Canadian drugmaker tells CMS it can make cheaper version of cancer drug Xtandi
- Ontario-based Biolyse Pharma says it can provide a 40-mg tablet of Xtandi (enzalutamide) for $3 per tablet, versus the $69.41 Medicare paid in 2014, reports Stat. Biolyse made the offer through an April 22 email to the directors of the Centers for Medicare and Medicaid Services, and the National Institutes of Health.
- Biolyse notes the U.S. government has a royalty-free right to use three patents on this product, thereby allowing it to bypass any patent infringement concerns. Biolyse also suggested that the NIH could use its rights to supply affordable versions of generic Xtandi to patients in low-income nations.
- A group of 12 lawmakers last month pushed NIH to use its so-called march-in rights for Xtandi in order to lower the cost of the drug. However, their request was later turned down.
March-in rights allows the U.S. government to require a pharma company out-license its patent, as a way to "alleviate health or safety needs." Democratic lawmakers have unsuccessfully asked the NIH to issue new guidelines on its use.
The U.S. government, however, has been reluctant to use the authority to address pricing.
However, Biolyse is coming at this issue from a different angle, asking the federal government use its royalty-free rights to obtain less expensive supplies of the drug.
Sales of Xtandi, which is indicated for treatment of late-stage metastatic castration-resistant prostate cancer, has soared since its approval in 2012. In 2015, the drug earned $1.9 billion in sales, an 80% year over year increase. The drug has been shown to significantly improve overall survival rates in this population and delay time to progression.
Xtandi is co-marketed by Astellas and Medivation and has sparked buyout interest in Medivation from Sanofi. The French company went public with a $9.3 billion acquisition bid this week, although its offer has been rebuffed by Medivation's board. AstraZeneca is also reported to be interested in Medivation.