USA — Novotech, a contract research organization CRO biotech based in Asia Pacific, has acquired CBR International, a global product development, clinical oversight, and strategic regulatory operations group, in order to expand drug development and FDA regulatory expertise.
CBR was founded in 2002 as a consultancy company focused on assisting biotechnology and pharma companies navigate FDA requirements from early-stage development through to approval.
CBR adds a group of experts to Novotech to provide US and global regulatory, scientific, quality, and clinical development services.
As a result of the acquisition, CBR International will be now known as Novotech Drug Development Consulting.
CBR’s operations will include full-service product development, clinical oversight, and strategic regulatory operations providing comprehensive “lab to launch” program development services.
CBR’s specific regulatory expertise and services include long-range Regulatory Strategy and Writing, FDA Representation, eSubmissions, and Scientific Affairs to support requirements for cGMP commercial product development.
The acquisition will further strengthen Novotech’s capabilities in regulatory strategy and US FDA interactions and submissions including investigational new drug (IND), investigational device exemption IDE, New Drug Application (NDA), Biologics License Application (BLA), Fast-Track, Break-through, and Orphan Drug Applications.
Meanwhile, Novotech, has acquired EastHORN, a European CRO with clinical, medical, and regulatory expertise in a number of strategically important locations across the continent.
The acquisition of EastHORN gives Novotech a foothold in the European market, allowing Novotech’s clients to access markets on that continent for broader drug development.
The financial details of the two acquisitions were not disclosed, but all employees will now work for Novotech. For the time being, EastHORN will be known as a “Novotech company.”
Novotech’s push beyond the Asia-Pacific region began last year, when the CRO acquired Charleston-based NCGS in May to broaden its global client offerings.
Drug research has attracted private equity firms that deemed drug development too risky for their liking in the past and they are increasingly investing in the sector, raising dedicated funds, and coming up with deals that compensate them for the uncertainty involved, Reuters reports.
Annual spending on pharmaceutical research and development globally is projected to rise to US$254 billion by 2026 from around US$200 billion in 2020, according to Evaluate Pharma, a research firm focused on healthcare.
Blackstone Inc has led the charge, with ten investments from a US$4.6 billion dedicated life sciences fund launched in 2020.
Among Blackstone’s investments are a 300 million-euro (US$320 million) commitment to the development of Sanofi SA’s immunotherapy drug Sarclisa, and a US$150 million investment in the advancement of Autolus Therapeutics Plc’s cancer treatment pipeline.
The portfolio of investments also includes a US$1.15 billion check to support Alnylam Pharmaceuticals Inc’s drugs for tackling cholesterol.
Some of these deals included investments in the drug developers’ stock as well as loans to them.
Other private equity firms racing to get a piece of the action include Apollo Global Management Inc which last year acquired a minority stake in life sciences investment firm Sofinnova Partners and committed up to 1 billion euros (US$1.08 billion) in its funds, and EQT AB, which acquired Life Sciences Partners, a life sciences-focused venture capital firm, in 2021.
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