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.
PR Newswire | January 08, 2024
Isomorphic Labs, a digital biology company with a mission to redefine drug discovery using the power of artificial intelligence, today announced that it has entered into a strategic research collaboration with Eli Lilly and Company. This marks Isomorphic Labs' first pharmaceutical partnership.
Under the terms of the agreement, Isomorphic Labs will partner with Lilly to discover small molecule therapeutics against multiple targets and will receive an upfront cash payment of $45 million. Isomorphic Labs is eligible to receive up to $1.7 billion in performance-based milestone payments, excluding the upfront payment and any subsequent tiered royalties of up to low double digits on net sales.
"We're thrilled to embark on this partnership and apply our proprietary technology platform, the next generation of AlphaFold, and access to massive computing power to Lilly's development programs," said Demis Hassabis, CEO and founder of Isomorphic Labs. "The focus we share on advancing groundbreaking drug design approaches and appreciation of state-of-the-art science makes this partnership particularly compelling."
Isomorphic Labs operates autonomously within Alphabet, with its own dedicated resources and exclusive focus on the application of AI to drug discovery. The company is reimagining the entire drug discovery process from first principles with an AI-first approach, working to build powerful new predictive and generative models of biological phenomena to anticipate how drugs will perform and design novel molecules.
Building on the success of AlphaFold and working in collaboration with Google DeepMind, Isomorphic Labs has made remarkable progress in developing the Next Generation of AlphaFold. This new iteration of AlphaFold expands beyond proteins to include small molecules and nucleic acids. Through deep integration of this next generation AlphaFold with other breakthrough AI models developed at Isomorphic Labs, the company is able to better understand the underlying biological mechanisms of drug targets, and rationally design novel therapeutics.
ABOUT ISOMORPHIC LABS
Isomorphic Labs is an autonomous subsidiary of Alphabet that was launched from Alphabet's DeepMind in 2021 to build on the success of AlphaFold, the company's groundbreaking work in protein folding. That work was heralded as the 'Breakthrough of the Year' by Science and 'Method of the Year' by Nature in 2021. Based in London and now with a second location in Lausanne, Switzerland, Isomorphic Labs was founded and is led by AI pioneer Demis Hassabis, who also co-founded and leads Google DeepMind. As pioneers in digital biology, the company's mission is to use AI to accelerate drug discovery and ultimately find cures for some of humanity's most devastating diseases. Using its AI-first approach to drug discovery and biology, the company's ambition is to advance a new era of medical breakthroughs.
PR Newswire | January 24, 2024
IDBS announced today that it has entered into a partnership with Massachusetts-based PharmaEssentia Innovation Research Center (PIRC) on its Polar platform to help digitize data management and facilitate collaboration between the company's global research and development (R&D) teams.
The Polar platform will provide PIRC, the newly established U.S. hub of PharmaEssentia's R&D efforts, the ability to electronically collaborate with its team headquartered in Taipei, Taiwan, who have traditionally recorded experimental data on paper.
"The IDBS Polar platform provides superior functionality beyond traditional Electronic Laboratory Notebook (ELN) offerings, backed up by our broad customer base and customer support, as well as the ability to support languages like Mandarin," said Pietro Forgione, General Manager at IDBS. "We are proud to help PIRC better capture, structure and interrogate their key data from a single source of truth, thereby making their collaboration more efficient."
"We are looking forward to partnering with IDBS, not only to implement the Polar platform to help us manage our data more efficiently and to more seamlessly collaborate with our R&D team in Taipei, but also to work together to further explore ways to bring our innovative therapeutics to market faster," said Lih-Ling Lin, Ph.D., PIRC Founder and Chief Scientific Officer, PharmaEssentia.
IDBS helps BioPharmaceutical organizations accelerate the discovery, development and manufacturing of the next generation of life-changing therapies that advance human health worldwide. From lab through manufacturing, IDBS leverages its 30+ years of experience working with a diverse list of customers – including 18 of the top 20 global BioPharma companies – and deep expertise in scientific informatics and process data management to tackle today's most complex challenges.
Known for its signature IDBS E-WorkBook product, IDBS has extended solutions across the entire value chain for BioPharma Lifecycle Management (BPLM). Built on analytics-centric and cloud-native technology, IDBS Polar and IDBS PIMS platforms are powered by a digital data backbone to drive faster and smarter decisions in drug development and across the supply chain.