G1 Therapeutics steered a first-of-its-kind lung cancer drug to FDA approval, but long maintained that development and commercialization globally would require partnerships. There’s a new path forward for the drug, though it will be through an acquisition rather than a strategic alliance.
Pharmacosmos is acquiring G1 in a deal that values the Research Triangle Park, North Carolina-based biotech at $405 million, the companies announced Wednesday. Closely held Pharmacosmos, which is based in Denmark, has agreed to pay $7.15 for each share of G1. That price represents a 68% premium to G1’s closing share price on Tuesday and a 133% premium to G1’s average share price over the past 30 days. When G1 went public in 2017, it priced shares at $15 apiece.
G1’s commercialized drug is Cosela, a treatment for patients with extensive-stage small cell lung cancer. The intravenously infused therapy is an inhibitor of CDK4 and CDK6, proteins key to the proliferation of cells from bone marrow. Rather than treating the cancer directly, Cosela is intended to block CDK4/6 proteins to protect bone marrow from the effects of the chemotherapy that patients receive for their cancer. Cosela is dosed about four hours prior to the administration of chemotherapy. FDA approval of the G1 drug in 2021 made it the first drug of this type to pass the agency’s regulatory bar.
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For 2023, G1 reported Cosela accounted for $46.3 million in product sales, a 47.8% increase over sales in the prior year. G1 has not had luck expanding the drug’s use beyond lung cancer. Last year, the company stopped development of Cosela in colorectal cancer after preliminary Phase 3 results showed patients were living longer in the placebo arm. In June, preliminary results from a Phase 3 clinical trial testing Cosela in metastatic triple negative breast cancer showed the study drug fell short of the control arm. G1 discontinued the trial and commenced layoffs to extend the company’s cash runway into the second half of 2025.
In its annual report, G1 said European regulators have indicated the drug’s existing data are sufficient to support a marketing authorization application in extensive-stage small cell lung cancer. But the company added that it planned to pursue that path with a partner.
Partnerships have been a mixed bag for G1. Cosela is available in certain Asian markets, commercialized under an alliance with Simcere Pharmaceutical. Lerociclib, an oral CDK4/6 inhibitor that G1 designed with potential dosing and safety advantages over cancer drugs from Pfizer and Novartis, is partnered in certain Asian markets and Australia with Genor Biopharma. Rest of the world rights to lerociclib were outlicensed to EQRx. But when Revolution Medicines acquired EQRx last year, it did not want the G1 cancer drug. The lerociclib licensing agreement was terminated.
Acquiring G1 enables Pharmacosmos to expand its scope to cancer. Founded in 1965, the company focuses on carbohydrate chemistry. Pharmacosmos has one FDA-approved product, the iron deficiency anemia drug Monoferric. The 500-employee company markets other iron and carbohydrate products in markets outside of the U.S. In a prepared statement, Pharmacosmos CEO Tobias Christensen said the combination of the two companies will enable broader and better patient access for both Cosela and Monoferric.
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“While Monoferric is available around the world, Cosela is so far only approved in the U.S. and in China,” Christensen said. “It will be a focus for us to bring this important product to more patients both in U.S. and worldwide to help minimize the number of lung cancer patients suffering from myelosuppression after chemotherapy.”
In a letter sent to employees, G1 CEO Jack Bailey explained the rationale for the business combination is the opportunity to make Cosela more widely available.
“As a global company with extensive experience in supportive care, Pharmacosmos will enable even more rapid availability, access, and adoption for Cosela globally,” he said. “I have personally seen the clear commitment and experience in supportive care that they have, along with a deep appreciation for what Cosela can represent to patients. The combined entity will clearly offer greater hope to more patients sooner than we could on our own.”
G1 spun out of the University of North Carolina at Chapel Hill in 2008 based on research from co-founder Norman Sharpless, who was a professor of medicine and genetics in the UNC School of Medicine prior to his stints at the National Cancer Institute and the FDA. The company was initially named G-Zero Therapeutics. One of G-Zero’s initial goals was to develop a pill that could protect people after radiation exposure for potential biodefense applications. The company changed its name to G1 Therapeutics in 2012.
The G1 and Pharmacosmos boards of directors have approved the transaction, which is expected to close late in the third quarter of this year.
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