News & numbers “There is growing evidence that Covid-19 will continue to pose a public health
challenge for years.” Ugur Sahin, CEO and co-founder, BioNTech
Disappointment for CureVac, positive results for Novavax
A late-stage trial of CureVac’s first- generation Covid-19 vaccine candidate has disappointed, with CVnCoV demonstrating an interim vaccine efficacy of just 47% against Covid-19 of any severity. Notably, the study identified at least 13 variants circulating within the study population. Meanwhile, Novavax has announced that NVX-CoV2373, its recombinant nanoparticle protein-based Covid-19 vaccine, demonstrated 100% protection against moderate and severe disease, 90.4% efficacy overall, and met the primary end point in its PREVENT-19 pivotal phase-III trial. The company intends to file for regulatory authorisations in the third quarter. There has been further good news from Novavax.
The company also announced its data from the first co-administration study of a SARS-CoV-2 vaccine candidate and an approved influenza vaccine. The findings from the study suggest that a simultaneous vaccination may be a viable immunisation strategy. In addition, the protection afforded by the candidate vaccine was consistent with the main study at 87.5% and 89.8% respectively.
The total cumulative spending on Covid-19 vaccines through 2025.
$157bn IQVIA Institute for Human Data Science Controversial Aduhelm approval
The US FDA has approved Biogen’s Aduhelm (Aducanumab) for the treatment of Alzheimer’s. The agency noted that Aduhelm represents a first-of-its-kind treatment approved for Alzheimer’s disease. It is the first new treatment approved for Alzheimer’s since 2003 and is the first therapy that targets the fundamental pathophysiology of the disease. The news came despite an FDA advisory committee voting against approval of the drug in November 2020. Indeed, Reuters and the New York Times reported the resignations of three of the 11 members of the agency’s independent advisory panel.
Despite uncertainty over its effectiveness, Aduhelm may become one of the top-selling drugs in US history, with peak annual sales of up to $50bn being estimated. However, pricing is once again under the spotlight; ICER’s preliminary draft report calculated a fair annual price to lie between $2,500–8,300,
6
whereas Biogen has announced a list price of $56,000 per year. Aduhelm was approved using the accelerated approval pathway. Under the accelerated approval provisions, the FDA is requiring the company, Biogen, to conduct a new randomised, controlled clinical trial to verify the drug’s clinical benefit. If the trial fails to verify clinical benefit, the FDA may initiate proceedings to withdraw its approval. Notably, there is a potential competitor on the horizon. Eli Lilly intends to submit a biologics licence application (BLA) for Donanemab under the accelerated approval pathway in late 2021, based on data from its phase-II trial, TRAILBLAZER-ALZ.
$56,000
List price announced for Biogen's Aduhelm. Biogen
Inclusion of patients with
incurable cancers The US FDA has issued a draft guidance encouraging the industry to include patients with incurable cancers in cancer clinical trials, regardless of whether they have received existing alternative treatment options. Historically, many clinical trials have required that participating patients previously received multiple therapies. This draft guidance is part of the FDA’s broader initiative to encourage rational expanded patient eligibility for oncology clinical trials.
CGT Catapult
forms consortium Amid growing investment in the sector, a consortium of over 20 organisations has been formed by the Cell and Gene Therapy Catapult, comprising of pharmaceutical companies, technology providers, therapy developers and charities, with the aim to accelerate technology development and potentially lower cost in cell and gene therapy manufacturing. The consortium will assess the application and combination of multiple technologies for process analytics within the cell and gene therapy industry.
Multi-billion dollar acquisitions
In April 2021, Thermo Fisher Scientifi c announced its intent to acquire PPD, a leading global clinical research organisation, for $17.4bn. PPD will become part of Thermo Fisher's Laboratory Products and Services segment once the transaction is completed, expected by the end of 2021. Meanwhile, Danaher has entered into a defi nitive agreement to acquire privately held Aldevron, for a cash purchase price of approximately $9.6bn. Aldevron manufactures high-quality plasmid DNA, mRNA and proteins, serving biotechnology and pharmaceutical customers. Aldevron will operate as a stand-alone operating company and brand within Danaher's Life Sciences segment.
Clinical Trials Insight /
www.worldpharmaceuticals.net
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