Frequency Therapeutics, the Woburn biotech that wants to restore hearing lost as a result of long-term exposure to loud music, leaf blowers, and other features of modern life, has found a like-minded business partner in Japan.
Frequency will receive $80 million up front in a licensing deal with Tokyo-based Astellas Pharma. The latter firm hopes to develop and market outside the United States the startup’s experimental drug to restore hearing. Frequency plans to develop and sell the medicine domestically.
If the drug wins approval and achieves certain sales goals — always big ifs in the world of drug development — Frequency could receive an additional $545 million, as well as royalties.
“Collaborating with Astellas provides us an opportunity to work with a partner that has deep, global clinical development and commercial expertise and shares our focus in pursuing novel regenerative medicines for patients with diseases where there are no therapeutic options,” said David Lucchino, Frequency’s chief executive.
It’s the first licensing deal for Frequency, a privately held firm that has raised more than $85 million in venture capital and has 38 employees.
“It’s also the first significant licensing deal ever for hearing regeneration,” said Lucchino, who also serves as chairman of the Massachusetts Biotechnology Council, a trade group.
Founded four years ago based on the premise of using the body’s dormant stem cells to combat disease, Frequency has developed an experimental drug that would be injected through the eardrum into the middle ear of patients with hearing loss, a fairly routine procedure.
The drug would activate so-called progenitor cells that can repair damage in the spiral cavity of the inner ear by generating new hair cells.
The medicine was well tolerated in an early-stage clinical trial of 23 patients. Fifteen patients received the drug in the injection, while eight got a placebo. Researchers followed the patients for three months.
Multiple patients who got the drug showed improvements in hearing, according to the firm. Frequency reported those results in April and got the attention of Astellas executives.
“Astellas is committed to exploring all types of partnership opportunities to turn cutting-edge science and technological advances into value for patients,” Naoki Okamura, chief strategy officer at Astellas, said in a statement Wednesday.
There are no approved drugs to treat hearing loss. Hearing aids and cochlear implants are often used to amplify sounds. But nothing is available to replace damaged hair cells, which have a role in clarifying sound and improving speech intelligibility.
Frequency is targeting sensorineural hearing loss, the most common form of hearing loss. It results from damage to the hair cells in the inner ear or problems with the nerve pathways that convert sound waves from the inner ear to the brain. Hair cells are commonly lost due to chronic noise exposure.
At least 10 million adults in the United States under the age of 70 — and perhaps as many as 40 million — have such hearing loss, according to a 2012 study by the federal Centers for Disease Control and Prevention.
The World Health Organization estimates that 1.1 billion people between the ages of 12 and 35 are at risk for hearing loss from exposure to loud noises during recreational activities — everything from attending rock concerts to shooting targets with firearms.
Lucchino said Astellas is “making a big play” in regenerative medicine.
Three years ago, the Japanese firm paid $379 million for Ocata Therapeutics, a small Marlborough biotech. Ocata had developed promising stem-cell therapies, including a potential one-time treatment for a leading cause of blindness. Ocata became a subsidiary of Astellas and is now called the Astellas Institute for Regenerative Medicine.