Astellas dives into gene therapy with $3-billion deal to buy Audentes Therapeutics

Astellas entered into a definitive agreement to acquire Audentes Therapeutics for $60 per share in cash, representing a total equity value of approximately $3 billion, the companies announced Tuesday. Kenji Yasukawa, CEO of the Japanese drugmaker, said that through the deal, which is expected to close in the first quarter of 2020, "we are establishing a leading position in the field of gene therapy."

Yasukawa remarked "Audentes has developed a robust pipeline of promising product candidates which are complementary to our existing pipeline, including its lead programme AT132 for the treatment of X-linked myotubular myopathy." Astellas noted that along with its four main areas of focus, it will now add a fifth covering genetic regulation through the acquisition of Audentes, with gene therapy set to "be a key driver" of the company's future growth.

AT132 is currently being investigated in the Phase I/II ASPIRO study, with Astellas suggesting that marketing applications for the therapy could be filed in mid-2020 in the US and the second half of next year in Europe. Audentes, which listed via an initial public offering in 2016, also has a number of other programmes in preclinical development, including for the treatment of Pompe disease, Duchenne muscular dystrophy and myotonic dystrophy.

Astellas noted that Audentes will operate as an independent subsidiary, with access to the global scientific and development resources of the wider company. Naoki Okamura, chief financial officer at Astellas, said that along with Audentes' adeno-associated virus gene therapy technology platform, the Japanese drugmaker also gains "proprietary manufacturing knowhow in gene therapy," adding "internal manufacturing capability is a great strength for companies with multiple programmes under development."

The transaction, which has been unanimously approved by the boards of directors both drugmakers, represents a premium of 110% to Audentes' closing share price on December 2. Jefferies analysts Stephen Barker and Naoya Miura noted that the premium is in line with recent trends, adding that while AT132 looks promising, "the real significance of this deal is what it represents in terms of Astellas' commitment to gene therapy."

Meanwhile, Citi analyst Hidemaru Yamaguchi suggested the purchase looked expensive, but was nevertheless a positive move for Astellas as Audentes had "cutting-edge gene therapy modalities." Yamaguchi remarked "we thought it was only a matter of time before Astellas entered the gene therapy market," having signed a deal last year for the gene therapy programme GT0001X for the treatment of sporadic amyotrophic lateral sclerosis.

There have recently been a number of deals in the gene therapy field, including Novartis' $8.7-billion purchase of AveXis, while Roche is still working to complete its $4.3-billion acquisition of Spark Therapeutics amid antitrust concerns in the US and UK. For further analysis, see Spotlight On: Gene Therapy buying spree continues despite long-term questions about pricing.

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