Amarin shares jump as FDA panel backs heart drug

Shares in Amarin jumped on news that it had won the backing of an FDA advisory panel to sell its heart drug Vascepa to a wider group of patients. The shares, which had jumped over 20 per cent earlier in the week as the panel prepared to meet, added another 8 per cent when the Nasdaq market re-opened on Friday. It was trading around the $22.87 mark at lunch in New York, up 6.4 per cent on the day. The specially convened FDA advisory committee voted unanimously to approve the expanded use of Amarin’s Vascepa drug as an add-on therapy for reducing the chance of heart attacks and strokes in high-risk patients with cardiovascular disease. However, there were differences within the group as to just how widely it should be prescribed. Vascepa is a highly purified fish oil capsule targeted at people who are at risk of stroke or heart attack because they continue to have high levels of harmful blood fats, called triglycerides, despite being prescribed treatment with statins.

Spotlight

Spotlight

Related News

PHARMACY MARKET

Iambic Therapeutics Announces Close of Oversubscribed $100 Million Series B Financing to Advance AI-Discovered Therapeutics into Clinical Development

Business Wire | October 10, 2023

Iambic Therapeutics a biotechnology company developing novel therapeutics from its unique generative AI discovery platform, today announced the closing of an oversubscribed $100 million Series B financing co-led by Ascenta Capital and Abingworth, and also including new investors NVIDIA, Illumina Ventures, Gradiant Corporation, and independent board member Bill Rastetter. Existing investors also participated, including Nexus Ventures, Catalio Capital Management, Coatue, FreeFlow, OrbiMed, and Sequoia Capital. As part of the Series B, Iambic is delighted to welcome two new board members, Evan Rachlin, M.D., from Ascenta Capital and Kurt von Emster from Abingworth. “At Iambic, our world-class team has combined physics and AI to create a differentiated drug discovery platform that achieves a step-change in the speed and success rate for delivering best-in-class and first-in-class development candidates to clinic,” commented Tom Miller, Ph.D., Co-founder and Chief Executive Officer of Iambic. “With the Series B funding, we intend to advance multiple AI-discovered candidates into the clinic and expand our pipeline, demonstrating how the Iambic platform can deliver better therapeutics to patients in less time, with optimized target product profiles for greater likelihood of clinical success.” “We were struck by the originality of these molecules, offering distinctive approaches in both deeply validated and more novel biological pathways,” added Evan Rachlin, M.D., Co-founder and Managing Partner of Ascenta Capital. “Iambic’s platform enables a more creative and expansive exploration of how to treat diseases with profound unmet needs. We are delighted to partner with Tom and his extraordinary team in translating these thoroughly tested medicines into humans.” “Abingworth is proud to support the remarkably talented team at Iambic in its drive to revolutionize drug discovery and speed to the market with highly selective drugs,” said Kurt von Emster, Managing Partner and Head of Life Sciences at Abingworth. “AI-driven technologies, including methods that Iambic and NVIDIA researchers have built together, are charting a new path for researchers in the discovery of new therapeutic candidates,” said Rory Kelleher, Director of Healthcare and Life Sciences at NVIDIA. “NVIDIA-accelerated computing and software are helping industry pioneers like Iambic drive scientific breakthroughs and our continued collaboration aims to speed innovation in drug discovery.” “We believe technology innovations powered by advanced computing and omics-derived data insights will transform drug discovery and pave the way for the next wave of groundbreaking medicines,” said Ron Mazumder, Ph.D., MBA, Partner of Illumina Ventures. “Iambic’s physics-informed machine learning approach has yielded promising lead candidates with superior profiles in record time.” Since its 2021 Series A financing, Iambic has rapidly built its AI-driven discovery platform, which unifies state-of-the-art, physics-informed machine learning and experimental automation, and has demonstrated the platform’s success in identifying therapeutic candidates with differentiated drug profiles. In addition to building out a deep bench of AI and drug-discovery experts, Iambic has discovered two candidates to advance into the clinic: IAM-H1, a highly selective and brain-penetrant inhibitor of HER2 and its oncogenic mutants, and IAM-C1, a potential first-in-class selective dual CDK2/4 inhibitor to address unmet needs in terms of therapeutic window and treatment resistance in cell-cycle-driven cancers. Further, Iambic has extended its leadership position in the AI community, creating methods such as NeuralPLexer and OrbNet to drive its discovery platform. With the funds raised in the Series B, Iambic intends to advance multiple candidates into clinical development, expand its pipeline with additional candidates with best-in-class and first-in-class potential, and continue to innovate and build next-generation AI and automation technologies for drug discovery. It plans to leverage NVIDIA technology such as the NVIDIA DGX Cloud AI supercomputing platform and the NVIDIA BioNeMo cloud service to accelerate discovery. The company retains the technology created under its prior name of Entos Inc., adopting the new name of Iambic Therapeutics to reflect its transition to a company with the additional capability of clinical development of candidates identified through its AI-driven discovery platform. About the Iambic Therapeutics Physics-Informed AI-Driven Discovery Platform The Iambic Therapeutics AI-driven platform was created to address the most challenging design problems in drug discovery, incorporating the most current AI technologies and purpose-built tools from Iambic. The integration of physics principles into the platform’s AI architectures improves data efficiency and allows molecular models to venture widely across the space of possible chemical structures. The platform’s algorithms enable identification of new chemical mechanisms for engaging difficult-to-address biological targets, discovery of defined product profiles that optimize therapeutic window, and exploration of the chemical space to discover candidates for development with highly differentiated properties. Through close integration of AI-generated molecular designs with automated experimental execution, Iambic completes design-make-test cycles on a weekly cadence. About Iambic Therapeutics Founded in 2019 and headquartered in La Jolla, California, Iambic Therapeutics is disrupting the therapeutics landscape with its unique AI-driven drug-discovery platform. Iambic has assembled a world-class team that unites pioneering AI experts and experienced drug hunters with strong track records of success in delivering clinically validated therapeutics. The Iambic platform has been demonstrated to deliver high-quality, differentiated therapeutics to clinic with unprecedented speed and across multiple target classes and mechanisms of action. The Iambic team is advancing an internal pipeline of clinical assets to address urgent unmet patient needs.

Read More

PHARMA TECH

OM1 Launches Asthma and Chronic Rhinosinusitis Datasets to Expand Real-World Evidence in Respiratory and ENT

Business Wire | October 05, 2023

OM1, a leading real-world data, AI, and technology company with a focus on chronic diseases, announced the launch of two new clinical datasets, Chronic Rhinosinusitis (CRS) and Asthma. Both datasets are derived from longitudinal follow-up of patients seen by specialists and focus on patient characteristics, symptoms, treatments, clinical outcomes and healthcare resource utilization. Rapidly growing, the CRS and Asthma datasets each follow approximately 500,000 patients in the U.S. The research-grade, real-world data available in the OM1 Respiratory & ENT Network is built with an exclusive partnership between OM1 and the American Academy of Otolaryngology and Head and Neck Surgery Foundation (AAO-HNSF). With access to thousands of clinicians and more than 25 million patient visits across all 50 states, the data is rich with the most representative network available, including patient reported outcomes, social determinants of health, and patient subtypes and classification data. Millions of Americans are impacted by respiratory diseases, and the number continues to rise as respiratory illnesses become more common and air quality declines. Taking a deeper look, it’s estimated that 25 million people in the United States are diagnosed with asthma and 5-12% of the global population is affected by CRS. Not only do the numbers continue to rise, it’s common for patients with respiratory diseases to have multiple illnesses. Studies show that up to 67% of people with CRS with nasal polyps, small noncancerous growths that increase the severity of the disease, also have asthma. "Having access to deep clinical information on clinical presentation, treatments, and outcomes opens a world of incredible opportunity to improve care at both the population and individual patient level,” said Dr. Richard Gliklich, CEO, OM1. Alongside AAO, OM1 and Dr. Gliklich will be participating and presenting at the AAO-HNSF Annual Meeting and OTO Experience in Nashville, October 1-4. About OM1 With specialization in chronic conditions, OM1 is re-imagining real-world evidence and insights by developing large electronically connected networks of clinicians and health data in dermatology, rheumatology, gastroenterology, cardiology, metabolism, respiratory, mental health, neurology and other specialty areas. Leveraging its data automation platform, OM1 Aspen, extensive clinical networks and artificial intelligence (AI) platform, PhenOM™, OM1 offers industry-leading enriched healthcare datasets, retrospective and prospective studies, advanced analytics, and AI-driven guidelines adherence and decision-support around diagnosis, risk management, and treatment. With a focus on high-quality data and clinical outcomes, the offerings are used for accelerating research, demonstrating treatment effectiveness, supporting regulatory submissions, monitoring safety, and informing commercialization.

Read More

PHARMACY MARKET

TailorMed Partners with Eagle Pharmaceuticals to Streamline Patient Financial Assistance Enrollment

Business Wire | October 25, 2023

TailorMed, a leading technology company offering the nation’s largest network of patients, providers, pharmacies, life science companies, and other partners dedicated to improving healthcare affordability, announced Eagle Pharmaceuticals, Inc. will be implementing TailorMed’s Express Enroll solution. This partnership will introduce new efficiencies in seeking to secure financial assistance for patients prescribed Eagle’s Pemfexy to manage and treat lung cancer. With Express Enroll, providers and pharmacies within the TailorMed network can now complete Pemfexy Copay Assistance Program enrollments through a fully digital process, without leaving the TailorMed platform. Nearly half of cancer patients with high out-of-pocket costs have abandoned or delayed filling a prescription. Cost-related prescription abandonment and nonadherence lead to poor patient experiences and outcomes. TailorMed’s network-driven, technology-powered approach offers a comprehensive solution by uniting all impacted parties with the same goal: helping ensure that every patient, across all medical conditions, can afford care. TailorMed’s solutions have now been implemented across more than 700 hospitals, 1,200-plus clinics, and over 600 pharmacies. Without the use of technology, the process of identifying and enrolling patients in financial assistance is typically manual, cumbersome, and reactive, resulting in missed opportunities to maximize available resources. The TailorMed platform enables users—who include financial navigators, medication assistance coordinators, pharmacy technicians, and other healthcare professionals—to proactively match patients with the right resources at the right time. Its Express Enroll solution uses automatic data mapping, real-time API connections, and embedded e-signature workflows to facilitate seamless, in-platform enrollment in assistance offered by pharmaceutical companies. These capabilities will empower TailorMed users to complete Pemfexy Copay Assistance Program enrollments quickly and efficiently, supporting stronger patient experiences and medication adherence. “This partnership with TailorMed underscores our commitment to supporting patient access to Pemfexy,” said William Kim, VP of Market Access, Oncology at Eagle Pharmaceuticals. “A technology-driven enrollment approach will make enrollment in the Pemfexy Copay Assistance Program more efficient, which benefits patients and healthcare provider offices.” “The impact of healthcare affordability is far-reaching and requires a network approach, uniting stakeholders across the entire ecosystem,” said Srulik Dvorsky, Co-founder and CEO of TailorMed. “Trailblazers in the life sciences industry stand to strengthen this network considerably by providing direct access to financial assistance for lifesaving medications. We’re proud to partner with Eagle Pharmaceuticals to help further patient enrollment and improve access to Pemfexy.” About TailorMed TailorMed offers the nation’s largest network of patients, providers, pharmacies, partners, and life science companies focused on ensuring all patients across all medical conditions can afford treatment. Driven by TailorMed's best-in-class platform, network constituents can proactively identify, match, and enroll patients in financial assistance programs to deliver a world-class patient financial experience while reducing the cost of care delivery and increasing revenues. TailorMed’s secure, web-based financial assistance solutions are deployed across more than 1,000 sites of care, including Providence Health, UnityPoint Health, Yale-New Haven Health, and Advocate Aurora Health. About Eagle Pharmaceuticals, Inc. Eagle is a fully integrated pharmaceutical company with research and development, clinical, manufacturing and commercial expertise. Eagle is committed to developing innovative medicines that result in meaningful improvements in patients’ lives. Eagle’s commercialized products include PEMFEXY®, RYANODEX®, BENDEKA®, BELRAPZO®, TREAKISYM® (Japan), and Byfavo® and Barhemsys® through its wholly owned subsidiary Acacia Pharma Inc. Eagle’s oncology and CNS/metabolic critical care pipeline includes product candidates with the potential to address underserved therapeutic areas across multiple disease states, and the company is focused on developing medicines with the potential to become part of the personalized medicine paradigm in cancer care.

Read More