* Prostate cancer drug shown to improve overall survival
* Independent committee: placebo patients should take drug
* Drug could surpass Zytiga, Provenge -analysts
* Redemption for Medivation after Alzheimer's setback
* Medivation shares soar 110 percent
By Esha Dey and Lewis Krauskopf
Nov 3 A prostate cancer drug from Medivation
Inc helped patients live longer in a late-stage study,
sending the company's shares soaring on hopes that it will
become a strong contender in an estimated $9 billion market.
Medivation said on Thursday that an independent monitoring
committee even recommended stopping the clinical trial of the
experimental drug, MDV3100, after seeing interim results,
arguing that they showed enough benefit to warrant giving the
experimental drug to patients who were taking placebo.
Shares of Medivation more than doubled to $34.79 in heavy
trading, giving the company a market value of about $1.2
billion. It is developing MDV3100 with Japanese partner
Astellas Pharma Inc .
If approved, the Medivation pill could become the favored
treatment in a new generation of prostate cancer medicines,
surpassing Johnson & Johnson's Zytiga, also taken
orally, and Dendreon's infusion Provenge, analysts
Prostate cancer kills about 250,000 men a year globally and
is the second-most common cause of cancer death in men in the
United States, after lung cancer.
Better understanding of the molecular abnormalities
underlying prostate cancer has led to new approaches to
treating patients. Decision Resources, a healthcare advisory
firm, expects global sales of prostate cancer drugs to more
than double to $8.9 billion in 2019 from nearly $4 billion in
Medivation's prostate cancer success would also represent a
comeback for the company and its chief executive officer, David
Hung. MDV3100 is their main product after a closely watched
experimental drug for Alzheimer's failed in a late-stage study
in March 2010, slashing the company's share price from $40.
Hung, who owns 3.5 percent of the company according to
recent data, will also benefit from the 110 percent share
surge. Medivation's largest shareholders are investment funds
QVT Financial LP and Lansdowne Partners.
MEASURING UP TO RIVALS
The company's interim analysis found that MDV3100 improved
median overall survival by 4.8 months compared with a placebo.
The estimated median survival for men treated with the drug was
18.4 months, while those treated with placebo had a survival of
Wall Street was expecting a benefit of about three months,
according to JPMorgan analyst Geoff Meacham.
Medivation's data comes as Dendreon late on Wednesday
forecast only modest sales growth for its Provenge prostate
cancer vaccine for the next several quarters.
Dendreon shares were down 35 percent at $6.77.
The Phase III trial, named Affirm, tested MDV3100 against
placebo in 1,199 men with advanced prostate cancer who were
previously treated with chemotherapy based on the generic
Medivation and Astellas plan to meet with the U.S. Food and
Drug Administration early next year and will provide an update
on when they might seek approval for the drug. Analysts expect
approval at the beginning of 2013.
While both MDV3100 and Zytiga work by targeting the male
hormone testosterone that fuels prostate cancer cell growth,
their mechanisms differ.
Zytiga works inside cancer cells to block testosterone
production, while MDV3100 aims to interfere with the ability of
testosterone to bind to prostate cells.
Zytiga improved median overall survival by 3.9 months, so
"MDV3100 does look better than Zytiga from an efficacy
perspective," JPMorgan's Meacham said in a research note.
While Medivation did not give any details on MDV3100's
safety profile, the drug's main advantage over Zytiga is that
it does not need to be taken with a steroid.
The J&J drug can cause hypertension and liver damage and so
has to be taken in combination with the steroid prednisone.
Prednisone, in turn, has several side-effects ranging from
weight gain and pain to depression and weakness.
"Prednisone degrades the quality of life, which is very
important to this patient population," Wedbush Securities
analyst David Nierengarten said.
"When (MDV3100) is on the market it will displace Zytiga.
It is a once-a-day pill without prednisone, and beats Zytiga
which is twice-a-day with prednisone, very easily."
Shares of J&J were up 1 percent at $64.25.
Dendreon's Provenge also extended life by about four months
on average in clinical trials. But the infused product is
expensive at $93,000 for a course of therapy, and is a more
complicated approach that has been slow to gain physician
Provenge works by spurring a patient's immune system to
attack cancer cells, and so each therapy is individually
tailored to a patient.
One mitigating factor for Provenge could be that it is
approved for use prior to chemotherapy, while Zytiga and
MDV3100 have been tested for patients who have already taken
chemotherapy, so they may not be direct rivals.
However, analysts noted, Zytiga and MDV3100 are being
tested in a pre-chemo setting.
Provenge and MDV3100 "are two very different treatments and
target different populations, but that said, this news does not
bode well for Dendreon," Global Hunter Securities analyst Brian