Dendreon Corporation (NASDAQ: DNDN) is indicated higher this morning on news that came out last night. The company announced support for broad availability for on-label use of Provenge for asymptomatic or minimally symptomatic metastatic castrate resistant prostate cancer. The FDA also this week approved Dendreon’s Los Angeles immunotherapy manufacturing facility with 36 workstations. The big win is Medicare coverage.
Dendreon reported that the Centers for Medicare and Medicaid Services issued a final coverage decision for PROVENGE that will require Medicare contractors to cover the use of PROVENGE for treatment of asymptomatic or minimally symptomatic metastatic castrate resistant prostate cancer. The coverage decision will standardize coverage processes across the country for all Medicare patients in need of the drug.
The move provides local Medicare Administrative Contractors the specific criteria, which is said to be “consistent with the label,” on how PROVENGE should be covered. PROVENGE was also issued a product specific Q-code effective July 1, 2011.
Dendreon will also support programs to provide comprehensive assistance for eligible patients seeking access to treatment with PROVENGE. This will include grants to independent foundations and establishment of a patient assistance program for uninsured patients.
PROVENGE was approved by the FDA in April 2010, but what had been under attack was the $93.000 price tag for the treatment. Many felt that was too high. We do not have a formal “sale price” per treatment yet under Medicare coverage that will be paid to Dendreon but this is being treated as a win for PROVENGE and a win for Dendreon.
Dendreon shares closed at $39.44 on Thursday and the 52-week trading range is $25.78 to $43.96. Volume is thin so far with more than two hours until the market opens but shares are indicated up around $41.00 in pre-market trading.
In early May came a report that Dendreon was given an “Underperform” rating by Credit Suisse; late in May came a “Buy” rating from ISI Group. Goldman Sachs also initiated coverage with a “Buy” rating in early June.
JON C. OGG