West Coast Editor
Thanks to priority review status, action is due by May 15 on Dendreon Corp.'s biologics license application for the prostate cancer drug Provenge (sipuleucel-T), accepted last week by the FDA, renewing talk among analysts about the drug's chances.
"We believe that the complicated nature of the application, including secondary statistical analysis, may require a longer review period at the FDA," wrote Joel Sendek, with Lazard Capital Markets, in a research report.
Priority review, Sendek pointed out, is "based on the indication rather than the quality of the data submitted." He has a "hold" rating on the stock. Dendreon submitted the final portion of the BLA in November.
For the Seattle-based firm, much is riding on Provenge against hormone-refractory prostate cancer, a product that emerged from Dendreon's Antigen Delivery Cassette technology. It deploys a recombinant form of prostatic acid phosphatase, an antigen found in 95 percent of prostate cancers.
About a year ago, the company said goodbye to about 15 percent of its work force from early stage research and development programs and general functions, freeing resources for new manufacturing and marketing jobs ahead of Provenge's hoped-for approval. (See BioWorld Today, Jan. 23, 2006.)
Dendreon based the BLA on data from the rather small D9901A Phase III trial (127 patients), supplemented with results from the second Phase III study, called D9902A. The improvement in overall survival shown in the first trial was achieved by way of a secondary statistical analysis, "which we believe the FDA will view with skepticism," Sendek wrote.
Results from both trials, he added, are "confounded by treatment with Taxotere [docetaxel]," the approved chemotherapeutic agent for prostate cancer that Provenge would compete against, from Paris-based Sanofi-Aventis Group.
Sendek wrote that he doesn't expect approval until after data are produced by an ongoing, larger Phase III trial called D9902B (500 patients) which is "more straightforward in design" than earlier trials and should give the FDA a clearer idea about Provenge's safety and efficacy.
Analyst Jonathan Aschoff with Brean Murray Carret & Co. in New York told BioWorld Today last week that his negative position on Provenge is unchanged. In a research report at the start of 2005, when data from the D9902A study were disclosed, Aschoff said a rating was "already long overdue." Dendreon's stock plunged more than 26 percent on results. (See BioWorld Today, Jan. 12, 2005.)
Aschoff said he expects Dendreon's stock will drop into the $2 range, since the FDA will probably require more data. Friday the stock (NASDAQ:DNDN) closed at $4.33, up 3 cents.
Mark Monane, analyst with Needham & Co. in New York, has a "buy" rating on the stock, and agreed that D9902B's results will be important in the push to win Provenge approval. He also noted the FDA's "increasingly conservative viewpoint toward first-time applications."
Meanwhile, Monane predicted the Provenge BLA will be reviewed in the next meeting of the FDA's Oncologic Drugs Advisory Committee in March, providing clues to the agency's view of the trials so far.