BUSINESS INSIGHTS, PHARMA TECH
Tonix Pharmaceuticals | February 14, 2023
On February 13, 2023, Tonix Pharmaceuticals, a leading clinical-stage biopharmaceutical firm, announced that it has exercised an option to acquire an exclusive license from Columbia University to develop a portfolio of fully human (TNX-3600) and murine (TNX-4100) monoclonal antibodies (mAbs) for the prophylaxis or treatment of SARS-CoV-2 infection. COVID-19 is caused by SARS-CoV-2. Tonix Pharmaceuticals and Columbia University announced a research collaboration and option agreement in 2020, which resulted in the development of the licensed mAbs.
Although the FDA granted emergency use authorization (EUA) to five mAb products containing seven distinct mAbs for either prophylaxis or treatment of COVID-19, none stayed available or functional since January 26, 2023, when the FDA stated that the last remaining mAb, Evusheld®, is no longer authorized. Previously, either FDA or the National Institutes of Health COVID Treatment Guidelines Panel had revoked recommendations or clearances for the other mAbs.
Until recently, the earlier EUA-approved products were obtained from the blood of humanized mice or COVID-convalescent patients. Columbia University's TNX-3600 fully human mAbs were generated utilizing a proprietary system that involved a human hybridoma fusion partner.
The firm feels that murine monoclonal antibodies, such as TNX-4100, have the capacity to generate antibodies with a high affinity that detect distinct epitopes on the SARS-CoV-2 spike protein. This is due to the fact that mice have a different antibodies repertoire than humans, and the technology for making antibodies optimizes the selection of relevant B cells via harvesting approach, immunization timing and screening platform.
About Tonix Pharmaceuticals
Founded in 2007, Tonix Pharmaceuticals is a clinical-stage biopharmaceutical firm committed to finding, acquiring, licensing, and developing therapies for the treatment and prevention of diseases and the alleviation of human suffering. Its pipeline is focused on rare diseases, immunology, infectious diseases, and central nervous system (CNS) product candidates. The company's immunology portfolio consists of biologics for the treatment of organ transplant rejection, cancer and autoimmunity. At the same time, its infectious disease portfolio includes next-generation COVID-19 vaccines and vaccinations against smallpox and monkeypox.
BUSINESS INSIGHTS, PHARMA TECH
West Pharmaceutical Services | February 13, 2023
West Pharmaceutical Services, Inc., a leading global innovative injectable drug administration solutions provider, recently announced the expansion of its remarkable collaboration with Corning Incorporated, which now includes exclusive distribution rights for Corning Valor® Glass vials as well as the launch of its first product, West Ready Pack™ with Corning Valor® RTU Vials employing SG EZ-fill® technology.
The West Ready Pack™ with Corning Valor® RTU Vials integrates West's highest quality NovaPure® stoppers, Flip-Off® CCS (Certified, Clean, Sterilized) seals and Corning's best-in-class Valor® RTU Vials with SG EZ-fill® technology into a complete containment solution to assist in the introduction of parenteral drugs and diagnostics to the market.
West announced its agreement with Corning in January 2022, which includes a multimillion-dollar investment to develop Corning's Valor® Glass technology to improve patient safety and increase access to life-saving therapies. This strategic alliance provides premier elastomer-glass system solutions for injectable drug storage and delivery. In addition, West and Corning intend to collaborate to develop the next generation of integrated packaging and delivery system solutions.
Valor® RTU Vials with SG EZ-fill® technology improve medication storage and distribution, enable more reliable access to important medicines for public health, and maximize production efficiency. This pharmaceutical glass was explicitly created to handle the problems of modern industrial procedures.
The Ready Pack™ mixture of NovaPure® stoppers, Flip-Off® CCS seals, and Valor® RTU Vials with SG EZ-fill® technology offers drug developers the following advantages
Proven Container Closure Integrity (CCI), which includes the ability to sustain cold storage CCI when cooled to and kept at -80 degrees Celsius;
Ready-to-use sterile format that may be introduced immediately into filling operations, avoiding the requirement for component preparation;
Premium components with the most stringent particle requirements available from West; and
Availability in volumes appropriate for small-scale filling operations with continuity to quantity alternatives for large-scale commercial operations.
About West Pharmaceutical Services
Founded in 1923, West Pharmaceutical Services, Inc. is a leading high-quality, innovative injectable solutions and services provider. It is a trusted partner to both established and emergent drug producers and contributes to the safe, effective containment and delivery of life-enhancing and life-saving medications to patients. West supports its clients by supplying over 45 billion components and devices each year, with a team of approximately 10000 members spread across 50 facilities globally. Headquartered in Exton, Pennsylvania, the company has been operating for over a century and achieved $2.83 billion in net sales in the fiscal year 2021.
BUSINESS INSIGHTS, PHARMACY MARKET
Shields Health Solutions | March 17, 2023
Shields Health Solutions (Shields), the premier specialty pharmacy accelerator in the country, announced that it has partnered with Nemours Children’s Health, Delaware, to collaborate in developing a specialty pharmacy program that will provide patients with complex, chronic conditions access to specialized pharmacy services designed to lower costs, expand treatment options, enhance medication management, and improve overall health.
Shields will provide Nemours Children’s Health new support services through its partnership to meet the unique needs of patients with complex chronic conditions. Now, specialty pharmacy liaisons will work with patients on-site in clinics, offices, and pharmacies, among other locations, guiding patients who fill their prescriptions with Nemours Children’s. These liaisons work with teams of experts to assist patients and families with a multitude of tasks, including health insurance prior authorizations or securing financial assistance to help overcome one of the significant barriers to care.
These expanded patient support services, combined with access to recently approved and newly available drugs, will give Nemours’ patients greater availability for onsite treatment options. Shields currently partners with nearly 80 health systems around the country and has helped their patients reduce co-pays, promptly receive medication delivery, often within two days, and improved medication adherence greater than 90 percent on average.
Nemours Children’s Health is one of the largest multistate pediatric health systems in the country and provides award-winning care to more than 38,000 specialty patients. The complete health system includes two free-standing children's hospitals and a network of more than 70 primary, specialty and urgent care practices. US News & World Report ranked Nemours Children’s Hospital, Delaware among the 10 best children’s hospitals in the Mid-Atlantic region and recognized Nemours Children’s Hospital, Florida for excellence in orthopedics and endocrinology.
“Nemours’ commitment to outstanding care for children with chronic diseases aligns with Shields core mission,” said Stephen Davis, Senior Director of Health System Strategy. “Specialty pharmacy services provide challenges for all patient populations, but pediatric patients have unique needs that require tremendous support. We are proud to provide that support for patients at Nemours Children’s Health and help them achieve the best possible health outcomes.”
“As Nemours Children’s Health works toward creating the healthiest generations of children, it is imperative to address social determinants of health including access to medications that are affordable, said,” said Robert J. Mullen, BS, PharmD, RPh, Vice President, Patient Operations, Delaware Valley, at Nemours Children’s Health, Delaware. “Specialty pharmacy services can cause many challenges for the complex patients that Nemours Children’s cares for on a daily basis. We are proud to be partnering with Shields Health Solutions to help ease the burden for families acquiring prescription medication for their children and in turn achieve better health outcomes.”
About Shields Health Solutions
Shields Health Solutions (Shields) is the premier specialty pharmacy accelerator in the country. The Shields Performance Platform, an integrated set of solutions, services and technology, is intentionally designed to elevate payer and drug access for specialty pharmacies, elevate health outcomes for complex patients, and elevate growth throughout the entire health system. As the foremost experts in the health system specialty pharmacy industry, Shields has a proven track record of success including access to over 80 percent of all limited distribution drugs (LDDs) and most (health insurance) payers in the nation; and a clinical model proven to lower total cost of care by 13%. In partnership with more than 70 health systems across the country through national-scale collaboration, Shields has a vested interest in delivering measurable clinical and financial results for health systems.