Jazz, Alexion and Lundbeck to pay $122m to settle kickback probe

Jazz Pharmaceuticals | April 08, 2019

Drugmakers Jazz Pharmaceuticals, Lundbeck and Alexion Pharmaceuticals have agreed to pay a total of $122.6m to settle allegations of paying kickbacks via copay assistance foundations. The US Department of Justice (DOJ) said that the companies violated the False Claims Act by paying patients under Medicare and the Civilian Health and Medical Program (ChampVA) through purportedly charitable organisations. These charitable foundations allegedly subsidised the copays with financing from the companies. The Anti-Kickback Statute restricts drugmakers from offering or paying, directly or indirectly, in the form of money or any other thing of value to motivate Medicare or VA patients to buy their medicines.

Spotlight

Exosomes are tiny cell-derived vesicles which have captured the attention of cell biologists, and diagnostic and therapeutic industries. At first, it was thought that exosomes contained debris with no biological significance. However, recent studies have revealed that there is more to them than first thought.

Spotlight

Exosomes are tiny cell-derived vesicles which have captured the attention of cell biologists, and diagnostic and therapeutic industries. At first, it was thought that exosomes contained debris with no biological significance. However, recent studies have revealed that there is more to them than first thought.

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BUSINESS INSIGHTS

IntegriChain Partners with PurpleLab to Enhance Pharmaceutical Channel Data for More Accurate GTN Forecasting and Accruals

IntegriChain | November 18, 2022

IntegriChain, delivering pharma's only comprehensive technology, data, consulting, and outsourcing platform for data-driven commercialization, announced a strategic data partnership with PurpleLab, a healthcare technology company delivering analytics to drive real-world evidence decision-making. As a first step to this partnership, IntegriChain will incorporate PurpleLab prescription drug claims data to address challenges in visibility to demand and inventory that has resulted from evolving pharmaceutical channels for new specialty pharmaceutical products. "As the Pharma industry has shifted to more fragmented non-retail therapies such as specialty lite and specialty self- and HCP-administered products, distribution channels are more diverse and complicated. These new channels have visibility gaps that create unreasonable risk of errors in gross-to-net forecasting and accrual management. PurpleLab data – covering more than 350 million patient lives, 4 billion annual claims, and 98% of payers – enhances our ability to deliver true demand and inventory visibility, more accurate gross-to-net forecasting and accruals, and most importantly data-driven commercialization for specialty products to Pharma commercial and financial teams." Gary Palgon, IntegriChain's General Manager and Senior Vice President, Data Solutions With this partnership, IntegriChain will seamlessly integrate PurpleLab pharmacy and medical claims data into the ICyte platform and the Inventory Analytics product, improving demand and inventory visibility to actual dispensing volumes at the site of dispense or administration. This data integration will deliver a more accurate depiction of demand attributed to individual outlets, ensuring a closer alignment between net sales and demand at a channel and more accurate pipeline inventory calculations. In addition, IntegriChain will deliver increased fidelity of national and subnational datasets for targeting by incorporating PurpleLab data into ICyte's unblinding process. The seamless addition of PurpleLab data into the ICyte Platform will be generally available in ICyte Inventory Analytics in January 2023. Additional future data enhancements will be announced in due course. About ICyte Data Solutions IntegriChain offers a full suite of channel data products, including: Channel Data Aggregation: Aggregation of all channel and distribution datasets including ExFactory Sales, Distributor Inventories, Demand, and Returns to deliver the highest quality master data, including industry-leading data science and enrichment algorithms to deliver end-to-end views of product distribution. Inventory Analytics: Manufacturers have few existing measures of the inventory held in retail stores, distribution centers, and third-party returns processors. IntegriChain Inventory Analytics reports 100% of inventory in the retail channel, even in pharmacy stores and distribution centers that do not report their inventories. Distribution Contract Management: Distribution Contract Management is a single, auditable application for managing all aspects of trade partner agreements. Configurable trade partner scorecard functionality features payment adjudication, custom pay-for-performance metrics, payment roll forward, and top- and bottom-line functionality adjustments. Channel Data Consulting Services: Based on IntegriChain pioneering the field of channel data aggregation, stewardship, and advanced analytics, the Channel Insights and Optimization practice delivers Market Demand Analysis, Class of Trade, Downstream Inventory Analytics, Returns Forecasting, and Revenue Analytics consulting services to Pharma manufacturers of all types and sizes. About PurpleLab PurpleLab is a healthtech company with a mission to spur value-driven innovation in healthcare to improve outcomes for patients. HealthNexus™, the company's no-code analytics platform empowers life sciences, payers, providers and other stakeholders with real-world evidence to solve conventional and emerging challenges faster and more cost effectively. About IntegriChain IntegriChain delivers pharma's only comprehensive technology, data, consulting, and outsourcing platform for market access departments. We provide the strategy and operational execution for data-driven product commercialization and market access. More than 400 manufacturers rely on our consulting expertise and ICyte Platform to orchestrate their prescription management, patient data management, inventory and demand visibility, enterprise GTN technology, and platform insights. ICyte is the first and only platform that unites the financial, operational, and commercial data sets required to support commercialization and access in the era of specialty and precision medicine.

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PHARMA TECH

KiOmed Pharma and Hansoh Pharma Announce License Agreement for KiOmedinevsOne in China’s Mainland, Macau and Taiwan

KiOmed Pharma and Hansoh Pharma | September 27, 2022

KiOmed Pharma, a Belgian biotechnology company with a focus on the development, manufacture and distribution of safe and effective medical devices based on a medical-grade highly pure natural chitosan-derivative, and Hansoh Pharmaceutical Group Company Limited a leading biopharmaceutical company in Asia, today announced a license agreement for the development and commercialization of KiOmedinevsOne, a carboxymethyl chitosan injection that has been launched in Europe for the treatment of knee osteoarthritis, in China’s mainland, Macau and Taiwan. Under the terms of the agreement, KiOmed will receive an upfront payment and will be eligible to receive development, regulatory and commercial milestones of up to € 66 million, as well as tiered royalties on future product sales. Hansoh will receive exclusive rights to develop and commercialize KiOmedinevsOne and its future extensions in the territory. KiOmed retains the right to develop and commercialize KiOmedinevsOne in all other global markets. Osteoarthritis is a progressive and disabling disease affecting about 250 million people worldwide. According to a recent epidemiology report, the prevalence of knee osteoarthritis in China is 8.1%. As the population in China is aging rapidly, disease burden caused by knee osteoarthritis continues to rise while safe and effective treatment options are still lacking. “We are very excited to partner with Hansoh Pharma, one of the largest biopharmaceutical entities in Greater China. We believe that with Hansoh’s impactful presence in China, their support will be essential to bring this long-acting treatment to the large population of patients suffering from osteoarthritis in China. We launched KiOmedinevsOne last year in several regions of Europe, and the feedback we continue to receive from osteoarthritis patients and physicians is great. With just one single injection to the knee, it can provide symptoms relief including pain, stiffness, and function improvement for more than 6-month. It is the world-first next generation non-animal sourced chitosan injection with a potential safety advantage over animal-sourced chitosan,” added Dr. Houtaï Choumane, CEO and Managing Director of KiOmed. Mr. François Blondel, Founder and Executive Chairman of the Board of KiOmed Pharma “KiOmed is a leader and an expert in developing natural chitosan products to fulfill unmet medical needs in different spaces. Osteoarthritis negatively impacts an individual’s quality of life and creates a large burden for the patients and their families. We are very glad to see KiOmed’s product (KiOmedinevsOne) will help to solve this problem,” said Eliza Sun, Executive Director of the Board of Hansoh Pharma. “We are also very excited to partner with them and bring this unique product to much needed patients in China.” About KiOmedinevsOne KiOmedinevsOne is a new generation single injection for the treatment of knee osteoarthritis based on world-first exclusive animal free KiOmedine® CM-Chitosan. KiOmedine® CM-Chitosan is a highly purified polysaccharide derived from Agaricus Bisporus (button mushroom) and a patented technology made in Belgium, resulting from years of research and innovation. Different from hyaluronic acid, KiOmedinevsOne has dual mechanism of action to tackle osteoarthritis discomfort and other symptoms by reducing oxidative stress and enhancing joint lubrication. Clinical studies have shown that after a single injection of KiOmedinevsOne, significant pain reduction was observed within 2 weeks and the WOMAC pain score was reduced by 66%, with a long-lasting osteoarthritis symptom reduction for at least 6 months. KiOmedinevsOne is a regulated health product which bears the CE mark under this regulation. It has been launched in Europe in 2021. About KiOmed Pharma Based in Belgium, KiOmed Pharma has a history of innovation and expertise in exclusive natural chitosan chemistry. The company develops a unique pipeline of medical devices that address unmet medical needs in high impact pathologies and major social burdens such as osteoarthritis, skin aging and ophthalmology. KiOmed Pharma's innovative pipeline is based on a solid building block exclusive technology: KiOmedine®, a medical-grade highly pure natural chitosan-derivative. About Hansoh Pharmaceutical Group Hansoh Pharma one of the largest biopharmaceutical companies in China, is committed to discovering and developing life-changing medicines to help patients conquer serious diseases and disorders.

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PHARMACY MARKET

Jacobio Pharma to Collaborate with Merck on Clinical Trial of JAB-21822 in Combination with Cetuximab

Jacobio Pharma | October 13, 2022

Jaco Jacobio announced it has entered into a clinical trial collaboration agreement with Merck on clinical study of combination therapy between Jacobio's KRAS G12C inhibitor JAB-21822 and Merck's epidermal growth factor receptor inhibitor Erbitux®. This clinical study aims to evaluate the efficacy of JAB-21822 in combination with cetuximab in patients with KRAS G12C-mutated colorectal cancer. Jacobio is the sponsor of the combination study, and Merck will provide cetuximab for clinical trials in China and Europe under the collaboration agreement. "Our preclinical studies have shown that the combination of JAB-21822 and cetuximab can enhance the anti-tumor activity of JAB-21822 inhibitors in colorectal cancer tumor models, regressing tumors and delaying tumor regrowth after drug discontinuation. We look forward to new treatment options for patients through our collaboration with Merck," Dr. WANG Yinxiang, Chairman and Chief Executive Officer of Jacobio About JAB-21822 JAB-21822 is a KRAS G12C inhibitor independently developed by Jacobio. Jacobio has initiated a number of Phase I/II clinical trials in China, the United States and Europe for patients with advanced solid tumors, including monotherapy for STK11 co-mutated non-small cell lung cancer first-line treatment; combination therapy with SHP2 inhibitor, PD-1 monoclonal antibody and cetuximab. About ERBITUX®. ERBITUX is an IgG1 monoclonal antibody targeting the epidermal growth factor receptor (EGFR). As a monoclonal antibody, the mode of action of ERBITUX is distinct from standard non-selective chemotherapy treatments in that it specifically targets and binds to the EGFR. This binding inhibits the activation of the receptor and the subsequent signal-transduction pathway, which results in reducing both the invasion of normal tissues by tumor cells and the spread of tumors to new sites. It is also believed to inhibit the ability of tumor cells to repair the damage caused by chemotherapy and radiotherapy and to inhibit the formation of new blood vessels inside tumors, which appears to lead to an overall suppression of tumor growth. Based on in vitro evidence, ERBITUX also targets cytotoxic immune effector cells towards EGFR-expressing tumor cells. ERBITUX has obtained market authorization in over 100 countries worldwide for the treatment of RAS wild-type metastatic colorectal cancer and for the treatment of squamous cell carcinoma of the head and neck. Merck licensed the right to market ERBITUX, a registered trademark of ImClone LLC, outside the U.S. and Canada from ImClone LLC, a wholly owned subsidiary of Eli Lilly and Company, in 1998. About Jacobio Jacobio Pharma is committed to developing and providing new and innovative products and solutions to improve people's health. Our pipeline revolves around novel molecular targets on six major signalling pathways: KRAS, immune checkpoints, tumor metabolism, P53, RB and MYC. We aim for our key projects to be among the top three in the world. Our vision is to become a global leader recognized for our impact in drug R&D together with our partners. Jacobio has R&D centers in Beijing, Shanghai and Boston with our Induced Allosteric Drug Discovery Platform (IADDP) and our iADC Platform.

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