Thursday, July 17, 2008

The Enemies You Keep

Former Rep. Bill Thomas sure has it in for Amgen.

First, as chairman of the House Ways and Means Committee, Thomas made life difficult for Amgen by siding with sworn enemy Johnson & Johnson during the now-resolved EPO bundling dispute.

Thomas wasn’t particularly happy with allegations that Amgen gave large rebates for Aranesp (which competes with J&J’s Procrit) when purchasers committed to buying Neulasta and Neupogen.

And just before retiring from public service in 2006, Thomas teamed up with Rep. Pete Stark to criticize the Centers for Medicare & Medicaid Services’ reimbursement policy for Aranesp, in the hopes of making anti-Amgen changes in the way that the product was covered under Medicare Part B.

But while the Amgen/J&J feud has finally ended with a $200 million payout to J&J, Thomas can’t quite bury the hatchet.

This time around, he’s working against Amgen on the issue of follow-on biologics. Thomas has teamed up with Insmed Inc.—a company you might remember from a moderately infamous YouTube video—but that also just announced the results of a study demonstrating bioequivalence between its INS-19 and....wait for it...Amgen’s Neupogen.

Insmed has a long way to go on INS-19—that bioequivalence study was a Phase I trial. But the company says it is planning to petition FDA to commence Phase III studies of INS-19, and wants to move another “me-too” biologic, INS-20, which Insmed says is a “generic form” of Amgen’s Neulasta, into Phase I. (Are you sensing a pattern here yet?)

How Thomas’ vision for a follow-on biologics framework is different than the bipartisan legislation that’s already out there is unclear. It’s also unclear how the Congressional Budget Office’s scoring of the Senate’s version of the bill will affect the chances for near-term passage of any legislation.

But what is clear is that there’s no love lost between Thomas and Amgen. Conventional wisdom would suggest that it took a pretty sweet fee for Insmed to get Thomas on board as a strategic advisor. But given Thomas’ history with Insmed’s main target in the war on follow-on-biologics, maybe it didn’t take too much convincing.

No comments: