Mirati Therapeutics, long speculated to be a potential acquisition target in the world of Big Pharma, has now sealed a significant deal. Bristol Myers Squibb has stepped up as the buyer, committing to a substantial payment of up to $5.8 billion for the California-based cancer drug developer.
In a strategic move, BMS will acquire the FDA-approved non-small cell lung cancer (NSCLC) drug Krazati, touted as the leading KRAS G12C inhibitor in its class. Beyond the core equity value of $4.8 billion, this deal incorporates an additional component—a non-tradeable contingent value right. This component pledges to award Mirati shareholders an additional $1 billion should the FDA accept an application for the company’s pipeline drug, MRTX1719, designed for NSCLC patients who have undergone no more than two prior lines of therapy within seven years of the deal’s conclusion.
Also Read: Sanofi Considers Acquisition Of Mirati Amid Intensifying KRAS Cancer Drug Battle, Reports Bloomberg
The anticipated timeline for closing this transaction is within the first half of the upcoming year, signaling BMS’ eagerness to diversify its portfolio and strengthen its pipeline. This move is especially crucial for BMS, given its recent challenges in meeting sales expectations, prompting a revision of its 2023 sales projection from a 2% increase to a low-single-digit decline. This change was necessitated by underwhelming performances from its three top-selling drugs—Eliquis, Revlimid, and Opdivo. Moreover, these three key products face the looming threat of losing patent protection in the coming decade.
Prior to the Mirati acquisition, BMS had a strong focus on immuno-oncology within its solid tumor franchise, with limited emphasis on targeted therapies. However, this deal marks a strategic shift as BMS seeks to expand its horizons. They are also awaiting an FDA decision for repotrectinib, prioritized for use in ROS1-positive NSCLC by November 27.
“With multiple targeted oncology assets, including Krazati, Mirati is another important step forward in our efforts to grow our diversified oncology portfolio and further strengthen Bristol Myers Squibb’s pipeline for the latter half of the decade and beyond.”
– Chris Boerner, Ph.D, BMS’ CEO
Also Read: Mirati Fires Its CEO And Announces A New Lung Cancer Krazati-Keytruda Study Strategy
Krazati, granted FDA accelerated approval in December 2022 for previously treated KRAS G12C-mutant NSCLC, has demonstrated its potential by generating $19.7 million in sales during the first half of 2023, capturing over 40% of new patient starts. Mirati’s ambitious plans include launching a phase 3 trial in the fourth quarter, combining Krazati with Opdivo’s PD-1 rival, Merck & Co.’s Keytruda, targeting newly diagnosed NSCLC cases with high tumor PD-L1 expression levels. Furthermore, an FDA filing for accelerated approval in late-line colorectal cancer is anticipated by the end of 2023.
An investor presentation by BMS regarding the Mirati deal suggests that they don’t intend to alter the Keytruda component in the upcoming Krazati combination study. Instead, they aim to explore the synergistic potential between BMS’ immunotherapies and Mirati’s targeted drugs. Krazati’s unique advantage over Amgen’s competing drug, Lumakras, lies in their distinct profiles regarding liver toxicity, making Krazati a more favorable choice.
Both KRAS inhibitors received accelerated approvals, but recent input from FDA-invited external experts raises questions about the reliability of Lumakras’ positive confirmatory trial. Although the FDA doesn’t plan an immediate withdrawal of Lumakras from the market, this unfavorable review could potentially propel Krazati further ahead of Amgen’s first-to-market offering.
Also Read: Mirati’s KRAS Inhibitor Krazati Faces Rejection In Europe
Regarding MRTX1719, an inhibitor targeting PRMT5, it is slated to enter phase 2 testing in the first half of 2024. This innovative drug is designed to combat MATP-deleted tumors, which constitute approximately 10% of all cancers. In this arena, Mirati will face competition from Amgen, which is also in the early stages of developing AMG 193.
Mirati’s name has frequently cropped up in biopharma’s M&A rumors. Just prior to BMS’ announcement, Bloomberg reported that Sanofi had been considering a potential purchase of Mirati. Had Sanofi made an acquisition offer, it would have marked another significant deal that the French pharmaceutical company had missed out on, having previously lost out to Amgen in its bid for Horizon Therapeutics and for Reata Pharmaceuticals to Biogen.
