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

The site of Gien is the group's most important pharmaceutical production site. It manufactures and packages dry (hard capsules, tablets, sachets), paste and liquid forms under pharmaceutical, dermo-cosmetic, and medical device status. It makes its expertise available to third-party laboratories and offers processing activities for the following pharmaceutical forms: dry forms.

Spotlight

The site of Gien is the group's most important pharmaceutical production site. It manufactures and packages dry (hard capsules, tablets, sachets), paste and liquid forms under pharmaceutical, dermo-cosmetic, and medical device status. It makes its expertise available to third-party laboratories and offers processing activities for the following pharmaceutical forms: dry forms.

Related News

PHARMACY MARKET

Jubilant HollisterStier LLC enters into cooperative agreement of $149.6 Mn with US Government to expand critical vaccine manufacturing capacity

Jubilant Pharmova Limited | May 31, 2022

Jubilant Pharmova Limited has announced today that Jubilant Pharma Limited, a wholly owned subsidiary of the Company, through one of its wholly owned subsidiaries, Jubilant HollisterStier LLC, (JHS) a leading US-based pharmaceutical contract manufacturer has entered into a cooperative agreement for $149.6 million (USD) with the Army Contracting Command, in coordination with the Joint Program Executive Office for Chemical, Biological, Radiological, and Nuclear Defense (JPEO-CBRND) on behalf of the Biomedical Advanced Research and Development Authority (BARDA), within the US Department of Health and Human Services. The effort was funded under the American Rescue Plan, this agreement will enable the Company to double its injectable filling production capacity at a total cost of $193 million, at its Spokane, Washington manufacturing facility. This will be completed by 2025. This agreement is in addition to the $92 million filling line expansion announced in November 2021, which will be commercially available by the end of 2024. "Jubilant HollisterStier LLC is committed to making the US pharmaceutical supply chain more resilient with domestic manufacturing facilities and less reliant on foreign suppliers. Jubilant HollisterStier has a long history of supporting the US Department of Health and Human Services (HHS) and Department of Defense (DOD) biodefense and medical countermeasure programs, including production for national preparedness efforts. We are proud to support the US government in their efforts of making the US more prepared and ready for future pandemics." Speaking on the announcement, Pramod Yadav, CEO, Jubilant Pharma Limited "Jubilant HollisterStier LLC's expansion will target large Pharmaceuticals and Biotech companies for parenteral products as well as feature a flexible manufacturing platform able to produce several types of vaccines (live, mRNA and inactivated/subunit). We are committed to investing in capability and capacity. This investment will ensure our ability and flexibility to speedily produce quality vaccines and treatments for our customers and be better prepared for any future threats to the country," shared Amit Arora, President, Contract Manufacturing Organization (CMO), Jubilant HollisterStier LLC. About Jubilant HollisterStier LLC Jubilant HollisterStier LLC, a subsidiary of Jubilant Pharma Limited, is a leading integrated contract manufacturer of sterile injectables, ophthalmics, optics, sterile and non-sterile topicals and liquids. With facilities in North America, Jubilant HollisterStier LLC provides specialized manufacturing for the pharmaceutical and biopharmaceutical industries. Services include a full range of support to streamline manufacturing, from process qualifications through commercial release. About Jubilant Pharma Limited Jubilant Pharma Limited, a Company incorporated under the laws of Singapore and a wholly-owned subsidiary of Jubilant Pharmova Limited, is an integrated global pharmaceutical company engaged in manufacturing and supply of Radiopharmaceuticals with a network of radio-pharmacies in the US, Allergy Immunotherapy, Contract Manufacturing of Sterile Injectables and Non-sterile products, APIs and Solid Dosage Formulations through six manufacturing facilities that cater to all the regulated market including USA, Europe and other geographies. The Company has a team of over 4,600 multicultural people across the globe and is committed to delivering value to its customers spread across over 75 countries. It is well recognized as a 'Partner of Choice' by leading pharmaceutical companies globally. About Jubilant Pharmova Limited Jubilant Pharmova Limited is a company engaged in Pharmaceuticals, Contract Research and Development Services and Proprietary Novel Drugs businesses. Pharmaceuticals business through Jubilant Pharma Limited Singapore (JPL) is engaged in manufacturing and supply of Radiopharmaceuticals with a network of 48 radio-pharmacies in the US, Allergy Immunotherapy, Contract Manufacturing of Sterile Injectables and Non-sterile products, APIs and Solid Dosage Formulations through six manufacturing facilities that cater to all the regulated market including USA, Europe and other geographies. Jubilant Biosys Limited provides contract research and development services through two world class research centers in Bangalore and Noida in India. Jubilant Therapeutics is involved in Proprietary Novel Drugs business and is an innovative biopharmaceutical company developing breakthrough therapies in the area of oncology and auto-immune disorders. Jubilant Pharmova Limited has a team of over 6,000 multicultural people across the globe. The Company is well recognized as a 'Partner of Choice' by leading pharmaceuticals companies globally.

Read More

BUSINESS INSIGHTS

Fusion Pharmaceuticals and Niowave Announce Actinium-225 Collaboration and Supply Agreement

Fusion Pharmaceuticals Inc. | June 13, 2022

Fusion Pharmaceuticals Inc. a clinical-stage oncology company focused on developing next-generation radio pharmaceuticals as precision medicines, and Niowave, Inc., a manufacturer of medical radioisotopes from radium and uranium, today announced that the companies have entered into a collaboration and supply agreement for the development, production, and supply of actinium-225. Under the agreement, Fusion will invest up to $5 million in Niowave to further develop their technology to increase current production capacity of actinium-225, and in return Fusion will have guaranteed access to a pre-determined percentage of Niowave's capacity of the resulting actinium-225, as well as preferred access to any excess supply produced. As part of the agreement, Fusion will also have an option to invest in future production of actinium-225 to scale with Fusion's needs. "As excitement for the tumor-killing potential of alpha-emitting radio pharmaceuticals increases, we intend to stay at the forefront of actinium development and supply to support our growing pipeline of targeted alpha therapies. We continue to prioritize manufacturing and access to actinium as a critical component of Fusion's platform, and our partnership with Niowave further strengthens and diversifies our supply chain as we advance multiple actinium-based radio pharmaceuticals in the clinic." Fusion Chief Executive Officer John Valliant, Ph.D "The Niowave team has worked hard to scale up our actinium-225 production to the millicurie level and this has allowed us to start working with oncology community partners," said Niowave Chief Executive Officer/Senior Scientist Terry Grimm, Ph.D. "We have been watching Fusion's progress in the development of their pipeline of targeted alpha therapies and we are very excited to partner with them on this journey." Fusion is developing actinium-based TATs leveraging the potency and precision offered by alpha particles. Actinium-225 decay gives off four alpha emissions in relatively rapid succession, maximizing the damage to the DNA of tumor cells, with a 10-day half life that allows for central manufacturing and distribution of products to clinical sites in a ready-to-use form. About Fusion Fusion Pharmaceuticals is a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines. Fusion connects alpha particle emitting isotopes to various targeting molecules in order to selectively deliver the alpha emitting payloads to tumors. Fusion's lead program, FPI-1434 targeting insulin-like growth factor 1 receptor, is currently in a Phase 1 clinical trial. The pipeline includes FPI-1966, targeting the fibroblast growth factor receptor 3 (FGFR3), advancing to a Phase 1 study following the investigational new drug (IND) clearance; and FPI-2059, a small molecule targeting neurotensin receptor 1 (NTSR1). In addition to a robust proprietary pipeline, Fusion has a collaboration with AstraZeneca to jointly develop novel targeted alpha therapies (TATs) and combination programs between Fusion's TATs and AstraZeneca's DNA Damage Repair Inhibitors (DDRis) and immuno-oncology agents. Fusion has also entered into a collaboration with Merck to evaluate FPI-1434 in combination with Merck's KEYTRUDA® (pembrolizumab) in patients with solid tumors expressing IGF-1R. Fusion and Hamilton, Ontario-based McMaster University are building a current Good Manufacturing Practice (GMP) compliant radiopharmaceutical manufacturing facility designed to support manufacturing of the Company's growing pipeline of TATs. About Niowave Niowave manufactures radioisotopes to cure cancer and save lives. Niowave builds and operates superconducting electron linear accelerators and is using that expertise to produce various radioisotopes for nuclear medicine. Niowave is a Cooperative Agreement partner with the National Nuclear Security Administration to develop a domestic supply of molybdenum-99 and currently produces yttrium-90 for use in cancer therapy. Niowave is licensed by the NRC to manufacture radioisotopes from uranium and radium and has partnerships with several universities and national laboratories focused on production and purification of radioisotopes for use in cancer therapy. By using radium targets and electron beams, Niowave is able to produce ultra pure and carrier-free actinium-225. Niowave's R&D facility is currently supplying actinium-225 samples to partners. Production-scale operations are ramping up at a second, FDA-compliant facility capable of meeting the growing actinium-225 market.

Read More

PHARMA TECH

BlackRock and QLS Advisors Partner Through BlackRock Systematic to Invest in Biomedical Innovation

BlackRock and QLS Advisors | July 19, 2022

BlackRock and QLS Advisors LLC, a life sciences technology and advisory firm, have announced a partnership through BlackRock Systematic to develop data-driven investment solutions to help accelerate biomedical innovation. The partnership will leverage the firms’ combined Research and Development and investment experience, directing funding toward public and private companies that have the potential to create transformative therapies while seeking to earn attractive investment returns for clients. Biomedicine is at an inflection point: breakthrough therapies—with the potential to extend longevity and improve quality of life—are emerging at an ever-increasing pace. Funding these therapeutic development programs has the potential to deliver attractive investment returns, but as biomedicine has grown more complex, so have the risks to investors. QLS has developed proprietary technology for estimating the probability of success of clinical trials, a key driver of financial performance, and systematically incorporating these forecasts into fundamental valuation models and portfolio construction algorithms. Their approach applies machine learning techniques to a multitude of predictive factors including therapeutic characteristics, clinical trial design features, disease-specific characteristics, and drug company track records. This methodology, coupled with BlackRock Systematic’s global platform, proprietary analytics, and more than 35 years1 of data-driven investment experience, presents a differentiated approach to investing in life sciences companies. “BlackRock’s partnership with QLS applies sophisticated quantitative investment technologies to the intersection of finance, academia, and life sciences. QLS brings an industry-leading approach to investing in life sciences that complements the work that BlackRock Systematic is doing in our actively managed portfolios. We expect this will create compelling, differentiated solutions that can deliver attractive returns for our clients while providing funding for life-changing therapies.” Rich Kushel, Head of the Portfolio Management Group BlackRock Andrew Lo, QLS Co-founder and Professor of Finance at the MIT Sloan School of Management commented: “We founded QLS to improve the way financial resources are allocated to emerging therapies, with the goal of lowering the cost of capital in this important sector. With BlackRock, we gain a partner who is a recognized leader in data-driven investing and shares our passion for delivering investment returns with positive outcomes for society. We’re thrilled and honored to join forces with a firm that has such a strong and trusted global brand, broad network, and access to world-class investment resources.” BlackRock and QLS have also assembled a Scientific Advisory Council comprising renowned academics, medical doctors, and inventors. The Council will support sourcing, due diligence, and value creation through the members’ vast networks and decades of experience as industry leaders in their respective fields. The Council is expected to include Dr. Robert Langer, Institute Professor, MIT Department of Chemical Engineering, and founder of over 40 biotechnology companies including Moderna. Ms. Lita Nelsen, retired director of the MIT Technology Licensing Office; now consultant in technology licensing. Dr. Larry Norton, Senior Vice President, Norna S. Sarofim Chair in Clinical Oncology and Medical Director of the Evelyn H. Lauder Breast Center at Memorial Sloan Kettering Cancer Center, Past President of the American Society of Clinical Oncology, ASCO David Karnofsky Awardee, FASCO, FAACR. Dr. Richard H. Scheller, Chairman of Research and Development BridgeBio. Board of Directors BridgeBio, Alector, 23andMe, DICE and others. Former Executive Vice President Research and Early Development Genentech and former HHMI Investigator and Professor Stanford University Medical School. Dr. Phillip A. Sharp, Institute Professor, MIT Department of Biology, geneticist and molecular biologist who co-discovered RNA splicing, co-founded Biogen and Alnylam, and the recipient of the 1993 Nobel Prize in Physiology or Medicine. About BlackRock Systematic BlackRock’s systematic investment platform brings together BlackRock’s community of systematic investors across equity, fixed income, and factor-based strategies. Systematic portfolios combine cutting-edge technology, scientific research, and human insight in the relentless pursuit of investment performance. With over 35 years of experience and nearly 200 professionals across the globe managing over US$200 bn in client assets as of March 31, 2022, BlackRock Systematic partners with clients to deliver quantitative alpha-seeking and factor-based investment solutions for the whole portfolio. About QLS Advisors LLC QLS Advisors LLC is a life sciences technology and advisory company based in Cambridge, MA, dedicated to fostering biomedical innovation. QLS employs a unique blend of fundamental and quantitative tools to help clients manage risk, assess reward, and develop investment and financing strategies for portfolios of healthcare-related assets.

Read More