Kyowa Kirin Agrees to Acquire Orchard Therapeutics

Rare Daily Staff

Kyowa Kirin and Orchard Therapeutics have entered into a definitive agreement under which Kyowa Kirin will acquire Orchard Therapeutics for up to $477.6 million.

Kyowa Kirin will pay Orchard $16.00 per American Depositary Share (ADS) in cash (approximately $387.4 million), and an additional contingent value right (CVR) of $1.00 per ADS if certain conditions are met for a total of $17.00 per ADS, or approximately $477.6 million.

Kyowa Kirin has established a 2030 Vision to consistently create and deliver medicines with life-changing value by matching transformative science to areas of great unmet need and the potential of cell and gene therapies to help patients aligns with this vision and Kyowa’s emerging expertise in commercializing rare disease medicines worldwide.

“Joining Kyowa Kirin’s global network ensures we are well-resourced to progress anticipated commercialization of OTL-200 in the U.S., 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,” said Bobby Gaspar, co-founder and CEO of Orchard Therapeutics.

Under the terms of the agreement, Kyowa Kirin will initiate an arrangement to acquire all Orchard Therapeutics’ ADSs at a price of $16.00 per ADS in cash at closing, which represents a premium of 144 percent with respect to Orchard Therapeutics’ volume-weighted average price per ADS over the previous 30 days ended October 4, 2023.

In connection with the transaction, a non-transferable CVR will be distributed to Orchard Therapeutics shareholders. Holders of the CVR will be entitled to receive a cash payment of $1.00 per ADS related to the approval of OTL-200 for the treatment of MLD in the United States as defined in the CVR Agreement.

The transaction has been unanimously approved by both company’s Board of Directors and is expected to close in the first quarter of 2024 subject to Orchard Therapeutics’ shareholder approval, receipt of applicable regulatory approvals and other customary closing conditions.

Following the completion of the acquisition, Orchard Therapeutics will become a wholly owned subsidiary of Kyowa Kirin.

Orchard Therapeutics’ gene therapy approach harnesses a patient’s own genetically modified hematopoietic stem cells to potentially correct the underlying cause of a genetic disease using a single administration. Upon closing, the acquisition would provide Kyowa Kirin with a global leadership position in the burgeoning field of genetic medicine, including a portfolio spanning commercial, clinical, and pre-clinical HSC gene therapies designed to address serious diseases where the burden is immense for patients, families and society and current treatment options are limited or do not exist.

Orchard’s portfolio includes Libmeldy, also known as OTL-200, a gene therapy intended for eligible patients with early-onset metachromatic leukodystrophy (MLD), a rare and life-threatening inherited disease of the body’s metabolic system. In the most severe form of MLD, babies develop normally but in late infancy start to rapidly lose the ability to walk, talk and interact with the world around them. Libmeldy is approved by the European Commission and U.K. Medicines and Healthcare products Regulatory Agency for the treatment of “late infantile” and “early juvenile” MLD patients. It is currently an investigational drug under Priority Review by the U.S. Food and Drug Administration with an expected action date of March 18, 2024.

Using the same HSC gene therapy technology platform, Orchard Therapeutics is progressing two clinical-stage programs known as OTL-203 and OTL-201 for the treatment of another group of severe pediatric neurometabolic disorders, mucopolysaccharidosis type I Hurler’s syndrome and mucopolysaccharidosis type IIIA, also known as Sanfilippo syndrome, respectively.

This acquisition will allow Kyowa Kirin to maximize the value of Libmeldy and efficiently accelerate the development of Orchard Therapeutics’ next-in-line MPS programs, as well as its other early research programs, including a severe, genetic form of Crohn’s disease and frontotemporal dementia. Furthermore, the combination of Orchard Therapeutics’ innovative HSC gene therapy platform technology and Kyowa Kirin’s capabilities, resources and infrastructure will enable the continued development of numerous promising biopharmaceutical candidates with the potential to deliver life-changing value in medical care, including in therapeutic areas and indications where Kyowa Kirin has deep experience, such as oncology and autoimmune diseases.

“With this transaction, we anticipate being able to use a new modality that can have a profound impact on patients’ lives,” said Takeyoshi Yamashita, chief medical officer and senior managing executive officer of Kyowa Kirin. “Orchard Therapeutics is a company with a steady track record in this field and has already launched its HSC gene therapy in Europe and filed for review in the U.S. Our hope is to combine the strengths of Kyowa Kirin and Orchard Therapeutics with mutual respect to realize the successful creation and delivery of life-changing value for patients living with rare and life-threatening inherited diseases.”

Photo: Bobby Gaspar, co-founder and CEO of Orchard Therapeutics