The Gilead effect: PCSK9 rivals Amgen, Sanofi/Regeneron prep for a price war

With the aggressive pharmaceutical benefits manager Express Scripts ($ESRX) lying in wait for two new cholesterol blockbuster contenders expected to debut this summer, the highly anticipated price war appears to already be well underway.

Reuters highlights the looming showdown between Amgen's ($AMGN) LDL-lowering PCSK9 drug Repatha (evolocumab), which has a PDUFA date of August 27, and Praluent (alirocumab), from Regeneron ($REGN) and Sanofi ($SNY). Praluent may be first to the market with a July 24 deadline at the FDA, an advantage that the partners acquired with their purchase of an accelerated review coupon.

Before that, though, there are back-to-back adcomm meetings on June 9 and 10 that may well help define exactly what kind of market the biopharma rivals can expect. And analysts will be tracking every minute of the expert discussions.

"We do not see significant risk to approval," UBS analyst Matthew Roden commented a few weeks ago. "Rather, we expect the key debate for the panels to be labelled indications to dictate the most appropriate patient subpopulations for treatment."

Assuming that both drugs will be approved, the Regeneron/Sanofi team plans to roll out a low-dose biweekly injection of 75 mg alongside a 150 mg biweekly dose, according to Reuters. Amgen is slated to come out with a 140 mg biweekly jab along with a 420 mg dose for an easier once-monthly schedule. And while the companies-maintaining a strict pre-approval silence on pricing and marketing strategies-aren't talking price, others are willing to do it for them.

U. of Iowa's Jennifer Robinson

Iowa epidemiologist Jennifer Robinson, who helped research Praluent, tells the news service that the 75 mg dose would offer payers a lower price start for patients who don't currently respond to statins.

"Sanofi will say you can start off at this cheaper, lower dose," Robinson said. "If you don't reach the LDL goal, you can move up" to a higher dose, at the higher price. And Sanford Bernstein analyst Geoffrey Porges is expecting the price war to begin with a $5,000-a-year price for low-dose Praluent against $10,000 for all the other higher doses of both drugs.

The price war can be attributed to the Gilead ($GILD) effect. After Gilead released its revolutionary hep C drugs at jaw-dropping prices, Express Scripts and other payers have made it clear that they intend to press hard for lower prices, pitting drug manufacturers against each other whenever possible. As both PCSK9 drugs appear closely similar, targeting a protein that plays a key role in LDL levels and demonstrating a dramatic effect in clinical trials, payers will have an immediate advantage in bargaining for lower prices as they decide where to position these drugs on formularies offered to millions of members.

One wild card in the showdown: Pfizer's ($PFE) PCSK9 therapy. Most of the attention in this class has centered on the blockbuster potential for the therapies from the two leaders. But Pfizer's therapy is in Phase III, and could come in later to help further scramble the market for the pioneers in the field.

- here's the Reuters story