J and J boasted about defending Remicade from biosims. Now its under FTC investigation

FiercePharma | July 30, 2019

Johnson and Johnsons big-selling Remicade has held most of its ground against biosimilar competition, thanks in part to some aggressive payer contracts that rivals including Pfizer have called into question. Now, the FTC has some questions of its own. The Federal Trade Commission issued a civil investigative demand to J and J last month, looking into whether the companys biosimilar defense strategy violates federal antitrust laws, the company said in a second-quarter filing with the SEC. The agency's probe follows years of biosimilar competition that yielded little result for Remicade's challengers until just recently. And J&J hasn't been shy about touting its brand's success in the face of rivals. The drug initially lost sales much slower than many market watchers had expected, and company executives attributed its performance to savvy contracting. J&J used those contracts to battle copycat attack, first from Pfizer in 2016 and then from Merck the following year. Ahead of those biosim launches, the company’s then-pharma chairman Joaquin Duato said J&J planned to develop “innovative contracts” intended to “utilize the full breadth” of its portfolio. In July 2017, Bernstein analyst Ronny Gal wrote a note to clients detailing the company’s three-pronged approach. J&J set up exclusive contracts in nearly half the market, leveraging its large market share and the rebates it pays out, not only on Remicade, but other meds in its portfolio.

Spotlight

America is in the midst of a prescription opioid epidemic. It is estimated that in 2016, 11.8 million Americans, or 4.4 percent of the population, age 12 years and older were nonmedical users of opioids – defined as prescription pain relievers and heroin. Of these nonmedical users, and over the course of the previous year, 10.9 million reported the misuse of only pain relievers, 641,000 reported the misuse of pain relievers and heroin, and 948,000 reported the misuse of only heroin.

Spotlight

America is in the midst of a prescription opioid epidemic. It is estimated that in 2016, 11.8 million Americans, or 4.4 percent of the population, age 12 years and older were nonmedical users of opioids – defined as prescription pain relievers and heroin. Of these nonmedical users, and over the course of the previous year, 10.9 million reported the misuse of only pain relievers, 641,000 reported the misuse of pain relievers and heroin, and 948,000 reported the misuse of only heroin.

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BUSINESS INSIGHTS

Ascential Digital Commerce and GSK Consumer Healthcare Announce Launch of Ascential Digital Commerce Connect at Cannes Lions

Ascential Digital Commerce and GSK Consumer Healthcare | June 15, 2022

Ascential Digital Commerce, whose technology driven products power brands to win in digital commerce, and GSK Consumer Healthcare, a science-led healthcare company, will join forces on June 20th during the Cannes Lions International Festival of Creativity to launch Ascential Digital Commerce Connect, a first-of-its-kind, data-rich, digital commerce platform that provides C-suite executives with visibility of brand sales and performance from multiple data sources. Ascential Digital Commerce Connect improves reaction time to market dynamics, increasing a brand's performance in the rapidly growing eCommerce retail market. Ascential Digital Commerce and GSK Consumer Healthcare partnered together to develop Ascential Digital Commerce Connect to provide visibility and clarity of GSK Consumer Healthcare's eCommerce brands performance, improve reaction time to market dynamics and position the brand for further growth. GSK Consumer Healthcare anticipates eCommerce growth to reach the mid-teens percentage of the business by 2025, thereby making eCommerce a priority channel to drive overall sales. According to Nasdaq research, 95% of all purchases by 2040 will be conducted via eCommerce and a 2021 IDC study revealed that the digital commerce applications market will see double-digit growth through 2025. “Visibility of data is becoming increasingly vital to businesses every day. Especially as eCommerce has become a core business capability for businesses around the globe, managing data streams for those businesses has become increasingly challenging.” Filippo Battaini, Research Manager at IDC Retail Insights The Ascential Digital Commerce Connect web-based platform captures, analyzes, visualizes, and displays critical marketing data about each brand and competitor to monitor key activities and answer marketers' key questions when it comes to Understanding the current brand/sales performance in the eCommerce marketplace – standalone vs. key competitors and owned channels vs. major online retailers like Amazon and Alibaba Dissecting what brand health looks like regionally throughout EMEA, US/North America, Asia-Pacific, and Latin America Navigating potential challenges and outages around supply chain, research and development, disruptive markets, and other key metrics. More accurately calculating marketing spending as a percentage of gross revenue During Cannes Lions 2022, Ascential Digital Commerce and GSK Consumer Healthcare will host a panel discussion to discuss the catalyst for developing Ascential Digital Commerce Connect and how GSK Consumer Healthcare currently leverages the platform for brand success. Product demos will also be available to showcase the platform. "The next five years represent a tipping point in the retailing industry," says Duncan Painter, CEO at Ascential. "Retailers and brands with the deepest, most recent insights into the digital performance of their products and services will gain an informed, competitive edge. The Connect platform turns data into actionable insights, and GSK Consumer Healthcare is on a strong path to further realize eCommerce growth." "Healthcare today is driven by the digital economy, whether consumers and patients are searching for healthcare information and services online, logging into exercise classes, ordering health and beauty products from their favorite online retailers, or managing prescription medications online," says Taryn Marella, Global Head of Digital Commerce, GSK Consumer Healthcare. "Ascential Digital Commerce Connect delivers actionable insights that help us monitor the health of our business and identify growth opportunities, update messaging and enhance creativity in the digital environment." About Ascential Digital Commerce Ascential Digital Commerce powers the global eCommerce ecosystem. Our platform allows brands, businesses and their agency partners to connect to consumers in every touchpoint of their journey to purchase goods and products. We transform data into actionable insights, allowing brands to build their competitive edge and drive growth with better, faster decisions. We solve the most complex challenges that global brands and businesses face in the digital commerce landscape with technology and human expertise to drive sales growth on the leading digital eCommerce marketplaces globally. About Ascential Ascential delivers specialist information, analytics, and eCommerce optimization platforms to the world's leading consumer brands and their ecosystems. Our world-class businesses improve performance and solve problems for our customers by delivering immediately actionable information combined with visionary longer-term thinking across Digital Commerce, Product Design, and Marketing. We also serve customers across Retail & Financial Services. With over 2,800 employees across five continents, we combine local expertise with a global footprint for clients in over 120 countries. Ascential is listed on the London Stock Exchange. About GSK Consumer Healthcare GSK’s Consumer Healthcare business is on track to become an independent company through a proposed demerger from GSK, expected in July 2022. The new business, to be named Haleon, is expected to be a world-leader in consumer healthcare. Led by its purpose to deliver better everyday health with humanity, it will be strongly positioned to play a vital role in a growing sector that is more relevant than ever. Haleon will have a world-class portfolio of category-leading global brands, including Sensodyne, Voltaren, Panadol and Centrum, brands that are trusted by healthcare professionals, customers and people worldwide to improve the health and wellbeing of individuals and their communities.

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PHARMA TECH

assisTek Announces New Partnership with Medical Device Technology Creator, Strados Labs

assisTek Inc | June 21, 2022

assisTek, based in Doylestown, PA, has announced its latest partnership with Philadelphia based Strados Labs. Strados Labs is known for their creation of cutting-edge smart technology medical devices for respiratory illnesses. assisTek, has been a longtime leader in the eSource industry across various therapeutic areas, over 900+ Global clinical Trials and offers an array of services for the electronic collection of clinical data. Their technology offerings include eCOA, ePRO, eConsent, BYOD modules and an extensive reputation for their custom solutions to support clinical trial teams worldwide. "We are very excited to announce this partnership and are looking forward to working together with Strados to provide another way for clinicians and patients to gather novel information during their trials. By making the integration seamless into our current eDiary offerings, this paired technology will allow for better patient engagement and more efficient information gathering, with the ultimate goal of improved data for cures and treatment of these conditions," explains Richard Gastineau, CEO of assisTek. Strados Labs is a medical technology company developing smart sensor platforms that utilize machine learning and proprietary algorithms to detect and predict compounding conditions associated with serious, chronic respiratory diseases to improve the lives of patients globally. "We are grateful and proud to solidify our partnership with assisTek. They have been a leader in integrating technology and data collection in clinical trials for over 20 years," said Strados Labs Director of Business Development, Shane Krauss. "We look forward to working with their experienced and knowledgeable team in clinical trials by helping them scale their digital therapeutics using our clinically validated measures for wheeze, cough, and other adventitious breath sounds, or CABS—which is something no other cleared device can measure." The Company developed a first-of-its-kind smart sensor platform for respiratory health, RESP®. Strados recently received FDA Class II 510(k) clearance for home use of its first product, RESP®, its second FDA clearance in less than 18 months. RESP® was also granted a CE Mark late last year. The Company is developing a robust pipeline algorithm to support and address other chronic diseases, as well as chronic disease management pathways. Strados will continue to target asthma, COPD and infectious respiratory diseases (COVID, RSV, and more)—with plans to add heart failure and pediatrics later this year. The Company is based in Philadelphia and is a privately held company.

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BUSINESS INSIGHTS

Aditxt, Inc. Successfully Completes Preclinical Toxicity Study of Its Psoriasis Drug Candidate ADI™-100 Advancing it Closer to First-in-Human Trials

Aditxt | July 11, 2022

Aditxt, Inc. a biotech innovation company developing and commercializing technologies focused on monitoring and reprogramming the immune system, today announces that its therapeutic program Adimune™, has successfully completed a toxicology study that indicates the safety profile of ADI™-100, the Company’s immunotherapeutic technology drug that addresses rejection of transplanted organs, skin allografting, autoimmune diseases and allergies. The toxicology findings will provide vital supporting evidence when the Company files an Investigational New Drug application with the regulatory agencies. “Our drug is truly antigen-specific in the treatment of autoimmune diseases. In preparation of the clinical study, we performed a toxicology study and found: no premature death, no signs of local intolerance, no test item-related influence on clinical signs, body weight and body weight gains, food consumption, biochemistry or urinalysis. No anti-nuclear antibodies, no macroscopic post-mortem findings, no changes in histopathology were noted, confirming the safety profile of our drug product, which we have seen in all pre-clinical experiments before.” Joachim-Friedrich Kapp, M.D., Ph.D., Aditxt senior vice president of Clinical Development-Autoimmunity ADI™-100 consists of two DNA molecules, which together restore immune tolerance in autoimmune disease and establish tolerance in allogeneic skin transplantation applied in large skin wounds. Modulating the immune system by restoring/inducing tolerance is a unique mechanism of action, with a potentially huge efficacy and safety benefit for the patients affected because there is no immunosuppression involved. “These findings are very promising,” said Dr. Kapp. Amro Albanna, co-founder and CEO of Aditxt, said the encouraging toxicology results of ADI™-100 illustrate the Company’s commitment to advancing promising technologies to address rising unmet needs of patients with autoimmune diseases and those needing life-saving organ transplantation procedures. “We are excited about the progress Adimune™ is making towards human trials, which represents a significant inflection point for the program and Aditxt as a whole,” Albanna said. “Adimune™ is an example of our business model accelerating promising innovation into commercialization and monetization.” “In addition, and separately, we clearly demonstrated that our drug does not display any general immunosuppressive effect,” Dr. Kapp explains. “This was shown in safety studies, when using a Listeria model for infection and a melanoma model for potential effects on tumor growth. As one could have predicted, considering the mechanism of action, there was no interference with the immune system and its capacity to fight infection or tumor disease, at all. These findings are very promising and certainly will support our story when filing the IND.” About Aditxt Aditxt is a biotech innovation company developing and commercializing technologies focused on monitoring and reprogramming the immune system. Aditxt’s immune monitoring technologies are designed to provide a personalized immune profile. Aditxt’s immune reprogramming technologies, currently preclinical, are being developed to retrain the immune system to induce tolerance to address rejection of transplanted organs, autoimmune diseases, and allergies.

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