Pfizer and Astellas avoid forced price reduction for cancer therapy Xtandi

The National Institutes of Health (NIH) has declined to use so-called "march-in" rights to force Pfizer (NYSE:PFE) and Astellas Pharma (OTCPK:ALPMF) to lower the price of the blockbuster prostate cancer therapy Xtandi.

The NIH communicated its decision on Tuesday in response to a petition filed by prostate cancer patients Robert Sachs and Clare Love.

"Given the remaining patent life and the lengthy administrative process involved for a march-in proceeding, NIH does not believe that use of the march-in authority would be an effective means of lowering the price of the drug," NIH wrote in a letter to Sachs and Love.

March-in rights introduced in 1980 under the Bayh-Dole Act permits the issuance of additional licenses to third parties for government-funded inventions if the original patent holder has not made the products available to the public on reasonable terms.

Xtandi, which has a list price of $60K – $180K per patient per year, was invented at the University of California, Los Angeles, with funding from the U.S. Army and NIH.

In 2016, NIH declined a similar request from Love's brother James Love, the director of Knowledge Ecology International, an advocacy group that seeks equitable access to medications, and the Union for Affordable Cancer Treatment.

Xtandi, an androgen receptor inhibitor, brought $1.2B in revenue for Pfizer (PFE) and Astellas (OTCPK:ALPMY) from the U.S. in 2022 with ~1% YoY growth.