12:00 AM
 | 
Jul 30, 2007
 |  BioCentury  |  Finance

Ebb & Flow

Pharmion (PHRM) had its second bad week in a row, weighed down by the unanimous recommendation of FDA's Oncologic Drugs Advisory Committee last Tuesday against accelerated approval of Orplatna satraplatin from GPC Biotech (FSE:GPC; GPCB).

PHRM slid $0.97 to $24.42 on the week, after losing $1.76 to $25.39 the prior Friday when the ODAC briefing documents suggested the agency would delay action on Orplatna until overall survival data become available (see Cover Story).

GPC granted PHRM European rights to the candidate to treat hormone-refractory prostate cancer (HRPC) patients who have failed prior chemotherapy. Last week, EMEA accepted PHRM's MAA for review. The filing is based on the same ongoing Phase III SPARC trial as the GPC filing, which had pain and radiological progression endpoints that were elements of the co-primary progression-free survival (PFS) endpoint.

"What impact the ODAC meeting may have on our filing is unknown," said President and CEO Patrick Mahaffy on PHRM's earnings call last week. "But it certainly could raise the importance of overall survival in the review process."

On a conference call, GPC said it would need about six months to provide overall survival data. On its call, PHRM said it anticipates having overall survival data to submit to EMEA by fall, but that it has until February to do so. Mahaffy acknowledged that there has been "a lot of confusion" about when the data would emerge, but said he does not think the companies have disparate timelines.

Max Jacobs of Mehta Partners suggested EMEA would wait to make a decision until PHRM submitted overall survival data, which he expects in 1Q08. But based on the interim survival data, Jacobs suspects the trial will show little survival benefit.

"What will probably have to happen is another survival trial," he said. "This one took four years beginning to end; I would expect it would take at least that long for another trial."

Jacobs suggested the companies would be likely to proceed with another study since satraplatin has shown "modest efficacy," but that PHRM may want to renegotiate the deal.

"The deal was based on the assumption that Phase III was almost done and it would be on the market in a couple of years," Jacobs noted. In PHRM's position, "I would definitely negotiate that royalty down to a much lower level."

GPC currently is eligible for royalties of 26-30% on sales up to $500 million and 34% on sales above that.

Collateral damage

GlaxoSmithKline (LSE:GSK; GSK) disclosed the first full quarter of Coreg CR carvedilol sales last week and the numbers failed to move investors in Flamel (FLML), whose Micropump technology is used in the formulation. The biotech's shares lost $2.79 (13%) to $18.71 on the week.

The once-daily, extended-release formulation of the adrenergic receptor beta blocker to treat hypertension, heart attack and heart failure had 2Q sales of £10 million ($20.3 million). GSK reported that Coreg CR scrips now account for 21% of new prescriptions for the Coreg franchise, which brought in £202 million ($411 million) in total, up 37% from 2Q06.

The pharma noted Coreg CR lost momentum after a strong start last quarter when the attention of the sales force "turned to defend the Avandia franchise," which has come under siege since The New England Journal of Medicine suggested that diabetics taking Avandia rosiglitazone had an increased risk of myocardial infarction (MI) and death from cardiovascular causes (see BioCentury, May 28).

On its earnings call, GSK President of Pharmaceutical Operations David Stout said the company had "made adjustments" to its Coreg CR sales force...

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