Drugmakers reveal list prices online after pressure from Trump

Houstonchronicle | April 19, 2019

The world's biggest pharmaceutical companies are revealing prices of their prescription drugs on websites for the first time in a bid to stave off pressure from the Trump administration to make even more public disclosures. The move by companies ranging from pharma giant Pfizer to biotechnology pioneer Amgen comes almost a year after President Donald Trump suggested in a blueprint for lowering medical costs that the government might require drugmakers to put list prices in their TV advertisements. When federal regulators officially proposed such a requirement in October, drugmakers protested. The industry's main trade association said the rule would give patients watching TV the false impression that they're required to pay the full price and that the ads would deter them from seeking treatment. The group also said the proposal would violate the First Amendment by compelling commercial speech.

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commenced work on a new standard to provide a global policy to limit these impurities in drug products and
ingredients.


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BUSINESS INSIGHTS

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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BUSINESS INSIGHTS, PHARMACY MARKET

Phio Pharmaceuticals Announces New Clinical Program to Study PH-762 for the Treatment of Cutaneous Squamous Cell Carcinoma

Phio Pharmaceuticals Corp. | December 22, 2022

Phio Pharmaceuticals Corp., today announced it expects to file an IND in the US in the first half of 2023 for a Phase 1b clinical trial of its INTASYL™ compound, PH-762. Phio is a clinical stage biotechnology company whose proprietary INTASYL self-delivering RNAi technology is designed to make immune cells more effective in killing tumor cells. PH-762 has been shown to reduce the expression of PD-1, a protein that inhibits T cells' ability to kill cancer cells. When administered intratumorally in preclinical models PH-762 primes an anti-tumor immune response, and inhibits tumor growth. Phio is currently conducting a Phase 1b clinical trial of PH-762 for the treatment of advanced melanoma at the Gustave Roussy Institute, one of the largest cancer centers in Europe. Phio expects to commence a US Phase 1b clinical trial early in the 2nd half of 2023. The initial US trial is expected to focus on the treatment of cutaneous squamous cell carcinoma and other selected cutaneous malignancies, following successful regulatory review of the IND. "Therapeutic interventions for cSCC are limited, and there is increasing unmet medical need. As cSCC tumors comprise approximately 51% of the total incidence of solid tumors in the US, excluding basal cell cancers, we recognize the growing need for alternative therapies for cSCC," said Robert Bitterman, Phio's Principal Executive Officer and Executive Chairman. Mr. Bitterman has over 25 years of executive leadership experience in the pharmaceutical and biologic life science industry with a proven track record in operations, finance and investor relations. "While monoclonal antibody therapies are available for the treatment of cSCC, mechanistically they only block the interaction between PD-1 and PD-L1 on the cell surface. PH-762 also has the potential to address PD-1 inside the T cell, essentially further enhancing the activity of the T cell to kill the tumor cells," said Dr. James Cardia, Phio's Vice President of Scientific Operations. Dr. Cardia led the team that discovered INTASYL. "PH-762 has the potential to meet a significant medical need in patients who have failed to respond to mAbs, as well as those with resectable and metastatic solid tumors. Phio is committed to advancing the study of PH-762 to provide a meaningful therapy for patients with a broad range of solid tumors." Dr. Mary Spellman, Phio's Medical and Clinical Development Advisor About INTASYL INTASYL compounds are chemically modified siRNAs that are designed to provide efficient, spontaneous cellular uptake and potent, long lasting intracellular activity targeting a broad range of cell types and tissues. INTASYL drugs precisely target specific proteins that reduce the body's ability to fight cancer, without the need for specialized formulations or drug delivery systems. INTASYL has demonstrated preclinical efficacy in both Direct-to-Tumor and Adoptive Cell Therapy applications. In comparison to biologics and cell and gene therapies, INTASYL has a favorable pre-clinical toxicity and safety profile, and a streamlined chemical synthesis that reduces costs and offers substantial convenience to the prescriber and patient. Phio believes that INTASYL is the only self-delivering RNA interference technology focused on immuno-oncology therapeutics. About Phio Pharmaceuticals Phio Pharmaceuticals Corp. is a clinical stage biotechnology company whose proprietary INTASYL™ RNAi technology is designed to make immune cells more effective in killing tumor cells. Phio believes that INTASYL is the only self-delivering RNAi technology focused on immuno-oncology therapeutics. INTASYL drugs precisely target specific proteins that reduce the body's ability to fight cancer, without the need for specialized formulations or drug delivery systems.

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PHARMACY MARKET

A novel azapeptide editing method provides potential for new drug development, Feinstein Institutes research shows

Feinstein Institutes | November 29, 2022

Peptides, short sections of proteins made up of chains of amino acids, are an important area of new drug development due to their potential for increased specificity and fewer side effects. Their main drawback is the rapid degradation by the body’s own enzymes, which has led to the need to develop longer-lasting peptide alternatives. Azapeptides are one type of peptide alternative that has shown great potential as therapeutics, exemplified by the HIV drug, Atazanavir. A new paper published in the journal Nature Communications by researchers at The Feinstein Institutes for Medical Research details proprietary reagents and methods that can selectively replace only those amino acids known to be targeted by enzymes with more stable versions to create azapeptides. The paper, authored by Yousef Al-Abed, PhD, co-director of the Institute of Bioelectronic Medicine at the Feinstein Institutes, describes the proprietary building blocks and method used to conduct systematic and robust peptide editing, replacing targeted amino acids with aza-amino acids to form more stable and efficient azapeptides. The azapeptides created could expedite the novel therapies to treat many diseases and conditions, including metabolic disease, influenza, pulmonary arterial hypertension, Crohn’s disease, arthritis, and irritable bowel diseases, among others. The paper, titled “Thiocarbazate building blocks enable the construction of azapeptides for rapid development of therapeutic candidates,” provides multiple examples of azapeptide construction, screening, and selection using a known peptide inhibitor of inflammation and bradykinin. “Peptides as drug candidates are easy to discover yet difficult to develop as final drugs because of their fast degradation in our body. A technology that circumvents these problems inherent to native peptides will change the future landscape of drug discovery. Our technology provides a platform of tools that enable minimal modification of any peptide at highly prone degradation sites, thereby increasing its life span in our body, allowing it more time to find its target and neutralize it.” Dr. Al-Abed Through peptide editing, going from peptide to azapeptide, using methods that Dr. Al-Abed and his team detail in the new paper, scientists can create potential therapies that have enhanced characteristics compared to natural peptides, like longer stabilities in a more efficient manner. Dr. Al-Abed and his team have precisely engineered thiocarbazates (a novel functional group) in the proprietary process to achieve an almost universal and more efficient means to selectively replace amino acids in a peptide chain. “Peptide drugs are a crucial resource for patients and the global pharmaceutical industry,” said Kevin J. Tracey, MD, president and CEO of the Feinstein Institutes and Karches Family Distinguished Chair in Medical Research. “Dr. Al-Abed and his team invented a fully automated chemical strategy using novel chemistry to make new peptide drugs which is an important new avenue for peptide drug discovery.” About the Feinstein Institutes The Feinstein Institutes for Medical Research is the research arm of Northwell Health, the largest health care provider and private employer in New York State. Home to 50 research labs, 3,000 clinical research studies and 5,000 researchers and staff, the Feinstein Institutes raises the standard of medical innovation through its five institutes of behavioral science, bioelectronic medicine, cancer, health innovations and outcomes, and molecular medicine. We make breakthroughs in genetics, oncology, brain research, mental health, autoimmunity, and are the global scientific leader in bioelectronic medicine – a new field of science that has the potential to revolutionize medicine.

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BUSINESS INSIGHTS

Cambrex to Acquire Snapdragon Chemistry, a Leader in Continuous Flow API Development Services

Cambrex | November 22, 2022

Cambrex, a leading global contract development and manufacturing organization providing drug substance, drug product, and analytical services across the entire drug lifecycle, today announced that it has entered into a definitive agreement to acquire Snapdragon Chemistry, a leading US-based provider of chemical process development services to a broad range of emerging and established biopharma customers. Snapdragon specializes in active pharmaceutical ingredient batch and continuous flow process development, utilizing state-of-the-art automation technology and proprietary equipment to solve complex process and analytical development challenges. The team of scientists and engineers apply deep process understanding afforded by data-rich experimentation to design and rapidly execute efficient GMP and non-GMP manufacturing processes. With R&D and manufacturing headquartered in Waltham, Massachusetts, Snapdragon's 74 employees come with strong ties to the local scientific community, with 31 PhD scientists on staff. "The acquisition of Snapdragon will accelerate our growth in the area of continuous flow process development and manufacturing, complementing our recent organic investments in our High Point, North Carolina facility. With R&D and manufacturing capabilities in the heart of Boston's biopharma hub, Snapdragon will continue to focus on solving their customers' most difficult process development challenges." Tom Loewald, CEO of Cambrex "We are excited to be joining Cambrex, a company with over 40 years of drug substance development and manufacturing expertise," said Matt Bio, CEO of Snapdragon. "Partnering our best-in-class process development capabilities with Cambrex's larger scale manufacturing facilities in North America and Europe is a natural fit, both for our employees and our customers." Snapdragon recently opened its second facility, a new 51,000-square-foot facility to manufacture experimental pharmaceutical products for human clinical trials. The new facility expanded the company's capacity for supplying clinical intermediates and drug substances. The transaction is expected to close following the completion of customary regulatory approvals. This will be Cambrex's second acquisition within a year along with Q1 Scientific, consistent with its strategy to expand its portfolio of specialized solutions for pharmaceutical development and manufacturing. About Cambrex Cambrex is a leading global contract development and manufacturing organization that provides drug substance, drug product, and analytical services across the entire drug lifecycle. With over 40 years of experience and a growing team of over 2,300 experts servicing global clients from North America and Europe, Cambrex is a trusted partner in branded and generic markets for API and finished dosage form development and manufacturing. Cambrex offers a range of specialized drug substance technologies and capabilities, including biocatalysis, continuous flow, controlled substances, solid-state science, material characterization, and highly potent APIs. In addition, Cambrex can support conventional dosage forms, including oral solids, semi-solids, and liquids, and has the expertise to manufacture specialty dosage forms such as modified-release, fixed-dose combination, pediatric, bi-layer tablets, stick packs, topicals, controlled substances, sterile, and non-sterile ointments.

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