[Ip-health] Democrats ask NIH for Xtandi march-in hearing - BioCentury.com

Thiru Balasubramaniam thiru at keionline.org
Tue Mar 29 05:25:36 PDT 2016


Democrats ask NIH for Xtandi march-in hearing

Published on Monday, March 28, 2016

A group of 12 U.S. House and Senate Democrats sent a letter to NIH Director
Francis Collins and HHS Secretary Sylvia Burwell asking NIH to hold a
public meeting to discuss whether it should exercise march-in rights for
prostate cancer drug Xtandi enzalutamidefrom Astellas Pharma Inc.

In January, two patient advocacy groups asked NIH to exercise the rights
for Xtandi, citing the drug's price as a barrier to its use. InMonday's letter,
the lawmakers said Xtandi is not "available to U.S. residents on reasonable
terms." The letter said a public hearing "would help provide insight into
NIH's decision-making process on this case" and would "allow the public to
engage in a dialogue" with HHS and NIH to understand their positions on use
of march-in rights (see BioCentury Extra, Jan. 14).

The group included Sens. Bernie Sanders (I-Vt.), Al Franken (Minn.),
Patrick Leahy (Vt.), Sheldon Whitehouse (R.I.), Elizabeth Warren (Mass.)
and Amy Klobuchar (Minn.), and Reps. Lloyd Doggett (Texas), Peter Welch
(Vt.), Elijah Cummings (Md.), Jan Schakowsky (Ill.), Rosa DeLauro (Conn.)
and Mark Pocan (Wis.).

Earlier this month, Burwell declined a request from 50 House Democrats to
issue guidance on when NIH may exercise its march-in authority, which
allows the agency to require the holder of a patent developed using
federally funded research to license the patent to other parties. Burwell
said NIH would exercise march-in rights "if statutory criteria are met."
NIH has never exercised march-in rights (see BioCentury Extra, March 8).

Xtandi is an oral androgen receptor antagonist.

The letter came to light after market close on Monday. Astellas has rights
to Xtandi from Medivation Inc.(NASDAQ:MDVN), which fell $1.32 to $41.25
during the day, and lost $2.56 to $38.69 in early after-hours trading.

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