BUSINESS INSIGHTS, PHARMA TECH
ADC Therapeutics | January 03, 2023
Sobi® and ADC Therapeutics SA informed that Zynlonta® (loncastuximab tesirine) has recently received conditional marketing authorization from the European Commission (EC) for the treatment of diffuse large B-cell lymphoma ((DLBCL) that has relapsed or become resistant. The approval comes after the European Medicines Agency's Committee for Medicinal Products for Human Use issued a favorable opinion in September.
Sobi has said that it wants to give Zynlonta, a new treatment for diffuse large B-cell lymphoma, to people in the European Union who have this debilitating blood cancer.
The approval was granted based on the findings from LOTIS-2, which was a large (n=145), phase 2 multinational, single-arm clinical study of Zynlonta for treating adult patients who had relapsed or refractory DLBCL following two or more prior lines of systemic therapy. Zynlonta was granted accelerated approval by the United States Food and Drug Administration in April 2021. This approval made it the first CD19-targeted antibody-drug conjugate to be used as a single-agent treatment for adult patients who had relapsed or been resistant to two or more lines of systemic therapy for their DLBCL.
Sobi announced an exclusive license agreement with ADC Therapeutics to develop and commercialize Zynlonta in Europe and other international markets. The license aims to boost Sobi's presence in hematology, one of its two main disease areas. Besides, Zynlonta will be sold with other Sobi hematology drugs.
ADC Therapeutics added that this approval expands Zynlonta's global reach. Zynlonta will fill a critical unmet need for DLBCL patients in Europe. The EU decision applies to Iceland, Norway, and Liechtenstein.
According to the terms of the license agreement and as previously communicated, Sobi will pay ADC Therapeutics USD 50 million as a result of the EU's approval of DLBCL. Sobi's clinical development and product supply are handled by ADC Therapeutics.
About ADC Therapeutics
ADC Therapeutics next-generation, targeted antibody-drug conjugates help cancer patients. With a deep understanding of oncology and an ADC platform that the FDA's approval of Zynlonta has proven, the company is working to meet unmet medical needs and improve outcomes for people with hard-to-treat hematological cancers and solid tumors. ADC Therapeutics' highly skilled global team is committed to fighting cancer with science, bringing targeted therapies and hope to patients and their families.
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.
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.
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.
BUSINESS INSIGHTS, PHARMACY MARKET
West Pharmaceutical Services, Inc. | February 01, 2023
On January 31, 2023, West Pharmaceutical Services, Inc., a global pioneer in novel injectable drug administration solutions, announced its participation in Pharmapack Europe 2023 in Paris, France, to demonstrate its leadership and insights on industry packaging and containment trends and challenges.
With the introduction of three new products, the company expands its innovations for its patients and customers worldwide - Daikyo Crystal Zenith® 2.25mL Insert Needle Syringe System, West Ready Pack™ with Corning Valor® RTU Vials using Stevanato Group's EZ-fill® SG EZ-fill® technology and FluroTec® 5-10mL Cartridge Plunger.
West Pharmaceutical Services Vice President and General Manager, Biologics Li Chen commented, "This year, we are introducing three new product solutions at Pharmapack." He added, "With these innovations, we are addressing the growing market needs for today's complex and sensitive molecules, including large-volume delivery and a complete vial containment solution that can protect and scale from development through commercialization."
(Source – PR Newswire)
Meanwhile, West's participation in this year's conference includes the following
Learning Lab - How Market Trends Drive Innovation and Enable the Pharmaceutical Pipeline on Wednesday, February 1, 2023
Panel Session - Innovation of Novel Medicines and Trends in Demand for Injectable Home and Self-Administration on Wednesday, February 1, 2023
Innovation Tours - West Ready Pack™ with Corning Valor® RTU Vials using Stevanato Group's EZ-fill® Technology on Wednesday, February 1, 2023
Daikyo Crystal Zenith® 2.25mL Insert Needle Syringe System on Thursday, February 2, 2023
About West Pharmaceutical Services, Inc.
Founded in 1923, West Pharmaceutical Services, Inc. is a market leader in developing and delivering innovative, high-quality injectable solutions and services. As a trusted partner to both established and emergent drug producers, it contributes to the safe, effective containment and distribution of life-saving and life-enhancing medications to patients. West Pharmaceutical supports its clients by supplying over 45 billion components and devices annually, with roughly 10,000 team members spread across 50 facilities globally. The company marks its 100th anniversary of growth and innovation in 2023, as well as the essential role it continues to play in healthcare and the patient experience. Headquartered in Exton, Pennsylvania, it had generated $2.83 billion in net sales for the fiscal year 2021.