Recently, Bayer (BAYRY) initiated patient enrollment in a phase III trial of one of its late stage pipeline candidates, regorafenib. The drug is being studied to treat patients with metastatic colorectal cancer (CRC) who have not responded properly to standard therapies.
In the CORRECT (Patients with metastatic colorectal cancer treated with regorafenib or placebo after failure of standard therapy) trial, about 690 patients are expected to be enrolled. They will either receive regorafenib plus best supportive care (BSC) or placebo plus BSC.
While overall survival is the primary endpoint of the trial, secondary endpoints consist of progression-free survival, objective tumor response rate and disease control rate. Additionally, the safety and tolerability of the two groups will be compared.
Successful commercialization of the drug will enable Bayer to generate robust sales growth as treatment options are limited for patients with CRC who have not responded to standard therapies. CRC is the second most prevalent cancer globally, with over one million cases every year. The mortality rate from CRC is quite high – about half of its global incidence.
Although we are pleased with the advancement in Bayer’s pipeline, we remain concerned about the litigation issues it faces. In May 2009, Onyx Pharmaceuticals (ONXX) – Bayer’s collaboration partner for Nexavar (sorafenib) – sued Bayer over the rights to regorafenib.
The molecular structure of both the drugs is similar except for one atom. Onyx has filed a complaint claiming its right to the drug. It alleges that the drug should be treated under the collaboration agreement while Bayer claims sole rights. Given the advanced status of the drug, stakes are quite high for both the companies.
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