Insulin: a case study for why we need a public option in the pharmaceutical industry

STAT | September 10, 2019

When Frederick Banting, Charles Best, and James Collip filed for a U.S. patent on insulin in 1923 and sold it to the University of Toronto for $1 each, they did it because, as Best once said, “insulin belongs to the world.” They also believed that securing the patent was a form of publication, and wrote to the university president, “When the details of the method of preparation are published anyone would be free to prepare the extract, but no one could secure a profitable monopoly.” Sadly, they were mistaken. Today, three companies — Eli Lilly, Novo Nordisk (NVO), and Sanofi (SNY) Aventis — control virtually the entire global market for insulin. This oligopoly, which may have colluded to fix insulin prices, charges exorbitant amounts for a medicine that people with type 1 diabetes cannot live without. Since the 1990s, they have raised the price of insulin more than 1,200%. In the past few years we’ve learned about the tragic and preventable deaths of 20-somethings who simply couldn’t afford their insulin, even with insurance. Diabetes-related complications like amputations are on the rise again after decades of decline, and many people who depend on insulin to survive are sacrificing their rent, their cars, and their dignity just to get by.

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Using antibiotics from time-to-time within a large population creates a higher risk of resistance to the drugs than heavy use among a small population, according to a new study. "We know that efforts to reduce inappropriate use of antibiotics are critical to addressing the problem of antibiotic resistance," Yonatan Grad, a professor of immunology and infectious diseases and senior author of the study, said in a press release.


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BUSINESS INSIGHTS

Spotlight Therapeutics Appoints Visionary Global Pharma Drug Developer Antoine Yver, M.D., M.Sc. as First Independent Board Member

Spotlight Therapeutics | July 18, 2022

Spotlight Therapeutics, Inc. a biotechnology company applying new insights to develop cell-targeted in vivo CRISPR gene editing biologics, announced the appointment of Antoine Yver, M.D., M.Sc. to the Spotlight Board of Directors. Trained as an oncologist and immunologist, Dr. Yver’s extensive industry experience and perceptive acumen will be extremely valuable as Spotlight continues to strengthen its highly differentiated TAGE platform and advance lead therapeutic candidates towards the clinic. “We are thrilled to welcome Antoine to Spotlight’s Board of Directors. Few people in our industry enjoy such a remarkable track record of successful drug development, exercising extreme rigor in following the science to deliver practice-changing medicines that serve patients with significant unmet medical needs.” Mary Haak-Frendscho, Ph.D., President and Chief Executive Officer of Spotlight As Executive Vice President and Global Head of Oncology R&D at Daiichi Sankyo, Dr. Yver played a key role in the development of the new breakthrough cancer biologic, Enhertu®, that is redefining breast cancer treatment and promises to set a new standard of care, as well as other Daiichi Sankyo DXd ADCs. From 2009 to 2016, Dr. Yver held executive leadership positions at AstraZeneca, including SVP & Global Head of Oncology Development. Under his leadership, Tagrisso® and Lynparza® were successfully developed and commercialized for patients. Prior to joining AstraZeneca, Dr. Yver held roles at Merck, Johnson & Johnson, Aventis and Rhone-Poulenc Rorer. Dr. Yver is Executive Vice President and Chairman of Development at Centessa Pharmaceuticals plc and currently serves as an Independent Director of the Board of Directors at Sanofi. “I am delighted to join the Spotlight Board and support the mission to unlock the full potential of gene editing and enable effective single administration therapeutics for patients,” said Dr. Yver. “Spotlight’s biologics-based delivery approach has the potential to forge a new generation of cell-targeted in vivo CRISPR gene editing medicines across multiple therapeutic areas.” “Antoine’s deep insights and vast global pharma experience will help propel Spotlight to becoming a clinical stage company,” said Craig Gordon, M.D., Spotlight board member, Founder, CEO, and CIO of GordonMD™ Global Investments. “We look forward to working together to impact the strategic decisions of the company that will ultimately provide benefit to patients.” About Spotlight Therapeutics Established in mid-2018, Spotlight Therapeutics is a privately held biotechnology company advancing a pipeline of cell-targeted in vivo CRISPR gene editing therapies. Spotlight's proprietary technology platform TAGE is a new class of biologics, CRISPR effectors engineered for direct delivery in vivo, to achieve cell-selective therapeutic genome editing. Spotlight's pipeline is advancing its modular programmable CRISPR effectors towards clinical studies in immuno-oncology, ophthalmic diseases and hemoglobinopathies.

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

Innocoll Pharmaceuticals | July 07, 2022

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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SS&C Partners with Xcentuate to Support Customer Digital Transformation Journeys

SS&C | June 23, 2022

SS&C Technologies Holdings, Inc. announced a new partnership in the EMEA and APAC regions with Xcentuate, an award-winning international provider of digital productivity and performance solutions to the financial services, agricultural, pharma and public sectors. The partnership follows SS&C's recent acquisition of Blue Prism, the leading Robotic Process Automation provider, further demonstrating its commitment to the intelligent automation solutions market. Xcentuate, based in Dublin, Ireland, will serve as a consulting and implementation partner, acting as an extended team to advise, implement, support and deliver complex projects. "We are delighted to partner with Xcentuate," said Gautam Moorjani, General Manager, SS&C Intelligent Automation Solutions. "The EMEA and the Asia Pacific regions are markets with a lot of appeal - with resilient and developing economies and talented, skilled workforce. In addition, the potential for operational automation to transform how businesses work is significant." The partnership will enable SS&C to leverage Xcentuate's vast experience to access new potential customers, take new value propositions to market, develop point solutions to address current market needs, and enhance its specialized professional services to our customers. "The SS&C partnership is of significant strategic importance to us regarding our offer to the market. The breadth and depth of SS&C's expertise in financial services and healthcare technology are unmatched. In addition, this new partnership further broadens the suite of services we can offer to firms in EMEA and the Asia Pacific with an ambitious digital transformation agenda." Ray Bowe, Xcentuate founder and CEO About Xcentuate Headquartered in Dublin, Ireland, Xcentuate serves a range of industries including financial services, agriculture, pharma and public sector. Xcentuate works with customers in EMEA and Asia-Pacific regions to transform their business operations using a suite of best-in-class technology to deliver sustainable advantage. Combined with award-winning operational expertise and a track record of delivery, they support businesses in transforming their customer experiences and enabling them to optimise control and productivity while building an engaged, enthused workforce. About SS&C Technologies SS&C is a global provider of services and software for the financial services and healthcare industries. Founded in 1986, SS&C is headquartered in Windsor, Connecticut, and has offices around the world. Some 20,000 financial services and healthcare organizations, from the world's largest companies to small and mid-market firms, rely on SS&C for expertise, scale and technology.

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Asahi Kasei Bioprocess to Showcase Award-winning MOTIV™ Buffer Management Technology for Pharmaceutical Manufacturing at ACHEMA 2022

Asahi Kasei Bioprocess | August 01, 2022

Asahi Kasei Bioprocess America, subsidiary of diversified Japanese multinational company Asahi Kasei, will be featuring their MOTIV™ Buffer Management Technology at ACHEMA 2022 in Frankfurt this August. Winner of “Best in Show” at Interphex in 2017, “Technology of the Decade” from Bioprocess international in 2012 and originator of the concept for inline buffer formulation (IBF™), Asahi Kasei Bioprocess is a market leader that keeps pharmaceutical production moving efficiently and precisely through solutions like MOTIV with built-in automation software so that medicine can get to patients sooner and safer. Buffers are used for the vast majority of processes in pharmaceutical development, which has traditionally required storage in extremely large tank farms to be utilized as necessary. MOTIV can blend buffers from concentrates in small, single-use bags and is controlled with sensors to maintain and assure precision. It is also able to blend buffers to exact specifications as needed during a downstream development process and can handle a wide variety of buffer formulations. In addition, it is automated by the integrated OCELOT™1 System Control software to be repeatable and also helps to reduce waste created in the development process, so it is a more sustainable means of pharmaceutical manufacturing. “We have been working to ‘standardize’ system designs as much as we can, to make them more readily available with shorter lead times; but are also very capable at building custom systems to meet the specific needs of customers,” says Chris Rombach, Vice President of Sales and Marketing at Asahi Kasei Bioprocess America. “One of our strengths is not only having an innovative product, but also an extensive family of MOTIV systems to choose from. Buffer is the lifeblood of pharma manufacturing and with the R&D opportunities of being a part of the Asahi Kasei Group we have been able to develop MOTIV to be the most reliable and efficient IBF technology in the market today. Not to mention, Operation Warp Speed helped push capacity to expand globally and billions of dollars are being invested by manufacturers to ramp up production as quickly as possible. This drives a new sense of value for systems like our MOTIV family that can streamline processes.” 1 The OCELOT System Control is an Asahi Kasei Bioprocess proprietary technology that integrates and/or interfaces with plant-wide control systems in a universally compatible format, allowing for far-reaching data collection and analysis. About Asahi Kasei Bioprocess The Fluid Management Business Unit of Asahi Kasei Bioprocess is devoted to solving therapeutic product safety, efficiency and purity challenges within the pharmaceutical and bioprocessing industries. With technology platforms for virus filtration, chromatography, inline buffer formulation and oligonucleotide synthesis, our bioprocessing systems, columns, and automation solutions advance GMP manufacturing of critical drug substances around the world. Built with pride, built with quality, built to exceed your high expectations. “Built for You.” About Asahi Kasei The Asahi Kasei Group contributes to life and living for people around the world. Since its foundation in 1922 with ammonia and cellulose fiber businesses, Asahi Kasei has consistently grown through the proactive transformation of its business portfolio to meet the evolving needs of every age. With more than 46,000 employees around the world, the company contributes to a sustainable society by providing solutions to the world's challenges through its three business sectors of Material, Homes, and Health Care. Its health care operations include devices and systems for acute critical care, dialysis, therapeutic apheresis, transfusion, and manufacture of biotherapeutics, as well as pharmaceuticals and diagnostic reagents.

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Spotlight

Using antibiotics from time-to-time within a large population creates a higher risk of resistance to the drugs than heavy use among a small population, according to a new study. "We know that efforts to reduce inappropriate use of antibiotics are critical to addressing the problem of antibiotic resistance," Yonatan Grad, a professor of immunology and infectious diseases and senior author of the study, said in a press release.

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