Drug Prices Will Now be Included in TV Ads as Part of Effort to Drive Costs Down

biospace | May 09, 2019

Television advertisements for prescription medications that are covered by Medicare or Medicaid will begin to display the list price of the drug. The rule, which has been favored by the White House and supported in Congress, was finalized Wednesday, Department of Health and Human Services Secretary Alex Azar said. If drug prices covered by the government-funded plans have a list price, the wholesale acquisition cost, greater than $35 for a month’s supply. The inclusion of the list price is part of an effort from the administration to lower the cost of prescription drugs.

Spotlight

Formulation, process, and analytical development for antibody-drug conjugates, or ADCs, is complex. While the development of an aqueous solution formulation may be preferred over a lyophilized product, it is useful to initially pursue a dual path and develop drug product formulations for both a sterile solution and a freeze-dried solid presentation, ultimately choosing the most successful candidate for final development. An antibody-drug conjugate, or ADC, consists of a monoclonal antibody (mAb) joined to a highly potent or cytotoxic drug by a stable, chemical linker with labile bonds. The antibody is targeted to attach to an antigen on the surface of a tumor cell. Once the connection is made between surface antigen and antibody, the antibody and linked drug are incorporated into the tumor cell. The drug is then cleaved from the antibody, and goes to work to destroy the tumor cell. Once internalized, the amount of “payload drug” required to cause cell death is relatively small. For that reason, ADC’s are generally better tolerated by patients than more traditional forms of chemotherapy.

Spotlight

Formulation, process, and analytical development for antibody-drug conjugates, or ADCs, is complex. While the development of an aqueous solution formulation may be preferred over a lyophilized product, it is useful to initially pursue a dual path and develop drug product formulations for both a sterile solution and a freeze-dried solid presentation, ultimately choosing the most successful candidate for final development. An antibody-drug conjugate, or ADC, consists of a monoclonal antibody (mAb) joined to a highly potent or cytotoxic drug by a stable, chemical linker with labile bonds. The antibody is targeted to attach to an antigen on the surface of a tumor cell. Once the connection is made between surface antigen and antibody, the antibody and linked drug are incorporated into the tumor cell. The drug is then cleaved from the antibody, and goes to work to destroy the tumor cell. Once internalized, the amount of “payload drug” required to cause cell death is relatively small. For that reason, ADC’s are generally better tolerated by patients than more traditional forms of chemotherapy.

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PHARMACY MARKET

Xeris Pharmaceuticals Completes Enrollment of Its Phase 1 Study of Levothyroxine (XP-8121)

Xeris Pharmaceuticals, Inc. | September 01, 2021

Xeris Pharmaceuticals, Inc., a specialty pharmaceutical company leveraging its novel formulation technology platforms to develop and commercialize ready-to-use injectable drug formulations, today announced that the company has completed enrollment and successfully dosed all participants in a Phase 1 study of levothyroxine (XP-8121) to evaluate the pharmacokinetics, safety and tolerability, and potential for weekly dosing of the investigational, novel, subcutaneous (SC) injection for the treatment of hypothyroidism. XP-8121 is a novel formulation that could potentially mitigate many of the challenges associated with oral formulations, such as identification of an ideal dose due to absorption variation and medication adherence for patients who have difficulty maintaining a stable, therapeutic serum level. Preclinical studies of SC XP-8121 showed a sustained plasma exposure profile and similar maximum plasma concentration (Cmax) when compared with equivalent doses of the oral formulation. The Phase 1 clinical study of levothyroxine (XP-8121) is a single ascending dose crossover design in 30 healthy participants to compare matching doses of oral levothyroxine (Synthroid®) and subcutaneous (SC) XP-8121. The primary endpoints of the study are to characterize the absorption and elimination kinetics of XP-8121 and compare bioavailability of XP-8121 to oral levothyroxine. Secondary endpoints are safety and tolerability of XP-8121. The study is being conducted in partnership with Dr. Danielle Armas and Celerion, a leading contract research organization with extensive experience performing first-in-human studies. “The potential for a once weekly subcutaneous injection of levothyroxine would represent a promising novel approach in treating patients with hypothyroidism. Drug non-compliance, resistant hypothyroidism, and limited GI absorption are some of the major reasons for treatment failure or suboptimal treatment with oral levothyroxine. These challenges could be mitigated by XP-8121 and translate into the long-term health benefit of achieving a euthyroid state for patients,” said Dr. Armas, Senior Principal Investigator, Celerion. “Because our levothyroxine formulation enables a small volume SC injection, as an injectable maintenance therapy, it may facilitate less frequent dosing. This may provide clinical advantages over the established oral daily route, by providing predictable bioavailability, comparable safety, and ease of use,” said Dr. Ken Johnson, Xeris’ Senior Vice President of Global Development and Medical Affairs. About Levothyroxine and Hypothyroidism. The thyroid gland is responsible for the synthesis, storage, and release of metabolic hormones including thyroxine (T4) and triiodothyronine (T3) [Colucci et al, 2013]. These hormones are crucial in the regulation of critical metabolic processes and are vital for normal growth and development during fetal life, infancy, and childhood. Therapeutically, levothyroxine is administered when the body is deficient in the endogenous hormone. The goal of therapy is restoration of the euthyroid state which can reverse the clinical manifestations of hypothyroidism and significantly improve quality of life [Winther et al, 2016]. The treatment of choice for correction of hypothyroidism is levothyroxine, which is the mainstay of thyroid hormone replacement therapy. It is one of the most widely prescribed drug products in the United States, but the complexity of maintaining biochemical and clinical euthyroidism in patients undergoing treatment with oral levothyroxine cannot be underestimated. It has been reported that nearly 40% of patients undergoing treatment with oral levothyroxine are either over- or under-treated [Laurent et al, 2018] due to factors that include, but are not limited to, drug formulation, use of the drug with food, adherence to the drug, use of concomitant medications, and pre-existing medical conditions. Many patients failing to reach target TSH levels are generally managed by simply increasing their levothyroxine daily dose [Chiovato et al, 2019]. However, levothyroxine is a drug with a narrow therapeutic index [Vita et al, 2014], meaning that relatively small deviations from the proper dose can cause a clinically meaningful shift in pharmacological effects when administered to a patient; thus, the titration of levothyroxine oral drug may be a tailored and incremental process. About Xeris Pharmaceuticals, Inc. Xeris is a pharmaceutical company delivering innovative solutions to simplify the experience of administering important therapies that people rely on every day around the world. With a novel technology platform that enables ready-to-use, room-temperature stable formulations of injectable drug, the company is advancing a portfolio of solutions in various therapeutic categories, including its first commercial product, Gvoke® in the U.S. Its proprietary XeriSol™ and XeriJect™ formulation technologies have the potential to offer distinct advantages over conventional product formulations, including eliminating the need for reconstitution, enabling long-term, room-temperature stability, significantly reducing injection volume, and eliminating the requirement for intravenous (IV) infusion. With Xeris’ technology, new product formulations are designed to be easier to use by patients, caregivers, and health practitioners and help reduce costs for payers and the healthcare system. Xeris is headquartered in Chicago, IL.

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PHARMACY MARKET

Insilico Medicine Announced Strategic Collaboration with EQRx

Insilico Medicine | March 25, 2022

A clinical-stage end-to-end artificial intelligence driven drug discovery firm, Insilico Medicine announced the formation of a strategic partnership with EQRx, a company dedicated to creating and delivering novel medications to patients at much-reduced costs. The cooperation will use Insilico's Pharma.AI technology to accelerate the design and creation of de novo small molecules and EQRx's clinical development and commercialization experience. In addition, EQRx and Insilico will form a co-development partnership in which each party will get a profit share according to its investment level. The collaborative agreement identifies and selects up to three therapeutic targets using Insilico's AI-powered platform, Pharma. AI. From small molecule hit identification through lead optimization and preclinical candidate nomination, Insilico will guide the drug discovery process. EQRx will be in charge of clinical development, regulatory affairs, and commercialization. In addition, Insilico may invest in the product candidate(s) at different phases of clinical outcome in exchange for enhanced commercialization income. "Both EQRx and Insilico Medicine strive to accelerate the discovery and development of new medicines and make effective therapeutics more accessible and affordable. This partnership will combine our end-to-end AI-powered drug discovery capabilities with EQRx's innovative partnership model and expertise in clinical development and patient access to accelerate innovative therapies' discovery and development, " Alex Zhavoronkov, Ph.D., founder and founder CEO of Insilico Medicine "We are pleased to partner with Insilico Medicine, a leader in AI-based drug discovery," said Carlos Garcia-Echeverria, Ph.D., chief of Rx Creation at EQRx. "This collaboration will further expand our early-stage R&D efforts to fuel potential pipeline growth as we continue to apply the best of today's innovation in biomedical sciences and digital solutions to discover high-quality, innovative, and more affordable medicines."

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PHARMACY MARKET

Mallax acquires Sana Pharma Medical, Establishing a New Nordic Pharmaceutical Platform

Mallax | July 05, 2021

Mallax Pharmaceuticals AB has acquired Sana Pharma Medical AS, forming a new Nordic pharmaceutical platform. SPM, founded in Norway in 2014, is a rapidly growing OTC company with complete pharmaceutical infrastructure and Nordic distribution coverage. With the well-established brands such as Lunixen and Sedix and additional products based on the chemical melatonin, the Company has a leading position in the fast-growing sleep and anxiety sector. SPM is a well-resourced platform with about 15 FTEs that provides extensive in-house pharmaceutical expertise and experience to serve as an appealing basis for Mallax. Furthermore, the Company has a sizable and steadily growing pipeline of new products that will be released in the future years. Mallax was founded in 2020 by Impilo, a Nordic healthcare-focused investment firm, and Anders Larnholt, a seasoned pharma, and healthcare executive, with the long-term goal of creating a large and diverse platform with established pharmaceuticals and OTC products for customers and patients across Europe. Dr. Peter Sjöstrand, the former deputy CEO and CFO of Astra and the former Chairman of the Boards of Gambro and Meda, is named Chairman of the Board of Mallax as part of the transaction. About Mallax Mallax was founded in 2020 by Impilo and Anders Larnholt with the ambition of building a leading pharma company and investing significant capital and resources behind the right acquisition opportunities across Europe, with a wide size range for any individual deal ranging from EUR 10 million to EUR 300 million. Mallax's strategy is based on three pillars: sustainability, medical need, and profitable growth. Mallax currently has operations in all Nordic markets due to the acquisition of Sana Pharma Medical. About Impilo Impilo is a Nordic investment firm that makes long-term investments in healthcare companies involved in pharmaceuticals, medical technology, healthcare services, and other health-related sectors. Impilo seeks to enhance the value of its assets via long-term active ownership and generate consistent returns for its stakeholders. Impilo has a well-diversified investment portfolio and has raised over SEK 9 billion in capital from leading Nordic and international investors since its inception in 2017.

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