- Hitachi Chemical has agreed to buy Apceth Biopharma, a German cell and gene therapy manufacturer, for roughly $86 million, according to a regulatory filing submitted Thursday.
- Hitachi Chemical Regenerative Business Sector currently has facilities in the U.S. and Japan. Through this acquisition, the company will grow its cell therapy manufacturing presence into Germany by picking up Apceth's two plants located in Munich.
- The transaction is expected to close in April.
One of Apceth's most notable partners is Bluebird bio. The two entered a commercial drug product manufacturing deal for Europe in 2016. The partnership focused on making Lenti-D and LentiGlobin, the biotech's two most advanced gene therapy programs.
Hitachi's acquisition of Apceth is yet another demonstration of growing expectations around cell and gene therapy research. Earlier this month, for instance, two top officials from the Food and Drug Administration outlined coming regulatory actions and plans to keep pace with the accelerating field.
Manufacturing was acknowledged as a particular problem, with the FDA leaders calling it a "critical challenge" to develop these products in a "safe, reliable and cost-effective way." The agency stated it plans to release additional guidance documents specifically on manufacturing hurdles for cell and gene therapies.
Outside of this agreement, Hitachi was already expanding its manufacturing capabilities. In addition to plants in Allendale, New Jersey, Mountain View, California and Yokohoma, Japan, the company plans to open a second facility in Allendale in the second quarter of 2019.
In a statement, Robert Preti, CEO of Hitachi Chemical Advanced Therapeutic Solutions, highlighted the importance of the geographic expansion into Europe, which it claims is the second largest market for cell and gene therapies behind the U.S.
Apceth is a private CDMO founded in 2007. Hitachi Chemical, founded in 1981, manufactures various medical products.
In 2017, the Japanese company bought out a remaining 80% ownership interest in PCT for $75 million. Hitachi then renamed PCT Hitachi Chemical Advanced Therapeutic Solutions and dubbed its global service platform PCT.
Correction: Robert Preti is CEO of Hitachi Chemical Advanced Therapeutic Solutions. A previous version of this article misidentified his role. Additionally, Hitachi Chemical, rather than Hitachi Chemical Advanced Therapeutics Solutions, entered into an agreement to buy Apceth.