Globenewswire | July 14, 2023
Ardelyx, Inc. a biopharmaceutical company founded with a mission to discover, develop and commercialize innovative, first-in-class medicines that meet significant unmet medical needs, today announced that a New Drug Application (NDA) for tenapanor has been accepted for review by China’s Center for Drug Evaluation of the National Medical Products Administration (NMPA) for the control of serum phosphorus in adult patients with chronic kidney disease on hemodialysis. This acceptance triggers a $2 million milestone payment to Ardelyx under the terms of the license agreement between Ardelyx and its collaboration partner in China, Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd. (Fosun Pharma). A potential approval of the NDA submission in China is expected by the end of 2024.
“The NDA acceptance for tenapanor for hyperphosphatemia in China marks a significant step forward in Ardelyx’s commitment to bringing our novel therapies to patients with unmet medical needs and our desire to expand internationally alongside best-in-class partners who complement our capabilities and share our mission,” said Mike Raab, president and chief executive officer of Ardelyx. “I commend our collaboration partner, Fosun Pharma, on the impressive clinical results they generated which demonstrate the important role that tenapanor can play in offering a new treatment option for patients with hyperphosphatemia. We look forward to further collaboration as Fosun Pharma brings this treatment to patients.”
Under the terms of its agreement with Fosun Pharma, Ardelyx received an upfront payment of $12 million and is eligible to receive additional developmental and commercialization milestones of up to $110 million and tiered royalty payments on net sales ranging from the mid-teens to 20 percent. Fosun Pharma has the exclusive rights to market and sell tenapanor in China, Hong Kong and Macau.
About Ardelyx, Inc.
Ardelyx was founded with a mission to discover, develop and commercialize innovative, first-in-class medicines that meet significant unmet medical needs. Ardelyx’s first approved product, IBSRELA® (tenapanor) is available in the United States and Canada. Ardelyx is developing XPHOZAH® (tenapanor), a novel product candidate for the control of serum phosphorus in adult patients with chronic kidney disease (CKD) on dialysis, which has completed three successful Phase 3 trials. Ardelyx has a Phase 2 potassium lowering compound, RDX013, for the potential treatment of elevated serum potassium, or hyperkalemia, a problem among certain patients with kidney and/or heart disease and an early-stage program in metabolic acidosis, a serious electrolyte disorder in patients with CKD. Ardelyx has established agreements with Kyowa Kirin in Japan, Fosun Pharma in China and Knight Therapeutics in Canada for the development and commercialization of tenapanor in their respective territories.
About Fosun Pharma
Founded in 1994, Shanghai Fosun Pharmaceutical (Group) Co., Ltd.* ("Fosun Pharma"; stock code: 600196. SH, 02196. HK) is a global innovation-driven pharmaceutical and healthcare industry group. Fosun Pharma directly operates businesses including pharmaceuticals, medical devices, medical diagnosis, and healthcare services. As a shareholder of Sinopharm Co., Ltd., Fosun Pharma expands its areas in the pharmaceutical distribution and retail business.
Fosun Pharma is patient-centered and clinical needs-oriented. The company continuously enriches its innovative product pipeline through independent research and development, cooperative development, license-in, and in-depth incubation. Fosun Pharma improves the research and clinical development capabilities of FIC (First-in-class) and BIC (Best-in-class) new drugs as well as accelerates the R&D and launch of innovative technologies and products.
Business Insights, PHARMACY MARKET
PRNewswire | August 09, 2023
Verista, a leading business and technology services company offering specialized solutions for the life sciences industry, is delighted to announce a new partnership with Sware. This collaboration underscores Verista's commitment to its clients to provide advanced and innovative digital validation solutions, helping them realize Pharma 4.0.
By incorporating Sware's Res_Q platform, clients can enhance, streamline, and optimize the flow of content and data, effectively addressing the challenges posed by static documents and disjointed workflows in the validation discipline. Together, Verista services and Res_Q provide a powerful combination, offering customers a comprehensive and efficient risk-based approach to validation processes in the life sciences industry.
"In this partnership, Verista will drive the efficient execution of digital transformations with Res_Q enabling clients to modernize their processes and leverage the latest regulated technologies in compliant ways," says Manny Soman, CEO of Verista. "We are delighted that Verista and Sware share the same goal to reduce and manage validation efforts while helping clients unleash the full potential of digital transformation to bring their products to market more quickly and safely."
"Digitizing the validation process is crucial for compliance-focused life sciences companies to be able to meet stringent global regulatory requirements, but digitizing processes means much more than putting paper processes on glass," says Bryan Ennis, Co-Founder and CEO of Sware. "Our partnership with Verista couples our deep digital technology expertise with robust industry experience to deliver the most comprehensive, intelligent and digital validation solutions on the market today."
Verista is a leading business, technology and compliance company that enables clients to improve health and improve lives. We help clients solve their most critical and complex challenges across the GxP lifecycle, from clinical to commercialization, manufacturing and distribution. Verista's experts continually deliver consistent, safe, and high-quality results across the product development lifecycle in the areas of enterprise and lab solutions, technology solutions, manufacturing solutions, and regulatory compliance and product management.
Sware is changing how the life sciences industry manages validation – helping companies deliver safer therapies through better technology. Sware provides one validation solution crafted specifically for the entire life sciences industry. Res_Q by Sware automates validation – effortlessly navigating through each step of the validation process for both GxP and non-GxP systems.
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.
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.