BUSINESS INSIGHTS
Businesswire | May 22, 2023
Closed Loop Medicine Ltd, a leading TechBio company, developing combination prescription drug plus software therapy products that enable personalized dose optimization, and Pharmanovia, a global pharmaceutical company that commercializes novel medicines and revitalizes, extends and expands the lifecycle of established medicines, today announced that they have entered a global co-development partnership.
The partnership will initially focus on the development and launch of a drug + software combination version of a first-line anti-hypertensive in the UK, before phased global roll-out and additional therapies are added.
Hypertension is the leading preventable cause of morbidity and premature death worldwide, impacting over 1 in 4 men and 1 in 5 women, and costing the NHS alone over £2.1 billion/year (1, 2). Managing high-blood pressure through medication and lifestyle modifications significantly reduces associated health risks and improves quality of life; research in the US demonstrating improved standards of care could prevent 91,900 heart attacks, 139,000 strokes and 115,400 cardiovascular deaths within just 5 years (3). However, poor drug tolerability and treatment-related side effects significantly impact adherence, with less than 50% of patients maintaining their treatment regimen after a year, ultimately hindering treatment effectiveness, patient outcomes and overall disease management (4).
As part of this partnership, Closed Loop Medicine’s proprietary Software-as-a-Medical Device (SaMD) dosing optimization technology will be combined with Pharmanovia’s established anti-hypertensive medicines, under a single prescription. Recent preliminary clinical trial results have demonstrated that Closed Loop Medicine’s technology may provide the ability to dose optimize drug therapy, improve blood pressure control, and minimize side effects (5). By developing a new class of combination products for the treatment of hypertension, both companies aim to support patients and healthcare professionals to better manage high blood pressure.
Dr. Hakim Yadi OBE, CEO & Co-Founder of Closed Loop Medicine, commented: “This pioneering partnership is a great example of where the power of software integration can add value to iconic medicines to make them more effective for patients. Through this co-development agreement, we will bring our IP, insight and technical know-how of dose optimized drug plus software integration alongside Pharmanovia’s innovative business model, to enable well-known and trusted brands to be positioned as value-driven precision medicine product solutions globally.”
Dr. James Burt, CEO of Pharmanovia, said: “Combining our experience in lifecycle management with Closed Loop Medicine’s unique approach and technology is an exciting next step in our strategy. It enables us to use innovative technology to enhance established medicines and bring much needed innovation to an area of large-scale unmet need. Together we aim to deliver a first in class combination regulated software and medicine – with the aim of delivering better patient outcomes, while enabling healthcare systems to reduce costly hospital procedures through better adherence and patient engagement.”
AboutPharmanovia
Pharmanovia is a global lifecycle management healthcare company. Our purpose is to make medicines fit for tomorrow, to improve the lives of patients globally. We do this by enhancing established medicines either by rediscovering, repurposing or re-engineering iconic brands to improve patient outcomes and experiences both through in-house development and through strategic partnerships.
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PHARMACY MARKET
Businesswire | May 29, 2023
Elixir, a pharmacy benefit management company owned by Rite Aid has announced details of the next release of its Laker Software technology platform. The upcoming enhancements include new automated workflows, a customer service tool and modernization of the user interface.
"Already a leader in the industry, Laker Software is going from good to great,” said Jeff Mallad, VP, PBM Technology Sales for Elixir. "Elixir’s technology platform is one of the fastest and most reliable pharmacy claims systems available—and it’s about to become turbo-charged! We’re modernizing the future of pharmacy benefits to support our customers’ business growth, the digital world and cost reduction.”
The upgrade will include a range of advanced functionalities that are designed to help customers better manage their pharmacy claims adjudication data and streamline workflows. The new features will allow users to access and share data more efficiently, collaborate more effectively, and improve productivity.
For more than 20 years, the Laker Software platform has been a leading technology solution and one of only a few that can manage multiple lines of business including
Medicare, Medicaid and Exchange Commercial payers Adjudication and claims processing for 340B pharmacies Prescription savings card programs Workers’ compensation
Built on a resilient, scalable architecture, the Laker Software platform is a 100% virtualized environment. The platform processes millions of paid claims per year and is SOC 1 Type 2 certified. It has multiple levels of data security and redundant backup systems. Laker Software provides a full set of robust capabilities, including
Claims Processing/Adjudication Call Center Plan Set Up Eligibility Accumulator Accounts Payable/Receivable Prior Authorization Reporting
Customers will begin to beta test some of the platform’s newest features shortly, and other enhancements will follow as the next generation of Laker Software evolves. Customers can expect to see improvements in cost reduction due to automation, solutions for improved plan design and channel management, and advanced analytics and statistical analyses. This is in addition to a cloud-based infrastructure and redesigned user interface, allowing for even more flexibility and a better customer experience.
"Elixir is committed to investing in innovative solutions to meet the evolving needs of the pharmacy benefits industry,” said Mallad. “In addition to our Laker platform, customers can rely on our full suite of pharmacy benefit services to custom design their ideal solution. We support your business, enable your growth and help you succeed in every segment of the pharmacy lifecycle."
About Elixir
Elixir, a fully owned subsidiary of Rite Aid Corporation, is a pharmacy services provider that offers pharmacy benefit management services, Medicare-approved prescription drug plans, mail and specialty pharmacy solutions, and prescription discount programs. With the unique ability to optimize the full pharmacy care experience, Elixir is crafting solutions for today’s pharmacy benefits challenges.
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PHARMA TECH
Globenewswire | June 01, 2023
The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the submission of a Type II variation application to the European Medicines Agency (EMA) seeking approval of a new indication for CARVYKTI® (ciltacabtagene autoleucel; cilta-cel) for the treatment of adult patients with relapsed and lenalidomide-refractory multiple myeloma.
“The previous European Commission approval recognised the potential for cilta-cel to positively impact outcomes for people living with relapsed and refractory multiple myeloma,” said Edmond Chan, MBChB M.D. (Res), Senior Director, EMEA Therapeutic Area Lead Haematology, Janssen-Cilag Limited. “Today’s submission to the EMA is an important step towards helping patients benefit from this CAR-T therapy earlier in their treatment journey. If approved, this will be the first and only CAR-T therapy available to treat relapsed and refractory multiple myeloma patients as early as second line.”
The application is supported by data from the CARTITUDE-4 study the first randomised Phase 3 study evaluating the efficacy and safety profile of cilta-cel versus pomalidomide, bortezomib and dexamethasone (PVd) or daratumumab, pomalidomide and dexamethasone (DPd) in the treatment of patients with relapsed and lenalidomide-refractory multiple myeloma who received one to three prior lines of therapy.1
The CARTITUDE-4 study results will be presented in a special session at the upcoming American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, IL on Monday 5 June 2023 at 16:45 CEST.
“This submission is a testament to our relentless commitment to advance science, transform outcomes, challenge what a multiple myeloma diagnosis means for patients and ultimately, work towards our goal of one day curing this complex disease,” said Sen Zhuang, M.D., Ph.D., Vice President, Clinical Research and Development, Janssen Research & Development, LLC. “We look forward to collaborating with the EMA to bring this potential new indication for cilta-cel to the multiple myeloma community as soon as possible.”
About Ciltacabtagene Autoleucel (cilta-cel)
Cilta-cel received conditional marketing authorisation from the European Commission in May 2022, for the treatment of adults with relapsed and refractory multiple myeloma who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody, and have demonstrated disease progression on the last therapy.3,4 In February 2022, the FDA approved cilta-cel for the treatment of adults with relapsed or refractory multiple myeloma after four or more prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.5
Cilta-cel is a B-cell maturation antigen (BCMA)-directed, genetically modified autologous T-cell immunotherapy, which involves reprogramming a patient’s own T-cells with a transgene encoding a chimeric antigen receptor (CAR) that identifies and eliminates cells that express BCMA.6 BCMA is primarily expressed on the surface of malignant multiple myeloma B-lineage cells, as well as late-stage B-cells and plasma cells.7,8 The cilta-cel CAR protein features two BCMA-targeting single domain antibodies designed to confer high avidity against human BCMA.6 The CAR-modified T-cells express fusion proteins of antigen receptors against tumour-associated surface antigens and T-cell activation domains, and upon binding to BCMA-expressing cells redirect the effector T-cells and enhance tumour-specific immunosurveillance.9
In December 2017, Janssen Biotech, Inc. (Janssen) entered into a worldwide license and collaboration agreement with Legend Biotech USA, Inc. to develop and commercialise cilta-cel.10
About Multiple Myeloma
Multiple myeloma is an incurable blood cancer that affects a type of white blood cell called plasma cells, which are found in the bone marrow.11 In multiple myeloma, these malignant plasma cells change and grow out of control.8 In Europe, more than 50,900 people were diagnosed with multiple myeloma in 2020, and more than 32,400 patients died.12 While some patients with multiple myeloma initially have no symptoms, others can have common signs and symptoms of the disease, which can include bone fracture or pain, low red blood cell counts, tiredness, high calcium levels, or kidney failure.13
About the Janssen Pharmaceutical
At Janssen, we're creating a future where disease is a thing of the past. We're the Pharmaceutical Companies of Johnson & Johnson, working tirelessly to make that future a reality for patients everywhere by fighting sickness with science, improving access with ingenuity, and healing hopelessness with heart. We focus on areas of medicine where we can make the biggest difference: Cardiovascular, Metabolism & Retina; Immunology; Infectious Diseases & Vaccines; Neuroscience; Oncology; and Pulmonary Hypertension.
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