Kyowa Kirin, a Japan-based global speciality pharmaceutical company, has announced the successful completion of its acquisition of Orchard Therapeutics, a developer of hematopoietic stem cell gene therapies, for an equity value of $477.6m (Y70.47bn).

Orchard becomes a fully owned Kyowa Kirin subsidiary.

The integration of Orchard into Kyowa Kirin’s operations will enhance the company’s focus on addressing the unmet medical needs of individuals with genetic and other severe diseases.

Orchard’s portfolio includes Libmeldy (atidarsagene autotemcel), a gene therapy approved in the EU and UK for early-onset MLD, a rare disease.

Libmeldy, also called OTL-200 in the US, is under priority review by the US Food and Drug Administration. A decision on its approval is anticipated on 18 March 2024, under the Prescription Drug User Fee Act.

Orchard is also advancing two other clinical-stage programmes using its hematopoietic stem cell gene therapy platform: OTL-203 for mucopolysaccharidosis type I Hurler’s syndrome and OTL-201 for mucopolysaccharidosis type IIIA.

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The acquisition will enrich Kyowa Kirin’s portfolio, supporting the development of therapeutic candidates and facilitating the ongoing and future launches of Libmeldy in early-onset MLD.

Orchard co-founder and CEO Bobby Gaspar will join Kyowa Kirin’s senior research and development leadership team, reporting to president and CEO Masashi Miyamoto.

Orchard’s employees will continue their work from the company’s existing locations in London, UK, and Boston, US.

Miyamoto said: “We are truly excited about the acquisition of Orchard Therapeutics, a leading provider of HSC gene therapy.

“This platform offers significant potential to deliver more innovative treatments and breakthrough therapies and aligns with our purpose to deliver life-changing value for people living with rare and complex diseases.

“Going forward, our companies will build on the extensive experience of Orchard’s gene therapy platform and apply it to under-served indications and diseases where we believe it to be scientifically and clinically differentiated.”

In January 2024, Kyowa Kirin and Boehringer Ingelheim entered a licensing agreement to develop a new treatment for fibro-inflammatory diseases.  

Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva.

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