Regeneron Pharmaceuticals, Inc. | May 31, 2022
Regeneron Pharmaceuticals, Inc. and Sanofi announced that the U.S. Food and Drug Administration has accepted for Priority Review the supplemental Biologics License Application (sBLA) for Dupixent® Medical (dupilumab) to treat adults with prurigo nodularis, a chronic skin disease that causes extreme itch and inflammatory skin lesions. The target action date for the FDA decision is September 30, 2022.
The sBLA is supported by data from two pivotal Phase 3 trials evaluating the efficacy and safety of Dupixent in patients 18 years and older with prurigo nodularis Both trials met the primary and key secondary endpoints, showing Dupixent significantly improved disease signs and symptoms compared to placebo, including reduction in itch and skin lesions. The safety results from these trials were generally consistent with the known safety profile of Dupixent in its approved dermatology indications. The adverse event more commonly observed with Dupixent was conjunctivitis.
The FDA grants Priority Review to therapies that have the potential to provide significant improvements in the treatment, diagnosis or prevention of serious conditions. Additional regulatory filings around the world are also planned in 2022.The potential use of Dupixent in prurigo nodularis is currently under clinical development, and the safety and efficacy have not been fully evaluated by any regulatory authority.
About Prurigo Nodularis
People with prurigo nodularis experience intense, persistent itch, with thick skin lesions (called nodules) that can cover most of the body. Prurigo nodularis is often described as painful with burning, stinging and tingling of the skin. The impact of uncontrolled prurigo nodularis on quality of life is one of the highest among inflammatory skin diseases due to the extreme itch and is comparable to other debilitating chronic diseases that can negatively affect mental health, activities of daily living and social interactions. High-potency topical steroids are commonly prescribed but are associated with safety risks if used long-term. There are approximately 75,000 people in the U.S. who are unable to control their disease with systemic therapy and are most in need of a treatment option.
Dupixent, which was invented using Regeneron's proprietary VelocImmune® technology, is a fully human monoclonal antibody that inhibits the signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways and is not an immunosuppressant. The Dupixent development program has shown significant clinical benefit and a decrease in type 2 inflammation in Phase 3 trials, establishing that IL-4 and IL-13 are key and central drivers of the type 2 inflammation that plays a major role in multiple related and often co-morbid diseases. These diseases include approved indications for Dupixent such as asthma, atopic dermatitis, chronic rhinosinusitis with nasal polyposis (CRSwNP) and eosinophilic esophagitis, as well as investigational diseases such as prurigo nodularis.
Dupixent is approved for use in certain patients with atopic dermatitis, asthma, CRSwNP or eosinophilic esophagitis in different age populations in a number of countries around the world. Dupixent is currently approved across these indications in the U.S. and for one or more of these indications in the European Union and Japan and more than 60 countries. More than 400,000 patients have been treated with Dupixent globally.
About Regeneron's VelocImmune Technology
Regeneron's VelocImmune technology utilizes a proprietary genetically engineered mouse platform endowed with a genetically humanized immune system to produce optimized fully human antibodies. When Regeneron's President and Chief Scientific Officer George D. Yancopoulos was a graduate student with his mentor Frederick W. Alt in 1985, they were the first to envision making such a genetically humanized mouse, and Regeneron has spent decades inventing and developing VelocImmune and related VelociSuite® technologies. Dr. Yancopoulos and his team have used VelocImmune technology to create approximately one in five of all original, FDA-approved or authorized fully human monoclonal antibodies currently available. This includes Dupixent, REGEN-COV® (casirivimab and imdevimab), Libtayo® (cemiplimab-rwlc), Praluent® (alirocumab), Kevzara® (sarilumab), Evkeeza® (evinacumab-dgnb) and Inmazeb™.
Dupilumab Development Program
Dupilumab is being jointly developed by Regeneron and Sanofi under a global collaboration agreement. To date, dupilumab has been studied across 60 clinical trials involving more than 10,000 patients with various chronic diseases driven in part by type 2 inflammation.
Babson Diagnostics | July 27, 2022
Babson Diagnostics, a science-first, health care technology company, announced a media partnership with the Pharmacy Podcast Network in connection with the 2022 National Association of Chain Drug Stores’ Total Store Expo, the largest gathering of retailers and suppliers in the health and wellness industry.
As part of the partnership, the Pharmacy Podcast Network, the most popular and downloaded podcast about the pharmacy industry, will be integrated into Babson Diagnostics’ booth at the Total Store Expo. Todd Eury, founder and chief executive officer of the media company, will host podcasts from the booth featuring industry leaders attending the trade show.
In addition, Babson will sponsor two podcasts that will be broadcast prior to the expo, which takes place Aug. 27 through Aug. 29 in Boston. The first of those shows, “Diagnostic Testing in Community Pharmacies,” went live today.
“Babson is excited to be collaborating with one of the leading media outlets aimed at community pharmacists, who are the face of neighborhood healthcare. Babson is working with pharmacies to offer medically accurate blood testing that is easier, more convenient and less invasive than traditional methods.”
David Stein, CEO of Babson Diagnostics
Launched in 2009, the Pharmacy Podcast Network reaches more than 80,000 listeners per month with audio content focused on the critical role pharmacists play in the healthcare industry.
“I look forward to bringing exciting new content to my audience through this partnership with Babson Diagnostics,” Eury said. “The Total Store Expo is a one-of-a-kind opportunity to bring insights to pharmacists about new and innovative products and services in health and wellness, such as Babson’s blood-testing ecosystem.”
About Babson Diagnostics
Babson Diagnostics is a science-first healthcare technology company bringing convenient, medically accurate diagnostic blood testing to the local pharmacy. We are the first and only company to do broad blood panels from a capillary microsample, collected from a finger, at a retail setting.
Our core technology was incubated at Siemens Healthineers in 2015, and we became Babson Diagnostics in 2017. We have exclusive partnerships with Siemens Healthineers and BD (Becton, Dickinson and Company), two global leaders in healthcare innovation and medical technology. Together we are reimagining the entire blood testing process, helping people get the care they need, when they need it.
Babson, based in Austin, Texas, is named in honor of Art Babson, whose legacy of scientific innovation and excellence is the foundation on which the company is built.
About Pharmacy Podcast Network
Pharmacy Podcast Nation is the flagship show hosting all of the Pharmacy Podcast Network 1400+ episodes. With more than 30 different podcast programs and some 40 different co-hosts helping to develop audio content about the pharmacy sector, its reach includes communities, hospitals, senior-care residences, military and public health settings that meet the information needs of 300,000 pharmacists with more than 100,000 monthly listeners. PPN also delivers a unique publication called Rx Influencer to all healthcare professionals with a specific focus on pharmacy.
Mauna Kea Technologies | July 12, 2022
Mauna Kea Technologies inventor of Cellvizio®, the multidisciplinary probe and needle-based confocal laser endomicroscopy platform, and Tasly Pharmaceuticals announced the execution of an agreement to form a Joint Venture.
Under terms of the agreement, Tasly and Mauna Kea will form a Joint Venture that will (i) commercialize selected Cellvizio indications in China, (ii) develop and commercialize Cellvizio globally in the fields of Neurology and Neurosurgery, and (iii) manufacture Cellvizio units for the Chinese market. The JV will utilize both existing distribution partners and its own network of China-based marketing professionals to accelerate market adoption.
In exchange for contributing licenses and other intellectual property to the JV, Mauna Kea will receive cash payments totaling $10 million, a 44.1% equity interest in the JV, and a 5-year commitment to purchase minimum quantities of Cellvizio systems and probes. Mauna Kea’s equity holdings are net of shares issued to Cenponts Tech Limited in consideration for strategic advisory services provided in connection to the transaction. The Joint Venture will be majority owned and funded by Tasly and jointly managed by Tasly and Mauna Kea.
The Joint Venture will be in an immediate position to leverage Mauna Kea’s position as global leader in probe and needle-based confocal laser endomicroscopy, with its FDA clearance for neurosurgery applications, its broad regulatory clearances in the Chinese market as well as its significant installed based in leading hospitals in China.
“We are delighted to partner with Tasly Pharmaceuticals, a life sciences leader in Asia-Pacific with a global presence. This transaction both expands the addressable market for Cellvizio and increases Mauna Kea’s capacity to invest further in product and clinical development, including molecular imaging and artificial intelligence. This announcement builds on the strategic repositioning we announced in December 2021 and our emphasis on forming capital-efficient partnerships that leverage the commercial reach of global biopharma and medtech firms while increasing patient access to Cellvizio.”
Sacha Loiseau, Ph.D., founder and Chairman of Mauna Kea Technologies
Kaijing Yan, Chairman of Tasly Pharmaceuticals Group, commented: “The field of biomedical engineering is an important part of Tasly Pharmaceuticals’ second growth curve strategy. The cooperation with Mauna Kea Technologies will enable us to quickly access large markets in China addressed by the multiple clinical applications of Confocal Laser Endomicroscopy. The recent advances in molecular imaging with Cellvizio are also of great interest to us since Tasly Pharmaceuticals could assist the Joint Venture in developing new combinations of Cellvizio with novel molecular markers, aligned with our vision of providing integrated solutions from diagnosis to treatment. We very much look forward to a fruitful and rich collaboration with Mauna Kea Technologies.”
About Tasly Pharmaceuticals Group
Adhering to the business mission of "To share the joy of health with all", Tasly has always been promoting the integrative development of traditional Chinese medicine and modern medicine. Tasly continuously focuses on the three disease fields of cardio-cerebro-vascular diseases, digestive and metabolic diseases and tumors, which have the largest market share and the fastest development in China. It is committed to providing drug R&D that is urgently needed for clinical use and even addresses the unmet needs in China's clinical market. By leveraging the coordinated development advantages of modern TCM, biological medicine and chemical medicine, it carries out the strategic layout of innovative drugs and continues to maintain its leading position in the industry and the development momentum of R&D and innovation.
About Mauna Kea Technologies
Mauna Kea Technologies is a global medical device company that manufactures and sells Cellvizio®, the real-time in vivo cellular imaging platform. This technology uniquely delivers in vivo cellular visualization which enables physicians to monitor the progression of disease over time, assess point-in-time reactions as they happen in real time, classify indeterminate areas of concern, and guide surgical interventions.
Medison Pharma | May 30, 2022
Medison Pharma a global pharma company focused on providing access to highly innovative therapies to patients in international markets, announced the addition of new markets to its multi-territorial agreement with Immunocore Holdings plc a commercial-stage biotechnology company pioneering the development of a novel class of T cell receptor bispecific immunotherapies designed to treat a broad range of diseases, including cancer, infection and autoimmune disease. The multi-territorial agreement to help seek regulatory authorization and commercialize Immunocore's KIMMTRAK® for the treatment of unresectable or metastatic uveal melanoma, a rare and aggressive form of melanoma that affects the eye, which covers Canada, twenty markets across Central Eastern Europe and Israel, will now extend to Australia and New Zealand.
KIMMTRAK has been approved by both by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), where it is the first and only treatment approved in the E.U. to treat patients with unresectable or metastatic uveal melanoma.
"We are delighted to deepen our partnership with Immunocore and proud to further grow the reach of their breakthrough treatment, as part of our mission that knows no borders. We believe that every patient, wherever they are in the world, deserves a fair chance to receive lifesaving, highly innovative therapies. By adding new countries and continents, we are continuing in our efforts to turn our mission into a reality."
Meir Jakobsohn, Founder and CEO of Medison
"It can be challenging for biotechs to commercialise in a large number of countries, often resulting in delayed access to highly innovative therapies in many areas of the world. Medison's global platform is designed to address this challenge," said Gil Gurfinkel, VP Corporate Development at Medison. "Immunocore's novel therapy for unresectable or metastatic uveal melanoma and our ability to treat patients suffering from this rare and aggressive form of cancer in additional countries is a win-win outcome of our partnership."
Medison's expansion of its commercial presence to Australia and New Zealand is the latest addition to its geographic growth, enabling Medison to capitalize on growing market opportunities for its commercial partners.
Medison is further enlarging its footprint in Europe with a new office location for its international headquarters in Zug, Switzerland, and operations in Greece and Cyprus, which enlarge its European offering of Central Eastern Europe, the Baltic states, and Balkans. In Canada, the team is also growing and recently moved into larger office space in downtown Toronto.
With this latest growth, Medison increases its commercial presence across 25 locations around the world. Medison is hiring across all locations and in key functions.
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.
Medison is also an active investor in disruptive healthcare technologies and provides its partners with exposure to innovation in biotech and digital health.
KIMMTRAK is a novel bispecific protein comprised of a soluble T cell receptor fused to an anti-CD3 immune-effector function. KIMMTRAK specifically targets gp100, a lineage antigen expressed in melanocytes and melanoma. This is the first molecule developed using Immunocore's ImmTAC technology platform designed to redirect and activate T cells to recognise and kill tumour cells. KIMMTRAK has been granted Breakthrough Therapy Designation, Fast Track designation and orphan drug designation by the FDA in the United States, Accelerated Assessment by the EMA, and Promising Innovative Medicine (PIM) designation under the UK Early Access to Medicines Scheme for metastatic uveal melanoma. KIMMTRAK is currently approved in 31 countries, including the United States and European Union.