Bristol-Myers Squibb is Obtain Turning Point Therapeutics acquired a lung cancer drug candidate that rivals what Pfizer and Roche currently have on the market for $4.1 billion.
The turning point drug repotrectinib is in phase 2 testing in non-small cell lung cancer (NSCLC). The deal announced Friday comes nearly two months after the biotech reported preliminary Phase 2 clinical data, which the biotech said could make the drug a class of its own for cancers characterized by specific genetic mutations. the best of all. Armed with encouraging data, the biotech company said it expects to open discussions with the FDA about potential new drug applications.
BMS is already gearing up for regulatory approval of repotrectinib, with an FDA decision expected in the second half of next year. Based on expectations for the drug, Bristol-Myers Squibb agreed to buy Turning Point for $76 a share in cash, a 122% premium to the stock’s closing price of $34.16 on Thursday. But that price is still below the stock’s peak of $133 a share in early 2021. When Turning Point went public in 2019, Pricing Its stock price is $18 per share.
San Diego-based Turning Point develops therapies that target the genetic drivers of cancer. Its small molecule is a tyrosine kinase inhibitor, a drug that blocks an enzyme that plays a key role in various cellular functions. In cancer, overactivity of these enzymes contributes to tumor growth. This hyperactivation may stem from the fusion of one gene with another. Repotrectinib is designed to address two such genetic signatures: fusions of the ROS1 gene with another gene in NSCLC, and NTRK fusions in solid tumors. Turning Point will bring other drugs to BMS. The biotech’s pipeline includes therapeutic candidates in early stages of development to address other genetic traits.
Pfizer’s Xalkori and Roche’s drug Rozlytrek have received FDA approval for the treatment of ROS1-positive NSCLC that has spread. Meanwhile, Rozlytrek and Bayer’s drug Viktrakvi accelerated FDA approval for the treatment of patients with metastatic solid tumors caused by NTRK gene fusions that do not have known acquired resistance mutations. Mutations can make cancers resistant, a known problem with tyrosine kinase inhibitors. Such drugs can also cause toxic effects that limit the length of time patients receive treatment. Side effects of Xalkori include visual disturbances, nausea, diarrhea, vomiting, and dizziness. Adverse effects of the Roche drug include fatigue, constipation, dizziness, swelling and muscle aches. In cases where cancer has spread to the brain, Pfizer’s drugs have limited activity in the central nervous system. With repotrectinib, Turning Point aims to provide advantages on all of these fronts.
April, the turning point report A pooled analysis of Phase 1 and 2 data showed a confirmed overall response rate of 79% among 79 patients. Four of these responders achieved a full response, while 52 achieved a partial response. Response duration ranged from 1.4 to 35.1 months. In the acquisition announcement, BMS said the duration of responses observed in the study was longer than that achievable with currently available ROS1 drugs as first-line NSCLC treatments. But when those preliminary results were published, Turning Point said the data were not mature enough to report on median response duration. When assessing safety, Turning Point said its drug was well tolerated by patients. The most commonly reported adverse event was dizziness. The company said it expects to reveal more details at a medical conference later this year, but BMS has seen enough to convince it to make a purchase.
“With repotrectinib, we have an opportunity to change the standard of care and address a significant unmet medical need for patients with ROS1-positive non-small cell lung cancer,” Samit Hirawat, chief medical officer at BMS, said in a prepared statement.
In a note to investors on Friday, William Blair analyst Matt Phipps wrote that Turning Point’s price tag is high “given that recently approved therapies for these indications have not had meaningful commercial success to date.” But Phipps added BMS believes the acquisition will start contributing to earnings in 2025, a key timing as the company seeks additional revenue growth to offset patent expiry on products like Revlimid, Pomalyst and Abraxane, the company said.
“As a result, while this transaction is likely to be expensive based on the peak sales multiple of the main asset, we generally encourage management to continue to use the current strong free cash flow to acquire late-stage assets that will provide revenue from 2025 to 2030. time frame, early-stage assets have potential upside,” Phipps said.
The acquisition has been approved by the boards of both companies and is expected to close in the third quarter of this year.
Image via Flickr user Ed Osman through Creative Commons license
