Coronavirus Vaccine: Johnson & Johnson Pledges 100M Doses to U.S. For $10 Each

Johnson & Johnson | August 06, 2020

With leading COVID-19 vaccines in late-stage testing, companies have been inking supply deals with the U.S. government for a quick rollout if their programs succeed. Now, Johnson & Johnson is getting into the act. The pharma giant struck a deal to supply 100 million doses of its candidate, Ad26.COV2.S, if the shot is cleared for use by the FDA. The U.S. government is committing just over $1 billion under the agreement for a price per dose of about $10.  That compares with a lower price-per-dose of $4 for AstraZeneca and a higher figure of $19.50 for Pfizer and BioNTech under agreements between those drugmakers and the U.S. government. J&J and AZ have pledged to provide their vaccines under a not-for-profit basis during the pandemic. Under the new J&J deal, which stipulates manufacturing in the U.S., the feds could later buy another 200 million doses under a separate agreement. The company previously won $456 million in funding to support its R&D and manufacturing scale-up, according to a government database.

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Spotlight

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PHARMA TECH

Nucleai Announces a Partnership with Sirona Dx for AI-Driven Discovery of Novel Spatial Biomarkers in Solid Tumors

Nucleai and Sirona Dx | July 14, 2022

Nucleai, a leader in AI-powered spatial biology transforming precision medicine by unlocking the power of pathology data, and Sirona Dx, a leading provider of multiomic single-cell analytical services, today announced a collaboration to advance the discovery of novel spatial biomarkers in solid tumors. The partnership combines Nucleai’s powerful AI spatial analytics platform with Sirona Dx’s leading multiplex assay development expertise to identify novel spatial signatures in high-plex assays that predict response to therapy and inform treatment decisions. Through this strategic collaboration, Sirona Dx will provide Nucleai and its customers with a CRO partner that will enable the deployment of AI-based diagnostic algorithms to support biopharma clinical trials. Nucleai’s robust computational AI-powered spatial biology algorithm supports various image modalities and cancer indications, offering a highly customizable, deployable solution across the drug development ecosystem. These capabilities earned Nucleai the position of one of the top 10 spatial biology companies in 2022. “Multiplex imaging technologies have improved rapidly over the years; however, identifying actionable insights from all the data collected remains immensely challenging. This powerful synergy between Sirona Dx and Nucleai is very exciting as it will allow us to identify actionable spatial signatures that can predict response to immunotherapy.” Avi Veidman, Co-Founder & Chief Executive Officer of Nucleai Sirona Dx is recognized as the original pioneers of spatial biology, having launched the first spatial-omics CRO service to biopharma in 2018. Today, their technology-agnostic, spatial biology suite includes the leading multiplexed imaging platforms and combines deep technical expertise required to develop high-performance multiplexed assays as large as 50 markers. Sophisticated multiplexed tissue imaging capabilities contributed to their selection as a Top 10 CRO of 2021 by Medhealth Outlook. “We are delighted to announce a partnership with Nucleai,” said Andrew Brown, Ph.D. Chief Commercial Officer at Sirona Dx. “Nucleai’s AI-driven analytical capabilities are exceptional. Our combined expertise in multiplexed tissue assay development, data generation and state-of-the-art analysis will unlock new spatial insights and accelerate the spatial biology revolution in precision medicine.” About Nucleai Nucleai is an AI-powered spatial biology company with a mission to transform drug development and clinical treatment decisions by unlocking the power of pathology data. Nucleai provides pharmaceutical companies, contract research organizations, and diagnostics laboratories with a state-of-the-art AI platform to improve clinical trials and clinical decision-making. About Sirona Dx Sirona Dx is a technical, CLIA accredited CRO, founded in 2016 to accelerate the pace of immunotherapy and targeted therapy development. With a leading-edge menu of specialized high complexity, single-cell proteomics and genomics services, Sirona Dx supports exploratory biomarker programs and advanced precision medicine initiatives to deliver safer and more effective treatment solutions.

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BUSINESS INSIGHTS

Amylyx Pharmaceuticals Announces ALBRIOZA™ is Now Available in Canada for the Treatment of ALS

Amylyx Pharmaceuticals, Inc | August 01, 2022

Amylyx Pharmaceuticals, Inc. announced that ALBRIOZA™ is now commercially available in Canada for people living with amyotrophic lateral sclerosis. ALBRIOZA is an oral fixed-dose combination therapy that may reduce neuronal cell death as a stand-alone therapy or when added to existing treatments. In a clinical trial, ALBRIOZA significantly slowed disease progression and loss of functional decline in people living with ALS. “We have remained steadfast in our commitment to ensure ALBRIOZA would be available in Canada as quickly as possible following Health Canada’s decision to approve ALBRIOZA, with conditions, in June,” said Margaret Olinger, Chief Commercial Officer at Amylyx. “We are pleased that starting this week, we are ready to fill prescriptions for ALBRIOZA.” Amylyx filed reimbursement submissions to the Canadian Agency for Drugs and Technologies and Institut national d’excellence en santé et en services sociaux in Quebec as part of an aligned Health Technology Assessments (HTA) review with Health Canada in parallel with the regulatory process to reduce the timelines required for patient access. The Company is continuing to work with the pan-Canadian Pharmaceutical Alliance, Federal, Provincial, and Territorial public drug plans, and private insurers to expeditiously achieve listing and reimbursement, so that eligible Canadians living with ALS can have access to ALBRIOZA as quickly and efficiently as possible. “In Canada, prescription drugs undergo a thorough and often long review and approval process across regulatory, HTA, pricing negotiations, and formulary listing with public drug plans. In addition, private insurers have their own review and listing processes. We continue to work diligently to navigate reimbursement processes to pursue broad and equitable access to ALBRIOZA across all provinces in Canada.” Chris Aiello, General Manager and Head of Canada at Amylyx “Market availability is an important milestone in the available treatment options for people living with ALS,” said Tammy Moore, CEO of the ALS Society of Canada. “As we look forward, we do not want to see coverage decisions become a barrier to access, and we urge the decision-makers throughout the drug access and reimbursement process to work expeditiously to provide equitable access for all eligible Canadians living with ALS who are in desperate need.” As part of Amylyx’ continued commitment to the ALS community, through the Amylyx Care Team Support Program, Amylyx provides insurance navigation, treatment coordination and educational support for people living with ALS who have been prescribed ALBRIOZA in Canada and their caregivers. Eligibility and enrollment into the ACT Support Program can be discussed with prescribing health care professionals. About ALBRIOZA™ ALBRIOZA™ is an oral fixed-dose medication approved with conditions to treat amyotrophic lateral sclerosis (ALS) in Canada and with marketing applications pending in the United States and European Union. The combination of sodium phenylbutyrate and taurursodiol may reduce neuronal cell death, hypothesized to occur by simultaneously mitigating endoplasmic reticulum stress and mitochondrial dysfunction. ALBRIOZA is also being explored for the potential treatment of other neurodegenerative diseases. About Amylyx Pharmaceuticals Amylyx Pharmaceuticals, Inc. is committed to supporting and creating more moments for the neurodegenerative community through the discovery and development of innovative new treatments. Amylyx is headquartered in Cambridge, Massachusetts and has operations in Canada and EMEA.

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BUSINESS INSIGHTS

Sanofi Global Health launches nonprofit Impact® brand for 30 medicines in low-income countries

Sanofi | July 05, 2022

Sanofi Global Health announces the launch of Impact®, a new brand of standard of care medicines produced by Sanofi dedicated for nonprofit distribution to at-risk populations in the world’s most impoverished countries. The Impact® brand, which includes insulin, glibenclamide and oxaliplatin amonst others, will enable the secure distribution of 30 Sanofi medicines in 40 lower-income countries. Considered essential by the World Health Organization, the medicines cover a wide range of therapeutic areas, including diabetes, cardiovascular disease, tuberculosis, malaria and cancer. The launch of the Impact® brand is among the steps taken since the formation last year of Sanofi Global Health, a nonprofit unit within the company aiming to increase access to healthcare through the distribution of medicines, and the building and bolstering of local healthcare systems in countries with among the lowest per capita GDP. Sanofi Global Health is the first and only global initiative to provide access to such a broad portfolio of medicines in so many countries and across multiple therapeutic areas while funding local support programs and strengthening local inclusive businesses. “At Sanofi, we believe we have a responsibility to make a difference for the health of those most in need, and we know we have the ability and the ambition to bring about lasting change. With critical medicines, relentless drive and impactful partnerships, we can take our innovation beyond the lab and use it to strengthen health systems and access to medicines for those most vulnerable communities of patients. Sanofi Global Health aims to improve the lives of millions of people who now cannot get the help they need. Sanofi’s renewed purpose is to chase the miracles of science to improve people’s lives. And our quest to make life better for all people must include helping to provide better access to care and quality medicines for underserved populations.” Paul Hudson Chief Executive Officer, Sanofi The company also announces the establishment of an Impact fund that will support startup companies and other innovators that can deliver scalable solutions for sustainable healthcare in underserved regions. By providing inclusive businesses financing and technical assistance, the fund will complement the GHU mission of leveraging global, regional and local investment to support the training of healthcare professionals and aiding communities in running sustainable care systems. The announcements come as Sanofi gathers key global health stakeholders to discuss how to build effective end-to-end health programs that are embedded in the communities in which they serve, to best reach, treat and manage patients’ health effectively and sustainably. About Sanofi We are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve people’s lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions.

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