Astellas' Xtandi under pressure as U.S. lawmakers push for generic swap

The price tag of Astellas' prostate cancer drug Xtandi (enzalutamide) is coming under heavy fire in the U.S. as lawmakers in the country are urging the Department of Health and Human Services to dramatically lower its cost by signing off on copycat versions. 

The Japanese drugmaker, which partners with U.S. biopharma Medivation ($MDVN) to co-market the drug in the region, has been subject to mounting pressure in recent months over the price of its treatment, which costs around $129,000 per year, per patient, Bloomberg BNA reports. Xtandi is however sold in Japan and Sweden for around $39,000 and in Canada for $30,000.

In a letter to the heads of the HHS and the National Institutes of Health (NIH), reps. Lloyd Doggett (D-TX) and Peter Welch (D-VT) and Democratic presidential candidate Sen. Bernie Sanders (I-VT) urged the agencies to step in to cut prices for Xtandi, saying it costs four times as much in the U.S. as in some other developed countries.

They are now asking for public hearings on the drug. In a bold and controversial move, the lawmakers want the NIH to consider overriding Xtandi's patent, which guarantees Medivation and Tokyo-based Astellas exclusive sales for a decade or more.

Overriding the patent would dramatically reduce Xtandi's price--with many generics being between 30% and up to 90% cheaper than the originator drug.

"Under current law, NIH can take this step if federal funds supported a drug's development and the company is selling it at an unreasonably high price," the lawmakers said in a statement cited by Bloomberg BNA--although this power hasn't been used since 1980.

The lawmakers are extra-aggrieved as they say the drug was developed at UCLA through taxpayer-supported research grants. At the same time, reports say potential buyers are circling Medivation, which has hired investment bankers at JPMorgan Chase to help fend off a deal.

Astellas has however hit back and said this week that the lawmakers' campaign "doesn't reflect what insurers or patients actually pay for Xtandi," adding that around 80% of patients with Medicare or private insurance have a monthly co-payment of $25 or less.

It said that more than 2,000 men with poor or no insurance and household incomes of $100,000 or less received Xtandi free of charge last year.

This follows a growing bitterness in U.S. politics against high drug prices and so-called price gouging, with notable ire being directed at Canada's Valeant ($VRX) and biopharma Turing Pharmaceuticals in recent months.

- read the Bloomberg BNA post

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