Lilly Making First Milestone Payment in $1.9B Collaboration with AC Immune

GEN | September 20, 2019

Eli Lilly will pay AC Immune CHF 30 million ($30.2 million) in the first milestone payment tied to the companies’ CHF 1.89 billion ($1.9 billion) collaboration launched in December to develop new treatments for Alzheimer’s disease and other neurodegenerative disorders, the Swiss biotech said today. AC Immune said it will receive the milestone payment on or before October 7, 2019, in “a recognition of progress in the collaboration between the two companies”—namely the launch in July of a Phase I trial of ACI-3024, the company’s lead tau aggregation inhibitor small molecule candidate. The Phase I trial is designed to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of ACI-3024 in healthy volunteers, AC Immune said, through a randomized, placebo controlled, double blind, sequential single and multiple ascending dose study with open label food effect and pharmacodynamics assessment arms. “The start of the ACI-3024 Phase 1 study, represents an important advancement in the broader effort we are making and further expands our robust clinical pipeline to address neurodegenerative diseases, in particular for therapeutics and diagnostics targeting Tau,” AC Immune CEO Prof. Andrea Pfeifer said in a statement.

Spotlight

Raman spectroscopy has taken large strides in recent years as more Raman vendors have developed handheld Raman units capable of carrying out raw material identification or verification. Raman spectroscopy is used as a fingerprinting tool to capture the unique Raman spectrum of each raw material. There are many benefits of adopting this new Process Analytical Technology (PAT) tool to the biopharmaceutical industry. Critical technical considerations and unique challenges that must be overcome to implement Raman spectroscopy in the biopharmaceutical industry are discussed.

Spotlight

Raman spectroscopy has taken large strides in recent years as more Raman vendors have developed handheld Raman units capable of carrying out raw material identification or verification. Raman spectroscopy is used as a fingerprinting tool to capture the unique Raman spectrum of each raw material. There are many benefits of adopting this new Process Analytical Technology (PAT) tool to the biopharmaceutical industry. Critical technical considerations and unique challenges that must be overcome to implement Raman spectroscopy in the biopharmaceutical industry are discussed.

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COEUS Holdings Announces Partnership With Insight Consulting Group (ICG) to Address the Healthcare Industry’s Changing Research and Insight Landscape

COEUS Holdings | September 18, 2021

COEUS Holdings, LLC, and its subsidiaries, together a leading boutique life sciences technology and consulting firm, today announced that it has entered a partnership with Insight Consulting Group (ICG). The partnership seeks to bridge the gaps between payers, healthcare providers, and consumers by developing insights and strategies that are reflective of today’s integrated needs. The partnership will produce and apply comprehensive insights to inform strategy that could advance access to more medications and help to address the unmet needs of Physicians and Patients. While ICG’s expertise, proprietary processes, and deliverables will be leveraged by various organizations that are part of COEUS Holdings’ group of subsidiaries, Mirador Global, led Chuck Peipher, Managing Partner, will be most regularly engaged. Mirador delivers consulting expertise in early commercial development for global and domestic drug commercialization and market access efforts. This partnership takes direct aim at the delivery of game-changing insights and market research that will take shape in a variety of touchpoints through the commercial development process. Together, we’ll be able to work more quickly and effectively through this partnership given the common knowledge of the social sciences, brand development processes, and a commitment to our clients who are focused on serving the needs of Physicians and Patients. - Chris Schnaars, Principal at Insight Consulting Group. Ultimately, all stakeholders in the healthcare ecosystem (patients, caregivers, HCPs, influencers, extenders, payers, and provider organizations) must work together to create an optimal care environment. Through shared resources that deliver deeper research and insights, the ICG and COEUS partnership will facilitate a more comprehensive and robust understanding of how healthcare clients can meet the needs and achieve ideal outcomes for all stakeholders. The ICG and COEUS partnership will enable clients to realize the benefits of working with one team, with end-to-end research and payer capabilities. It’s the combination of insights being leveraged simultaneously during the design and development of marketing and payer strategies that will deliver incremental value to the industry. About ICG ICG inspires deeper healthcare understanding by bringing its clients’ most important interactions into research. Understanding human needs and translating them into behavioral insights is at the forefront of the design of our deliverables. ICG brings high proficiency and experience to analysis of insights, raising the bar of confident decision making and commercial impact. ICG is focused on meeting people where they are (not where we want them to be) and understanding what true core human and emotional needs can be addressed to influence behavior and impact outcomes. About Mirador Global LP Founded in 2016, Mirador Global LP is an international consulting practice that specializes in strategic global commercial development for specialty diseases, including rare diseases, oncology/​immuno-oncology, immunology, and CNS disorders. Mirador Global client engagements are developed bringing together Global Marketing, Analytics, Market Access, HEOR, Medical Affairs, R&D, and other functions delivered by a team of pharmaceutical industry experts. The company provides its clients with a bio-pharma line of sight unlike any other unique to Mirador Global. About COEUS Holdings The COEUS Holdings teams are singularly driven to optimize market access and commercialization infrastructure for pharmaceutical products. COEUS is a multi-specialty, commercially aligned consultancy, offering a comprehensive suite of informed solutions for successful engagement with organized customers, providers, and patients. Leveraging years of collective real-world market expertise, we offer unique perspectives into clinical and business opportunities to support your brands’ position in the marketplace. COEUS mission is to ensure patient access beyond the prescription. We focus on becoming your ally in navigating the healthcare universe. COEUS teams advance thought leadership, technology solutions, and communication initiatives to ensure your brands’ lifelong success. Together, we strive to redefine access solutions in the evolving domestic and global managed care markets.

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Applied BioMath, LLC Announces Collaboration with BYOMass™ for Systems Pharmacology Modeling in Oncology

Applied BioMath | October 18, 2021

Applied BioMath, the industry-leader in applying systems pharmacology and mechanistic modeling, simulation, and analysis to de-risk drug research and development, today announced a collaboration with BYOMass, Inc. for systems pharmacology modeling in chronic diseases. BYOMass is a preclinical stage pharmaceutical company focused on the TGF-ß superfamily. "We chose Applied BioMath given their proven track record of helping companies identify ideal therapeutic properties and platforms, We hope that this collaboration will help us identify the properties of a lead candidate as efficiently as possible and aid in the design of future studies." - Margaret Jackson, D.Phil., Founder and CEO of BYOMass Applied BioMath employs a rigorous fit-for-purpose model development process which quantitatively integrates knowledge about therapeutics with an understanding of its mechanism of action in the context of human disease mechanisms. Their approach employs proprietary algorithms and software that were designed specifically for systems pharmacology model development, simulation, and analysis. "We often work with early-stage companies to help them understand what their therapeutic needs to look like in order to be best in class, We look forward to collaborating with BYOMass and helping them decide next steps for this project." - John Burke, PhD, Co-Founder, President, and CEO of Applied BioMath. About Applied BioMath Founded in 2013, Applied BioMath's mission is to revolutionize drug invention. Applied BioMath uses mathematical modeling and simulation to provide quantitative and predictive guidance to biotechnology and pharmaceutical companies to help accelerate and de-risk drug research and development. Their approach employs proprietary algorithms and software to support groups worldwide in decision-making from early research through clinical trials. The Applied BioMath team leverages their decades of expertise in biology, mathematical modeling and analysis, high-performance computing, and industry experience to help groups better understand their candidate, its best-in-class parameters, competitive advantages, patients, and the best path forward into and in the clinic.

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Innovent and GenFleet Announce Exclusive Global License Agreement for GFH925 (KRAS G12C Inhibitor)

Innovent Biologics | September 02, 2021

Innovent Biologics, Inc., a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of cancer, metabolic, autoimmune and other major diseases, and GenFleet Therapeutics (Shanghai) Inc., a clinical-stage biotechnology company developing cutting-edge therapies in oncology and immunology, today jointly announced that they have entered into an exclusive license agreement for the development and commercialization of GenFleet's lead KRAS G12C candidate, GFH925 in China, including mainland China, Hong Kong, Macau and Taiwan with additional option-in rights for global development and commercialization. GFH925, GenFleet's lead KRAS G12C candidate, has recently received Investigational New Drug (IND) approval from National Medical Products Administration (NMPA) in China. Preclinical data showed that GFH925 has potential best-in-class activity that can effectively inhibit the growth of a variety of tumor cell lines carrying the KRAS G12C mutation, which may be helpful in accelerating the clinical validation of GFH925. In addition, other preclinical data have also demonstrated the potent potential for GFH925 in combination therapies. According to the agreement, Innovent will be responsible for clinical development and commercialization of GFH925 in China, while retaining option-in right for development and commercialization outside of China as well. Following approval of a New Drug Application (NDA), Innovent will leverage its broad commercialization capability that includes an experienced commercialization team with extensive nationwide coverage to roll out GFH925, with the goal to benefit cancer patients in China. GenFleet will continue to be responsible for supplying GFH925 for both development and commercial purposes in China. GenFleet will receive an upfront payment of US$22 million at signing. If Innovent exercises the option-in rights, GenFleet will receive up to US$50 million of global development support from Innovent. Upon achieving certain pre-specified milestones in development, registration, and annual sales performance of GFH925 globally, GenFleet is eligible to receive up to US$240 million in milestone payments in addition to tiered royalties based on annual net sales of GFH925 both in China and global markets. About GFH925 (KRAS G12C Inhibitor) Being developed by GenFleet Therapeutics, GFH925 is a novel, orally active, potent KRAS G12C inhibitor designed to effectively target the GTP/GDP exchange, an essential step in pathway activation, by modifying the cysteine residue of KRAS G12C protein covalently and irreversibly. Preclinical cysteine selectivity studies demonstrated high selectivity of GFH925 towards G12C. Subsequently, GFH925 effectively inhibits the downstream signal pathway to induce tumor cells' apoptosis and cell cycle arrest. About Innovent Inspired by the spirit of "Start with Integrity, Succeed through Action," Innovent's mission is to develop, manufacture and commercialize high-quality biopharmaceutical products that are affordable to ordinary people. Established in 2011, Innovent is committed to developing, manufacturing and commercializing high-quality innovative medicines for the treatment of cancer, autoimmune, metabolic and other major diseases. On October 31, 2018, Innovent was listed on the Main Board of the Stock Exchange of Hong Kong Limited with the stock code: 01801.HK. Since its inception, Innovent has developed a fully integrated multi-functional platform which includes R&D, CMC (Chemistry, Manufacturing, and Controls), clinical development and commercialization capabilities. Leveraging the platform, the company has built a robust pipeline of 26 valuable assets in the fields of cancer, metabolic, autoimmune disease and other major therapeutic areas, with 5 products. About GenFleet Therapeutics Dedicated to serving significant unmet medical needs, GenFleet Therapeutics established its proprietary R&D platform based on the deep understanding of disease biology, translational medicine, as well as researches into latest biological mechanism of cancer pathways, tumor microenvironment and human immunoregulation. GenFleet's rich and diversified pipeline highlights multiple cutting-edge products with novel mechanisms and global IP. Since its inception in 2017, GenFleet has built up industry-leading capabilities and expertise in developing novel drug candidates - both small molecules and biologics. Its pipeline includes over 13 programs in development, four of which have entered clinical stages. GenFleet is expected progress additional programs into clinics, as well as transition from a clinical stage biotech company into a commercial stage biopharmaceutical company in the next 3-5 years.

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