SEATTLE, Wash. (
) --Danger Will Robinson! Danger!
CEO Jim Bianco is on the road again -- and he has
Rodman & Renshaw
bankers in tow.
A little birdie tells me that Bianco was in New York City last week meeting with investors and talking up the company's prospects, including what he predicts will be very early approval of the cancer drug
by the U.S. Food and Drug Administration.
Bianco reportedly told investors that pixantrone should be approved this month, well ahead of the expected approval decision date in April, my source says. How or why FDA would choose to approve pixantrone early wasn't explained, especially since FDA has been delaying, not accelerating, drug approvals this year.
Bianco did make similar comments about an early pixantrone approval during the third-quarter conference call in early November.
Bianco's New York visit was billed as a non-deal road show but then, when Rodman bankers are involved, "non-deal" tends to be a very fungible term. Don't be surprised to see Cell Therapeutics raising money if, or when, pixantrone receives a positive FDA nod. Then again, don't be surprised to see Cell Therapeutics raise money if pixantrone's approval is
Bianco + Rodman = Dilution.
Ariad, Cephalon Make ASH Splash
(At 10:45 AM EST)
An early-stage leukemia drug from
generated some positive buzz at the American Society of Hematology (ASH) annual meeting.
Data from a Phase I study of AP24534 showed that the drug had activity in patients with resistant or refractory chronic myeloid leukemia (CLL) and Philadelphia-chromosome positive acute lymphoblastic leukemia (Ph+ CLL.) These are hard-to-treat patients because current leukemia drugs, including
Gleevec and Tasigna and
Sprycel, have limited or no positive effect.
Ariad wants to start a pivotal study in refractory CML patients next year, but the bigger news may come if the company can find a Big Pharma partner for the drug.
Ariad shares were up 4% to $2.57 in recent trading.
In other ASH-related news, the body of clinical data supporting use of
( CEPH) Treanda as a new standard of care in first-line non-Hodgkin's lymphoma (NHL) continues to grow.
Newly diagnosed NHL patients treated with a combination of Treanda and Roche/Genentech's Rituxan demonstrated superior progression-free survival (55 months) compared to patients treated with the current standard of care, Rituxan plus a chemotherapy cocktail known as CHOP (35 months), according to final results from an investigator-led proof-of-concept study.
The R-Treanda regimen was also safer and better tolerated than R-CHOP, with lower rates of infection and nerve damage reported.
Treanda is currently approved for more advanced NHL patients that fail to respond to R-CHOP. Getting Treanda's label expanded to include first-line NHL would translate into a big sales boost, but the data from this one study isn't likely sufficient for that to happen.
An interim step might be to get a compendia listing for Treanda in first-line NHL, which would allow the drug to be reimbursed by certain insurers, including Medicare, even without an approved label.
If Cephalon can get this done in 2010, Treanda sales -- which have been a bit stagnant lately -- will re-accelerate, says J.P. Morgan analyst Chris Schott, in a note to clients Tuesday.
Cephalon shares were down fractionally to $56.38 in recent trading.
Hemispherx CEO Buys After Stock Collapse
(At 9:56 AM EST)
CEO Bill Carter purchased 30,000 shares of the company's common stock on Dec. 7. The purchase price was 57 cents a share, according to a filing with the Securities and Exchange Commision.
No doubt, Carter is hoping to send a message that he's confident in Hemispherx's future, even though the Food and Drug Administration
drug last week. That rejection sent Hemispherx shares tumbling, inflicting the big hurt on existing shareholders.
Carter spent $17,100 on his open market purchase of Hemispherx stock, which is chump change compared to his $600,000-plus annual salary and the $300,000 bonus awarded to him in May.
If Carter wants investors to start believing him, he might work on improving his dismal, decades-long track record of
false promises and dead-end drug development
. Buying stock
Hemispherx blows up, costing his shareholders tons of money, isn't exactly going to inspire much confidence or sympathy.
Slowing Swine Bursts BioCryst Bubble
(At 9:11 AM EST)
stock price continues to fall as H1N1 flu activity wanes in the U.S., signaling less need for its intravenous antiviral drug peramivir.
Despite all the worries, the H1N1 pandemic appears to be
and may not cause any more patient hospitalizations or deaths than the typical seasonal flu, according to a new study published Monday in
The study used H1N1 activity data reported by health officials in Milwaukee and New York City -- two cities with a good track record of reporting consistent flu data -- to re-assess the virus' overall impact on hospitalizations and death rates.
The study's findings "suggest that an autumn–winter pandemic wave of pH1N1 will have a death toll only slightly higher than or considerably lower than that caused by seasonal influenza in an average year, provided pH1N1 continues to behave as it did during the summer. Similarly, the estimated burden on hospitals and intensive care facilities ranges from somewhat higher than in a normal influenza season to considerably lower," according to a editor's summary of the study available on the
The study does caution that a H1N1 flu activity could increase again in January, although an increase in the vaccination rate against the virus decreases the likelihood of a flu resurgence.
You can download the study
report on the study can be found
remains mum on international stockpiling orders for peramivir. Foreign media outlets have reported small purchases of peramivir in Israel, Mexico and South Korea, but BioCryst has yet to make any announcement. A story published just after Thanksgiving in the
reported that the country's public health agency had ordered "200 doses", or courses, of peramivir.
BioCryst shares closed Monday at $7.05. The stock is down 42% since hitting a mid-November high of $12.32.
-- Reported by Adam Feuerstein in Boston
Adam Feuerstein writes regularly for TheStreet.com. In keeping with TSC's editorial policy, he doesn't own or short individual stocks, although he owns stock in TheStreet.com. He also doesn't invest in hedge funds or other private investment partnerships. Feuerstein appreciates your feedback;
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