Gilead Sciences has announced that it will be expanding its liver disease pipeline by acquiring CymaBay Therapeutics for $4.3bn.
The deal gives the company access to CymaBay’s lead experimental candidate, seladelpar, which is currently being evaluated as a treatment for primary biliary cholangitis (PBC).
Affecting approximately 130,000 people in the US, PBC is a rare cholestatic liver disease mainly affecting women.
The most common early symptoms of PBC are pruritus (itching) and fatigue, and disease progression is associated with an increased risk of liver-related mortality.
CymaBay’s seladelpar is an investigational, oral, selective peroxisome proliferator-activated receptor delta agonist which has been shown to regulate critical metabolic and liver disease pathways, Gilead said.
According to results from the late-stage RESPONSE trial, seladelpar achieved statistical significance over placebo across primary composite endpoints of biochemical response, normalisation of alkaline phosphatase at 12 months, as well as statistically significant improvement in pruritus at six months that was sustained to month 12 among patients experiencing moderate-to-severe itch.
The candidate has already been accepted for priority review by the US Food and Drug Administration (FDA), with a Prescription Drug User Fee Act target action date of 14 August set.
Daniel O’Day, chairman and chief executive officer at Gilead, said: “We are looking forward to advancing seladelpar by leveraging Gilead’s long-standing expertise in treating and curing liver diseases.
“Building on the strong research and development work by the CymaBay team to date, we have the potential to address a significant unmet need for people living with PBC and expand on our existing broad range of transformational therapies.”
Under the terms of the agreement, which is expected to close during the first quarter of this year, Gilead will acquire CymaBay for $32.50 per share in cash, a 27% premium to the company’s closing price on 9 February.
CymaBay’s president and chief executive officer, Sujal Shah, said: “[The] agreement with Gilead is the culmination of years of focus and determination at CymaBay to advance seladelpar and bring new hope to people living with PBC and their families.
“Now that seladelpar has achieved priority review with the FDA, we are excited that Gilead, with its long-standing commitment to patients with liver disease, can apply its regulatory and commercial expertise to bring seladelpar as quickly as possible to people with PBC.”