G1 Therapeutics steered a first-of-its-kind lung most cancers drug to FDA approval, however lengthy maintained that growth and commercialization globally would require partnerships. There’s a brand new path ahead for the drug, although it is going to be by means of an acquisition somewhat than a strategic alliance.
Pharmacosmos is buying G1 in a deal that values the Analysis Triangle Park, North Carolina-based biotech at $405 million, the businesses introduced Wednesday. Carefully held Pharmacosmos, which relies in Denmark, has agreed to pay $7.15 for every share of G1. That value represents a 68% premium to G1’s closing share value on Tuesday and a 133% premium to G1’s common share value over the previous 30 days. When G1 went public in 2017, it priced shares at $15 apiece.
G1’s commercialized drug is Cosela, a therapy for sufferers with extensive-stage small cell lung most cancers. The intravenously infused remedy is an inhibitor of CDK4 and CDK6, proteins key to the proliferation of cells from bone marrow. Quite than treating the most cancers straight, Cosela is meant to dam CDK4/6 proteins to guard bone marrow from the results of the chemotherapy that sufferers obtain for his or her most cancers. Cosela is dosed about 4 hours previous to the administration of chemotherapy. FDA approval of the G1 drug in 2021 made it the primary drug of this sort to cross the company’s regulatory bar.
For 2023, G1 reported Cosela accounted for $46.3 million in product gross sales, a 47.8% enhance over gross sales within the prior yr. G1 has not had luck increasing the drug’s use past lung most cancers. Final yr, the corporate stopped growth of Cosela in colorectal most cancers after preliminary Part 3 outcomes confirmed sufferers had been residing longer within the placebo arm. In June, preliminary outcomes from a Part 3 scientific trial testing Cosela in metastatic triple detrimental breast most cancers confirmed the examine drug fell in need of the management arm. G1 discontinued the trial and commenced layoffs to increase the corporate’s money runway into the second half of 2025.
In its annual report, G1 mentioned European regulators have indicated the drug’s current information are ample to assist a advertising and marketing authorization utility in extensive-stage small cell lung most cancers. However the firm added that it deliberate to pursue that path with a companion.
Partnerships have been a blended bag for G1. Cosela is accessible in sure Asian markets, commercialized below an alliance with Simcere Pharmaceutical. Lerociclib, an oral CDK4/6 inhibitor that G1 designed with potential dosing and security benefits over most cancers medication from Pfizer and Novartis, is partnered in sure Asian markets and Australia with Genor Biopharma. Remainder of the world rights to lerociclib had been outlicensed to EQRx. However when Revolution Medicines acquired EQRx final yr, it didn’t need the G1 most cancers drug. The lerociclib licensing settlement was terminated.
Buying G1 allows Pharmacosmos to increase its scope to most cancers. Based in 1965, the corporate focuses on carbohydrate chemistry. Pharmacosmos has one FDA-approved product, the iron deficiency anemia drug Monoferric. The five hundred-employee firm markets different iron and carbohydrate merchandise in markets outdoors of the U.S. In a ready assertion, Pharmacosmos CEO Tobias Christensen mentioned the mixture of the 2 corporations will allow broader and higher affected person entry for each Cosela and Monoferric.
“Whereas Monoferric is accessible all over the world, Cosela is up to now solely accepted within the U.S. and in China,” Christensen mentioned. “It can catch the attention of us to deliver this vital product to extra sufferers each in U.S. and worldwide to assist reduce the variety of lung most cancers sufferers affected by myelosuppression after chemotherapy.”
In a letter despatched to staff, G1 CEO Jack Bailey defined the rationale for the enterprise mixture is the chance to make Cosela extra broadly obtainable.
“As a world firm with intensive expertise in supportive care, Pharmacosmos will allow much more speedy availability, entry, and adoption for Cosela globally,” he mentioned. “I’ve personally seen the clear dedication and expertise in supportive care that they’ve, together with a deep appreciation for what Cosela can signify to sufferers. The mixed entity will clearly provide larger hope to extra sufferers earlier than we may on our personal.”
G1 spun out of the College of North Carolina at Chapel Hill in 2008 primarily based on analysis from co-founder Norman Sharpless, who was a professor of drugs and genetics within the UNC College of Drugs previous to his stints on the Nationwide Most cancers Institute and the FDA. The corporate was initially named G-Zero Therapeutics. One in every of G-Zero’s preliminary targets was to develop a capsule that might shield individuals after radiation publicity for potential biodefense functions. The corporate modified its title to G1 Therapeutics in 2012.
The G1 and Pharmacosmos boards of administrators have accepted the transaction, which is predicted to shut late within the third quarter of this yr.
Picture: Mohammed Haneefa Nizamudeen, Getty Photos
