Cubist Pharmaceuticals Inc announced that results from human clinical research studies examining the bioavailability of a variety of oral formulations of ceftriaxone, a broad-spectrum antibiotic, were too variable to confirm therapeutic application of the formulations and did not meet the established threshold of bioavailability. As a result, Cubist will discontinue internal investment in the ceftriaxone formulations, known collectively as OCTX.
Michael W. Bonney, president & CEO of Cubist commented on the news: "While we are certainly disappointed that we will not be advancing OCTX into the clinic, we continue to believe that this technology platform could ultimately result in a commercial product. Over the past several years, our pharmaceutical sciences team has made important advances in increasing the oral bioavailability of an extremely difficult-to-absorb compound. We believe that the efforts made by Cubist on these formulations have added significant value to the programme and are hopeful that we will be able to realize a return on our investment in the future. In the meantime, we have decided that our resources are better spent optimizing the launch of our flagship product Cubicin (daptomycin for injection) and pursuing potential in-licensing candidates to strengthen our near-term product pipeline."
Cubist originally licensed the technology from International Health Management Associates, Inc. (IHMA) and The University of Utah in late 2000. In early 2002, Cubist announced the successful completion of studies demonstrating clinically relevant blood levels of ceftriaxone delivered intraduodenally, or directly to the small intestine, in human volunteers. These studies confirmed earlier work performed in both non-human primates and rodents. Since achievement of these results, Cubist scientists have worked to optimize oral dosage formulations, achieving significantly improved bioavailability in animal and humans, but insufficient levels to justify further development and investment by Cubist.