AstraZeneca and FibroGens roxadustat, not yet filed in U.S., nabs 2nd anemia nod in China

FiercePharma | August 22, 2019

FibroGen has not even filed its AstraZeneca-partnered oral anemia drug roxadustat for U.S. approval. But the collaborators have already scored their second nod for the blockbuster hopeful in China. Last December, the pair made a rare if not only case out of roxadustat by racking up its first-in-class approval in China before any other country. At that time, Chinese authorities greenlighted the drug for patients on dialysis. With this second approval, it’s now allowed to treat the larger nondialysis-dependent group. Assuming a green light across the chronic kidney disease population was close, SVB Leerink analyst Geoffrey Porges has projected roxadustat sales could reach $1 billion in China alone by 2025. The current approval is primarily based on a phase 3 trial that showed roxadustat could increase patients’ hemoglobin levels by a mean of 1.9 g/dL, compared with a reduction of 0.4 g/dL among patients on placebo. In a previous China-specific trial on dialysis-dependent patients, the drug produced a numerically greater hemoglobin improvement versus Johnson & Johnson and Amgen’s Epogen/Procrit. Because FibroGen was relocating its Chinese manufacturing site, the drugmakers couldn’t immediately launch roxadustat in China, and they’re still eyeing an official rollout later this year. But AstraZeneca has already been preparing for talks with the Chinese government to include roxadustat on the country��s National Reimbursement Drug List. Results of those talks are expected around the end of this year, Leon Wong, AstraZeneca’s EVP in charge of China and emerging markets told investors on a conference call in July.

Spotlight

Good Manufacturing Practice (GMP) – is part of a quality system covering the manufacture and testing of active pharmaceutical ingredients, diagnostics, foods, pharmaceutical products, and medical devices.

Spotlight

Good Manufacturing Practice (GMP) – is part of a quality system covering the manufacture and testing of active pharmaceutical ingredients, diagnostics, foods, pharmaceutical products, and medical devices.

Related News

BUSINESS INSIGHTS

MilliporeSigma Invests $ 286 Million in U.S. Drug Safety Testing Capacity

MilliporeSigma | November 16, 2022

MilliporeSigma, the U.S. and Canada Life Science business of Merck KGaA, Darmstadt, Germany, a leading science and technology company, announced that its Life Science business sector is investing more than $ 286 million in its biosafety testing capacity at the company's site in Rockville, Maryland, USA. This will significantly increase the company's ability to conduct biosafety testing and analytical development services. Biosafety testing and analytical development are critical and fundamental requirements of the drug development and commercialization process to ensure the safety of medicines. Global demand for these services is growing at a double-digit rate. "MilliporeSigma is harnessing its broad portfolio of modern technologies and enabling services to help ensure the safety of the world's medicines. These significant investments in Rockville and other sites across our global network will help us meet growing demand for the robust testing studies that biologics manufacturers depend upon to comply with stringent regulatory guidelines. This is a prime example of our focus on sustainable growth in areas with strong underlying upwards dynamics." Belén Garijo, Chair of the Executive Board and CEO of Merck KGaA, Darmstadt, Germany "This is the largest investment in contract testing in Merck KGaA, Darmstadt, Germany's history. Our Rockville campus has a long track record of testing for both traditional and novel therapies. We have been driving innovation in biosafety testing for 75 years and this expansion enables our Life Science business sector to lead in shaping the future of testing," said Matthias Heinzel, Member of the Executive Board of Merck KGaA, Darmstadt, Germany and CEO Life Science. "We thank the State of Maryland and Montgomery County, Maryland, for their collaboration in making this new campus a reality for our employees and clients. Together, we are impacting life and health with science." The BioReliance® contract testing portfolio from MilliporeSigma provides best-in-class biosafety testing and analytical development methods for both traditional and novel therapies. The new state-of-the-art, 250,000-square-foot facility at MilliporeSigma's Rockville site will house biosafety testing, analytical development, viral clearance suites, and cell bank manufacturing services. Currently, about 600 employees work at the site. Over the next four years, the expansion will create more than 500 new jobs. With more than 30 years of drug development, material science and process technology expertise, Millipore® CTDMO Services offerings span pre-clinical development to commercial manufacturing, including testing, across multiple modalities including mAbs, highly potent active pharmaceutical ingredients, antibody-drug conjugates, viral vector therapies, mRNA, and lipid nanoparticle formulation. Contract testing and the newly formed Millipore® CTDMO Services are part of the Life Science Services business unit, which together with the Process Solutions business is one of Merck KGaA, Darmstadt, Germany's "Big 3" growth drivers. The company aims to increase its Group sales to approximately € 25 billion by 2025. Recently, the company's Life Science business sector announced investments in Martillac and Molsheim, France; Shanghai, China; Sheboygan and Verona, Wisconsin, USA; Cork, Ireland; Wuxi, China; Carlsbad, California, USA; Jaffrey, New Hampshire and Danvers, Massachusetts, USA; Buchs, Switzerland; and Darmstadt, Germany. These expansions are part of an ambitious, multi-year program. It aims to increase the capacity and capabilities of Merck KGaA, Darmstadt, Germany's Life Science business sector to support the growing global demand for lifesaving medications and to make significant contributions to public health. About the Life Science business of Merck KGaA, Darmstadt, Germany The Life Science business of Merck KGaA, Darmstadt, Germany, which operates as MilliporeSigma in the U.S. and Canada, has more than 26,000 employees and more than 55 manufacturing and testing sites worldwide, with a portfolio of more than 300,000 products focused on scientific discovery, biomanufacturing and testing services. Merck KGaA, Darmstadt, Germany, a leading science and technology company, operates across healthcare, life science and electronics. Around 60,000 employees work to make a positive difference to millions of people's lives every day by creating more joyful and sustainable ways to live. From advancing gene-editing technologies and discovering unique ways to treat the most challenging diseases to enabling the intelligence of devices – the company is everywhere. In 2021, Merck KGaA, Darmstadt, Germany generated sales of € 19.7 billion in 66 countries. The company holds the global rights to the name and trademark "Merck" internationally. The only exceptions are the United States and Canada, where the business sectors of Merck KGaA, Darmstadt, Germany operate as EMD Serono in healthcare, MilliporeSigma in life science, and EMD Electronics. Since its founding in 1668, scientific exploration and responsible entrepreneurship have been key to the company's technological and scientific advances. To this day, the founding family remains the majority owner of the publicly listed company. All Merck KGaA, Darmstadt, Germany news releases are distributed by email at the same time they become available on the EMD Group website. In case you are a resident of the U.S. or Canada please go to www.emdgroup.com/subscribe to register again for your online subscription to this service as our newly introduced geo-targeting requires new links in the email. You may later change your selection or discontinue this service.

Read More

BUSINESS INSIGHTS, PHARMACY MARKET

West Pharmaceutical Introduces Three New Product Innovations at Pharmapack Europe

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.

Read More

BUSINESS INSIGHTS

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.

Read More