Companies

LexisNexis Reed Tech | April 27, 2022

Reed Technology and Information Services Inc. a leading provider of data management and analytics solutions for the life sciences industry, announced an alliance with Schlafender Hase®, the market leader for intelligent, automated proofreading software and services for regulated industries. Current and prospective customers of both companies can leverage exclusive benefits as part of this new alliance ecosystem. Pharmaceutical labelers who have regulatory deadlines for US FDA can benefit from the expert conversion and submission services offered by Reed Tech while ensuring reduced risk and greater accuracy in the proofreading process for drug labels and related documentation with Schlafender Hase's TVT®, the Text Verification Tool®. "Schlafender Hase is already a trusted ally as part of our pharmaceutical SPL conversion process. By offering our UDI and pharma customers the benefits of TVT, we continue advancing our mission of providing innovation for the unique workflows of these specialty manufacturers. Ensuring the accuracy of labels, barcodes, graphics and IFU language is essential. With TVT®, regulatory team members around the world benefit from superior, automated proofreading in order to reduce risk and meet the compliance requirements of local health authorities," Arshad Rahman, General Manager of the Reed Tech Life Sciences division "Schlafender Hase is pleased to recognize Reed Tech as an industry-leading, core SPL conversion service provider. It will be productive for our customers to have access to their deep understanding of regulatory submission requirements for drug manufacturers and distributors," said Peter Muller, Sales Director, North America at Schlafender Hase. Those manufacturers bringing new products to market or maintaining existing portfolios will benefit from the subject-matter expertise offered by Reed Tech." Both the pharmaceutical and medical device industries are continually upgrading processes and preparing for multiple global health authority requirements. The complementary solutions and services between Reed Tech and Schlafender Hase offer critical efficiency gains in managing the product life cycle. About LexisNexis Legal & Professional LexisNexis® Legal & Professional provides legal, regulatory, and business information and analytics that help customers increase their productivity, improve decision-making, achieve better outcomes, and advance the rule of law around the world. As a digital pioneer, the company was the first to bring legal and business information online with its Lexis® and Nexis® services. LexisNexis Legal & Professional, which serves customers in more than 150 countries with 10,500 employees worldwide, is part of RELX, a global provider of information-based analytics and decision tools for professional and business customers. Reed Tech serves manufacturers and distributors of medical device and drug products, and for those who support them in consulting and IT roles by delivering better outcomes for the collection, transformation, submission and analysis of regulatory data. Our solutions support the innovation ecosystem and enable you to achieve regulatory compliance and improved product data management contributing to impactful innovations to our world. The corporate mission is to advance humanity by delivering better outcomes to the innovation community. Reed Tech is a LexisNexis® company. About Schlafender Hase Schlafender Hase leads the way in intelligent, automated text and graphic proofreading solutions. With its flagship product, TVT®, the Text Verification Tool®, users can quickly compare source content with output formats, detecting changes and deviations prior to publication. Schlafender Hase serves regulated industries across the globe. Clients include the world's leading pharmaceutical and medical device companies, as well as healthcare regulatory bodies. The continued success of Schlafender Hase is based on delivering quality products and a strong understanding of customer pain points. Easy to use, our products reduce proofreading workloads, assure the quality of printed and online materials, and mitigate the risk of costly errors.

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Data integrity is a fundamental element of ensuring compliance in a regulated laboratory and is not a new concept - it dates back decades. However, with computerized laboratory systems now taking the place of paper systems, your compliance strategy must adapt, or you risk difficult regulatory inspections.

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