The Japan-based pharmaceutical company Kyowa Kirin has entered into a definitive agreement to acquire Orchard Therapeutics to bolster its gene therapy pipeline.

Gene therapies are a growing area of interest, with multiple gene therapies gaining approval from the US Food and Drug Administration (FDA) in recent years. In recent months, multiple companies have entered the gene therapy market by acquiring or merging with specialist companies and pipelines. 

In July, Alexion AstraZeneca Rare Disease signed a definitive agreement for acquiring and licensing Pfizer’s early-stage gene therapy portfolio for rare diseases. The deal included a $1bn payment and net sale royalties from the acquired therapies. Despite the recent interest, the uptake of gene therapies is limited due to its high price tags.

As per the agreement, Kyowa will pay $16.00 per American Depositary Share (ADS) in cash for Orchard, totalling about ¥57.3bn ($387.4m). Orchard shareholders will hold an additional contingent value right (CVR) of $1.00 per ADS.

Orchard shareholders will be eligible for an additional $1.00 CVR, which will be paid for a total of $17.00 per ADS (about $477.6m) if some undisclosed pre-determined conditions are met. The acquisition is expected to be completed in Q1 2024, leading to Orchard becoming a wholly owned subsidiary of Kyowa.

Orchard gene therapy portfolio consists of Libmeldy (atidarsagene autotemcel), which has been approved to treat the rare genetic metabolic disorder metachromatic leukodystrophy (MLD) in the UK and Europe. The therapy is also under review by the US Food and Drug Administration (FDA), with the Prescription Drug User Fee Act (PDUFA) action date set for 18 March 2024.

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Orchard is also developing two other gene therapies, OTL-203 and OTL-201, for paediatric neurometabolic disorders, mucopolysaccharidosis type I Hurler’s syndrome (MPS-IH) and mucopolysaccharidosis type IIIA (MPS-IIIA), respectively.

All of the gene therapies in Orchard’s pipeline were developed using autologous genetically modified haematopoietic stem cells (HSCs) to potentially correct the underlying cause of a genetic disease through a single administration. Kyowa intends to leverage this HSC technology to develop more gene therapies.

Orchard CEO commented that “joining Kyowa Kirin’s global network ensures we are well-resourced to progress anticipated commercialization of OTL-200 [Libmeldy] in the US, if approved, continue investing in initiatives aimed at accelerating Libmeldy growth in Europe, capitalize on opportunities for global expansion, as well as advance our next-in-line neurometabolic programs in MPS disorders and earlier-stage research programs.”

Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by CytivaEditorial content is independently produced and follows the highest standards of journalistic integrity. Topic sponsors are not involved in the creation of editorial content.