Washington Week: Drugmakers, PBMs Hammered Over High Drug Prices

medpagetoday | April 12, 2019

WASHINGTON -- Members of Congress blamed and shamed key players in the pharmaceutical market for high drug prices, while also asking for their help; and the Trump administration quietly advanced its block grant strategy for Medicaid. Drugmakers, PBMs Run the Gauntlet at House Hearing No punches were thrown, but tensions were high during a House hearing on Wednesday, as witnesses representing drug companies and pharmacy benefit managers (PBMs) fought to shield themselves from blame for high insulin prices, and desperate and dying patients. Members of the House Oversight and Investigations Subcommittee, mostly Democrats, leveled a number of threats around price-fixing, and turning PBMs into utilities or getting rid of them entirely. "You're in trouble ... If you think you can out-talk us without any transparency, without any accountability, I just want you to know your days are numbered," said Rep. Jan Schakowsky (D-Ill.) to drugmakers after highlighting how "curiously close in price" each one's product was -- in the range of $270-$280.
In the Senate, PBMs Plead Innocent Senators chastised pharmacy benefit managers (PBMs) for using backdoor tactics and secret schemes that make drugs costlier to patients than they otherwise would be, during a Senate Finance Committee hearing on Tuesday.

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Teva Announces Unique Collaboration with HealthSnap to Expand the Reach of its Respiratory Digital Health Platform

Teva Pharmaceuticals | November 21, 2022

Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. announced a new collaboration with HealthSnap, a leading full-service Virtual Care Management Platform for chronic disease management. The collaboration will enable more consumers to have access to Teva’s Digihaler® system, a digital health platform designed to enable patients to have more informed treatment discussions with their healthcare providers through personalized care. The collaboration will enable healthcare providers to better integrate patient data into their workflows, supporting proactive remote care across large populations. The platform can be used to monitor and manage large populations by a network of health systems. It can capture objective and actionable data for asthma patients, thereby creating the mechanism for personalized care. “Digital health platforms will succeed only by seamlessly integrating multiple data sources into workflows and systems like electronic medical records (EMR). We believe in building an ecosystem and are delighted to partner with HealthSnap as we seek to expand the reach of our platform, and continue to shape digital therapeutics and the integrated care landscape,” said Manny Montalvo, Senior Vice President, Head of Digital Health & Innovation at Teva. “We believe that the future of healthcare is in predictive and preventative care, which is a significant paradigm shift from the standard of care today. That is why we will focus our collaboration and our services on facilitating this change, to help providers deliver better care and help patients manage their condition.” “With a rich heritage of delivering innovative medicines, alongside technology development capabilities, Teva is uniquely positioned to help the healthcare ecosystem move toward greater integration of objective health data, and create meaningful population-scale solutions to help patients and providers. We envision broad utilization of our platform by consumers, healthcare providers and other technology organizations. In respiratory care, our long-term vision is ambitious and clear: harnessing the power of technology and therapeutics to predict asthma attacks.” Montalvo continued, “Over the past few years, through a talented and continuously evolving in-house team we have built a robust technology arm within Teva to continue exploring ways to improve patient outcomes. Through our vision for connected therapy, we strive to be at the nexus between patients, healthcare providers, technology, and the future of medicine, exploring new ways for digital health to serve as an economically sustainable solution for small and large healthcare provider organizations, offering timely, data-driven solutions to benefit patients. Our hope is that by working with HealthSnap and other capable companies in this space, we will fulfill our mission of improving the lives of patients, and do so by improving the health and effectiveness of our healthcare system – and we’re just getting started.” “By partnering with Teva, HealthSnap is expanding its reach to patients with respiratory diseases, allowing them to receive personalized care based on their data. HealthSnap is continuously seeking partnerships and we look forward to delivering quality at home programs with this new and exciting collaboration with Teva,” Samson Magid, Co-Founder and CEO of HealthSnap About Teva Teva Pharmaceutical Industries Ltd. has been developing and producing medicines to improve people’s lives for more than a century. We are a global leader in generic, biosimilar and specialty medicines with a portfolio consisting of over 3,500 products in nearly every therapeutic area. Around 200 million people around the world take a Teva medicine every day, and are served by one of the largest and most complex supply chains in the pharmaceutical industry. Along with our established presence in generics, we have significant innovative research and operations supporting our growing portfolio of specialty and biopharmaceutical products. Learn more at www.tevapharm.com About Teva Digital Health Teva aims to be a global leader in personalized, predictive care, continuously investing in platforms and regulatory-compliant systems that will help change the nature of digital health as we know it. Teva’s proprietary software platform Digihaler® – developed and maintained in-house by a team of research specialists and programmers – is built into a series of FDA-approved inhalers, currently marketed in the U.S., and with plans to expand to Europe in 2023. About HealthSnap HealthSnap is an integrated Virtual Care Management Platform that helps healthcare organizations improve patient outcomes, reduce utilization, and diversify revenue streams. From chronic disease-agnostic Remote Patient Monitoringand Chronic Care Management to AI-guided care coordination, virtual care delivery, automated care management billing, population analytics - and so much more, HealthSnap is the simplest way to manage chronic conditions remotely.

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VIEWS AND ANALYSIS, PHARMACY MARKET

Soligenix Initiates Phase 2 Clinical Trial of SGX302 (synthetic hypericin) for the Treatment of Mild-to-Moderate Psoriasis

Soligenix, Inc. | December 20, 2022

Soligenix, Inc. a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that patient enrollment has been opened for its Phase 2a study evaluating SGX302 in the treatment of mild-to-moderate psoriasis. Psoriasis is an ongoing unmet medical need, with as many as 7.5 million people in the U.S. and 60-125 million people worldwide affected by this incurable disease. "We are excited to expand synthetic hypericin's development into different cutaneous T-cell diseases such as psoriasis, as a component of our long-term strategy to enhance the value of this unique compound. Given our promising published results with hypericin to date, including a small Phase 1/2 proof of concept clinical trial in mild-to-moderate psoriasis, and the Phase 3 FLASH study in cutaneous T-cell lymphoma, where we filed a New Drug Application this month, we are hopeful synthetic hypericin will have a role to play in helping patients suffering from this difficult to treat and chronic disease." Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix The Phase 2a clinical trial will target enrollment of up to 42 patients ages 18 years or older with mild to moderate, stable psoriasis covering 2 to 30% of their body. In both Parts A and B, all patients will apply the study drug twice per week and will activate the drug with visible light 24 ± 6 hours later using the supplied visible light devices and according to the manufacturer's instructions. Patients will undergo treatments for a total of 18 weeks and, on completion, will be followed for a 4-week follow-up period in which patients will not receive other psoriasis treatments. In Part A, 5-10 patients will be assigned open-label SGX302 at the time of enrollment. Once the tolerability and response to SGX302 has been established, Part B of the protocol will commence. In Part B, patients will be randomized to double-blind treatment groups at a ratio 1:1 of active drug to placebo ointment. Active dermatologic assessment of treated lesions for adverse events will be performed immediately before and during light treatments. Patients will be assessed for overall disease status through 4 weeks of follow-up. Efficacy endpoints will include the extent of lesion clearance and patient reported quality of life indices. Routine safety laboratories also will be collected. About Synthetic Hypericin Visible light-activated synthetic hypericin is a novel, first-in-class, photodynamic therapy that is expected to avoid much of the long-term risks associated with other PDT treatments. Synthetic hypericin is a potent photosensitizer that is topically applied to skin lesions and taken up by cutaneous T-cells. With subsequent activation by safe, visible light, T-cell apoptosis is induced, addressing the root cause of psoriasis lesions. Other PDTs have shown efficacy in psoriasis with a similar apoptotic mechanism, albeit using ultraviolet light associated with more severe potential long-term safety concerns. The use of visible light in the red-yellow spectrum has the advantage of deeper penetration into the skin potentially treating deeper skin disease and thicker plaques and lesions, similar to what was observed in the positive Phase 3 FLASH study in CTCL. Synthetic hypericin or HyBryte™ was demonstrated in this study to be equally effective in treating both plaque and patch lesions in this orphan disease caused by malignant T-cells. In a published Phase 1/2 proof of concept clinical study using synthetic hypericin, efficacy was demonstrated in patients with CTCL. This treatment approach avoids the risk of secondary malignancies (including melanoma) inherent with both the frequently used DNA-damaging drugs and other phototherapies that are dependent on UV A or B exposure. The use of synthetic hypericin coupled with safe, visible light also avoids the risk of serious infections and cancer associated with the systemic immunosuppressive treatments used in psoriasis. The Phase 3 FLASH trial enrolled a total of 169 patients with Stage IA, IB or IIA CTCL. The trial consisted of three treatment cycles. Treatments were administered twice weekly in 6-week cycles. In the first double-blind treatment cycle, 116 patients received HyBryte™ treatment and 50 received placebo treatment of their index lesions. A total of 16% of the patients receiving HyBryte™ achieved at least a 50% reduction in their lesions (using the standard Composite Assessment of Index Lesions Severity [CAILS] score) compared to only 4% of patients in the placebo group after just 6 weeks of treatment (p=0.04). Further treatment with HyBryte™ increased the number of treatment successes to 40% and 49% after 12 and 18 weeks, respectively (p<0.0001 for both). Additional analyses also indicated that HyBryte™ is equally effective in treating both plaque (42% treatment response rate after 12 weeks treatment, p<0.0001 relative to placebo treatment in Cycle 1) and patch (37%, p=0.0009) lesions of CTCL, a particularly relevant finding given the historical difficulty in treating plaque lesions. This is also relevant to psoriasis where the lesions can be thicker than the patches observed in CTCL. In a subset of patients evaluated during their third treatment cycle, it was demonstrated that HyBryte™ is not systemically available, consistent with the general safety of this topical product observed to date. At the end of Cycle 3, HyBryte™ continued to be well tolerated despite extended and increased use of the product to treat multiple lesions. About Psoriasis Psoriasis is a chronic, non-communicable, itchy and often painful inflammatory skin condition for which there is no cure. Psoriasis has a significantly detrimental impact on patients' quality of life, and is associated with cardiovascular, arthritic, and metabolic diseases, as well as psychological conditions such as anxiety, depression and suicide. Many factors contribute to development of psoriasis including both genetic and environmental factors. The lesions develop because of rapidly proliferating skin cells, driven by autoimmune T-cell mediated inflammation. Of the various types of psoriasis, plaque psoriasis is the most common and is characterized by dry, red raised plaques that are covered by silvery-white scales occurring most commonly on the elbows, knees, scalp, and lower back. Approximately 80% of patients have mild-to-moderate disease. Mild psoriasis is generally characterized by the involvement of less than 3% of the body surface area (BSA), while moderate psoriasis will typically involve 3-10% BSA and severe psoriasis greater than 10% BSA. Between 20% and 30% of individuals with psoriasis will go on to develop chronic, inflammatory arthritis (psoriatic arthritis) that can lead to joint deformations and disability. Studies have also associated psoriasis, and particularly severe psoriasis, with an increased relative risk of lymphoma, particularly CTCL. Although psoriasis can occur at any age, most patients present with the condition before age 35. Treatment of psoriasis is based on its severity at the time of presentation with the goal of controlling symptoms. It varies from topical options including PDT to reduce pain and itching, and potentially reduce the inflammation driving plaque formation, to systemic treatments for more severe disease. Most common systemic treatments and even current topical photo/photodynamic therapy such as UV A and B, carry a risk of increased skin cancer. Psoriasis is the most common immune-mediated inflammatory skin disease. According to the World Health Organization Global Report on Psoriasis 2016, the prevalence of psoriasis is between 1.5% and 5% in most developed countries, with some suggestions of incidence increasing with time. It is estimated, based upon review of historic published studies and reports and an interpolation of data that psoriasis affects 3% of the U.S. population or more than 7.5 million people. Current estimates have as many as 60-125 million people worldwide living with the condition. The global psoriasis treatment market was valued at approximately $15 billion in 2020 and is projected to reach as much as $40 billion by 2027. About Soligenix, Inc. Soligenix is a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need. Our Specialized BioTherapeutics business segment is developing and moving toward potential commercialization of HyBryte™ as a novel photodynamic therapy utilizing safe visible light for the treatment of cutaneous T-cell lymphoma. With a successful Phase 3 study completed, regulatory approval is being sought and commercialization activities for this product candidate are being advanced initially in the U.S. Development programs in this business segment also include expansion of synthetic hypericin into psoriasis, our first-in-class innate defense regulator technology, dusquetide for the treatment of inflammatory diseases, including oral mucositis in head and neck cancer, and proprietary formulations of oral beclomethasone 17,21-dipropionate for the prevention/treatment of gastrointestinal disorders characterized by severe inflammation including pediatric Crohn's disease.

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BUSINESS INSIGHTS, PHARMACY MARKET

insitro Appoints Philip Tagari, Industry-Leading Scientist and Drug Hunter, as Chief Scientific Officer

insitro | December 02, 2022

insitro, a machine learning-powered drug discovery and development company announced that Philip Tagari has been appointed as chief scientific officer. Tagari joins insitro following a 24-year career at Amgen, where he has led the organization's research platforms for over a decade as vice president, research - therapeutic discovery. “I am deeply excited to partner with Philip on insitro’s journey to build a transformative biology platform for the efficient discovery and development of effective medicines for patients in need. Philip brings unparalleled experience in drug development, including building and utilizing cutting-edge platforms, profound scientific expertise across therapeutic areas and modalities, and most importantly, the humility and courage to transcend the drug discovery status quo and do things differently.” Daphne Koller, Ph.D., founder and CEO of insitro Tagari joins a cross-functional team of experts in biology and technology at insitro, part of a uniquely collaborative culture that spans the boundaries of both fields. “Philip’s inspiring track record of fusing science and technology to build innovative platforms and leading therapeutic programs from bench to approval will guide us in the next step of insitro’s journey, as we deploy our expertise to identify exciting new targets and design therapeutic molecules,” said Koller. “insitro is completely redefining our understanding of disease biology and developing novel therapeutic strategies for a variety of grievous illnesses. Using machine learning on genetics and multi-modal phenotypic data at scale from human cohorts and cellular systems, their cutting edge laboratories are rapidly generating differentiated approaches to currently intractable unmet needs,” Tagari said. “I’m thrilled to partner with Daphne and insitro’s world-class scientists and technologists in achieving a patient-driven vision brought to life in a different kind of drug company.” Tagari joins insitro in early 2023 from Amgen, where he has held a variety of roles since 1998, and served as vice president, research - therapeutic discovery, since 2012. During his time at Amgen, Tagari built and led a global organization of over 600 scientists that delivered numerous experimental and marketed therapies in neurology, inflammation, cardiovascular disease and oncology. Throughout his career, which includes a decade at Merck and research positions at McGill University and Oxford University, Tagari made significant contributions toward multiple first-in-class, disease-modifying, life-changing therapies including Lumakras, Repatha, Singulair, Aimovig, Evenity, Tarlatamab, Acapatamab, Efavaleukin alfa, and AMG 133. With more than 30 years of research experience, he brings expertise across neurobiology, metabolic disease, hematology/oncology, immunology and inflammation, cell and molecular biology, antibody discovery and biologics engineering, medicinal, peptide and oligonucleotide chemistry, analytical chemistry and biochemistry, structural biology, pharmacokinetics, safety pharmacology, laboratory automation and information technologies. Tagari has published or contributed to more than 70 peer-reviewed publications. “I had the privilege of working with Philip for more than 15 years, first at Merck, and thereafter at Amgen, and can say unequivocally that he ranks among the most accomplished, and most innovative, scientific leaders in the industry,” said Roger M. Perlmutter, M.D., Ph.D., currently president, chief executive officer, and chairman of Eikon Therapeutics, Inc., (formerly EVP R&D both at Amgen and at Merck), and is a member of insitro’s Board of Directors. “With Philip as chief scientific officer and partner to Daphne, insitro will be well positioned to ensure that insights from its machine learning-enabled discovery platform contribute to the development of important new medicines that will make a meaningful difference for patients.” About insitro insitro is a data-driven drug discovery and development company using machine learning and data at scale to transform the way that drugs are discovered and developed for patients. insitro is developing predictive machine learning models to discover underlying biologic states based on human cohort data and in-house generated cellular data at scale. These predictive models are being brought to bear on key bottlenecks in pharmaceutical R&D to advance novel targets and patient biomarkers, design therapeutics and inform clinical strategy. insitro is advancing a wholly owned and partnered pipeline of biologic insights and molecules in metabolism and neuroscience. Since formation in mid 2018, insitro has raised over $700 million from top tech, biotech, and crossover investors, and from collaborations with pharmaceutical partners.

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VIEWS AND ANALYSIS, PHARMA TECH

Virpax Pharmaceuticals Reports on FDA Pre-IND Response for NobrXiol™ (formerly VRP324)

Virpax Pharmaceuticals | December 15, 2022

Virpax® Pharmaceuticals, Inc. a company specializing in developing non-addictive products for pain management, post-traumatic stress disorder, central nervous system disorders and viral barrier indications, today announced that it has received pre-Investigational New Drug application guidance from the U.S. Food and Drug Administration for NobrXiol™, the Company’s product candidate for the delivery of cannabidiol in the management of epilepsy in children and adults. NobrXiol utilizes the Nanomerics Molecular Envelope Technology as its delivery system to cross the blood brain barrier, propelling the cannabidiol nanoparticles through the nose to the brain via the olfactory nerve. The main purpose of a pre-IND submission is to obtain FDA guidance on the overall development plan for a new drug and to identify any need for further data prior to submitting the IND. “Virpax now has guidance on how to proceed with the IND enabling studies and possible regulatory pathways to pursue for NobrXiol. Based on the written responses from the FDA and its recommendations, we believe that we can proceed with the next steps in the process towards an IND application for this product candidate.” Dr. Sheila A. Mathias, Chief Scientific Officer for Virpax “This is a significant step forward for the NobrXiol project and we are very pleased with the outcome of the pre-IND meeting with the FDA,” said Anthony P. Mack, Chairman and CEO of Virpax. “We believe this product candidate has potential benefits over existing oral CBD treatments for epilepsy including Dravet Syndrome and Lennox-Gastaut Syndrome. We believe that by using the MET delivery system there may be significant advantages for patients including fewer side effects, avoidance of drug-to-drug interaction and lower dosing of CBD required,” concluded Mr. Mack. About NobrXiol™ Virpax has acquired the exclusive worldwide rights from Nanomerics to use Nanomerics' MET platform for the nasal delivery of cannabidiol or the management of epilepsy in children and adults. As part of this agreement, Nanomerics is developing an investigational formulation delivered via the nasal route to enhance CBD transport to the brain which could potentially eliminate any drug interaction issues and bypass the digestive system, possibly eliminating many of the side effects associated with the product currently in use on the market. Nanomerics demonstrated the ability of its platform technology to deliver CBD directly to the brain in an animal model. About Virpax Pharmaceuticals Virpax is developing branded product candidates for non-addictive pain management and neurological disorders using its proprietary technologies that optimize and target drug delivery. Virpax is initially seeking FDA approval of its three different patented drug delivery platforms. Epoladerm™ is a topical diclofenac spray film formulation being developed to manage pain associated with osteoarthritis of the knee. Probudur™ is a single injection long-acting liposomal bupivacaine formulation being developed to manage post-operative pain. Envelta™ is an intranasal Molecular Envelope Technology enkephalin formulation being developed for the management of acute and chronic pain, including pain associated with cancer, as well as post-traumatic stress disorder under the name PES200. MET technology is also used in AnQlar™, a candidate to inhibit viral replication caused by influenza or SARS-CoV-2. Virpax acquired global rights to NobrXiol™, a product candidate for the nasal delivery of a pharmaceutical-grade cannabidiol for the management of epilepsy in children and adults.

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