Erythropoietin(Stem Cell Therapeutics)

GSK's decision to not market daprodustat in EU comes shortly after Astellas took a sizable impairment charge for its rival oral anemia drug. Despite a positive opinion from local drug reviewers, GSK has decided not to bring its FDA-approved oral anemia drug daprodustat to Europe—or any additional countries for that matter. Daprodustat, marketed as Jesduvroq in the U.S., earned backing from the drug evaluation committee at the European Medicines Agency a month ago. The recommended indication was for treating anemia associated with chronic kidney disease (CKD) in patients on chronic dialysis. From there, an official approval from the European Commission was largely considered a done deal. But in reporting its second-quarter financial results (PDF) on Wednesday, GSK said it has decided not to commercialize daprodustat in Europe. The company said it will withdraw the application in Europe and won’t seek approvals in other territories. Besides the U.S., daprodustat is also available in Japan under the brand name Duvroq. It's distributed there by Kyowa Kirin. In making this decision, GSK cited the “significant reduction” in the size of the drug’s potential market opportunity, the fact that the EMA didn’t include non-dialysis patients in its opinion, and other existing rivals. Thanks to a 2021 go-ahead, FibroGen’s partner Astellas has been selling rival drug Evrenzo, or roxadustat, in Europe for CKD anemic patients regardless of their dialysis status. And in April, Akebia's vadadustat won an EU green light for dialysis-dependent patients. Despite Evrenzo's broad label in Europe, Astellas recently booked an impairment charge worth 47.1 billion Japanese yen ($340 million) based on its reduced sales outlook for the drug. During the 12 months that ended in March, Evrenzo only brought in 3.2 billion yen ($23 million) for Astellas across Japan and EU. In China, where FibroGen is partnered with AstraZeneca, the drug generated $209 million in 2022. In recent years, discrepancies among drug regulators in the U.S., EU and Japan have been laid bare in their reviews of the HIF-PHI drug class. Jesduvroq, Evrenzo and Vafseo all belong to this group, which once looked promising enough to replace injectable erythropoietin-stimulating agents. Japanese authorities embraced all three drugs early on, endorsing them in dialysis-dependent and nondialysis CKD patients. In the U.S., heart disease and other safety signals prompted the FDA to completely reject FibroGen and AstraZeneca's roxadustat in 2021. The agency knocked back vadadustat, too, based on similar cardio risk factors, but it now appears open to re-considering the med in the dialysis-dependent population after Akebia's appeal. As for GSK's Jesduvroq, the drug in February became the first oral treatment for CKD-related anemia approved in the U.S., but it’s not allowed for patients who aren’t on dialysis. Before the safety fallout, analysts had predicted blockbuster sales for members of the HIF-PHI class. GSK had previously predicted around 500 million pounds to 1 billion pounds of peak sales for Jesduvroq. Now, the drug will obviously have a hard time reaching that mark.

Duopharma Biotech is a worldwide pioneer in the research and development of halal pharmaceuticals. SAN ANTONIO, July 25, 2023 /PRNewswire/ -- Frost & Sullivan recently researched the Malaysian halal pharmaceutical industry and, based on its findings, recognizes Duopharma Biotech Berhad (Duopharma Biotech) with the 2022 Malaysian Company of the Year Award. Duopharma Biotech aims to produce safe, effective, and high-quality Halal products for all consumers and set the standard for the Malaysian pharmaceutical industry. Continue Reading Duopharma Biotech is expanding and improving its Halal portfolio to differentiate itself from competitors. Halal is an Arabic word that describes lawful or permissible products targeted at Muslim consumers. According to the State of Global Islamic Economy Report 2022, the Halal pharmaceutical market was valued at $100 billion in 2021 and is likely to reach $129 billion by 2025. As a result, Duopharma Biotech can benefit from the growing demand and is in a privileged position to fulfill the need for Halal pharmaceutical products. The company is expanding and improving its Halal portfolio to differentiate itself from competitors. It is the first pharmaceutical company to market a biosimilar erythropoietin, branded as ERYSAA®, a biosimilar product for treating anemia in chronic kidney disease. Duopharma Biotech designed this product to meet the health and wellness needs of the Malaysian population in a cost-effective manner that also complies with medical and Muslim standards. "As the world's first halal biosimilar, ERYSAA® secures Duopharma Biotech's leadership in the Halal pharmaceutical industry. In 2021, as physicians prescribed ERYSAA® to more dialysis patients, product sales grew by 52%. Despite the fierce competition from short and long-acting erythropoietin stimulating agents, ERYSAA® expanded into the dialysis market, with approximately 49% of dialysis centers and hospitals prescribing it to their renal anemia patients," said Dr. Maeirah Ashaie, Best Practices Research Consultant at Frost & Sullivan. Part of Duopharma Biotech Biotech's initiatives includes leading halal pharmaceutical awareness campaigns and exploring international collaborations to share halal-certified products. The company is building partnerships with international organizations to raise awareness of the importance of halal products to the Muslim population and is planning to expand to other markets, including the United Arab Emirates (UAE). Duopharma Biotech regularly conducts online surveys to ensure high customer service and quality standards and support its continued growth. As a result, the company scored 98% on the customer satisfaction index, higher than its previous two years' figures. "In 2021, the Halal Development Corporation Berhad (HDC) introduced a Sectoral Roadmap for halal pharmaceuticals to promote industry development. Duopharma Biotech is a member of the Sectoral Working Group, whose mission is to review and monitor the implementation of established measures. The company seeks to establish itself as a global thought leader in halal pharmaceuticals," noted Ashaie. Each year, Frost & Sullivan presents a Company of the Year award to the organization demonstrating excellence in growth strategy and implementation in its field. The award recognizes a high degree of innovation with products and technologies and the resulting leadership in customer value and market penetration. Frost & Sullivan Best Practices awards recognize companies in various regional and global markets for demonstrating outstanding achievement and superior performance in leadership, technological innovation, customer service, and strategic product development. Industry analysts compare market participants and measure performance through in-depth interviews, analyses, and extensive secondary research to identify best practices in the industry. About Frost & Sullivan For six decades, Frost & Sullivan has been world-renowned for helping investors, corporate leaders, and governments navigate economic changes and identify disruptive technologies, Mega Trends, new business models, and companies to action, resulting in a continuous flow of growth opportunities to drive future success. Contact us: Start the discussion. Contact: Tammy Chan [email protected] About Duopharma Duopharma Biotech Group ("Duopharma Biotech" or "the Company") began with the establishment of Duopharma (M) Sendirian Berhad in 1978. Duopharma Biotech was incorporated in 2000 and is today one of Malaysia's leading pharmaceutical companies listed on the Main Market of Bursa Malaysia Berhad. Duopharma Biotech has core competencies in the pharmaceutical industry inclusive of Manufacturing, Research & Development, and Commercialization & Marketing of over 300 generic drugs such as Crystorvas, Prelica, and Omesec as well as Consumer Healthcare ("CHC") products including CHAMPS®, FLAVETTES®, PROVITON®, and Uphamol, which are well-recognized and accepted by consumers in Malaysia, regionally and globally. The Company has also diversified into the biosimilars space with technology and commercialization collaborations with credible and strong international partners. ERYSAA®, Basalog One®, and Zuhera are a few commercialized biosimilar brands. Headquartered in Kuala Lumpur, Malaysia, Duopharma Biotech owns and operates three manufacturing plants in Klang, Bangi, and Glenmarie, Selangor. Duopharma Biotech also has subsidiary companies in the Philippines, Singapore and Indonesia. Website: SOURCE Frost & Sullivan