Pharmaceutical Technology Editors

Bayer announced on Oct. 26, 2020 that it will acquire Asklepios BioPharmaceutical (AskBio), a Research Triangle Park, NC-based biopharmaceutical company focused on the manufacturing of gene therapies, for up to $4 billion.

Under the terms of the acquisition, Bayer will pay $2 billion upfront and will provide up to $2 billion more in success-based milestone payments, a Bayer press release said.

Bayer will now own the rights to AskBio’s adeno-associated virus (AAV)-based gene therapy platform, its intellectual property portfolio, and an established contract development and manufacturing organization, the press release said. Additionally, Bayer will acquire AskBio’s gene therapy technology platform and its existing gene therapy manufacturing platform through the agreement.

“In line with our purpose ‘science for a better life’, we are committed to bringing significant improvements for patients through innovation,” said Werner Baumann, chairman of the board of management and CEO of Bayer, in the press release. “With this acquisition, Bayer significantly advances the establishment of a cell and gene therapy platform that can be at the forefront of breakthrough science, contributing to preventing or even curing diseases caused by gene defects and further driving company growth in the future.”

“With Bayer‘s worldwide reach and translational expertise, especially in pathway diseases, our combined cultures of scientific advancement and commitment to patients, along with the retention of AskBio’s independent structure, Bayer and AskBio are positioned to provide accelerated development of gene therapies to treat more patients who can benefit from them,” said Sheila Mikhail, CEO and co-founder of AskBio, in the press release.

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Bayer will own the rights to AskBio’s AAV-based gene therapy platform, its intellectual property portfolio, and an established CDMO.

Bayer to Acquire AskBio for up to $4 Billion

FDA announced on Oct. 22, 2020 the approval of Gilead’s antiviral drug Veklury (remdesivir) as the first treatment for patients with COVID-19 that require hospitalization. The approval was designated for adult and pediatric patients 12 years of age and older, weighing at least 40 kilograms (88 pounds) and must be administered in a hospital or in a healthcare setting that provides acute care comparable to inpatient hospital care.

The agency also issued a new Emergency Use Authorization for Veklury for hospitalized pediatric patients under 12 years of age weighing at least 3.5 kg or hospitalized pediatric patients weighing 3.5 kg to less than 40 kg with suspected or laboratory confirmed COVID-19 for whom use of an intravenous agent is clinically appropriate. Clinical trials to assess the safety and efficacy for the pediatric patient group are ongoing.

In announcing the approval, FDA noted that the decision was based on analysis of three randomized, controlled clinical trials that included patients hospitalized with mild-to-severe COVID-19.

In one study, the median time to recovery from COVID-19 was 10 days for the Veklury group compared to 15 days for the placebo group. The odds of clinical improvement at Day 15 were also statistically significantly higher in the Veklury group when compared to the placebo group, FDA reported.

A second trial showed the odds of a subject’s COVID-19 symptoms improving were statistically significantly higher at day 11 for a five-day Veklury treatment group when compared to those receiving only standard of care. For patients in a 10-day treatment group, odds of symptom improvement when compared to those receiving only standard of care were numerically favorable, but not statistically significantly different, FDA reported.

A third trial of hospitalized adults with severe COVID-19 compared treatment with Veklury for five days and treatment with Veklury for 10 days, with clinical status evaluated on day 14. The study found the odds of a subject’s symptoms improving were similar for those in the five-day Veklury group as those in the 10-day Veklury group; there were no statistically significant differences in recovery rates or mortality rates between the two groups, FDA reported.

FDA granted Veklury Fast Track and Priority Review designations and a Material Threat Medical Countermeasure Priority Review Voucher.

Gilead’s antiviral drug Veklury is the first approved treatment in the US for COVID-19.

FDA Approves Remdesivir for Hospitalized Patients

The third part of the CPhI annual report, which was released during the Festival of Pharma virtual event, has predicted a significant amount of pressure will be placed on bioprocessing networks should COVID-19 biologics gain approval.

According to an Oct. 19, 2020 press release, Dawn M. Ecker, managing director of bioTRAK Database Services at BDO, provided her expertise in the report and specified that although short-term capacity issues for biologics have been eased, there may be challenges encountered beyond 2024. Primarily, future commercial capacity may be impacted by the progress of Alzheimer’s drugs, PDL/PDL-1 checkpoint inhibitors, and COVID-19 therapeutics currently in late stage development.

“Should indications, such as treatments for Alzheimer’s disease or broad cancers obtain regulatory approval, a significant increase in demand for manufacturing capacity could occur, potentially leading to a serious capacity shortage,” Ecker said in the press release. “We also face an additional challenge of incorporating demand for recombinant proteins to combat COVID-19. We conservatively estimate that the demand for these products could require approximately 30 metric tonnes per year—so this potential demand will add significant pressure to manufacturing networks with large-scale capacity.”

In the report, Ecker has highlighted that the global capacity for biomanufacturing is expected to increase to 6500 kL by 2024, yet the demand for capacity will increase at a faster compound annual growth rate of approximately 12% by 2024. Additionally, in her analysis of manufacturing trends, Ecker reports that capacity is moving from big pharma to contract manufacturing organizations and hybrids.

“Over the last five years there has been modest capacity growth in North America and Europe, with significantly greater growth in Asia. The next few years, however, will see significant growth rates projected in both Asia (~7%) and Europe (~12%), and by 2024 Europe will have equivalent capacity to the US for the first time,” added Ecker, in the press release. “Looking deeper at the country level, particularly Korea, Singapore, and Ireland, we see that growth here reflects government incentives and tax advantages, amongst other factors.”

The third part of the CPhI annual report has predicted a significant amount of pressure will be placed on bioprocessing networks should COVID-19 biologics gain approval.

Biomanufacturing Capacity Facing Huge Pressure, Notes CPhI Annual Report

California-based JSR Life Sciences has increased its European footprint with a new expanded facility in Geneva, Switzerland, that will combine the company’s two affiliates, KBI Biopharma and Selexis SA, in one campus. The expansion was announced in an Oct. 20, 2020 press release.

The Stellar 32 campus will provide 8700 m

 of space for the affiliate companies to co-locate and will provide the opportunity for European customers of JSR Life Sciences to receive current good manufacturing practice (CGMP) biologics bulk drug substance manufacturing and highly specialized mammalian cell line development services. It is anticipated that the new campus will create more than 250 new highly technical jobs.

“JSR Life Sciences is proud to have best-in-class companies focused on translating customers’ ideas into novel biologics that are improving patients’ lives worldwide,” said Tim Lowery, president of JSR Life Sciences, in the press release. “This strategic investment in our European operations creates new options by linking the core strengths of our affiliates, increases efficiencies, and ultimately accelerates our customers’ ability to bring innovative life science products into the marketplace. In addition, KBI and Selexis will benefit from the extensive biopharma industrial base, advanced technical resources, and specialized education offerings in this region.”

Part of the expansion will comprise a 5600 m

 biologic bulk drug substance manufacturing facility for KBI Biopharma, which is expected to be operational by mid-2022. Through this facility, KBI Biopharma will be able to supply customers with CGMP bulk drug substance for clinical trials. Selexis’ expanded footprint will include new standard cell line development suites and two separate cell culture suites to accommodate quarantined client-specific cell lines or client-dedicated cell line spaces, which are expected to be operational by mid-2021.

“This expansion is a cornerstone of our European growth strategy, which builds on Selexis’ innovative cell line technologies and KBI’s strong expertise in biologics manufacturing to meet the needs of our clients’ clinical trial requirements. The new facility allows us to increase engagement with a broader client base with whom we can partner more effectively due to our local presence,” added Dirk Lange, president and CEO of KBI Biopharma and CEO of Selexis SA, in the press release. “As science progresses, research and treatments become increasingly complex and sophisticated, and we are fully prepared to keep pace with our clients’ needs by providing the latest life science discovery and development technology. Furthermore, by co-locating these operations, the synergies for rapid cell line and process development and introduction to manufacturing will be tremendous, which we see as a true advantage for our client base.”

JSR Life Sciences has increased its European footprint with a new expanded facility in Switzerland, that will combine the company’s two affiliates in one campus.

Author | Pharmaceutical Technology Editors

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