The only newsletter at the intersection of biotech, politics, and policy
October 7, 2022
Shionogi shares COVID-19 therapeutics without waiving intellectual property rights. A new report explains biotech's significant contribution to sustainable food production. (695 words, 3 minutes, 28 seconds)
Shionogi shows how to share COVID-19 therapeutics while preserving IP
In the latest example of how biotech firms can retain IP while ensuring essential medicines reach everyone, Shionogi—a Japan-based pharmaceutical company—announced a licensing agreement Tuesday that would make its COVID-19 therapeutic candidate available in low- and middle-income countries (LMICs).
Shionogi’s antiviral candidate ensitrelvir would be produced by qualified generic manufacturers in 117 countries under the agreement with the UN-backed Medicines Patent Pool (MPP), an organization that increases drug access through voluntary licensing. MPP will grant sublicenses to manufacturers in LMICs, and Shionogi will waive royalties for as long as COVID-19 is qualified as a public health emergency by WHO.
Proven in trials: Shionogi last week announced a successful Phase 2/3 clinical trial of ensitrelvir, which demonstrated a statistically significant reduction of five key COVID-19 symptoms and also reduced viral RNA. Japan’s regulator deliberated emergency approval of ensitrelvir on July 20, and review is continuing.
A history of sharing: Shionogi is taking the lead in the battle with “the next pandemic,” antimicrobial resistance (AMR), developing one of the few new drugs for AMR, cefiderocol. Shionogi entered a similar sublicensing agreement to ensure LMICs have access to this vital drug, Bio.News reports.
Why it matters: The WTO is considering waiving global intellectual property (IP) rights for COVID-19 diagnostics and therapeutics, like Shionogi’s ensitrelvir, with the intention of facilitating access for LMICs, but this will not improve access.
Biotech sharing does what waivers can’t: More than 20 major biotech firms have initiated hundreds of IP sharing arrangements with governments and universities to expand availability of COVID-19 treatments, Bio.News reports. Sharing arrangements like the ones Shionogi and others have entered are only possible if drugmakers are confident their IP is protected, as BIO has explained.
More Health Care News:
The Wall Street Journal (Opinion): You Didn’t Invent That Drug “The Biogen drug’s apparent success is mainly the result of sustained private investment in drug research and development over many decades that has resulted in dozens of failures and billions of dollars in investment write-offs. Biogen may finally recoup some of its investment with its new Alzheimer’s drug, if the Biden Administration will let it,” writes the Wall Street Journal Editorial Board.
Biotech-enhanced agriculture improves output sustainably, study shows
Over the last 25 years, genetically modified crops significantly improved farmers’ productivity while reducing their environmental footprint, offering an essential tool for feeding the world sustainably, shows a study released Wednesday.
The key finding: Crop biotechnology enabled an increase in global food, feed, and fiber production of nearly 1 billion tons between 1996-2020, with an environmental footprint decrease of 17.3% thanks to a 748.6 million kilogram reduction in use of crop protection products like insecticides, according to the study from PG Economics.
Greenhouse gas reduction: Because biotech-enhanced crops can be grown more sustainably, for example with less tilling, fossil fuel use declined during 1996-2020, reducing carbon emissions by 39.1 billion kilograms (43 million tons), or the equivalent of removing 25.9 million cars from the roads, the report says.
Financial benefits to farmers included large increases for those in developing countries—$5.22 for each dollar invested in genetically modified seeds during 1996-2020—and a global farm income benefit of $261.3 billion during that period. And making land more productive means less new land needs to be cultivated for agriculture.
Biotech helps to ensure food security sustainably. “Increasing food security involves not only growing more food and improving crop nutrition but also quickly breeding crops to thrive under changing weather patterns,” says an opinion piece in Foreign Policy last month arguing for passage of the UK’s Genetic Technology Bill. The bill would make it easier for researchers to test-grow gene-edited crops.
Regulatory improvements to help unlock the benefits of biotechnology for agriculture are also needed in the United States, and are proposed under the new executive order advancing biotechnology biomanufacturing. BIO outlined specific improvements needed in a recent letter to the administration.
More Agriculture and Environment News:
New York Times: Climate change made summer hotter and drier worldwide, study finds “Human-caused global warming has made severe droughts like the ones this summer in Europe, North America and China at least 20 times as likely to occur as they would have been more than a century ago, scientists said Wednesday. It’s the latest evidence of how climate change caused by the burning of fossil fuels is imperiling food, water and electricity supplies around the world.”
BIO Beltway Report
President Biden’s Friday: Visiting Volvo Group Powertrain Operations in Hagerstown, MD, to promote his administration’s economic achievements in a district with a competitive congressional race.
What’s Happening on Capitol Hill: Recess.
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