January 9, 2015
By Riley McDermid, BioSpace.com Breaking News Sr. Editor
Shares were up in morning trading Friday after Pfizer Inc said late Thursday that its breast cancer drug palbociclib has begun its label review by the U.S. Food and Drug Administration, a sign Wall Street is taking to mean that the drug will soon be approved for consumers.
Pfizer’s share price was up about 3 percent in early morning trading to $32.57.
Indeed, the FDA talks have appeared to leapfrog the standard advisory committee meeting typically held in this portion of a drug’s regulatory approval process. That likely is a sign that the drug is on schedule to be approved by its previously set April 13 decision date, if not before.
Palbociclib has already been given the brand name Ibrance and has been warmly received by analysts who follow biotech. Annual sales of the drug have been forecast at $3 billion but some analysts have estimated it could bring in as much as $5 billion annually. It is part of a class of drugs called CDK4/6 inhibitors, which block two enzymes, CDK4 and 6, which typically make cancer cells divide and reproduce rapidly.
In its most recent trial, the drug almost doubled the time it took for breast cancer to progress or get worse, though Pfizer has not yet produced data to show its effects on rates of survival. Dubbed PALOMA 1, the mid-stage study enrolled 165 women who received Ibrance either alone or with a supplementary drug, letrozole. The cancer for the women taking Ibrance did not worsen for 20.2 months on average, which is twice as long as for women only receiving letrozole.
“The statement from Pfizer this morning that there is no FDA Adcom (advisory committee) planned for palbo reaffirms our high confidence for a first pass approval in April,” wrote Jeffrey Holford, an analyst for boutique bank Jefferies, in a note to investors.
The drug has long been considered one of the Pfizer’s most promising experimental therapies, with the value it could add to the company’s cancer drug pipeline a considerable factor when analysts have calculated future earnings for the drugmaking giant.
“We think consensus continues to underestimate this opportunity,” said Holford. In a note to investors late Thursday, Credit Suisse analyst Vamil Divan said he’s “somewhat surprised” by the news but not surprised that the agency is working hard to make the drug available.
“We have consistently believed this is a product that the FDA sees value in and is committed to getting to the market as quickly as possible,” said Divan.
