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Pharmasset share price gets a boost after 100-percent cure rate in HCV trial
11-08-2011
EDIT CONNECT
SHARING OPTIONS:
PRINCETON,
N.J.—Nov. 6 saw the announcement by Pharmasset
Inc. that its
experimental drug PSI- 7977 demonstrated a cure rate of 100
percent among hepatitis C patients in the company's Phase II study of the
compound. That
shot the company's stock prices up by more than 8 percent at
some points over the next day, at one point climbing as high as $74.45, though
shares
closed closer to $72 by the end of trading on Nov. 7. By Nov. 8, they
had dropped back to around $69, comparable to the price prior to the
announcement.
Overall, Pharmasset's shares have shown an upward
trend in the past 12 months,
rising from around $20 last November, reaching the
30s by March 2011, hitting the 50s in April and remaining mostly between $60
and $80 since June.
Presenting its data at the annual meeting of the
American Association for the Study of Liver
Diseases in San Francisco, the
company reported that all 40 patients who received PSI- 7977 drug in the
ELECTRON study were responsive after 12 weeks,
about half the patients had been
followed up to 24 weeks, and they were all cured of their HCV infection—with no
significant adverse events.
Notable was the group of 10 patients with genotype
2/3 HCV who received a 12-week course of the
nucleotide analog PSI-7977
combined with ribavirin but without pegylated interferon. The other three
groups took PSI-7977 plus ribavirin with either
four, eight or 12 weeks of
pegylated interferon as well, according to Dr. Edward Gane, of the Auckland
City Hospital in Auckland, New Zealand, and a member of the ELECTRON study team.
This is in line with earlier studies of PSI-7977,
such as the PROTON study in which PSI-7977 combined
with pegylated interferon
plus ribavirin resulted in sustained virologic responses in 96 percent of study
volunteers with HCV genotype 2/3 and 91
percent of those with HCV genotype 1—the
most common type of the infection in the United States and the hardest to
treat.
Gane says that no "rescue" therapy was necessary
for the patients and that at virtually all study time points—weeks four,
eight
and 12 during therapy and weeks four, eight, 12 and 24 after completion of
treatment—100 percent of the patients in each group maintained
undetectable HCV
viral loads. He also notes that HCV viral load suppression was rapid in all
four treatment groups and that study participants were at
HCV levels below the
level of detection within three weeks of starting treatment.
Another good
sign from the study, Gane says, is
that all patients experienced a rapid normalization of key liver enzyme ALT—the
patients who didn't receive
interferon gained this positive sign by the end of
the third week of treatment.
Headache,
fatigue, depression, insomnia, anxiety,
irritability, muscle soreness and upper respiratory tract infections were side
effects more likely to be
documented in patients who were part of the 12-week
pegylated interferon group (72 percent), compared with those who didn't receive
any pegylated
interferon (40 percent). Some 70 percent of those in the 12-week
pegylated interferon group experienced moderate-to-severe drops in neutrophils,
though
no one in the interferon-free PSI-7977/ribavirin group experienced this
toxicity. In addition, PSI-7977 plus ribavirin without interferon also had much
less effect on hemoglobin levels, a marker of anemia.
Commenting on the 400 milligram, once-daily
dose
of the drug, Gane says, "PSI-7977 remains very well tolerated with no
attributable safety signal, no treatment discontinuations and no treatment
emergency laboratory abnormalities."
"Although patient numbers are small, we believe
the
results are extremely impressive," analyst Brian Abrahams of Wells Fargo
Securities wrote in a note to investors Nov. 7.
Responding to the study results at the American
Association for the Study of Liver Diseases meeting, analysts at Brean Murray
Carret issued a statement that "We believe this
validates the company's
decision to move into Phase III program with this [drug] combination and
supports a new front line standard of care in these
patients. Given the
substantially better safety profile, we believe it will be unethical to use
interferon in untreated Gt. 2/3 patients once PSI-7977
is approved."
Canaccord Genuity biotechnology analyst Dr. George Farmer is also bullish, claiming that this study provides "an
advance
signal of strong proof of concept from the ELECTRON trial, and lending support to our thesis that nucs such
as 7977 will represent the backbone of an
interferon-free future for HCV
therapy." He currently holds a "buy" rating on the company and a price target of $92.
However, TheStreet.com had a different
view on
Nov. 8, when Pharmasset's share prices dropped back into the 60s, rating
Pharmasset as a "Sell" and maintaining that "The company's
weaknesses can be seen in
multiple areas, such as its deteriorating net income, weak operating cash flow
and feeble growth in its earnings per share.
" Code: E11091101 Back |
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