Can Lilly JAK Olumiant, plagued by side effects, really challenge Dupixent in dermatitis?

FiercePharma | August 26, 2019

Eli Lilly and Incytes Olumiant has run up against safety hurdles in the past. But can those hurdles stop the drugmakers from adding another feather to the drugs cap, this time in the booming and increasingly competitive atopic dermatitis AD market? Adding Olumiant to standard-of-care corticosteroids significantly cleared AD trial patients skin over placebo at 16 weeks. Those were the findings from the drugs phase 3 trial Breeze-Ad7, the third of five placebo-controlled trials for Olumiant in AD, Lilly said in a release. Lilly said it plans to release top-line data from the remaining two phase 3 trials in late 2019 and early 2020. Strong performances could set up Olumiant as a potential late entry into a field dominated by Regeneron and Sanofi’s Dupixent, the first-to-market med. But that doesn't mean Olumiant could seriously challenge the reigning star. SVB Leerink analyst Geoffrey Porges pointed to Dupixent's higher response rates—as well as a pulmonary embolism reported in the Olumiant arm. "We believe that we now know enough about the current generation of JAK inhibitors to more or less dismiss them as threats to Dupi in benign dermatological and atopic indications," he wrote.

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Tasly Pharmaceuticals and Mauna Kea Technologies Announce Joint Venture and Licensing Agreements

Mauna Kea Technologies | July 12, 2022

Mauna Kea Technologies inventor of Cellvizio®, the multidisciplinary probe and needle-based confocal laser endomicroscopy platform, and Tasly Pharmaceuticals announced the execution of an agreement to form a Joint Venture. Under terms of the agreement, Tasly and Mauna Kea will form a Joint Venture that will (i) commercialize selected Cellvizio indications in China, (ii) develop and commercialize Cellvizio globally in the fields of Neurology and Neurosurgery, and (iii) manufacture Cellvizio units for the Chinese market. The JV will utilize both existing distribution partners and its own network of China-based marketing professionals to accelerate market adoption. In exchange for contributing licenses and other intellectual property to the JV, Mauna Kea will receive cash payments totaling $10 million, a 44.1% equity interest in the JV, and a 5-year commitment to purchase minimum quantities of Cellvizio systems and probes. Mauna Kea’s equity holdings are net of shares issued to Cenponts Tech Limited in consideration for strategic advisory services provided in connection to the transaction. The Joint Venture will be majority owned and funded by Tasly and jointly managed by Tasly and Mauna Kea. The Joint Venture will be in an immediate position to leverage Mauna Kea’s position as global leader in probe and needle-based confocal laser endomicroscopy, with its FDA clearance for neurosurgery applications, its broad regulatory clearances in the Chinese market as well as its significant installed based in leading hospitals in China. “We are delighted to partner with Tasly Pharmaceuticals, a life sciences leader in Asia-Pacific with a global presence. This transaction both expands the addressable market for Cellvizio and increases Mauna Kea’s capacity to invest further in product and clinical development, including molecular imaging and artificial intelligence. This announcement builds on the strategic repositioning we announced in December 2021 and our emphasis on forming capital-efficient partnerships that leverage the commercial reach of global biopharma and medtech firms while increasing patient access to Cellvizio.” Sacha Loiseau, Ph.D., founder and Chairman of Mauna Kea Technologies Kaijing Yan, Chairman of Tasly Pharmaceuticals Group, commented: “The field of biomedical engineering is an important part of Tasly Pharmaceuticals’ second growth curve strategy. The cooperation with Mauna Kea Technologies will enable us to quickly access large markets in China addressed by the multiple clinical applications of Confocal Laser Endomicroscopy. The recent advances in molecular imaging with Cellvizio are also of great interest to us since Tasly Pharmaceuticals could assist the Joint Venture in developing new combinations of Cellvizio with novel molecular markers, aligned with our vision of providing integrated solutions from diagnosis to treatment. We very much look forward to a fruitful and rich collaboration with Mauna Kea Technologies.” About Tasly Pharmaceuticals Group Adhering to the business mission of "To share the joy of health with all", Tasly has always been promoting the integrative development of traditional Chinese medicine and modern medicine. Tasly continuously focuses on the three disease fields of cardio-cerebro-vascular diseases, digestive and metabolic diseases and tumors, which have the largest market share and the fastest development in China. It is committed to providing drug R&D that is urgently needed for clinical use and even addresses the unmet needs in China's clinical market. By leveraging the coordinated development advantages of modern TCM, biological medicine and chemical medicine, it carries out the strategic layout of innovative drugs and continues to maintain its leading position in the industry and the development momentum of R&D and innovation. About Mauna Kea Technologies Mauna Kea Technologies is a global medical device company that manufactures and sells Cellvizio®, the real-time in vivo cellular imaging platform. This technology uniquely delivers in vivo cellular visualization which enables physicians to monitor the progression of disease over time, assess point-in-time reactions as they happen in real time, classify indeterminate areas of concern, and guide surgical interventions.

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DeepIntent Adds More Leading Data Providers to its Audience Marketplace, Simplifying Pharma Campaign Planning and Optimization

DeepIntent | July 14, 2022

DeepIntent, the leading healthcare advertising technology company built to influence better patient health and business outcomes announced the addition of audience segments from Redi-Data, MedFuse, HealthWise Data, Prognos Health, and TV viewership data from LG Ads Solutions to the DeepIntent Audience Marketplace. These segments are directly integrated into DeepIntent's demand side platform for immediate activation, with the ability to optimize campaigns in real-time toward audience quality and script performance using DeepIntent Outcomes™. Launched in September 2021, Audience Marketplace remains the industry's first and only healthcare-specific data marketplace with ready-to-activate and custom audience segments powered by a variety of medical and pharmacy claims, lab, genomic, contextual, and wellness data providers. In total, DeepIntent now offers hundreds of patients and HCP segments from leading digital health data providers and publishers, including HealthLink Dimensions, Fluent, Doc Delta, and ShareThis. Additionally, over two dozen leading pharmaceutical brands and advertising agencies have made use of custom or ready-to-activate segments available on the marketplace to simplify their campaign planning and tap into Outcomes to optimize their third-party segments. "Audience Marketplace meets an important need to have unique healthcare audience segments included in a healthcare-focused DSP with the ability to optimize towards pharma-specific KPIs, such as Audience Quality, all within a single platform. Many of our customers already use audience segments from our new partners, and their direct integration will make it much easier to execute, measure, and optimize campaigns." Jen Werther, chief strategy officer at DeepIntent Audience Marketplace users benefit from greater convenience, faster time-to-activation, and improved data integrity and reporting compared with conventional methods, which require the use of costly and time-consuming third-party platforms. Segments within the Audience Marketplace are also matched with DeepIntent's industry-leading identity graph to prepare advertisers for the cookieless future, and provide daily physician-level data reporting for healthcare provider audiences. "Using integrated health data and Prognos Clinical Truths™ to ensure relevancy, healthcare marketers can rest easy knowing their messages are reaching the right physicians at the right time. Our partnership with DeepIntent makes the process of onboarding and activating HCP segments from Prognos seamless, and segments can further be optimized toward script performance in real-time when leveraging the advanced machine learning capabilities of DeepIntent Outcomes," said Matt Apprendi, vice president of marketing and media solutions at Prognos Health. About DeepIntent DeepIntent is leading the healthcare advertising industry with data-driven solutions built for the future. Built purposefully for healthcare marketers, DeepIntent's platform is proven to drive higher audience quality and script performance. It enables marketers to plan, activate, measure, and optimize their campaigns all within a single platform. Conceived by former Memorial Sloan Kettering data scientists, DeepIntent empowers nine of the top ten pharmaceutical companies and the leading healthcare advertising agencies to improve patient outcomes through the artful use of advertising, data science, and real-world health data.

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Prime Medicine Expands Leadership Team with Key Appointments to Support Continued Growth and Advancement of Prime Editing Technology and Portfolio

Prime Medicine | July 29, 2022

Prime Medicine, Inc. a biotechnology company committed to delivering a new class of differentiated one-time curative genetic therapies, Prime Editors, to address the widest spectrum of diseases by deploying Prime Editing technology “Prime Medicine is advancing a first-of-its-kind technology intended to expand the number of patients who may benefit from genetic medicines. We are thrilled to welcome Richard, Niamh and Fubao to the team. Together, they bring strong business acumen, extensive clinical and regulatory experience and leadership of successful teams that position us well to achieve our mission. These esteemed leaders have deep expertise across their respective focus areas, each of which is key to the advancement of our novel Prime Editing technology.” Keith Gottesdiener, M.D., Chief Executive Officer of Prime Medicine Richard Brudnick, Chief Business Officer, brings extensive industry experience, including leading successful business development transactions, across multiple stages of development and an array of therapeutic areas. Mr. Brudnick was previously Chief Business Officer and Head of Strategy at Codiak BioSciences and, before that, was Executive Vice President of Business Development and Alliance Management at Bioverativ, Inc., a company he helped found in 2016. Mr. Brudnick joined Bioverativ at the time of its spinoff from Biogen where, over the course of nearly 15 years, he initiated, led and completed numerous transactions, including for several of the company's marketed products and late-stage pipeline, including Tecfidera, Spinraza and its biosimilars joint venture with Samsung. Previously, Mr. Brudnick was the Chief Executive Officer of a regional pharmaceutical distribution business that he sold to a strategic buyer, co-founded two companies, and was a strategy consultant at Bain & Company. Mr. Brudnick earned his undergraduate degree in management science from MIT and his M.S. in management from the Sloan School of Management at MIT. Niamh Alix, Chief Human Resources (HR) Officer, is a human resources leader who brings nearly 20 years of experience helping to grow teams from small, early-stage organizations to global enterprises. She joins Prime from Orchard Therapeutics, where she was Vice President, Global Talent and HR Business Partner. Prior to that, Ms. Alix held multiple global and regional roles at Lonza, including HR Business Partner for Americas, Mexico, and Canada where she led the HR team and people strategy for a 5,000+ employee population across corporate and manufacturing clients, and across multiple scientific platforms including cell and gene therapy. Prior to that, she held senior HR roles of increasing responsibility at Novartis and Bristol Myers Squibb. She holds a master’s degree in HR strategies from Dublin City University and a B.Sc. in management from the Technological University of Dublin. Fubao Wang, Ph.D., SVP, Head of Regulatory, has substantial experience leading product development of genomic medicine products, as well as regulatory strategies and execution for both clinical and commercial-stage products. Before Prime, Dr. Wang served as Senior Vice President, Head of Regulatory Affairs at Asklepios BioPharmaceutical where he built and led the regulatory team to support the development of clinical-stage AAV-based gene therapy products. Earlier, he was Vice President, Head of Regulatory CMC at Sarepta Therapeutics, where he supported the development of AAV gene therapy and RNA products, including the FDA approvals of Vyondys and Amondys. He also served as Associate Vice President, U.S. Site Head, CMC Dossiers at Sanofi to support the BLA approval of Dupixent, a monoclonal antibody product. Prior to that, he held a 16-year tenure at Merck serving in research, development and regulatory roles of increasing responsibility, most recently as director, global and emerging markets regulatory affairs, led and contributed to the discovery and development of a variety of vaccine and biologics products. Dr. Wang holds a Ph.D. in molecular biology from Heidelberg University and completed his postdoctoral work in molecular biology at Stanford University. About Prime Medicine Prime Medicine, Inc. is a biotechnology company committed to delivering a new class of differentiated, one-time, curative genetic therapies to address the widest spectrum of diseases. The company is deploying Prime Editing technology, a versatile, precise, efficient and broad gene editing technology, which is designed to make only the right edit at the right position within a gene. With the theoretical potential to repair approximately 90 percent of known disease-causing genetic mutations across many organs and cell types, medicines based on Prime Editing, if approved, could offer a one-time curative genetic therapeutic option to a broad set of patients.

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Iktos Announces Collaboration With Galapagos in AI For Drug Design

Iktos, | June 29, 2022

Iktos, a company specialized in Artificial Intelligence for new drug design, announced a collaboration with Galapagos, a leading global biopharmaceutical company focused on the discovery, development and commercialization of innovative medicines, to apply Iktos’s generative modelling artificial intelligence (AI) technology in one of Galapagos drug discovery programs. Under the agreement, Iktos will apply its de novo ligand and structure-based generative modelling technologies and software Makya™, its AI-based retrosynthesis analysis and planning tool Spaya™, and its know-how in computational drug design to expedite the identification of potential pre-clinical candidates and to identify additional novel chemical matter with suitable properties. Galapagos scientists will benefit from direct access to Makya™ and Spaya™ as part of the collaboration. Iktos’s AI technology, based on deep generative models, helps to bring new insights and directions into the drug discovery process based on a comprehensive data-driven chemical structure generation technology. This technology automatically designs virtual novel molecules with all of the characteristics of a successful drug molecule. This approach, validated through multiple collaborations, is a novel solution to one of the key challenges in drug design: rapid identification of molecules that simultaneously satisfy multiple parameters, such as potency, selectivity, safety, and project-specific properties. This approach uniquely enables the exploration of chemical space and produces innovative molecule designs with greater freedom to operate. Iktos has also diversified its R&D efforts into the development of an AI technology for retrosynthesis and has developed the AI-based retrosynthesis analysis and planning tool Spaya™ enabling systematic exploration and prioritisation of synthetic routes for a desired compound in minutes. “We are thrilled and proud to join forces with Galapagos with the aim to discover optimised lead compounds for one of Galapagos undisclosed small molecule drug discovery projects. Pleased to have earned Galapagos trust, we are confident that together with Galapagos established R&D team, we will be able to identify promising novel chemical matter and solve complex multiparametric optimisation problems. The insights and feedback from Galapagos research team will be highly valuable to guide us into improving our technology and products.” Yann Gaston-Mathé, President and CEO of Iktos About Iktos Incorporated in October 2016, Iktos is a French start-up company specialized in the development of artificial intelligence solutions applied to chemical research, more specifically medicinal chemistry and new drug design. Iktos is developing a proprietary and innovative solution based on deep learning generative models, which enables, using existing data, to design molecules that are optimized in silico to meet all the success criteria of a small molecule discovery project. The use of Iktos technology enables major productivity gains in upstream pharmaceutical R&D. Iktos offers its technology both as professional services and as a SaaS software platform, Makya™. Iktos is also developing Spaya™, a synthesis planning software based upon Iktos’s proprietary AI technology for retrosynthesis.

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Product highly similar to a biotherapeutic medicine that has already been authorized with full dossier. Subject to a tailored regulatory data package with full side-by-side analytical and clinical testing. Minor variations compared to the original biotherapeutic reference product with no clinically meaningful differences identified.

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