GSK Will Answer FDA “Complete Response” Letter For Cervarix In Q2

GlaxoSmithKline will answer FDA's "complete response" letter for its Cervarix BLA in the second quarter, but the firm expects the product will require advisory committee review for final approval, CEO JP Garnier said during GSK's year-end earnings call.

The firm received the complete response letter for the human papilloma virus vaccine in December, but would not reveal what issues were raised by the agency (¹ (Also see "GSK Cervarix Setback: FDA Questions On HPV Vaccine Bode Well For Merck" - Pink Sheet, 7 Jan, 2008.), p. 6).

During the Feb. 7 call, Garnier said the company will continue its discussions with FDA, but that the timeframe for launching the product is still unclear. "I don't know when the timing of the launch is going to be, because frankly the FDA is not going to give us an answer for quite a while, and they would want to go in front of the advisory committee first," he said.

"So as long as we haven't had an advisory committee and we very likely - it's not official - but we very likely will have one, it's going to be impossible" to say when the drug might launch.

The delay caused by FDA's action letter put Cervarix even further behind Merck's Gardasil, which has been approved since 2006 and already has reached blockbuster status.

Nonetheless, GSK remains confident Cervarix will give Gardasil a run for its money. The company is conducting a head-to-head trial of the drugs, with data expected to be released this year.

"We are excited about our entry into this market with a product which I think will demonstrate better cross-protection over time," Garnier stated, adding, "We are seeing some clear indicator that that is a fact."

"Needless to say, Gardasil will do great because the market is gigantic, but so will Cervarix," the exec maintained.

Approval of Cervarix is one of several "swing factors" Garnier has cited that will influence growth for GSK this year; another is the potential for a rebound in Avandia sales, which Garnier talked up at the recent JPMorgan Healthcare conference (² (Also see "JPMorgan Healthcare Conference In Brief" - Pink Sheet, 14 Jan, 2008.), p. 12).

Sales of rosiglitazone plummeted after a meta-analysis was released last May showing the type 2 diabetes drug was associated with an increased risk of heart attack. Avandia revenuesdropped 29 percent to £780 million ($1.6 billion) in the U.S. for the full year, with fourth-quarter revenues falling 55 percent to £130 million ($266 million), GSK reported.

The fact that the cardiovascular issues also may be seen with other type 2 diabetes drugs could aid a recovery for Avandia, Garnier indicated during the earnings call.

In November, FDA required updated labeling for Avandia to include data on the risk of heart attacks and related events, but did not draw a distinction between the drug and other oral anti-diabetics (³ (Also see "Avandia Adds Black Box For Heart Attack Risk; Actos Launches Ads" - Pink Sheet, 19 Nov, 2007.), p. 3).

"We are seeing more and more evidence that when you treat type 2 diabetes patients ... you get a small, very faint cardiovascular signal no matter what product you take," Garnier asserted. "That's what the FDA said, that's what the ACCORD [study] showed," he added.

Garnier referred to the National Heart, Lung, and Blood Institute's Action to Control Cardiovascular Risk in Diabetes trial, which was halted partially Feb. 6 because of an increased risk of death in patients who were being treated to intensively low blood glucose levels.

The trial "completely exonerated Avandia because they did a subanalysis - there were 2,000 patients on Avandia [and] that's not a small group - and they saw ... the negative effect on cardiovascular and mortality was due to all products; it wasn't due to Avandia," Garnier asserted.

While Avandia's earnings performance in 2007 was dismal, there were several bright spots for the company during the year, including its vaccines business, which grew 20 percent to £2 billion ($4.0 billion) during the year, driven by growth of 44 percent to £628 million ($1.3 billion) in the U.S.

Sales in GSK's Requip (ropinirole) franchise grew 36 percent to £346 million ($692 million) in the year. The non-ergot dopamine agonist, approved for Parkinson's disease and restless legs syndrome, is expected to lose patent protection in May, and GSK is seeking to transition Requip patients to newer versions of the drug ahead of that date. Extended-release Requip XL is under review, but GSK announced Feb. 5 that FDA has pushed back the user fee date to the second quarter.

- Brooke McManus ([email protected])