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

STAT | September 10, 2019

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

Spotlight

We’re nearing the end of 2017, and, for me, that means the third annual iteration of our Patent Expiration piece in the world of pharmaceuticals. If this ongoing series has taught me anything, it’s that people of the world are constantly looking to the promise of the future. No matter how difficult today may be, tomorrow, at least in thought, always has the potential to bring a fresh start. With each fresh start is an opportunity to make something better. To paraphrase little orphan Annie, the sun will always come out tomorrow.


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BUSINESS INSIGHTS

OPTEL ACQUIRES PHARMA TRACK-AND-TRACE UNIT OF KÖRBER

OPTEL Group | January 12, 2022

OPTEL GROUP, already a world leader in supply chain traceability, is expanding its expertise and global reach with the recent acquisition of the track-and-trace unit of the Körber Business Area Pharma, formerly known as Traxeed, based in Germany. Körber is a leading international technology group. The acquisition, announced today, will allow OPTEL to leverage the unit's expertise in pharmaceutical and agrochemical track-and-trace technologies, provide the company with a second foothold in the European marketplace and contribute to its diversification plans. "Creating a strong presence in the German market is key to the success of our strategic objectives because Germany is a well-established manufacturing hub, with a strong history of developing innovative manufacturing efficiency solutions and Industry 4.0 technologies," Louis Roy, founder and president of OPTEL "We are pleased that we have found a solid and future-oriented new owner with a broad international market access, from whose global network and years of experience in the highly specialized track-and-trace sector customers will clearly benefit. We are furthermore convinced that the new strategic owner can open up attractive development opportunities for the team," said Dr. Jürgen Krebs, Chief Technology Officer and Chief Operating Officer in the Körber Business Area Pharma. The acquisition allows OPTEL to welcome highly skilled pharma track-and-trace experts from Körber, complementing OPTEL's existing strengths in traceability, vision technologies, software and hardware. Furthermore, it will solidify and expand the company's presence in the European market by providing a second base of operations after Limerick, Ireland. In addition to the acquisition, a close collaboration between OPTEL and Körber's Business Area Pharma is planned in the future. The two companies plan to sign a partnership agreement whereby OPTEL becomes Körber's preferred partner for track-and-trace solutions for the pharmaceutical industry. Since its founding in 1989, OPTEL has become the world's foremost provider of track-and-trace solutions to the pharmaceutical industry. Its acquisitions in recent years have positioned it as the only company with the ability to provide complete, full-stack supply chain traceability. The Canadian multinational has since diversified into other industries, including consumer-packaged goods, metals and minerals, and agrochemicals. The acquisition of the track-and-trace unit of the Körber Business Area Pharma is expected to accelerate further expansion. ABOUT OPTEL OPTEL is a leading global provider of traceability systems whose goal is to use its innovative technologies to build a sustainable world through the Intelligent Supply Chain. OPTEL is the only company with the ability to offer complete end-to-end traceability, providing granular data at every step of the supply chain – from raw materials to the consumer and beyond. Founded in 1989, OPTEL is a Certified B Corporation headquartered in Canada, with facilities in Ireland, India and Brazil, as well as employees worldwide. ABOUT KÖRBER We are Körber – an international technology group with about 10,000 employees, more than 100 locations worldwide and a common goal: We turn entrepreneurial thinking into customer success and shape the technological change. In the Business Areas Digital, Pharma, Supply Chain, Tissue and Tobacco, we offer products, solutions and services that inspire. We act fast to customer needs, we execute ideas seamlessly, and with our innovations we create added value for our customers. In doing so, we are increasingly building on ecosystems that solve the challenges of today and tomorrow. Körber AG is the holding company of the Körber Group.

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RESEARCH

Hemogenyx Pharmaceuticals and Selexis SA Will Advance Hemogenyx’s Acute Myeloid Leukemia (AML) CDX Bispecific Antibody to Human Trials

Hemogenyx Pharmaceuticals plc | January 13, 2022

Hemogenyx Pharmaceuticals plc the biopharmaceutical group developing new therapies and treatments for blood diseases, and Selexis SA, a JSR Life Sciences company, have signed a service agreement to develop the cell line for Hemogenyx’s CDX bispecific antibody for the treatment of acute myeloid leukemia (AML). Under the agreement, Hemogenyx will leverage Selexis’ proprietary SUREtechnology Platform™, a suite of cell line development tools and technologies that significantly reduces the time, effort, and costs associated with developing high-performance mammalian cell lines. The CDX bispecific is made using the Hemogenyx’s proprietary humanised monoclonal antibody against a target on the surface of AML cells. CDX was co-developed by Hemogenyx Pharmaceuticals and Eli Lilly and Company (“Lilly”). This cutting-edge application of immune therapy offers a potentially more benign and effective form of treatment that, if successful, could have a significant impact on treatment and survival rates for AML. CDX is planned to be the Company’s second therapeutic candidate to enter clinical trials. Following the completion of the co-development phase, Lilly granted the Company an exclusive worldwide license to certain intellectual property developed by Lilly related to the CDX bispecific antibody for all uses, including the treatment of AML and other blood cancers. “We are delighted to partner with Selexis, and access its proprietary protein expression tools and technologies, IP and know-how. The partnership is key to advancing our CDX programme into clinical trials and accelerating the timeline to deliver this innovative therapy to patients in need of a more benign and effective treatment for AML.” Dr. Vladislav Sandler, Chief Executive Officer and co-founder of Hemogenyx Pharmaceuticals Mr. Dirk Lange, CEO of Selexis, added, “There’s an urgent need for effective treatments for AML, and we at Selexis are pleased to apply our technologies to help Hemogenyx advance the CDX bispecific antibody to the clinic. We’ve built a reputation for delivering cell lines rapidly and cost-effectively, without compromising safety. This is an exciting milestone for Hemogenyx and we welcome the opportunity to join the company on its journey toward delivering a promising and effective therapy for patients with AML.” Selexis’ modular SUREtechnology Platform™ facilitates the rapid, stable, and cost-effective production of recombinant proteins and vaccines, providing seamless integration of the development continuum from discovery to commercialization. About Hemogenyx Pharmaceuticals plc Hemogenyx Pharmaceuticals is a publicly traded company headquartered in London, with its US operating subsidiaries, Hemogenyx Pharmaceuticals LLC and Immugenyx LLC, located in New York City at its state-of-the-art research facility. The Company is a pre-clinical stage biopharmaceutical group developing new medicines and treatments to treat blood and autoimmune disease and to bring the curative power of bone marrow transplantation to a greater number of patients suffering from otherwise incurable life-threatening diseases. Hemogenyx Pharmaceuticals is developing several distinct and complementary product candidates, as well as a platform technology that it uses as an engine for novel product development. For more than 50 years, bone marrow transplantation has been used to save the lives of patients suffering from blood diseases. The risks of toxicity and death that are associated with bone marrow transplantation, however, have meant that the procedure is restricted to use only as a last resort. The Company’s technology has the potential to enable many more patients suffering from devastating blood diseases such as leukemia and lymphoma, as well as severe autoimmune diseases such as multiple sclerosis, aplastic anemia and systemic lupus erythematosus (Lupus), to benefit from bone marrow transplantation. About Selexis SA Selexis SA, a JSR Life Sciences company, is the global leader in cell line development with best-in-class modular technology and highly specialized solutions that enable the life sciences industry to rapidly discover, develop and commercialize innovative medicines and vaccines. Our global partners are utilizing Selexis technologies to advance more than 146 drug candidates in preclinical and clinical development and the manufacture of eight commercial products. As part of a comprehensive drug development process, the Company’s technologies shorten development timelines and reduce manufacturing risks.

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BUSINESS INSIGHTS

Vifor Pharma drives transformation with divestment of non-core finished drug manufacturing to CordenPharma

Vifor Pharma Group | December 17, 2021

Vifor Pharma Group announced the divestment of its finished drug product manufacturing business to CordenPharma, a full-service Contract Development & Manufacturing Organization of APIs, Excipients, Drug Products, and associated Packaging services. This decision reinforces Vifor Pharma’s strategy to transform the company into a multi-brand commercial organization, focusing on its core capabilities in-licensing, partnering and commercializing products in nephrology, and to further grow and maximize opportunities of its iron portfolio. “In support of our ambitious growth strategy, optimizing our manufacturing footprint will enable us to build an even stronger, more efficient organization focusing on core capabilities in nephrology, and to maximize and leverage our market-leading expertise and intellectual property in iron deficiency. With CordenPharma, we have found the best suitable solution for our manufacturing employees and the drug production activities in Fribourg, Ettingen and Lisbon. With this agreement, Vifor Pharma is well positioned to continuously drive the company sustainably and profitably over the long term, for all our stakeholders.” Abbas Hussain, CEO of Vifor Pharma Dr. Michael Quirmbach, Chief Executive Officer & President of CordenPharma said: “The acquired Vifor Pharma sites have competent teams with great cultural fit, state-of-the art infrastructure, and a strong compliance track record. This excellent opportunity aligns well with our strategy to broaden our CDMO capabilities. By incorporating these three Vifor Pharma manufacturing facilities into our global network, we look forward to not only supplying Vifor Pharma as a manufacturing partner, but also closing gaps in our service offering for oral solid dosage drug product manufacturing and increasing our overall capacity. In addition, this acquisition further strengthens our fully-integrated solutions to our customers.” Under the terms of the signed share purchase agreement, CordenPharma acquires all shares in Vifor SA, Fribourg, and OM Pharma SA, Lisbon, thus taking over Vifor Pharma’s finished drug product manufacturing operations at the three sites. The divestment will trigger an asset impairment, to be reported with Vifor Pharma’s 2021 financial results. The companies have agreed not to disclose financial terms of the agreement. CordenPharma will integrate the new facilities into its existing CDMO network of Current Good Manufacturing Practice and R&D plants across Europe & the US, and organize the operations of the Fribourg, Ettingen and Lisbon sites under its Small Molecule Platform. It plans to utilize the existing manufacturing workforce, while continuing to produce and supply Vifor Pharma products. Vifor Pharma’s Swiss and Portuguese country commercial organizations, located in Fribourg and Lisbon, will remain with Vifor Pharma Group. Vifor Pharma and CordenPharma will jointly ensure long-term continuity of supply for customers and patients who depend on them. This divestment, including all financial implications, has been disclosed to CSL Limited in the course of the due diligence process preceding the publication of the pre-announcement of the public tender offer by CSL Limited on 14 December and in so far has no impact on such tender offer. Vifor Pharma and CordenPharma anticipate closing the transaction in Q1 2022, contingent on customary closing conditions. About Vifor Pharma Group Vifor Pharma Group is a global pharmaceuticals company. It aims to become the global leader in iron deficiency, nephrology and cardio-renal therapies. The company is a partner of choice for pharmaceuticals and innovative patient-focused solutions. Vifor Pharma Group strives to help patients around the world with severe and chronic diseases lead better, healthier lives. The company develops, manufactures and markets pharmaceutical products for precision patient care. Vifor Pharma Group holds a leading position in all its core business activities and consists of the following companies: Vifor Pharma and Vifor Fresenius Medical Care Renal Pharma. Vifor Pharma Group is headquartered in Switzerland, and listed on the Swiss Stock Exchange About CordenPharma CordenPharma, the global pharmaceutical service & manufacturing platform of International Chemical Investors Group, is a full-service partner in the Contract Development & Manufacturing of APIs, Excipients, Drug Products, and associated Packaging Services. Through a growing network of cGMP facilities across Europe and the US organized under five Technology Platforms – Peptides, Lipids & Carbohydrates, Injectables, Highly Potent & Oncology, and Small Molecules – CordenPharma experts translate complex processes and projects at any stage of development into high-value products.

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BUSINESS INSIGHTS

Treatment to Expand Global Library of Medicine with Dermatologic Diseases

Treatment.com International Inc. | January 05, 2022

Treatment.com International Inc. a healthcare AI technology company, has entered into a research project agreement with the University of Minnesota to add more than 220 dermatologic diseases to their proprietary, responsive AI engine known as the Global Library of Medicine (GLM). The addition of these diagnoses will bring another level of accuracy and specificity to the GLM, enhancing soon-to-be-released products such as the Treatment Mobile app, which is set for release this month. Kevin A. Peterson, MD, MPH, FRCS(Ed), FAAFP and Chief Medical Officer of Treatment, says, “Engaging in research with the University of Minnesota Dermatology department brings extensive academic medical expertise that enhances our ability to provide richly detailed descriptions of dermatologic concerns. The rich experience of the University of Minnesota Medical School will help the GLM provide more accurate descriptions of complex presentations of skin diseases. Combining our advanced AI infrastructure with the rich clinical and research expertise of the Medical School will substantially enhance our AI platform’s ability to provide better access to high quality information and directly supports the mission of the GLM to enhance health outcomes for individuals around the world.” “We are proud that the University of Minnesota is participating with us on this latest research project, which is in addition to other mutually beneficial agreements we’ve entered into with the University. The Global Library of Medicine is one way we are realizing Treatment’s plan to provide the most accurate and reliable data about health concerns, made available to clinicians, organizations, and patients alike.” John Fraser, Treatment’s CEO The Global Library of Medicine is the foundation of Treatment’s Clinical solutions, which offer unique ways to bring healthcare into the digital age by providing better access to up-to-the-minute healthcare information and promoting better health outcomes around the world. Treatment Mobile and the intelligent digital assistant will be released in select North American clinics in 2022. About Treatment.com Treatment.com is a disruptive healthcare technology company that is harnessing the power of AI to help global citizens improve their health through personalized recommendations and insights. Based in Vancouver with a US subsidiary, the company spent the last five years working with a team of world-class doctors, engineers, mathematicians, and AI specialists to develop a complex AI engine that leverages the most robust, personalized data to generate highly predictive and accurate insights. Treatment.com is the parent company of Treatment Mobile, and an intelligent digital health assistant which will empower people to take control of their health through an innovative mobile app, powered by Treatment’s exclusive AI engine.

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Spotlight

We’re nearing the end of 2017, and, for me, that means the third annual iteration of our Patent Expiration piece in the world of pharmaceuticals. If this ongoing series has taught me anything, it’s that people of the world are constantly looking to the promise of the future. No matter how difficult today may be, tomorrow, at least in thought, always has the potential to bring a fresh start. With each fresh start is an opportunity to make something better. To paraphrase little orphan Annie, the sun will always come out tomorrow.

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