Gaining clinical and commercial manufacturing capabilities through the acquisition of Audentes will reduce reliance on third-party manufacturers in the gene therapy space, Astellas says.

Japan’s Astellas increased its presence in the gene therapy space yesterday by announcing plans to buy San Francisco-based Audentes Therapeutics for approximately $3 billion (€2.7 billion) in cash.

The deal, expected to close in the first quarter 2020, will add Audentes’ lead candidate AT132 – a Phase I/II clinical-stage experimental treatment for X-linked myotubular myopathy (XLMTM) – to Astellas’ portfolio but importantly will boost the firm’s production capabilities.

Image: iStock/SB

“As a result of this acquisition, Astellas will obtain not only Audentes’ programs but also its proprietary manufacturing know-how in the gene therapy area,” Astellas management said on a call discussing the deal. “We believe that this will provide us with the foundation for Astellas to gain a competitive advantage in the gene therapy business.”

Astellas has a foot in the gene therapy space, having acquired UK-based preclinical biotech Quethera in August 2018, and has several next-generation vaccines in development. However, until this acquisition, the firm has never had its own adeno-associated virus (AAV) production capabilities.

“An internal manufacturing capability is a great strength for companies with multiple programs under development,” management said. “If you are dependent on a CMO [contract manufacturing organization] then you will lose agility, or you will lose the flexibility because you will not be able to manufacture whatever is necessary at the necessary timing in a flexible manner.”

This, management added, will reduce the risk as both Astellas’s and Audentes’ candidates move through the clinic towards commercialization in the next few years.

“As we anticipate increasing manufacturing demand, acquiring Audentes’ manufacturing capabilities along with its programs is a big step forward for us.”

Capabilities

Audentes has an AAV manufacturing plant in San Francisco, designed and commissioned as a multi-product facility. The plant includes a GMP suite with two 500-liter bioreactors for use with the company’s serum-free suspension cell culture-based production system.

Audentes had also laid plans to expand the site to add an additional 8,000 liters of production capacity.

Astellas also gains a GMP plasmid manufacturing facility in South San Francisco in the deal. The facility, which began production in April this year, makes nonclinical and cGMP-grade plasmids for inhouse development programs.

“The addition of an internal plasmid manufacturing operation should further improve control over our supply chain, reduce costs, and significantly decrease the time it takes to advance our programs from discovery through to clinical development, and ultimately commercialization,” Audentes said at the time.