PR Newswire | January 08, 2024
Medison Pharma ("Medison"), a global pharma company focused on providing access to highly innovative therapies to patients in international markets, announced today their exclusive multi-national agreement with Regeneron Ireland DAC, a wholly owned subsidiary of Regeneron Pharmaceuticals, Inc., a leading biotechnology company that invents, develops and commercializes life-transforming medicines for people with serious diseases, to commercialize Libtayo (cemiplimab), a fully human monoclonal antibody targeting the immune checkpoint receptor PD-1 on T cells, in select European markets and additional markets around the world.
Libtayo was invented in laboratories at Regeneron, which acquired exclusive worldwide development, commercialization, and manufacturing rights to the medicine from Sanofi in July 2022. Medison and Regeneron will work together with all stakeholders and regulatory authorities to facilitate a seamless transition of commercialization activities to Medison during the first half of 2024.
Libtayo, which was invented using Regeneron's proprietary VelocImmune® technology, is currently approved by regulatory authorities in more than two dozen countries, including by the European Medicines Agency (EMA). In select markets, it is approved as monotherapy treatment for certain patients with advanced basal cell carcinoma (BCC), as monotherapy treatment for certain patients with advanced cutaneous squamous cell carcinoma (CSCC), as both monotherapy or in combination with chemotherapy for certain patients with advanced non-small cell lung cancer (NSCLC) and/or as monotherapy treatment for certain patients with recurrent or metastatic cervical cancer. Libtayo is a leading and first-in-class PD-1 inhibitor approved for the treatment of two non-melanoma skin cancers and is considered standard of care in these indications.
"Our multi-regional commercial platform is a great fit for Regeneron's go-to-market plan and another great opportunity for Medison to facilitate access to highly innovative therapies for people suffering from rare and severe diseases," said Meir Jakobsohn, Founder and Executive Chairman of Medison. "Regeneron's selection of Medison is yet another testimony of the unique value that our multi-regional solution can generate for innovative biotech companies wishing to focus on selected markets."
"We are proud to partner with Regeneron," said Gil Gurfinkel, CEO of Medison. "Our one-of-a-kind centralized, unified commercial platform, with single alliance management across multiple markets and regions, is of great value to more and more leading biotech companies. Our platform enables biotech companies to transform numerous complex and fragmented markets and regions into a unified territory."
Libtayo is a fully human monoclonal antibody targeting the immune checkpoint receptor PD-1 on T cells and was invented using Regeneron's proprietary VelocImmune technology. By binding to PD-1, Libtayo has been shown to block cancer cells from using the PD-1 pathway to suppress T-cell activation. In the U.S. and other countries Libtayo is indicated in certain patients with advanced BCC, advanced CSCC and advanced NSCLC, as well as in advanced cervical cancer in the European Union, Canada and Brazil. As of July 1, 2022, Libtayo is developed and marketed globally by Regeneron. Outside of the U.S., the generic name for Libtayo is cemiplimab.
The extensive clinical program for Libtayo is focused on difficult-to-treat cancers. Libtayo is currently being investigated in trials as a monotherapy, as well as in combination with either conventional or novel therapeutic approaches for other solid tumors and blood cancers. These potential uses are investigational, and their safety and efficacy have not been evaluated by any regulatory authority.
About Medison Pharma
Medison is a global pharma company focused on providing access to highly innovative therapies to patients in international markets. Medison is the first to create an international commercialization platform for highly innovative therapies, helping to save and improve lives by making the best available novel treatments accessible to patients in international markets. Medison has a track record of multi-territorial partnerships with leading pharmaceutical and biotech companies seeking to expand their global reach.
PHARMA TECH, PRACTICE MANAGEMENT
PR Newswire | January 05, 2024
Eli Lilly and Company today announced LillyDirect, a new digital healthcare experience for patients in the U.S. living with obesity, migraine and diabetes. LillyDirect offers disease management resources, including access to independent healthcare providers*, tailored support, and direct home delivery of select Lilly medicines through third-party pharmacy dispensing services.
"A complex U.S. healthcare system adds to the burdens patients face when managing a chronic disease. With LillyDirect, our goal is to relieve some of those burdens by simplifying the patient experience to help improve outcomes," said David A. Ricks, Lilly's chair and CEO. "LillyDirect offers more choices in how and where people access healthcare, including a convenient home delivery option to fill Lilly medicines they have been prescribed."
For patients living with obesity, migraine and diabetes, LillyDirect offers:
LillyDirect Pharmacy Solutions, a digital pharmacy for select Lilly medicines powered by third party online pharmacy fulfillment services. LillyDirect Pharmacy Solutions gives patients a simple option to get consistent access to Lilly medicines they have been prescribed with the added convenience of home delivery. By obtaining medicines directly from Lilly, patients can easily access Lilly's affordability solutions and savings card opportunities are automatically applied for patients who qualify. Medicines fulfilled by pharmacy service providers through LillyDirect Pharmacy Solutions ship free of charge.
Disease state and healthcare educational information to help empower and support patients on their care journeys.
Access to independent telehealth providers that could complement a patient's current primary care team or be an alternative to in-person care for certain conditions.
An independent search tool that allows a patient to find healthcare professionals near them if they prefer in-person care.
"We know that people have come to depend on the efficiency and convenience of digital solutions to meet a variety of their everyday needs – healthcare being one of them," said Frank Cunningham, group vice president, global value and access at Lilly. "We launched LillyDirect with the hope that it will offer patients an innovative end-to-end experience to manage their health and access their medicines, so they can get back to living their lives."
LillyDirect will continue to be updated and expanded to improve the customer experience. Future updates may include new products, partners and services, such as programs designed to help patients with adherence to their medicines.
Lilly unites caring with discovery to create medicines that make life better for people around the world. We've been pioneering life-changing discoveries for nearly 150 years, and today our medicines help more than 51 million people across the globe. Harnessing the power of biotechnology, chemistry and genetic medicine, our scientists are urgently advancing new discoveries to solve some of the world's most significant health challenges, redefining diabetes care, treating obesity and curtailing its most devastating long-term effects, advancing the fight against Alzheimer's disease, providing solutions to some of the most debilitating immune system disorders, and transforming the most difficult-to-treat cancers into manageable diseases. With each step toward a healthier world, we're motivated by one thing: making life better for millions more people. That includes delivering innovative clinical trials that reflect the diversity of our world and working to ensure our medicines are accessible and affordable.
PR Newswire | January 24, 2024
ValGenesis Inc., the market leader in enterprise validation lifecycle management systems (VLMS), and Performance Validation, Inc. a 100% employee-owned company serving the life sciences industry since 1988, have partnered to deliver unique compliance-focused digital validation solutions for life sciences companies in the US.
Performance Validation is an industry leader with over 30 years of experience in analyzing, identifying, and testing the most critical elements of the manufacturing process for FDA-regulated industries. The company provides environmental mapping, commissioning, qualification, computer system validation, and quality system consulting services.
ValGenesis is the industry innovator of digitized validation. The company's platform, which includes its flagship VLMS offering, is used in over 100,000 GMP systems worldwide, helping life sciences companies advance their digital transformation strategy, enforce compliance, and enable standardization with 100% digital, risk-based validation software.
In this partnership, Performance Validation will implement and manage next-generation digital validation tools developed by ValGenesis, including ValGenesis VLMS and VLMS Express, a simplified cloud-based digital validation solution for startups and midsized companies. ValGenesis and Performance Validation are providing an integrated governance approach to further strengthen risk and compliance across their customers' manufacturing processes.
"We are excited to partner with Performance Validation. Their extensive experience and our industry benchmarked digital validation platform can help life sciences companies implement their digitization plans efficiently according to Industry 4.0 standards," says Bo Olsen, ValGenesis' SVP of Partners. "By establishing a clear strategy that addresses their risk and compliance implications upfront, we can assure them of true business transformation."
"Performance Validation is thrilled to embark on this collaborative journey with ValGenesis, leveraging our extensive experience and knowledge of digital validation solutions. It's a powerful combination – our hands-on validation experience and their innovative digital tools. For our clients in the life sciences, this means more efficient, streamlined, and compliant solutions. We're not just adapting to Pharma 4.0; we're helping our clients lead the way in digital transformation," says Brad Henry, Vice President of Service Lines at Performance Validation.
ABOUT PERFORMANCE VALIDATION
Performance Validation (PV) is a global validation partner for pharmaceutical and medical device manufacturers. Headquartered in Indianapolis, IN, we specialize in turning compressed timelines into compliant ones using innovative, adaptive approaches that balance production realities with strict regulatory requirements. Our best-in-class, cGMP-compliant services cover diverse needs from fully managed CQV to on-demand temperature mapping, smoke studies, software assurance, and more. With a dedicated team consisting of more than 95% engineers, we work closely with regulators and equipment suppliers to keep validation ahead of production curves and keep quality moving forward.
ValGenesis, Inc. is the creator of an innovative software platform that serves as a foundation for managing compliance-based validation activities in life sciences companies. ValGenesis, Inc. is the provider of the first enterprise application that manages the corporate validation lifecycle process. This solution is fully compliant with U.S. FDA 21 CFR Part 11 and Annex 11 requirements. As the first fully paperless solution for electronic management of validation execution and approval, ValGenesis was selected by an industry peer review committee to receive the Parenteral Drug Association (PDA) New Innovative Technology Award in 2005.