Quote from NoDoji:
Still biotechs always run the risk of an adverse news event driving the price into the toilet, even after an approval of a drug. Seems like MUCH safer ways to be long than naked puts. IMHO.
Dendreon Shares Fall As Medicare Considers Provenge Coverage
6:23 PM ET 6/30/10 | Dow Jones
By George Stahl
NEW YORK (Dow Jones)--Dendreon Corp. (DNDN) shares plunged in late trading Wednesday after the U.S. government said it would analyze whether covering the costs of the company's expensive immunotherapy treatment for prostate cancer is "reasonable and necessary."
The answer to that debate--the latest hurdle in Dendreon's push to get Provenge used--will affect sales of the treatment. If the Centers for Medicare and Medicaid Services covers it, that would increase the number of patients eligible and likely force private insurers to do the same. A denial by CMS could severely stifle the product's growth.
The Provenge question is also seen as a test of President Barack Obama's health-care reform bill. The government's costs from the treatment could rise significantly when the 32 million currently uninsured Americans are expected to join the nation's health-care system in 2014.
The Centers for Medicare and Medicaid Services said Wednesday that it expects to complete its assessment by this time next year, with the public comment period lasting until July 30 and a proposed decision memo due March 30. It's unclear what CMS' investigation means for the drug's sales in the short term.
Dendreon shares, which fell 3.8% during the regular session, fell an additional 23% in after-hours trading to $24.95. Dendreon officials weren't available for comment.
Provenge, seen as the first in a new class of cancer-fighting drugs, is designed to use a patient's own cells to stimulate the body's immune system to fight the cancer. However, because of its complexity, a normal three-infusion course of treatment is expected to cost $93,000, making it difficult to pay for without insurance support.
When the Food and Drug Administration approved Provenge in April, Dendreon defended the treatment's price. Chief Operating Officer Hans Bishop said then that based on supporting clinical data, the price tag equates to about $23,000 per added month of survival for a patient, which "compares very favorably to many other widely used oncology products in similar advanced disease settings."
Prostate cancer is the second most common type of cancer among men in the U.S., behind skin cancer, and usually occurs in older men. In 2009, an estimated 192,000 new cases of prostate cancer were diagnosed and about 27,000 men died from the disease, according to the National Cancer Institute.
Dendreon had a tough time getting Provenge on the market. In 2007, the FDA rejected Provenge despite a unanimous vote from an expert panel in favor of the treatment. At the time, FDA said the two clinical studies submitted didn't meet study goals of reducing so-called time to progression, or the advancement, of cancer.
The rejection caused Dendreon's stock to plunge and provoked an uproar among some patients and investors. Two prominent cancer researchers who had urged the agency to wait for data from a large study before ruling on the treatment received death threats.
In 2009, Dendreon submitted additional data from a trial of 512 patients that showed an increase in overall survival of 4.1 months among those receiving Provenge. The median survival for patients receiving Provenge treatments was 25.8 months, compared with 21.7 months for those who didn't receive the treatment.