Pharmacy Market
Businesswire | July 07, 2023
Cytel Inc., provider of quantitative insights and health data analytics to leaders in life sciences, has acquired stève consultants, specialists in market access, real-world (RWE), and health economics and outcomes research (HEOR). The acquisition further expands Cytel’s real-world & advanced analytics (RWAA) capabilities, giving sponsors an expanded global offering, with access to additional specialists and localized expertise. This acquisition continues the company’s growth in key European markets, following the recent acquisition of Nordic regulatory affairs and RWE experts SDS Life Science. Cytel now stands as one of the largest global providers of HEOR, RWE, global value strategy and market access consulting.
Achieving favorable market access is crucial in today’s highly competitive clinical development environment. But doing so is challenging and requires access to deep region-specific expertise. Cytel has long excelled at using proven quantitative techniques to transform real-world data into actionable insights to help sponsors successfully tap into new markets. The acquisition of stève consultants continues this journey, augmenting and extending the localized market access, product launch, and regulatory support it can offer in France, a critical European market.
"stève consultants have crafted a team of unparalleled know-how in regional market access, HEOR, and RWE,” said Radek Wasiak, General Manager, Real-World and Advanced Analytics (RWAA), Cytel. “We look forward to welcoming them to Cytel as together we can now provide an exceptional service at the local level in France but also plug into the global dossier needs of our clients. For sponsors, this means a more global strategic offering, deeper connectivity to world-class expertise in France, and greater product launch success.”
stève consultants has spent 17 years optimizing the value of its customers’ healthcare products for the French market, with deep expertise in market access, HEOR, and RWE. stève consultants is a leader in market access and one of the largest and most accomplished RWE services providers in France.
“Joining forces with Cytel further expands the insight and support we can offer for market access and market maintenance in France,” said Stève Bénard, Executive Manager, stève consultants. “Both companies share a pioneering spirit, long-held market reputations for scientific rigor, and an excellent client service ethos. We’re proud to play a critical role in augmenting the way sponsors tap into markets and transform patients’ lives.”
The transaction was closed on June 30, 2023. Terms were not disclosed.
About Cytel
Cytel is the largest provider of statistical software and advanced analytics for clinical trial design and execution. For over thirty-five years, Cytel’s scientific rigor and operational excellence have enabled biotech and pharmaceutical companies to navigate uncertainty, prove value and make confident, evidence-based decisions. Its experts deliver industry-leading software, data-driven analytics, real-world evidence and strategic consulting. Headquartered in Waltham, Massachusetts, Cytel has more than 2,000 employees across North America, Europe and Asia.
About stève consultants
stève consultants, founded in 2006, is a consulting and research company specializing in optimizing the value of healthcare products on the French market. stève consultants supports its biotech and pharmaceutical clients in the development and the implementation of their regional market access strategy, including the implementation of early access programs, the demonstration of health-economic value, the generation of real-life data and the writing of HTA dossiers. stève consultants is a leader in market access, and one of the most accomplished RWE service providers in France. stève consultants has extensive experience and works on the latest therapeutic innovations.
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Research
Newswire | July 05, 2023
Cipher Pharmaceuticals Inc. ("Cipher" or "the Company") today announced that the Company's partner, Moberg Pharma AB, ("Moberg Pharma") has obtained European Union approval for MOB-015 (nail fungus treatment) as a result of demonstrating superior levels of mycological cure (76% vs. 42% for comparators) and a significantly better complete cure rate.
MOB-015 has been recommended for national approval in 13 European countries, which will be commercialized through partners such as Bayer and Allderma, and is expected to be launched in Nordic countries such as Sweden during 2023.
Cipher holds the exclusive Canadian rights to MOB-015, a new topical treatment of Onychomycosis (nail fungus) based on Moberg's patented proprietary formulation of terbinafine. In Canada, according to IQVIA, the total prescription market for Onychomycosis was greater than $82 million CDN at December 31, 2022 with a single product having over 90% market share.
Craig Mull, Interim CEO of Cipher commented, "This is a fantastic achievement whereby the European Union has recognised MOB-015 as delivering quick visible improvements to patients living with nail fungus. We are excited about our partnership with Moberg Pharma, who have a strong track record developing and commercializing nail fungus products previously in both Europe and North America. This approval is a tremendous step in the right direction towards ultimately receiving market approval in Canada and the United States. We will continue to work closely with Moberg in making this clinically proven effective treatment available to Canadians as soon as possible."
Moberg Pharma continues to invest and advance MOB-015 through an additional phase 3 trial of a total of 350 patients with sites across the United States and Canada. The purpose of this study is to facilitate market approval in North America as well as further strengthen the product's clinical evidence beyond the mycological and complete cure rates already demonstrated to the European Union. Patient enrollment in the clinical trial is progressing according to plan with full enrollment expected in 2023.
About Cipher Pharmaceuticals Inc.
Cipher Pharmaceuticalsis a specialty pharmaceutical company with a robust and diversified portfolio of commercial and early to late-stage products. Cipher acquires products that fulfill unmet medical needs, manages the required clinical development and regulatory approval process, and currently markets those products either directly in Canada or indirectly through partners in Canada, the U.S., and South America.
About Moberg Pharma
Moberg Pharma AB is a Swedish pharmaceutical company focused on commercializing proprietary innovations based on drug delivery of proven compounds. The company's main asset, MOB-015, is a novel topical treatment for onychomycosis. Data from phase 3 clinical trials in more than 800 patients for MOB-015 indicate that the product has the potential to become the future market leader in onychomycosis. Moberg Pharma has agreements with commercial partners in place in Europe and Japan, among others, and the company's goal is to receive its first market approval and launch MOB-015 in 2023.
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Pharmacy Market
PRNewswire | July 11, 2023
Signant Health, the leader in evidence generation for modern clinical trials, announced expanded flexibility and capabilities for its leading Signant SmartSignals Supplies software, empowering small and mid-size customers to experience the advantages of technology-driven clinical supply management.
Relaunched as Signant SmartSignals Supplies GxP Inventory, the solution provides sponsors and contract research organizations (CROs) with efficient, comprehensive management and oversight of the end-to-end supply chain. Unlike spreadsheet-based supply chain management, the GxP Inventory solution offers centralized, full visibility of clinical trial material creation, release, and distribution activities within a single system. Available as either an Essential or Enterprise option, clinical research sponsors can select the optimal solution for their needs, which is often dictated by size or trial volume.
The Essential option enables sponsors to deploy quickly using our pre-configured system for inventory manufacturing, management, and QA/QP release. The Enterprise option provides more advanced features for larger customers with internal supply chain capabilities to meet more individualized requirements, sponsor-specific terminology/labels, and additional workflow/process options. Both options are SaaS-based for cost-effective implementation, reduction of internal technology investments, and ease of ongoing maintenance.
"Signant is extremely proud of its heritage as a leading provider of GxP inventory management solutions to many top-20 sponsor organizations. Our Essential option now extends the same benefits to smaller sponsors and CROs who wish to have the same level of inventory control, regulatory compliance, and visibility in a more compact, per-protocol commercial offering," said Sanjiv Waghmare, Signant's chief product officer.
Technology-based solutions make clinical trials safer for patients through better visibility and control of supplies, particularly with respect to investigational products. From sourcing drug substance ingredients to randomized patient kits, these solutions ensure that all supply chain data is in one place, and not distributed across spreadsheets, emails, and external inventory management systems. With the launch of the Essential option, we are making the technology-based solution for clinical supply management accessible to sponsors of all sizes.
About Signant Health
Signant Health is the evidence generation company. We are focused on leveraging software, deep therapeutic and scientific knowledge, and operational expertise to consistently capture, aggregate, and reveal quality evidence for clinical studies across traditional, virtual, and hybrid trial models. For more than 20 years, over 600 sponsors and CROs of all sizes – including all Top 20 pharma – have trusted Signant solutions for remote and site-based eCOA, eConsent, RTSM, supply chain management, and data quality analytics.
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