German headquartered Bayer conmfirmed the acquisition of Asklepios BioPharmaceutical, a US-based biopharmaceutical company specialized in the research, development and manufacturing of gene therapies across different therapeutic areas.

Asklepios’s development portfolio includes investigational pre-clinical and clinical stage candidates for the treatment of neuromuscular, central nervous system, cardiovascular and metabolic diseases.

Following the aquisition, Bayer own full rights to Asklepios’ gene therapy platform, including a broad intellectual property portfolio and an established contract development and manufacturing organization (CDMO) laying the foundation for future partnerships in the area of adeno-associated virus (AAV) therapies. The addition of Asklepios to Bayer’s emerging cell and gene therapy (CGT) business strengthens Bayer’s commitment to the field. The aquisition complements the acquisition of BlueRock Therapeutics in 2019 and consolidates Bayer’s ambition to create platforms with the potential to have an impact in multiple therapeutic areas.

Under the terms of the agreement, Bayer will pays an upfront consideration of US $ 2 billion and potential success-based milestone payments of up to US $ 2 billion. Bayer expects that 75% of the potential success-based milestone payments are to be due during the course of the next five years and the remaining amount late thereafter.

“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 (CEO) of Bayer.

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“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,” Baumann added.

“As part of our strategy, we are building new therapeutic platforms including cell and gene therapies,” said Stefan Oelrich, Member of the Board of Management, Bayer and President of the Bayer’s Pharmaceuticals Division.

“As an emerging leader in the rapidly advancing field of gene therapies, the expertise and portfolio of AskBio supports us in establishing highly innovative treatment options for patients and further strengthens our portfolio. We want to help patients whose medical needs are not yet met by today’s treatment options and we are looking forward to work together with the team at Asklepios.” Oelrich said.

“Our innovation in capsid re-engineering and promoter design, coupled with our scaled manufacturing processes, gives us the tools to provide gene therapy solutions to more people suffering from a wider spectrum of disease that is not being adequately treated today,” said Dr. Richard Jude Samulski, Chief Scientific Officer and Co-Founder of Asklepios.

“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 Asklepios.

Industry-leading gene therapy
Through the acquisition, Bayer will add an industry-leading adeno-associated virus (AAV)-based gene therapy platform to its portfolio, which has already demonstrated applicability across different therapeutic areas. Besides multiple clinical-stage assets for indications with high unmet need, the acquisition includes a state-of-the-art gene therapy technology platform as well as existing gene therapy manufacturing platform.

Gene therapy offers new treatment options for many currently untreatable diseases, particularly genetic diseases caused by a single genetic defect.

Asklepios’s gene therapy platform includes an industry-leading cell line manufacturing process and an extensive AAV capsid and promoter library. The company has generated hundreds of proprietary third generation AAV capsids and promoters that offer differentiation through potentially improved efficacy, immune response and tissue and organ specificity.

The platform represents one of the most advanced gene therapy platforms with the promise to also tackle polygenetic indications thereby also helping a larger number of patients. AskBio’s lead research programs, which are focused on Pompe disease, Parkinson’s disease and congestive heart failure are currently in early phases of clinical development.

Independent division
To preserve its entrepreneurial culture as an essential pillar for nurturing successful innovation, Asklepios will continue to operate as an independent company on an arm’s-length basis. Bayer’s newly established CGT unit will bundle Bayer’s activities in this area moving forward in order to establish an innovation ecosystem for the participating partners within the Bayer organization.

Featured image: AskBio Bioreactor. Photo courtesy: © 2019 -2020 Bayer AG. used with permission.

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