FDA grants breakthrough designation to Achillion’s PNH drug

Pharmaceutical Technology | September 26, 2019

The US Food and Drug Administration (FDA) has granted Achillion Pharmaceuticals breakthrough designation for danicopan (ACH-4471) for patients with paroxysmal nocturnal haemoglobinuria (PNH). Achillion is studying danicopan combined with a C5 monoclonal antibody in a Phase II trial of patients with a suboptimal response to C5 inhibitors alone, the standard of care for the condition. The FDA’s designation is based upon positive efficacy and safety data from this ongoing study. PNH is a rare, genetic blood disease caused by somatic mutation, which results in the absence of key receptors, CD55 and CD59, on the surface of red blood cells. These are recognised by the alternative pathway (AP) as foreign and destroyed in the blood stream and in the liver. CD5 inhibitors targets intravascular haemolysis where these red blood cells are attacked in the blood stream, but, according to Achillion, 75% of those treated with C5 alone remain anaemic during treatment with a third needing blood transfusions.

Spotlight

It’s useful to review deal trends periodically to gain insight in how behaviours are changing from the perspective of numbers and value of deals as well as how emphasis shifts from one therapeutic area to another. The majority of small and mid-size development companies will still seek a deal with one of the major pharmaceutical companies in order to commercialise their asset.

Spotlight

It’s useful to review deal trends periodically to gain insight in how behaviours are changing from the perspective of numbers and value of deals as well as how emphasis shifts from one therapeutic area to another. The majority of small and mid-size development companies will still seek a deal with one of the major pharmaceutical companies in order to commercialise their asset.

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Vetsource Unveils New Brand Reflecting Company's Growth

Vetsource | November 17, 2022

Vetsource®, a pet health company designed to provide innovative pharmacy, technology and business services to those who care for pets, launched a new brand identity to signal the official start of three brands coming together as a single, unified portfolio of solutions for the veterinary industry. Already established as a leading provider of innovative prescription management and home delivery services for veterinary practices and pet owners since 2008, Vetsource announced the acquisitions of VetSuccess, a data and analytics provider, and Vet2Pet, a client engagement system, in 2018 and 2019, respectively. Since the acquisitions, the three companies have largely worked together under Vetsource corporate, while still maintaining their separate identities, to allow time to formalize and ease the transition for customers. Information about Vetsource's client engagement, and data and insights services can be found on Vetsource's new website at Vetsource.com, which received a complete redesign to reflect the company's rebrand and comprehensive solutions. The Vet2Pet and VetSuccess websites will be automatically redirected to Vetsource.com and will support access to customer logins. "Adding client engagement, and data and insights, to the Vetsource portfolio allows us to leverage their combined strength to add greater value for the industry. Our goal is to foster strong relationships and positive experiences so veterinarians can focus on what they do best – caring for pets." Kurt Green, Vetsource CEO The product sign-in URLs will remain the same for all three products. The Vet2Pet name will be retained as a product name under Vetsource's client engagement services. "There will be no disruption of service for any of our customers. They will receive the same support and access to services they always have," said Green. "When the companies joined, so too did the same innovative and talented team of people their customers know and trust. We're lucky to now count them as part of the Vetsource family." VMX attendees can find Vetsource at booth #1230 exhibiting its prescription management, client engagement and data and insights solutions for the first time as one united brand. About Vetsource Vetsource provides innovative pharmacy, technology and business services to the pet health industry. At Vetsource, we strive to be the most trusted advocate in a rapidly evolving world and constantly seek new ways to help our customers chart a course for a better, brighter future for pets and those who care for them. Our data-powered platform eliminates complexities and simplifies workflows to help veterinarians, retailers and others in the pet health industry foster engagement, loyalty and positive experiences that ensure strong relationships. Vetsource's solutions include prescription management, data and insights, and client engagement.

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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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Anokion Announces $35 Million Equity Investment from Pfizer

Anokion | October 19, 2022

Anokion SA, a clinical-stage biotechnology company focused on treating autoimmune disease by restoring normal immune tolerance announced that Pfizer has made a $35 million equity investment in Anokion through the Pfizer Breakthrough Growth Initiative. In conjunction with the investment, Michael Vincent, M.D., Ph.D., senior vice president and chief scientific officer, Inflammation & Immunology, Pfizer, has joined the company’s scientific advisory board, which will be announced later this year, and Allison Kean, M.D., executive director, Worldwide Business Development, Pfizer has joined Anokion’s board of directors as an observer. Separately, Anokion and Pfizer have entered into an agreement to leverage Pfizer’s development expertise and capabilities in support of the continued clinical development of KAN-101, Anokion’s lead candidate for the treatment of individuals with celiac disease. “We are excited about these agreements with Pfizer as they provide us with important resources and expertise to advance our KAN-101 clinical program and our earlier-stage pipeline. People living with autoimmune diseases like celiac disease need additional treatment options, and we are excited to work with Pfizer to potentially develop these utilizing our immune tolerance platform. We also look forward to leveraging Pfizer’s insights and capabilities in support of our Phase 2 clinical program in patients with celiac disease.” Deborah Geraghty, Ph.D., chief executive officer of Anokion “We believe Anokion has a unique opportunity to develop potential durable and disease-modifying treatment options for people with celiac disease and other immune-mediated disorders, and we look forward to supporting them in the continued development of KAN-101,” said Dr. Vincent. “The agreements announced today are yet another example of our commitment to collaborating with biotechs to accelerate compelling external science that could lead to true breakthroughs for patients.” Anokion intends to use a portion of the proceeds to fund its Phase 2 clinical program of KAN-101 for the treatment of individuals with celiac disease, a serious autoimmune disorder triggered by ingestion of gluten, for which there are no approved therapeutic treatments available. Data from Anokion’s Phase 1 ACeD study (Assessment of KAN-101 in Celiac Disease) were presented at Digestive Disease Week (DDW) 2022, showing that treatment with KAN-101 was safe and tolerated, reduced T cell responses following gluten challenge, and demonstrated a dose-dependent inhibition of gluten-induced serum IL-2 (interleukin-2), a key disease biomarker that may correlate with the timing and severity of symptoms after gluten exposure in celiac disease. Based on favorable findings, Anokion is preparing to initiate patient dosing in a Phase 2 clinical trial in the second half of 2022, supported by Pfizer. About KAN-101 KAN-101 is an investigational therapy being evaluated as a treatment for individuals with celiac disease, a serious autoimmune disease triggered by ingestion of gluten, for which there are no approved therapeutic treatments available. KAN-101 is designed to induce tolerance to gliadin, a core component of gluten, through natural pathways in the liver. KAN-101 has been granted Fast Track designation by the U.S. Food and Drug Administration for the treatment of celiac disease. About Anokion Anokion SA is a clinical-stage Swiss biotechnology company that aims to make a meaningful difference in the lives of patients suffering from autoimmune diseases by restoring normal immune tolerance. The company is focused on both prevalent and rare autoimmune diseases, including celiac disease, multiple sclerosis and type 1 diabetes. Anokion’s distinct approach leverages the company’s immune-based platform, which targets natural pathways in the liver to restore immune tolerance and address the underlying cause of autoimmune disease.

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