Ariad, Cephalon Make ASH Splash: BioBuzz

 

CAMBRIDGE, Mass. (TheStreet) -- An early-stage leukemia drug from Ariad Pharmaceuticals(ARIA) 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 Novartis'(NVS) Gleevec and Tasigna and Bristol-Myers Squibb's(BMY) 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 Cephalon's(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)

Hemispherx Biopharma(HEB) 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 refused to approve the company's chronic fatigue syndrome 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 after 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)

BioCryst Pharmaceuticals'(BCRX) 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 less severe than previously feared and may not cause any more patient hospitalizations or deaths than the typical seasonal flu, according to a new study published Monday in PLoS Medicine.

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.

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