Tremfya tops Cosentyx in late-stage study

PharmaTimes | August 12, 2019

Johnson and  Johnsons Janssen has announced results from the Phase III ECLIPSE study, which show superior long-term efficacy of Tremfya guselkumab compared with Cosentyx secukinumab in adults with moderate to severe plaque psoriasis. According to the data, published in The Lancet, a statistically significantly higher proportion of Tremfya patients achieved a PASI 90 response at Week 48 compared to those taking Cosentyx, and also demonstrate superiority of clinical response at Week 48 based on 90 Percent or better improvement in patients Psoriasis Area and Severity Index score compared to baseline. During the trial, patients were randomised to receive 100mg of Tremfya administered by subcutaneous injection at weeks zero and four, followed by every eight-week dosing; or 300mg of Cosentyx administered by two subcutaneous injections of 150mg at weeks zero, one, two, three and four followed by every four-week dosing.

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Nobel Biocare Receives FDA 510(k) Clearance for the Nobel Biocare N1™ Implant System

Envista Holdings Corporation | December 28, 2021

Envista Holdings Corporation announced that the U.S. Food and Drug Administration has cleared the Nobel Biocare N1™ implant system. Boasting a biologically driven design of components and forward-thinking treatment protocols, the N1™ implant system represents a significant step forward in patient-centric implant solutions. More than an implant, N1 is a comprehensive system of dedicated instruments, prosthetic components, and surgical protocols. New features of the system include an implant designed for immediate placement and predictable insertion torques, a trioval conical connection for the abutment to slide into place, and an emergence profile designed for soft tissue maintenance. Innovative site preparation for greater patient comfort The Nobel Biocare N1™ system includes the novel feature of the OsseoShaper™, an instrument that redefines site preparation and is set to reshape implantology with optimized workflows, greater patient comfort and faster treatment times. By gently 'shaping' the osteotomy at low speed and without irrigation, the OsseoShaper™ reduces noise and vibration compared to conventional drilling protocols. This leads to improved patient comfort and has been shown in pre-clinical studies to preserve vital bone. Embracing surface chemistry and digital workflows Fully embracing the new Mucointegration™ concept, the Nobel Biocare N1™ features the Xeal™ and TiUltra™ surface treatments. With their specially tailored surface chemistry and topography, TiUltra implants and Xeal abutments can benefit from this design to optimize tissue integration at every level. Nobel Biocare N1™ will be further integrated into the digital workflow with the DTX Studio™ suite, giving dental professionals more opportunities to provide patients with shorter time to teeth. "For over 50 years, Nobel Biocare has been a pioneering force behind implantology. The demand for high quality patient-centric solutions is higher than ever, and the Nobel Biocare N1™ system enables clinicians to set a new standard in personalizing, digitizing, and democratizing the implant treatment experience they can offer patients." Amir Aghdaei, Chief Executive Officer, Envista Patrik Eriksson, President Nobel Biocare, explained, "Drilling protocols have hardly changed over the past 50 years. However, the OsseoShaper™ provides a completely new approach designed for patient comfort, streamlined workflow, and improved predictability; while at the same time, respects biology to achieve fast osseointegration. We are excited to partner with clinicians to bring the N1 system to US-based patients." About Nobel Biocare Nobel Biocare is a world leader in the field of innovative implant-based dental restorations. The company's portfolio offers solutions from single tooth to fully edentulous indications with dental implant systems (including key brands NobelActive® and NobelParallel™ and ceramic implant NobelPearl™*) a comprehensive range of high-precision individualized prosthetics and CAD/CAM systems (NobelProcera®), digital solutions for treatment planning and guided surgery (NobelClinician® and DTX Studio™ suite) as well as biomaterials. Nobel Biocare supports its customers through all phases of professional development, offering world-class training and education along with practice support and patient information materials. The company is headquartered in Zurich, Switzerland. Production takes place at five sites located in the United States, Sweden, and Germany. Products and services are available in over 80 countries through subsidiaries and distributors. *Distributed by Nobel Biocare. Manufactured by Dentalpoint AG About Envista Envista is a global family of more than 30 trusted dental brands, including KaVo, Kerr, Nobel Biocare, and Ormco, united by a shared purpose: to partner with professionals to improve lives. Envista helps its customers deliver the best possible patient care through industry-leading dental consumables, solutions, technology, and services. Our comprehensive portfolio, including dental implants and treatment options, orthodontics, and digital imaging technologies, covers an estimated 90% of dentists' clinical needs for diagnosing, treating, and preventing dental conditions as well as improving the aesthetics of the human smile. With a foundation comprised of the proven Envista Business System (EBS) methodology, an experienced leadership team, and a strong culture grounded in continuous improvement, commitment to innovation, and deep customer focus, Envista is well equipped to meet the end-to-end needs of dental professionals worldwide. Envista is one of the largest global dental products companies, with significant market positions in some of the most attractive segments of the dental products industry.

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KemPharm Announces Strategic Acquisition of Arimoclomol from Orphazyme, Expanding its Rare CNS Diseases Pipeline

KemPharm | May 16, 2022

Arimoclomol is an NDA-stage, revenue-generating investigational drug candidate being developed for the treatment of Niemann-Pick disease type C a rare progressive neurodegenerative disease KemPharm plans to refile the New Drug Application (NDA) for arimoclomol in NPC with the U.S. Food and Drug Administration as early as the First Quarter of 2023 CELEBRATION, Fla., May 15, 2022 KemPharm, Inc. a specialty pharmaceutical company focused on the discovery and development of novel treatments for rare central nervous system (CNS) diseases, announced a definitive agreement with Orphazyme A/S to acquire arimoclomol, an orally-delivered, first-in-class heat shock protein (HSP) amplifier being developed as a treatment for Niemann-Pick disease type C (NPC). NPC is a rare progressive neurodegenerative disease that impacts children, adolescents, and adults, and is characterized by an inability of the body to transport cholesterol and lipids inside of cells, which leads to the abnormal accumulation of these substances within various tissues of the body, including the brain. Arimoclomol is currently being made available to NPC patients in the U.S., France and Germany under Orphazyme’s Early Access Programs (EAP). Under the terms of the agreement, KemPharm will purchase substantially all of the assets and operations of Orphazyme, including arimoclomol, for a cash payment of USD $12.8 million. The Company expects to finance the cash payment with a revolving line of credit secured by KemPharm’s balance sheet. KemPharm intends to retain the majority of Orphazyme’s current employees. In addition, KemPharm has agreed to assume an estimated reserve liability equal to approximately USD $5.2 million, which is an estimated future rebate due to the French regulatory authorities based on the revenue generated from the EAP in France. For the year ending December 31, 2022, the EAP is expected to generate at least USD $12 million in revenue based upon enrollment in France as of March 2022. The EAP is expected to remain in place until arimoclomol becomes commercially available in each of the current EAP markets. The transaction is expected to close on or before June 1, 2022, subject to customary closing conditions and approval by Orphazyme’s creditors and the Danish bankruptcy court. Canaccord Genuity LLC acted as a strategic advisor to KemPharm for the transaction. “This strategic acquisition of arimoclomol is a transformative event that significantly expands our rare CNS disease development pipeline, bringing to KemPharm an NDA-stage, revenue-generating product upon which we intend to build commercial capabilities that allow KemPharm to create and retain value for the benefit of shareholders. Moreover, the financial structure of the acquisition combined with the revenue currently being generated by arimoclomol from the early access program in France affords us the opportunity to acquire the asset in a capital efficient manner that has the potential to create positive cash flow, while incurring no shareholder dilution.” Richard Pascoe, Executive Chairman of KemPharm Arimoclomol is administered orally and has been studied in ten Phase 1, four Phase 2, and three pivotal Phase 2/3 trials. Arimoclomol has received Orphan Drug Designation (ODD) for NPC in the United States and the European Union. Arimoclomol has received Fast-Track Designation (FTD), Breakthrough Therapy Designation (BTD), and Rare Pediatric Disease Designation (RPDD) from the FDA for NPC. If approved in the U.S., arimoclomol would also be eligible to receive a Pediatric Priority Review Voucher. On June 17, 2021, Orphazyme received a Complete Response Letter (CRL) from the FDA regarding its NDA for arimoclomol for the treatment of NPC. Orphazyme also withdrew its European Marketing Authorisation Application (MAA) for arimoclomol for the treatment of NPC ahead of a final vote and opinion by the Committee for Medicinal Products for Human Use. “The acquisition of arimoclomol aligns perfectly with our strategy to build KemPharm’s value via the advancement and commercialization of novel treatments that address rare CNS conditions, including our lead clinical candidate, KP1077 in idiopathic hypersomnia,” stated Travis Mickle, Ph.D., President and Chief Executive Officer of KemPharm. “We have carefully evaluated the CRL issued by the FDA and the minutes from the subsequent Type A meeting, as well as the data that has been generated from the development work performed to date. We believe the efficacy signal for arimoclomol in NPC is convincing and that there is a viable regulatory path that could enable a successful NDA resubmission. KemPharm has significant experience with challenging regulatory situations, having successfully led or participated in three FDA product approvals, two of which followed an initial CRL. We welcome the opportunity to work with the FDA on the resubmission of the NDA for arimoclomol in NPC, which we expect to file as early as the first quarter of 2023.” NPC is a rare progressive lysosomal storage disorder characterized by an inability of the body to transport cholesterol and lipids inside of cells. This leads to dysfunction in organs such as the brain, spleen and liver. NPC can range from a fatal disorder within the first few months after birth (neonatal period) to a late onset, chronic progressive disorder that remains undiagnosed well into adulthood. Disease progression is irreversible in all patients, and loss of neuro-cognitive function adversely impacts their daily life. The mean age of death is 13 years (Bianconi, 2019), and there are no approved treatments for NPC in the United States. “NPC is an ultra-rare, inherited neurodegenerative disease that affects people of all ages from infancy to adulthood, and leads to progressive impairment of mobility, cognition, speech, and swallowing, culminating in premature death,” said Marc Patterson, MD, Professor of Neurology, Pediatrics and Medical Genetics at Mayo Clinic. “Therapies to treat NPC are desperately needed, and there is hope that a treatment such as arimoclomol could provide a solution to patients around the world who are living daily with the disease. It is encouraging that there is an opportunity to continue the regulatory process for arimoclomol with the FDA.” About KemPharm KemPharm is a specialty pharmaceutical company focused on the discovery and development of novel treatments for rare central nervous system diseases through its proprietary LAT® platform technology. KemPharm utilizes its proprietary LAT® platform technology to generate improved prodrug versions of FDA-approved drugs as well as to generate prodrug versions of existing compounds that may have applications for new disease indications. KemPharm’s prodrug product candidate pipeline is focused on the high need areas of idiopathic hypersomnia (IH) and other CNS/rare diseases. In addition, the U.S. Food and Drug Administration (FDA) has approved AZSTARYS®, a new once-daily treatment for ADHD in patients age six years and older containing KemPharm’s prodrug, serdexmethylphenidate (SDX), which is being commercialized by Corium, Inc. in the U.S., and APADAZ®, an immediate-release combination product containing benzhydrocodone, KemPharm’s prodrug of hydrocodone, and acetaminophen, which is being commercialized by KVK-Tech, Inc. in the U.S.

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Pneuma Systems collaborates with West Pharmaceutical Services, Inc. to improve the patient experience

Pneuma Systems Corporation | April 08, 2022

Medical technology company, Pneuma Systems Corporation, has entered a multi-faceted business collaboration with West Pharmaceutical Services, Inc. with the goal of improving the patient's experience with drug therapy. West is a leading global manufacturer in the design and production of technologically advanced, high-quality, integrated containment and delivery systems for injectable medicines. Pneuma Systems Corporation has developed a family of fluid flow technologies that are aimed at scientific and medical applications. The global intravenous pump market segment is expected to reach USD 20.5 billion over the next five years. Pneuma will provide a novel closed-loop fluid flow control platform that West will use to develop drug delivery solutions for pharmaceutical companies and clinical end users. West will provide technical and financial support to Pneuma and access to the emerging West Digital Platform, designed to improve transmission of data and other information. "West's almost century-long commitment to the development of drug delivery systems dovetails with our cutting-edge flow control technology. West's latest foray into a broad digital architecture is very important to us. When you improve both fluid flow and information flow, the result is an improvement in workflow, which results in higher levels of patient safety and lower costs," said Pneuma CEO Jeffrey Carlisle. "We are aiming at disruptive improvements in workflow." "We are excited about our collaboration with Pneuma and the potential of their technologies to address a variety of flow control challenges to drive improvements in healthcare. At West our mission is to improve patient lives not only through our products and services but also by investing in small innovative companies and offering our deep technical and commercial expertise to help them bring their transformation technologies to the market," Scott Young, VP Venture & External Collaboration at West Pneuma Systems, together with its strategic partners, plans to install PneumaDrive™ technology-based infusion devices in infusion centers, home care, and acute care settings around the world. The low cost PneumaDrive™ technology can replace existing infusion pumps and automate "gravity drip" infusions, providing patients with a safer and easier experience. About Pneuma Pneuma Systems is a New Hampshire based company founded by Jeffrey Carlisle, also Founder of the recently acquired Ivenix. Pneuma is dedicated to improving fluid flow, information flow, and workflow for the IV therapy process. About West West Pharmaceutical Services, Inc. is a leading provider of innovative, high-quality injectable solutions and services. As a trusted partner to established and emerging drug developers, West helps ensure the safe, effective containment and delivery of life-saving and life-enhancing medicines for patients. With approximately 10,000 team members across 50 sites worldwide, West helps support our customers by delivering over 45 billion components and devices each year.

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LexisNexis® Reed Tech™ and Schlafender Hase® Alliance Provides Mutual Customer Benefits for Pharmaceutical and Medical Device Companies

LexisNexis Reed Tech | April 27, 2022

Reed Technology and Information Services Inc. a leading provider of data management and analytics solutions for the life sciences industry, announced an alliance with Schlafender Hase®, the market leader for intelligent, automated proofreading software and services for regulated industries. Current and prospective customers of both companies can leverage exclusive benefits as part of this new alliance ecosystem. Pharmaceutical labelers who have regulatory deadlines for US FDA can benefit from the expert conversion and submission services offered by Reed Tech while ensuring reduced risk and greater accuracy in the proofreading process for drug labels and related documentation with Schlafender Hase's TVT®, the Text Verification Tool®. "Schlafender Hase is already a trusted ally as part of our pharmaceutical SPL conversion process. By offering our UDI and pharma customers the benefits of TVT, we continue advancing our mission of providing innovation for the unique workflows of these specialty manufacturers. Ensuring the accuracy of labels, barcodes, graphics and IFU language is essential. With TVT®, regulatory team members around the world benefit from superior, automated proofreading in order to reduce risk and meet the compliance requirements of local health authorities," Arshad Rahman, General Manager of the Reed Tech Life Sciences division "Schlafender Hase is pleased to recognize Reed Tech as an industry-leading, core SPL conversion service provider. It will be productive for our customers to have access to their deep understanding of regulatory submission requirements for drug manufacturers and distributors," said Peter Muller, Sales Director, North America at Schlafender Hase. Those manufacturers bringing new products to market or maintaining existing portfolios will benefit from the subject-matter expertise offered by Reed Tech." Both the pharmaceutical and medical device industries are continually upgrading processes and preparing for multiple global health authority requirements. The complementary solutions and services between Reed Tech and Schlafender Hase offer critical efficiency gains in managing the product life cycle. About LexisNexis Legal & Professional LexisNexis® Legal & Professional provides legal, regulatory, and business information and analytics that help customers increase their productivity, improve decision-making, achieve better outcomes, and advance the rule of law around the world. As a digital pioneer, the company was the first to bring legal and business information online with its Lexis® and Nexis® services. LexisNexis Legal & Professional, which serves customers in more than 150 countries with 10,500 employees worldwide, is part of RELX, a global provider of information-based analytics and decision tools for professional and business customers. Reed Tech serves manufacturers and distributors of medical device and drug products, and for those who support them in consulting and IT roles by delivering better outcomes for the collection, transformation, submission and analysis of regulatory data. Our solutions support the innovation ecosystem and enable you to achieve regulatory compliance and improved product data management contributing to impactful innovations to our world. The corporate mission is to advance humanity by delivering better outcomes to the innovation community. Reed Tech is a LexisNexis® company. About Schlafender Hase Schlafender Hase leads the way in intelligent, automated text and graphic proofreading solutions. With its flagship product, TVT®, the Text Verification Tool®, users can quickly compare source content with output formats, detecting changes and deviations prior to publication. Schlafender Hase serves regulated industries across the globe. Clients include the world's leading pharmaceutical and medical device companies, as well as healthcare regulatory bodies. The continued success of Schlafender Hase is based on delivering quality products and a strong understanding of customer pain points. Easy to use, our products reduce proofreading workloads, assure the quality of printed and online materials, and mitigate the risk of costly errors.

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Spotlight

The level of cyber threat faced by businesses today is attributable to both the increased sophistication of hackers and the increased use of digital. A recent survey revealed that over half of the pharma companies questioned had suffered from serious data breaches, while one in four had been the victims of hacking.

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