USA — Eli Lilly and Company is set to acquire Akouos, a developer of viral gene therapies for the treatment of inner ear conditions, including sensorineural hearing loss as the drugmaker seeks to expand its arsenal of gene therapies.
The consideration is approximately US$487 million, plus a contingent value right worth up to US$610 million.
According to the agreement, Lilly will pay US$12.50 per share in cash for Akouos, with one contingent value right (CVR) of up to US$3.00 per share.
AK-OTOF, Akouos’ lead product candidate, is a gene therapy for the treatment of hearing loss caused by otoferlin gene mutations (OTOF).
AK-CLRN1 for Usher Type 3A, an autosomal recessive disorder characterized by progressive loss of both hearing and vision, GJB2 for a common form of monogenic deafness and hearing loss, and AK-antiVEGF for the treatment of vestibular schwannoma are among the drugs in the company’s pipeline.
The planned acquisition of Akouos is Lilly’s latest large-scale investment in building a robust gene therapy pipeline across multiple indications.
In 2021, the company established a foothold in the sector by acquiring Prevail Therapeutics in a deal worth up to US$1 billion for its portfolio of clinical-stage and preclinical neuroscience candidates.
This clinical pipeline included gene therapy candidates for Parkinson’s disease, Gaucher disease, and frontotemporal dementia at the time of acquisition.
Alzheimer’s disease, amyotrophic lateral sclerosis (ALS), and other neurodegenerative disorders were among the preclinical candidates.
In February, Lilly announced the establishment of the Lilly Institute for Genetic Medicine, which includes a US$700 million investment in the development of a state-of-the-art facility in the Boston Seaport area.
The Institute will be based at the Prevail Therapeutics facility in both Boston and New York.
The new Institute will, according to the company, “fuel the development of genetic medicines, which already account for more than 20% of Lilly’s diabetes, immunology, and central nervous system research portfolio.”
Last month, Akouos received FDA approval for an AK-OTOF phase 1/2 trial.
The timing put Akouos slightly ahead of Decibel, which has also received FDA approval to begin trials for a competing OTOF gene therapy.
Decibel may eventually test its candidate on children younger than two years old, whereas Akouos plans to test its candidate on children as young as two years old