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.
Enable Injections, Inc. | August 12, 2022
Enable Injections, Inc. a company developing and manufacturing the enFuse® platform of investigational wearable drug delivery systems, is pleased to announce the appointment of John DeFord, Ph.D. to the company's Board of Directors, effective July 29, 2022.
Enable Injections' enFuse is an innovative drug delivery technology designed to subcutaneously (SC) deliver large volumes of up to 50mL for a wide range of therapies and diseases, dedicated to improving the patient experience.
Dr. DeFord brings over three decades of expertise as a global medical technology executive, most recently the executive vice president and chief technology officer for Becton, Dickinson and Company (BD) (BDX), a global medical technology company. Prior to BD, Dr. DeFord served in senior science, technology and leadership roles of increasing responsibility at organizations such as C.R. Bard and Cook Incorporated, with additional experience in venture capital as managing director of Early Stage Partners venture capital fund. He is currently also a member of the board of directors at Nordson Corporation (NDSN), NuVasive (NUVA), and Blue Spark, Inc. DeFord graduated from Purdue University with a bachelor's degree and master's degree in electrical engineering, and a Ph.D. in electrical/biomedical engineering, dedicating his career to innovative medical technologies to save lives, enhance quality of life and improve the patient experience.
"Enable Injections is at the forefront of both simplifying the therapeutic delivery of critical medications and enhancing quality of life for the patient. I am excited to join the Board of Directors at this important time in the company's growth and development; and I look forward to working with the management team and Board to help accelerate translation of this important technology to the clinical setting."
"We are pleased to welcome Dr. DeFord as a new director to Enable's Board," said Mike Hooven, President and CEO of Enable Injections. "We believe adding depth of experience in the global medical technology space such as Dr. DeFord's is key to the strong growth of our business."
About Enable Injections
Cincinnati-based Enable Injections is a global healthcare innovation company developing and manufacturing drug delivery systems designed to improve the patient experience. Enable's body-worn enFuse® delivers high-volume pharmaceutical and biologic therapeutics via subcutaneous administration, with the aim of improving convenience, supporting superior outcomes, and advancing healthcare system economics.
SS&C | June 23, 2022
SS&C Technologies Holdings, Inc. announced a new partnership in the EMEA and APAC regions with Xcentuate, an award-winning international provider of digital productivity and performance solutions to the financial services, agricultural, pharma and public sectors.
The partnership follows SS&C's recent acquisition of Blue Prism, the leading Robotic Process Automation provider, further demonstrating its commitment to the intelligent automation solutions market. Xcentuate, based in Dublin, Ireland, will serve as a consulting and implementation partner, acting as an extended team to advise, implement, support and deliver complex projects.
"We are delighted to partner with Xcentuate," said Gautam Moorjani, General Manager, SS&C Intelligent Automation Solutions. "The EMEA and the Asia Pacific regions are markets with a lot of appeal - with resilient and developing economies and talented, skilled workforce. In addition, the potential for operational automation to transform how businesses work is significant."
The partnership will enable SS&C to leverage Xcentuate's vast experience to access new potential customers, take new value propositions to market, develop point solutions to address current market needs, and enhance its specialized professional services to our customers.
"The SS&C partnership is of significant strategic importance to us regarding our offer to the market. The breadth and depth of SS&C's expertise in financial services and healthcare technology are unmatched. In addition, this new partnership further broadens the suite of services we can offer to firms in EMEA and the Asia Pacific with an ambitious digital transformation agenda."
Ray Bowe, Xcentuate founder and CEO
Headquartered in Dublin, Ireland, Xcentuate serves a range of industries including financial services, agriculture, pharma and public sector.
Xcentuate works with customers in EMEA and Asia-Pacific regions to transform their business operations using a suite of best-in-class technology to deliver sustainable advantage. Combined with award-winning operational expertise and a track record of delivery, they support businesses in transforming their customer experiences and enabling them to optimise control and productivity while building an engaged, enthused workforce.
About SS&C Technologies
SS&C is a global provider of services and software for the financial services and healthcare industries. Founded in 1986, SS&C is headquartered in Windsor, Connecticut, and has offices around the world. Some 20,000 financial services and healthcare organizations, from the world's largest companies to small and mid-market firms, rely on SS&C for expertise, scale and technology.
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.