Janssen hands back rights to Hanmi's diabetes/obesity drug

pharmatimes | July 04, 2019

Shares in Hanmi Pharmaceutical have taken a hit after Johnson & Johnson's Janssen handed back rights to HM12525A, a novel biologic GLP-1/Glucagon dual receptor agonist being developed for weight loss and blood glucose control in certain patients with diabetes. According to the Korean drugmaker, while two Phase II trials carried out by Janssen achieved the primary target of weight reduction, “its blood glucose control in obese patients accompanying diabetes fell short of Janssen’s internal standards”. An official at Hanmi Pharmaceutical was quoted by the Korea Biomedical Review as saying: “In Phase II studies, the treatment showed excellent efficacy in reducing weight in obese people with or without diabetes. We will have an internal review on the matter and confirm our plan for development as soon as possible. “We are aware that it is not easy to develop a new drug but will not stop challenging to commercialise Korea’s first successful new drug in the overseas market.” Janssen licensed exclusive global rights (excluding Korea and China) to the experimental drug in November 2015 in a deal valued at $915 million. Shares in Hanmi dropped nearly 30% as investors digested news of the deal's demise.

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PHARMA TECH

IACTA Pharmaceuticals and TALLC Corporation Announce Strategic Collaboration to Utilize Novel SmartCelle Topical Delivery Technology

IACTA Pharmaceuticals, Inc. | December 16, 2021

IACTA Pharmaceuticals, Inc. an innovation leader in ophthalmic therapeutics, and TALLC Corporation Inc. a pioneering ophthalmology company focused on the growing unmet needs of patients with corneal and retinal conditions, announced that they are entering into a strategic collaboration and licensing agreement. The agreement grants IACTA the use of TALLC’s proprietary SmartCelle™ micellar technology, a novel platform for pan-ocular drug delivery, for future clinical development. IACTA plans to utilize TALLC’s SmartCelle technology to deliver one or more of its novel ophthalmic therapeutics, as well as co-develop new ophthalmology therapeutic candidates that leverage IACTA’s formulation and clinical expertise with TALLC’s novel delivery technology. The collaboration also includes an option agreement, granting IACTA exclusive rights to negotiate a separate license agreement for the right to co-develop TALLC’s lead product candidate TA-A001, a novel anti-inflammatory anti-angiogenic molecule with analgesic properties in various disease state models. “I am thrilled to be able to partner with TALLC, a company with a shared vision focused on addressing the growing and significantly underserved ocular pain market. IACTA was formed with the mission of developing and commercializing innovative ocular therapies through novel compounds and utilizing leading drug delivery technologies, and we view this collaboration as the perfect synergy to realize the full potential of our ophthalmology pipeline. We are excited to explore how best to deploy the SmartCelle technology within our current pipeline, as well as the future co-development opportunities this partnership provides.” Damon Burrows, Chief Executive Officer of IACTA Pharmaceuticals TALLC’s proprietary SmartCelle pan-ocular drug delivery technology employs 30nm micelles that enable delivery of difficult to formulate drugs into corneal and retinal tissues after topical delivery. The company’s pipeline is led by SmartCelle TA-A001, a novel CB2 receptor activator, delivered topically to treat the effects of dry eye syndrome and age-related macular degeneration. “We are delighted to partner with the IACTA team for this important program. IACTA, with its in depth scientific and commercial understanding of the ophthalmic space is an ideal partner for TALLC as we drive towards further commercialization of the SmartCelle platform and TA-A001,” said Damon Smith, Ph.D., Chief Executive Officer of TALLC. “We look forward to working closely with the IACTA team and to co-developing SmartCelle versions of the IACTA pipeline.” About TALLC, Inc. TALLC is a Montreal-based developer of ophthalmic medicines actively engaged in the commercialization of SmartCelle TA-A001, and its pipeline of SmartCelle-delivered drug candidates, as treatments for acute and chronic inflammation. Focused initially on unmet needs in inflammatory front of eye indications, TALLC plans also to develop SmartCelle TA-A002 and TA-A003 in other chronic conditions including macular degeneration and glaucoma. SmartCelle enables pan ocular delivery of drug candidates by topical application directly to the ocular surface, by injection or by insufflation. About IACTA Pharmaceuticals, Inc. IACTA is an innovation leader in ophthalmic therapeutics, led by former top executives from one of the leading eye care companies in the world. The company currently has four products in development for major market opportunities. IC 800 is a novel, non-opioid, dual enkephalinase inhibitor, being studied for the treatment of acute ocular pain. In addition, IACTA’s IC 265, is a SYK kinase inhibitor being developed as a potential novel treatment for dry eye disease.

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BUSINESS INSIGHTS

Teva Reaches Agreement With Texas to Settle the State’s Opioid-Related Claims

Teva Pharmaceuticals | February 08, 2022

Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. and its affiliates, has reached an agreement with the Attorney General (AG) of Texas that settles the state’s and its subdivisions opioid-related claims. Under the terms of the settlement, Teva will pay Texas $150 million over a 15-year time period and will provide the recently launched, lifesaving medicine generic Narcan®, valued at $75 million over 10 years. “Expanding access to lifesaving medicines is at the core of Teva’s mission. The Texas Attorney General is taking steps to address the opioid epidemic in the State by negotiating a settlement that includes critical medicines as part of their solution. While the settlement includes no admission of wrongdoing by Teva or its affiliates, it remains in the best interest of Teva to put these cases behind us and continue to focus on the patients we serve every day.” Kåre Schultz, Teva’s President and CEO Naloxone is a life-saving medication that can reverse an overdose from opioids.1 As of December 2021, Teva has made available the first generic version of this critical medicine and has included this product in the Company’s ongoing pursuit of a national or narrower settlement with individual states such as the deal announced today. The Company will continue to defend itself in court in states where we have not reached terms of a settlement agreement. Teva believes that today’s settlement with the state of Texas is a critical step forward in getting life-saving treatments to people suffering from opioid addiction. About Teva Teva Pharmaceutical Industries Ltd. has been developing and producing medicines to improve people’s lives for more than a century. We are a global leader in generic and specialty medicines with a portfolio consisting of over 3,500 products in nearly every therapeutic area. Around 200 million people around the world take a Teva medicine every day, and are served by one of the largest and most complex supply chains in the pharmaceutical industry. Along with our established presence in generics, we have significant innovative research and operations supporting our growing portfolio of specialty and biopharmaceutical products.

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BUSINESS INSIGHTS

TendoNova wins FDA Clearance for Its New Microinvasive Ocelot Surgical Tool

TendoNova | March 24, 2022

TendoNova, an emerging leader in microinvasive sports medicine procedures, is pleased to announce the FDA 510 clearance of its new Ocelot surgical tool, which uses an innovative technology for fragmentation or debridement of soft tissue. The FDA found the Ocelot TDS 1000 substantially equivalent to the Tenex TX1 which is routinely used for percutaneous tenotomy in orthopedics, sports medicine, pain management, and podiatry. The Ocelot System's form factor and price point make it an exciting alternative to existing tools. Using technology licensed from Georgia Institute of Technology and Emory University School of Medicine, the Ocelot facilitates procedures that require fragmentation and debridement of soft tissue under external image guidance in a simple hand-held format. TendoNova was able to achieve this success through grants and investor backing of groups such as the Georgia Research Alliance and the NFL Players' Association. "According to studies cited by the Centers for Disease Control and Prevention, more than 30 million people in the U.S. suffer from chronic tendon pain, and half of those have little or no relief from physical therapy or medication. The Ocelot is the company's first product and was conceived in response to a request by Atlanta Hawks head team physician Dr. Ken Mautner for an improved tool." TendoNova CEO, Mark A Samuels Dr. Mautner, who practices at Emory, commented that, "After 15 years of treating elite and recreational athletes for tendinopathy, I have been frustrated by the tools we have had to help heal these injuries. The TendoNova device could be a game changer in getting our athletes back to the healthiest level possible." The Ocelot System performs mechanical fragmentation or debridement of a targeted area. The use of fragmentation and debridement is part of a common treatment for encouraging the growth of healthy tendon to supplant painful pathologic tendon tissue. Chronic tendon pain disorders, or tendinopathies, include tennis elbow, plantar fasciitis, and jumper's knee. Tendinopathy is prevalent in athletes and anyone else who engages in repetitive tasks. If left untreated, can lead to months or years of pain and even career-ending injuries. TendoNova plans to manufacture the Ocelot in Georgia and is presently working to validate the Ocelot disposable component production. The Ocelot is expected to be available to physicians in the second half of 2022. About TendoNova Founded in 2017, TendoNova is a medical device company that is an emerging leader in microinvasive sports medicine procedures. The company's initial product is the Ocelot™ TSD 1000, a patented, FDA cleared medical device for fragmentation or debridement of soft tissue. TendoNova is also working on a digital health solution projected to provide device operating feedback during a procedure to reduce training times and improve outcomes. Dedicated to helping people live healthier lives with less pain and fewer injuries, the company plans a series of instrumented microinvasive tools designed to help physicians better heal patients suffering from advanced tendon and other pathologies.

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BUSINESS INSIGHTS

Long Island University Extends Partnership with Dassault Systèmes to Innovation and Research in Life Sciences

Long Island University | March 23, 2022

Long Island University announced a new research and innovation partnership with Dassault Systèmes in life sciences. The partnership will focus on research with high societal impact to advance the fields of pharmaceutical sciences, precision medicine and health care in the digital age. Research includes precision medicine using "Virtual Twins," or exact digital models of human anatomy being developed by LIU and Dassault Systèmes; pandemic preparedness and the digitization of healthcare; innovation in medical devices; and telemedicine through the "Internet of Things," or the exchange and analysis of data between physical objects that are connected digitally. In addition, the partnership aims to provide a platform for technology transfer, or the sharing and transformation of inventions and scientific outcomes into commercialized products or services that benefit society. "Long Island University is at the forefront of revolutionizing health care training and research in higher education with our ongoing partnership with Dassault Systèmes. We are investing in opportunities and technology to ensure our students become future leaders and innovators in emerging industries." President Kimberly R. Cline As part of this commitment to students, LIU has also been designated as a Dassault Systèmes 3DEXPERIENCE Edu Center of Excellence. Dassault Systèmes created the global 3DEXPERIENCE Edu Centers of Excellence program in October 2021. The program is aimed at providing students, professionals, learners, businesses and governments with a network of centers dedicated to experiential, lifelong learning with its 3DEXPERIENCE platform that enables the current and future workforce to accelerate the digital transformation of industry. "At Dassault Systèmes, we have the profound belief that the virtual world extends and improves the real world helping to address today's social and environmental challenges," said Rama Kondru, Ph.D. co-CEO of Medidata, a Dassault Systèmes company. "This strategic initiative with LIU brings enormous opportunities since it is helping to prepare the next generation of life science experts to innovate in tomorrow's more sustainable economy, transform healthcare, and solve some of the biggest medical challenges in areas such as cancer and Alzheimer's disease." LIU is the second Center of Excellence in the U.S. in addition to Purdue University, which opened as a Center of Excellence in Advanced Composites in 2020. Additional centers have been established in France, Mexico, Germany, Switzerland, Brazil and India, and focus on various industry sectors. "Earning the distinction of being named a 3DEXPERIENCE Edu Center of Excellence is a testament to Long Island University's standing as a preeminent academic institution," said LIU Board of Trustees Chair Eric Krasnoff. "We are proud to partner with Dassault Systèmes to create an ecosystem where students, faculty and industry partners can collaborate on real-world, impactful learning." The University's extended and ongoing partnership with Dassault Systèmes, world leader in 3D design and engineering software, is in line with its vision to advance academic excellence through innovation, provide extraordinary and distinctive experiences to students, and create solutions for a sustainable global future. Forged in 2019, the partnership provides LIU students with hands-on experience using cutting-edge artificial intelligence and digital engineering technologies, and to collaborate on multidisciplinary research in the life sciences. "The LIU-Dassault Systèmes research partnership is centered on solving real-world problems through an integrated approach to education while simultaneously developing the future workforce for precision medicine, healthcare and pharmacy," said Dr. Randy Burd, senior vice president for academic affairs at LIU. "We look forward to using Dassault Systèmes' incredible technology to expand and enhance life sciences, liberal arts, humanities and performing arts degree programs throughout the University." In 2021, the University opened a state-of-the-art simulation laboratory that allows students to use Dassault Systèmes' patented 3D, augmented reality and virtual reality software to conduct experiential research, education and training. The laboratory is used in several areas of study, including artificial intelligence, robotics, virtual reality gaming, cybersecurity, data analytics, and drug discovery and development. LIU also employs Dassault Systèmes' cloud-based 3DEXPERIENCE platform in classrooms across the University. "LIU has entered a truly transformative niche in higher education by aligning with a digital healthcare industry that is on the rise," said Dr. Mohammed Cherkaoui, vice president for academic affairs at LIU. "We are honored to work with Dassault Systèmes, combining its content expertise and research tools to become a global leader in the innovation of healthcare." About Long Island University Long Island University, founded in 1926, continues to redefine higher education, providing high quality academic instruction by world-class faculty. Recognized by Forbes for its emphasis on experiential learning and by

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ABC delivers a broad array of GLP and CGMP-compliant product development and analytical testing services to the pharmaceutical, biotech, animal health, crop protection, consumer products and chemical industries. This cross-industry, cross-regulatory experience adds value to the process of product development--and will become increasingly important as public scrutiny and global regulations converge on the interrelationships between human, animal and environmental health.

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