BUSINESS INSIGHTS

Innocoll Announces Publication of Positive Results from Pivotal Clinical Trial of POSIMIR in Arthroscopic Subacromial Decompression

Innocoll Pharmaceuticals | July 07, 2022 | Read time : 3 min

Innocoll Announces
Innocoll Pharmaceuticals Limited, a commercial-stage biotechnology company and portfolio business of Gurnet Point Capital, announced the publication of the results of Study BU-002-IM evaluating the safety and efficacy of POSIMIR® for infiltration use in 107 patients undergoing arthroscopic subacromial decompression. The peer-reviewed paper, entitled “SABER-Bupivacaine Reduces Postoperative Pain and Opioid Consumption After Arthroscopic Subacromial Decompression: A Randomized, Placebo-Controlled Trial,” was published online on May 17, 2022 in the Journal of the American Academy of Orthopedic Surgeons Global Research & Reviews.

According to the report, POSIMIR 5 mL administered into the subacromial space at the end of arthroscopic subacromial decompression surgery in this double-blind, randomized, controlled, multicenter study, reduced mean postoperative pain on movement over 72 hours by 1.3 points on a 0-10 scale compared with vehicle control, a relative reduction of 20%. Simultaneous improvements in postoperative opioid use during the same 72-hour period provided evidence that the observed pain reduction was clinically meaningful. The median time to first request for opioid rescue medication was 12.4 hours among patients treated with POSIMIR compared with 1.2 hours in patients who received vehicle control. The median total opioid consumption in intravenous (IV) morphine milligram equivalents over 72 hours was 4.0 mg in the POSIMIR group vs 12.0 mg in the vehicle control group. The proportion of patients who were opioid free at 72 hours was 40% in the POSIMIR group vs 16% in the vehicle control group.

As reported in the paper, the most common treatment-emergent adverse events were headache, nausea, musculoskeletal pain, cardiac disorders, skin and subcutaneous tissue disorders, injury and procedural complications, general disorders and administration site conditions and respiratory, thoracic, and mediastinal disorders. Of 2 serious adverse events reported among patients in these treatment groups, only 1 occurred during the immediate 2-week postsurgical follow-up period, and none was considered related to treatment. There were no TEAEs leading to study discontinuation.

“These very compelling results, demonstrating up to three days of local analgesia after a single intra-operative injection, make POSIMIR an important new tool in treating postoperative pain from arthroscopic subacromial decompression,” said Sten Rasmussen, MD PhD, Professor and Head of Department of Clinical Medicine, Aalborg University, Denmark, the senior author and a principal investigator in the POSIMIR study.

We are excited to publish the positive results of this pivotal clinical trial of POSIMIR, the second approved product in our portfolio of nonopioid, extended-duration, locally-acting analgesics for postsurgical pain control. As the only company with two non-opioid extended release bupivacaine products on the market, we look forward to bringing POSIMIR to the orthopedic community,” 

Louis Pascarella, Innocoll President and Chief Executive Officer

About POSIMIR
POSIMIR for infiltration use contains more bupivacaine in a single dose than any other approved, sustained-release bupivacaine product. It employs a proprietary extended-release technology that enables the continuous release of bupivacaine, a non-opioid local anesthetic, directly to the surgical site for 3 days after administration. POSIMIR was approved in February, 2021 by the US Food and Drug Administration. POSIMIR is indicated in adults for administration into the subacromial space under direct arthroscopic visualization to produce post-surgical analgesia for up to 72 hours following arthroscopic subacromial decompression. Use in any other surgical procedure is investigational. POSIMIR is a registered trademark of Innocoll Pharmaceuticals Limited.

About Subacromial Decompression Shoulder Surgery
Subacromial decompression is a type of shoulder surgery used to treat impingement syndrome, a common repetitive-use injury that causes pain when the arm is raised over the head. The procedure is performed arthroscopically, meaning that several small incisions are made in the skin and muscle of the shoulder through which a camera (arthroscope) and surgical instruments are inserted during surgery. Arthroscopic subacromial decompression is generally performed as outpatient surgery, and most patients go home within a few hours of surgery. The most intense pain typically occurs during the first 3 days and is often managed with a combination of nerve block and oral opioids. There are over 600,000 surgeries involving arthroscopic subacromial decompression performed each year in the U.S.

About Innocoll Pharmaceuticals Limited
Innocoll Pharmaceuticals Limited is a global biotech pharmaceutical company headquartered in Athlone, Ireland and is a subsidiary of Innocoll Biotherapeutics Holding Limited. The Innocoll group of companies is focused on the development and commercialization of pharmaceutical technologies to meet some of today’s most important healthcare challenges.

About Gurnet Point Capital
Gurnet Point Capital is a unique healthcare investment platform within the B-Flexion Group and led by a team with deep expertise in an industry for which they share a passion, both as investors and senior executives. GPC invests long-term capital and supports entrepreneurs in building a new generation of companies that deliver outsized returns through active ownership. Based in Cambridge, MA, its remit encompasses life sciences and health care focused businesses, with a particular emphasis on businesses that have high growth potential in the product development and commercialization stages of their evolution. With its strategy of driving best in class operational transformation for these businesses, to create social impact while generating significant economic value, Gurnet is able to deliver differentiated results for its investors and partners. 

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Clinical research and drug development accelerated via analytics

SAS | June 22, 2022

Bringing life-changing therapies to market requires pharmaceutical companies to efficiently design and run clinical trials, gather and analyze massive amounts of data, and manage a complicated regulatory review process. SAS, a leader in clinical research analytics, delivers powerful technologies to support the life sciences industry – including machine learning, AI and analytics for IoT – through the SAS® Life Science Analytics Framework on Azure. The advanced analytics platform – a single, open, cloud-native statistical computing environment for clinical trial analysis and submission – helps pharmaceutical companies navigate the heavily regulated world of clinical research analytics and bring new therapies to the world faster. Delivering the power of analytics in the cloud From drug discovery to regulatory approval, developing a new medicine can take over a decade with a price tag in the billions. The clinical research required to achieve approval from the US Food and Drug Administration (FDA), European Medicines Agency (EMA), and other regulatory authorities involves massive amounts of data that can be difficult to manage, share and analyze, creating delays that affect patients' well-being. The cloud-based SAS Life Science Analytics Framework on Azure features an integrated and collaborative environment to manage and analyze clinical trial information as well as deliver trial results for the FDA and other global regulatory agencies' review. With the analytic solution, life sciences organizations can extract valuable insights from clinical data, mitigate risk, increase efficiency, and speed time to market for lifesaving pharmaceuticals. "The primary goal is to get drugs approved so that they can reach patients. The faster you can do that, the greater benefit for the patient and to help save lives." Bhawna Goel, CEO of Gunvatta Gunvatta USA, Inc, a contract research organization (CRO) headquartered in Washington, DC, helps clients collect, manage, analyze and visualize the terabytes of clinical and healthcare data produced by pharmaceutical and biotechnology companies, hospitals, and provider groups. With the SAS Life Science Analytics Framework, Gunvatta has modernized the way it approaches clinical trials. The CRO helps life sciences organizations reduce risk with secure data access, ensure data and results are validated, maintain an audit trail, and report their data to health authorities like the FDA. "The biggest advantage of the SAS Life Science Analytics Framework is that the analytics platform is cloud-based," said Goel. "I feel like SAS has jumped 15 to 20 steps ahead of where the market is." For more about Gunvatta's experience, see the customer story Helping pharmaceutical companies bring new therapies to the world faster using analytics for life sciences. Developing cutting-edge clinical research tools SAS life science experts will attend the DIA Global Annual Meeting this week in Chicago to share next generation approaches for driving excellence and innovation in clinical trial operations. At DIA, SAS will preview SAS Clinical Enrollment Simulation Cloud – a cloud-native, solution based in SAS® Viya® 4 – that enables life sciences and contract research organizations to simulate the outcome of the complex clinical trial enrollment process in a virtual world, resulting in faster, more strategic clinical trial enrollment plans. The new SaaS offering – available later this year on the Microsoft Azure Marketplace – uses a powerful discrete event simulation analytical engine to model the clinical trial enrollment process as it evolves over time, facilitating improved insights to guide enrollment strategy and meet contracted patient targets. "SAS Clinical Enrollment Simulation Cloud is highly differentiated from traditional methodologies for predicting trial enrollment," said Jim Box, Life Sciences Principal Data Scientist at SAS. "The technology helps life sciences organizations reduce timelines, minimize costs, and gain greater insight to inform clinical enrollment planning and rescue." Modernizing clinical trials for the future While the current clinical development research model can be an obstacle to the creation of safe, cost-effective therapies, the COVID-19 pandemic and other events set the stage for disruption in clinical trials. "The silver lining of the pandemic for the life sciences industry is the acceleration of digital transformation and modernization of clinical research," said Simon Tilley, Health and Life Sciences Product Director at SAS. "We experienced widespread adoption of innovative approaches, such as decentralized clinical trials for the development of new vaccines." "While the business benefits of modernizing clinical research include significant cost savings, efficiency improvements, accelerated time to regulatory approval and faster time to market, it is patients who stand to gain the most from clinical trial innovation." About SAS SAS is the leader in analytics. Through innovative software and services, SAS empowers and inspires customers around the world to transform data into intelligence. SAS gives you THE POWER TO KNOW®. SAS and all other SAS Institute Inc. product or service names are registered trademarks or trademarks of SAS Institute Inc. in the USA and other countries. ® indicates USA registration. Other brand and product names are trademarks of their respective companies. Copyright © 2022 SAS Institute Inc. All rights reserved.

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Aculys Pharma and SUSMED Have Entered into a Contract to Conduct the World's First Clinical Trial Utilizing Blockchain Technology

Aculys Pharma, Inc. | July 13, 2022

Aculys Pharma, Inc. a company focused on the development and commercialization of new innovative drugs in the fields of neurology and psychiatry, has entered into a contract with SUSMED, Inc., a company that promotes digital medicine to conduct the world's first1 corporate-sponsored clinical trial using blockchain technology. The clinical trial utilizing this blockchain technology, provided by SUSMED, will be conducted in collaboration with CMIC Co., Ltd., a pioneer in drug development support (CRO), with the cooperation of several medical institutions. With the sophistication of research and development and the increasing cost of new drug development, improving the efficiency of clinical trials is one of the challenges in the pharmaceutical industry that requires addressing. In such an environment, efficient use of resources and pursuit of efficiency are required. And improving productivity and quality of new drug development is also extremely important for society as a whole. Under these circumstances, Aculys Pharma is working to improve productivity and quality of clinical trials by utilizing AI and digital technologies for the development and commercialization of new drugs. The clinical trial system developed by SUSMED enables the reduction of data entry work and monitoring work2 by medical institutions by using the SUSMED-patented technology that binds e-worksheets and eCRF using blockchain technology. In addition to publishing multiple medical papers3, the clinical research that SUSMED conducted with the National Cancer Center has been approved by the Cabinet Office regulatory sandbox4. The result of the verification test conducted by the regulatory sandbox was published in the International Medical Journal in June 20205. With this outcome, The Ministry of Health, Labor and Welfare issued a notice on December 4, 2020 that source data verification (SDV: Source Data Verification) using blockchain technology is permitted as an alternative method under the GCP ministerial ordinance. CMIC will promote these efforts for attaining an efficient clinical trial by 1) supporting the operation of the system at the medical institution, 2) cooperating with development of the e-worksheet and eCRF, and 3) complementing the functions outside the scope of the system. This clinical trial which utilizes blockchain technology significantly reduces the number of processes around data entry at medical institutions and SDV compared to conventional methods, and also contributes to reducing the number of required CRA visits to the medical institutions. In addition, by taking advantage of blockchain technology, it is expected to have the effect of increasing the reliability of the clinical trial data itself. Through these methods, we aim to improve the efficiency of the clinical trial-related work-streams necessary for new drug development, and to optimize new drug development costs without compromising reliability. "We are delighted to be able to conduct a clinical trial utilizing blockchain technology in collaboration with SUSMED and CMIC as Aculys Pharma strives for providing new therapeutic modalities by making full use of the latest in digital technology. We expect this pioneering effort of three companies, which aim to improve the quality and efficiency of clinical trials, will realize digital transformation of clinical trial monitoring work and contribute to the optimization of new drug development costs. We will continue to actively introduce new technologies not bound by a conventional framework and aim to solve social issues surrounding Japanese healthcare by collaborating and partnering with external partners." Kazunari Tsunaba, President and CEO of Aculys Pharma, Inc Taro Ueno, President and CEO of SUSMED, Inc., stated as follows. "In the clinical trials conducted in the development of new medical technology, prevention of data tampering and cost efficiency have been issues. While developing therapeutic apps in the healthcare field, we have come to focus on the possibility of using blockchain technology in clinical development and continued research and development. This time, we are delighted to be able to collaborate with CMIC to conduct the world’s first clinical trials using blockchain technology in a corporate-sponsored clinical trial of Aculys Pharma, a company that focuses on the development and commercialization of new innovative drugs. We believe that utilization of blockchain technology enables us to realize efficient and reliable clinical development and we also can contribute for optimization and sustainability of future social security.” "CMIC was established in 1992 as Japan's first CRO and has supported a number of clinical trials of drug development. This time we are participating in the corporate-sponsored clinical trial of Aculys Pharma with SUSMED. While digitalization will furthermore drive acceleration of process efficiency, we will continue to pursue further improvement of quality and efficiency of clinical trials in monitoring work by utilizing CMIC's know-how based on numerous clinical trial experiences over the past 30 years." About Aculys Pharma, Inc. Aculys Pharma is a biopharmaceutical company focused on the development and commercialization of innovations in the fields of neurology and psychiatry. Its corporate name was created from the philosophy of "Catalyst to Access." Aimed to act as a bridge for innovative medical care in the field of neuropsychiatry, Aculys Pharma develops and commercializes novel pharmaceuticals and provides innovations for better medical care to patients, their families, healthcare professionals, and society.

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BUSINESS INSIGHTS

FDA Accepts Dupixent® (dupilumab) for Priority Review in Adults with Prurigo Nodularis

Regeneron Pharmaceuticals, Inc. | May 31, 2022

Regeneron Pharmaceuticals, Inc. and Sanofi announced that the U.S. Food and Drug Administration has accepted for Priority Review the supplemental Biologics License Application (sBLA) for Dupixent® Medical (dupilumab) to treat adults with prurigo nodularis, a chronic skin disease that causes extreme itch and inflammatory skin lesions. The target action date for the FDA decision is September 30, 2022. The sBLA is supported by data from two pivotal Phase 3 trials evaluating the efficacy and safety of Dupixent in patients 18 years and older with prurigo nodularis Both trials met the primary and key secondary endpoints, showing Dupixent significantly improved disease signs and symptoms compared to placebo, including reduction in itch and skin lesions. The safety results from these trials were generally consistent with the known safety profile of Dupixent in its approved dermatology indications. The adverse event more commonly observed with Dupixent was conjunctivitis. The FDA grants Priority Review to therapies that have the potential to provide significant improvements in the treatment, diagnosis or prevention of serious conditions. Additional regulatory filings around the world are also planned in 2022.The potential use of Dupixent in prurigo nodularis is currently under clinical development, and the safety and efficacy have not been fully evaluated by any regulatory authority. About Prurigo Nodularis People with prurigo nodularis experience intense, persistent itch, with thick skin lesions (called nodules) that can cover most of the body. Prurigo nodularis is often described as painful with burning, stinging and tingling of the skin. The impact of uncontrolled prurigo nodularis on quality of life is one of the highest among inflammatory skin diseases due to the extreme itch and is comparable to other debilitating chronic diseases that can negatively affect mental health, activities of daily living and social interactions. High-potency topical steroids are commonly prescribed but are associated with safety risks if used long-term. There are approximately 75,000 people in the U.S. who are unable to control their disease with systemic therapy and are most in need of a treatment option. About Dupixent Dupixent, which was invented using Regeneron's proprietary VelocImmune® technology, is a fully human monoclonal antibody that inhibits the signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways and is not an immunosuppressant. The Dupixent development program has shown significant clinical benefit and a decrease in type 2 inflammation in Phase 3 trials, establishing that IL-4 and IL-13 are key and central drivers of the type 2 inflammation that plays a major role in multiple related and often co-morbid diseases. These diseases include approved indications for Dupixent such as asthma, atopic dermatitis, chronic rhinosinusitis with nasal polyposis (CRSwNP) and eosinophilic esophagitis, as well as investigational diseases such as prurigo nodularis. Dupixent is approved for use in certain patients with atopic dermatitis, asthma, CRSwNP or eosinophilic esophagitis in different age populations in a number of countries around the world. Dupixent is currently approved across these indications in the U.S. and for one or more of these indications in the European Union and Japan and more than 60 countries. More than 400,000 patients have been treated with Dupixent globally. About Regeneron's VelocImmune Technology Regeneron's VelocImmune technology utilizes a proprietary genetically engineered mouse platform endowed with a genetically humanized immune system to produce optimized fully human antibodies. When Regeneron's President and Chief Scientific Officer George D. Yancopoulos was a graduate student with his mentor Frederick W. Alt in 1985, they were the first to envision making such a genetically humanized mouse, and Regeneron has spent decades inventing and developing VelocImmune and related VelociSuite® technologies. Dr. Yancopoulos and his team have used VelocImmune technology to create approximately one in five of all original, FDA-approved or authorized fully human monoclonal antibodies currently available. This includes Dupixent, REGEN-COV® (casirivimab and imdevimab), Libtayo® (cemiplimab-rwlc), Praluent® (alirocumab), Kevzara® (sarilumab), Evkeeza® (evinacumab-dgnb) and Inmazeb™. Dupilumab Development Program Dupilumab is being jointly developed by Regeneron and Sanofi under a global collaboration agreement. To date, dupilumab has been studied across 60 clinical trials involving more than 10,000 patients with various chronic diseases driven in part by type 2 inflammation.

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PHARMA TECH

Babson Diagnostics and Pharmacy Podcast Network Announce Partnership That Will Take Listeners Inside Largest Retail Pharmacy Trade Show

Babson Diagnostics | July 27, 2022

Babson Diagnostics, a science-first, health care technology company, announced a media partnership with the Pharmacy Podcast Network in connection with the 2022 National Association of Chain Drug Stores’ Total Store Expo, the largest gathering of retailers and suppliers in the health and wellness industry. As part of the partnership, the Pharmacy Podcast Network, the most popular and downloaded podcast about the pharmacy industry, will be integrated into Babson Diagnostics’ booth at the Total Store Expo. Todd Eury, founder and chief executive officer of the media company, will host podcasts from the booth featuring industry leaders attending the trade show. In addition, Babson will sponsor two podcasts that will be broadcast prior to the expo, which takes place Aug. 27 through Aug. 29 in Boston. The first of those shows, “Diagnostic Testing in Community Pharmacies,” went live today. “Babson is excited to be collaborating with one of the leading media outlets aimed at community pharmacists, who are the face of neighborhood healthcare. Babson is working with pharmacies to offer medically accurate blood testing that is easier, more convenient and less invasive than traditional methods.” David Stein, CEO of Babson Diagnostics Launched in 2009, the Pharmacy Podcast Network reaches more than 80,000 listeners per month with audio content focused on the critical role pharmacists play in the healthcare industry. “I look forward to bringing exciting new content to my audience through this partnership with Babson Diagnostics,” Eury said. “The Total Store Expo is a one-of-a-kind opportunity to bring insights to pharmacists about new and innovative products and services in health and wellness, such as Babson’s blood-testing ecosystem.” About Babson Diagnostics Babson Diagnostics is a science-first healthcare technology company bringing convenient, medically accurate diagnostic blood testing to the local pharmacy. We are the first and only company to do broad blood panels from a capillary microsample, collected from a finger, at a retail setting. Our core technology was incubated at Siemens Healthineers ​in 2015, and we became Babson Diagnostics in 2017. We have exclusive partnerships with Siemens Healthineers and BD (Becton, Dickinson and Company), two global leaders in healthcare innovation and medical technology. Together we are reimagining the entire blood testing process, helping people get the care they need, when they need it. Babson, based in Austin, Texas, is named in honor of Art Babson, whose legacy of scientific innovation and excellence is the foundation on which the company is built. About Pharmacy Podcast Network Pharmacy Podcast Nation is the flagship show hosting all of the Pharmacy Podcast Network 1400+ episodes. With more than 30 different podcast programs and some 40 different co-hosts helping to develop audio content about the pharmacy sector, its reach includes communities, hospitals, senior-care residences, military and public health settings that meet the information needs of 300,000 pharmacists with more than 100,000 monthly listeners. PPN also delivers a unique publication called Rx Influencer to all healthcare professionals with a specific focus on pharmacy.

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