First things first about Biontech and Evotec:
- Evotec expands cooperation with Bristol-Myers Squibb
- Biontech’s corona drug in the approval process
The drug researcher Evotec and the pharmaceutical company Bristol-Myers Squibb are expanding their research partnership. As part of the alliance that has existed since 2016 to identify therapeutic options for neurodegenerative diseases, the partners have added a further approach with a view to Alzheimer’s disease in the portfolio, Evotec announced in a press release. In this context, the German company is reported to receive a payment of six million dollars.
According to the company, currently approved drugs only relieve symptoms in the short term and there is a high unmet medical need for therapy options that slow or reverse the progression of neurodegenerative diseases.
“Our joint portfolio is growing in breadth but – more importantly – in depth, as significant progress is being made in most projects,” said Cord Dohrmann, Chief Scientific Officer of Evotec. While target-based approaches repeatedly fail in clinical development, Evotec believes it is delivering a new generation of disease-relevant drug candidates for better defined patient groups.
The corona vaccine candidate developed by the Mainz immunotherapy company Biontech is entering the approval process. The European Medicines Agency EMA will examine the active ingredient BNT162b2 in a so-called rolling review process, announced Biontech and the pharmaceutical company Pfizer in a press release. In this process, data from the clinical trial is continuously submitted and evaluated. This rolling submission process should accelerate the approval of the vaccine.
This makes Biontech the first German company and, with AstraZeneca, the second overall to be approved by the EMA for this process. The EMA’s decision to begin the process is based on encouraging preliminary data from both preclinical and early clinical trials in adults. The formal application for marketing authorization could be finalized following the ongoing review.
According to the press release, the vaccine candidate will continue to be subject to the strict quality, safety and effectiveness standards of the EMA. “As we work to develop a potential vaccine at an unprecedented rate to end this pandemic, it is our duty to ensure that we do so with the highest ethical standards and in accordance with sound scientific principles” said Ugur Sahin, co-founder of Biontech, according to the announcement.
According to the company, the vaccine candidate is currently being investigated in an ongoing global phase 2/3 study. The study includes more than 120 study centers worldwide, including in the USA, Brazil, South Africa and Argentina. To date, the study has enrolled about 37,000 participants, of whom more than 28,000 received their second vaccination.
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