Roche’s Tamiflu successor on target in phase 3 trial

pharmaphorum | July 04, 2019

A trial of Roche’s successor to flu medicine Tamiflu has met its goal in a phase 3 trial, with results showing that the new drug Xofluza is well tolerated in children with the flu. Roche’s Genentech unit said the MINISTONE-2 study also showed Xofluza is comparable with Tamiflu (oseltamivir) in terms of efficacy, the drug that Xofluza is designed to replace. The idea behind Xofluza (baloxavir marboxil) is to replace Tamiflu’s once-daily dosing regimen with a single dose that helps the body to fight the viral infection. Safety and efficacy of Xofluza in children with the flu under the age of one is also being studied in the global phase 3 MINISTONE-1 study. The FDA approved Xofluza last October in adults with uncomplicated flu in people aged 12 years of age and older. This latest study in part of a strategy to expand the drug’s use to include younger children and Roche has already filed a dossier with the FDA asking for an expanded label in people at high risk of complications from the flu. The safety and efficacy of Xofluza in children with the flu under the age of one is also being studied in the global phase 3 MINISTONE-1 study. Although Xofluza was hailed as one of the first novel flu antiviral drugs in almost 20 years at the time of approval, it faces significant competition from generics of Tamiflu. While Xofluza costs as much as $165, generic Tamiflu costs around $50 and it remains to be seen whether doctors and patients think the new drug’s benefits and dosing schedule justify the higher price tag. Xofluza was discovered by Japan’s Shionogi and the two companies are collaborating on development and marketing. Under the terms of this agreement, Roche holds worldwide rights to Xofluza excluding Japan and Taiwan, which will be retained exclusively by Shionogi.

Spotlight

The global oncology market is expected to grow at a rate of 7.5% with top-ten companies accounting for more than one-third of the market share. Roche tops the list with three drugs in the high rankings accounting for nearly 45% of the revenues. Celgene’s Revlimid is the bestselling drug also showing a 20% growth rate from 2015.

Spotlight

The global oncology market is expected to grow at a rate of 7.5% with top-ten companies accounting for more than one-third of the market share. Roche tops the list with three drugs in the high rankings accounting for nearly 45% of the revenues. Celgene’s Revlimid is the bestselling drug also showing a 20% growth rate from 2015.

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BUSINESS INSIGHTS

Septerna Strengthens Leadership Team to Advance Novel Small Molecule GPCR Medicines

Septerna | July 29, 2022

Septerna, a biotechnology company discovering and advancing novel small molecule medicines targeting G protein-coupled receptors announced the addition of Liz Bhatt, MS, MBA, as Chief Operating Officer, and Ran Xiao as Vice President of Finance and Business Operations to its leadership team. Septerna launched in January 2022 and is growing a pipeline of differentiated products using its GPCR Native Complex™ platform to unlock the vast untapped potential of GPCR drug targets for a wide range of diseases. We are thrilled to welcome Liz and Ran as we continue to build our exceptional team. Together, they bring deep experience in corporate, commercial, and business strategy. They also have significant operational expertise building and supporting both private and public companies,” said Jeffrey Finer, MD, PhD, Chief Executive Officer and Co-founder of Septerna and Venture Partner at Third Rock Ventures. “Since our launch in January, we’ve made rapid progress advancing our platform and early discovery programs, and now expanding our focus to strategic growth and operational excellence is absolutely critical so that we can fully realize the untapped opportunity space for new GPCR medicines.” “Septerna launched with the ambitious plan to expand the GPCR target landscape by developing and industrializing new drug discovery technologies and processes that can convert this target-rich superfamily of proteins into impactful new therapies for patients across a range of therapeutic areas. I’m excited to be working with a team of talented GPCR scientists and drug hunters and look forward to using my experience leading teams and developing corporate and product strategies to build Septerna into a robust company poised for long-term growth.” Ms. Bhatt Liz Bhatt brings more than 25 years of strategy, deal-making and company-building experience across a range of biotech and pharmaceutical companies. Liz was previously Chief Business & Strategy Officer at Applied Molecular Transport where she oversaw corporate development, portfolio and project management, and commercial strategy. Prior to AMT, Liz was Chief Operating Officer at Achaogen where she held various strategic and operational roles. Liz spent over a decade at Gilead Sciences as VP, Corporate Development leading deals across all therapeutic areas and as Senior Director, Commercial Strategy leading long-term global commercial and strategic planning, and supporting the launch of several products. Liz also held management roles at Eli Lilly and Maxygen and started her career in research at Affymax. She currently serves as an independent director on the board of eFFECTOR Therapeutics. Liz earned a BA in chemistry from Pomona College, an MS in biomedical sciences from the University of California San Diego, and an MBA from the Kellogg School of Management at Northwestern University. Ran Xiao has more than 20 years of experience in corporate accounting, finance, and business operations in the biotech industry. Prior to Septerna, Ran was the VP of Finance and Corporate Controller at Ambys Medicines, Inc, where she supported the company launch and managed various general and administrative functions through a rapid growth period. Before joining Ambys, Ran was the Corporate Controller at Corvus Pharmaceuticals, where she played a key role in the company’s initial public offering. Prior to Corvus, Ran held various managerial positions at Intermune, Natus Medical, Celera Genomics and CV Therapeutics. Ran has a BS in accounting from Shanghai University of Finance and Economics and an MBA from the Illinois Institute of Technology. Ran is a Chartered Financial Analyst. About GPCRs G protein-coupled receptors are the largest and most diverse family of cell membrane receptors, and humans have hundreds of different GPCRs, each involved in controlling specific biological functions. GPCRs on the surface of each cell bind a wide range of external signaling molecules from throughout the body, and the GPCR transmits the signal across the cell membrane to drive internal cellular mechanisms. GPCRs have been widely studied as drug targets and are the largest family of proteins targeted by approved drug products. An estimated 700 approved drugs target GPCRs, representing approximately one-third of all currently approved drugs. Despite the pharmacological success of GPCRs as a drug class to date, the large majority of potential therapeutic GPCR targets remain undrugged. About Septerna Septerna, Inc., is a biotechnology company creating broad new drug discovery opportunities across many disease areas for the abundant drug target class of G protein-coupled receptors. The company’s Native Complex™ Platform recapitulates GPCRs with their native structure, function, and dynamics outside of the cellular environment to enable new technologies for industrial-scale drug discovery for the entire GPCR target class for the first time. Septerna has an emerging pipeline of GPCR-targeted small molecule drug discovery programs, along with growth potential to reach many GPCRs that have been undruggable and unexploited to date. Septerna was launched in 2022 by scientific founders who have made groundbreaking GPCR discoveries and by founding investor Third Rock Ventures.

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PHARMACY MARKET

BC Platforms Drives Data Enablement and Collaboration to Accelerate Precision Medicine in Asia

BC Platforms | June 07, 2022

BC Platforms a leading provider of data and technology platforms for personalized medicine and drug development, will host a key, day-long, Precision Medicine and Data Science Conference in Singapore on 7 June 2022 to discuss how stakeholders can securely collaborate and enable the use of federated data at scale to empower precision medicine, population health, and preventive care initiatives in the region. The event features preeminent local and international experts from healthcare, government, and academia, including Professor Patrick Tan, Executive Director of the Genome Institute of Singapore, Associate Professor Neerja Karnani, BioInformatics Institute A*STAR and Dr Shay Ben-Shachar, Director of Precision Medicine and Genomics at Clalit Research Institute, Israel. It is part of BCP's efforts to support the growth of precision medicine activities in Asia Pacific. "Access to connected, secure data is a key pillar in overall healthcare development. High quality clinical and genomics information is foundational to predictive and preventive clinical care as well as drug development. Today, real-world data generated from Asian countries is not represented well enough and data diversity is key to solving the most pressing research questions. At BC Platforms we recognize that Asian countries continue to remain under-represented in global life science research; so it is important for healthcare systems in the region to collaborate, build highly secure, enabling technologies and ensure local legislation is supportive of real-world data initiatives. It will allow the whole ecosystem to stay in front of the development, and our vision focuses on personalized care models for patients in this region." Mr Tero Silvola, Chief Executive Officer of BC Platforms The company had expanded its R&D operations in Singapore earlier this year and partnered with SingHealth, Singapore's largest public healthcare group. Parties aim to build a series of research projects and by doing so accelerate relevant clinical research with pressing targets on diseases prevalent in the Asian population, including but not limited to cancer and cardiovascular diseases. This highly visible partnership is part of BC Platforms' rapidly growing data partner network for secure and regulatory compliant sharing of real-world data. The BCRQUEST.com global partner network now comprises 33 million patient lives from 37 data partners on five continents. While BC Platforms has been active in Singapore since 2019, it plans to ramp up activities and continue to build its presence in the region as it continues to develop and deploy safe and secure infrastructure for healthcare data. The company is also focusing on partnerships with local and regional healthcare and research institutions to strengthen translational research capabilities in Asia Pacific and improve care outcomes for patients in the region. About BC Platforms BC Platforms is a global leader in providing a powerful data and technology platform for personalised medicine and drug development, accelerating the translation of insights into clinical practice. Our technology drives the infinite loop between personalised care and research discoveries, leveraging latest science, deep technical expertise, strategic partnerships, and harmonized, diverse data collections. Our high performing genomic data discovery and analytics platform enables flexible data integration, secure analysis, and interpretation of molecular and clinical information.

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BUSINESS INSIGHTS

Astellas and Sutro Biopharma Announce Worldwide Strategic Collaboration to Advance Novel Immunostimulatory Antibody-Drug Conjugates (iADCs)

Sutro Biopharma, Inc.; Astellas Pharma Inc. | June 28, 2022

Astellas Pharma Inc. and Sutro Biopharma, Inc. announced a worldwide, strategic collaboration and licensing agreement focused on the discovery and development of novel immunostimulatory antibody-drug conjugates. The collaboration leverages the unique cancer-fighting potential of iADCs as a novel modality, enabled by Sutro’s ability to engineer complex conjugated antibodies, and Astellas’ global oncology R&D expertise. “We are delighted to work with Astellas, a premier biopharmaceutical company with substantial expertise in immuno-oncology, on this novel modality. iADCs hold promise well beyond the existing success of ADCs. Sutro’s unique conjugation technology enables dual conjugations that site-specifically incorporate a potent cytotoxin that can directly kill tumor cells together with an immunostimulatory component that has the potential to locally prime an immune response to the patient’s particular tumor cells. We look forward to collaboratively exploring the potential of this approach to treat cold tumors and bring new drug therapies to patients who do not respond to existing immunotherapies.” William J. Newell, Sutro’s Chief Executive Officer Naoki Okamura, Chief Strategy Officer, at Astellas commented, "Astellas considers Immuno-Oncology as one of the Primary Focuses of its R&D strategy; our goal is to bring effective drugs to patients who do not respond to existing immune checkpoint inhibitors. Sutro is a leading company in the area of iADCs, a new modality, and has its own original iADC technologies. The strategic partnership with Sutro will help us expand our pipeline and widen the choice of cancer immunotherapies.” A key challenge with cancer immunotherapies, including immune checkpoint inhibitors, is the tumor microenvironment*1 within cold tumors creating barriers to immune cell infiltration and thus preventing the cure. The immune checkpoint inhibitors approved to date are efficacious as a monotherapy in only about 20% of cancer types, which vary widely*1. This strategic partnership will engage in the development of iADCs, a next generation modality with the potential for effective and efficient approaches for treatment of cold tumors so as to bring new drug therapies to patients who do not respond to existing therapies. An iADC, which combines an antibody with a small molecule compound that induces immunogenic cell death*2 in addition to an immune activating molecule, has the potential to boost the anti-cancer action. This partnership will enable Astellas and Sutro to mutually leverage strengths in their respective fields to accelerate iADC development for three distinct biological targets; Sutro will engage in research and preclinical studies to identify candidate compounds and then Astellas will pursue clinical development. Sutro has advanced technologies for linking drugs to antibodies and proprietary component parts, including candidate antibodies and linkable cytotoxins and immunostimulatory molecules. For development of iADCs, Astellas will utilize the strength of its global R&D and commercialization capabilities in the area of antibodies and the small molecular components. These iADCs may have the potential to provide new therapeutic options for treatment of cancers for which no broadly effective therapy is currently available. Under the terms of the agreement, Sutro will receive an upfront cash payment of US$90 million to develop iADCs for three biological targets and may be eligible to receive up to US$422.5 million in development, regulatory and commercial milestones for each product candidate, and tiered royalties ranging from low double-digit to mid-teens on worldwide sales of any commercial products that may result from the collaboration, subject to Sutro’s cost and profit sharing option for the United States. Sutro has the option to share in the costs and profits for developing and commercializing product candidates in the United States. If Sutro exercises this option for a particular product candidate, Astellas and Sutro will equally share the costs of such co-development and co-commercialization, with the resulting profits/losses from co-commercialization also shared equally in the United States.

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