Champs & Chumps ..........Stock Market Winners & Losers

Wednesday, September 13, 2006

Stock Market Chumps..........9-13-06

Oscient Pharmaceuticals Corp. (OSCI)


Last Trade:1.00
Trade Time:12:02PM ET
Change:Down 0.14 (12.28%)

Oscient Pharmaceuticals Unlikely to Get Factive Acute Bacterial Sinusitis Approval From FDA

Drug maker Oscient Pharmaceuticals Corp. said Wednesday that an advisory panel to the Food and Drug Administration recommended the agency not approve the company's anti-infective drug Factive for the treatment of acute bacterial sinusitis.

Shares of Oscient fell 20 cents, or 17.5 percent, to 94 cents on the INET electronic exchange, after closing at $1.14 on the Nasdaq. Shares have traded between 60 cents and $2.81 over the past 52 weeks.

The FDA advisory panel voted 10 to 4 that data from the company's clinical trial showed that the treatment was not effective as a five-day treatment for acute bacterial sinusitis, or inflammation of the sinuses caused by bacteria. The panel also voted 11 to 2 that the benefits of the drug did not outweigh the risks in treating ABS.

The agency is set to rule on the company's application for ABS by Dec. 15. While the FDA is not bound by panel recommendations, it usually follows them. An approval doesn't look likely as the FDA earlier accepted the application under protest.

The company also has a Factive application on file as a five-day treatment for community-acquired pneumonia. The FDA is set to decide on that application by Sept. 21.

Factive is currently FDA-approved as a five-day treatment for worsening acute chronic bronchitis caused by bacteria, and as a seven-day treatment of mild to moderate community-acquired pneumonia.

Cardiome Pharma Corp. (CRME)

Last Trade:12.00
Trade Time:12:03PM ET
Change:Down 1.31 (9.84%)

Cardiome Reports Positive Heart Drug Data With Lower Dose Better Than Higher Dose

Cardiome Pharma Corp. said Wednesday that a mid-stage clinical trial showed its experimental drug normalized heartbeats in patients with the lower dose performing better than the higher dose.

The Phase IIa trial treated patients with atrial fibrillation, a type of irregular heart beat where the upper chambers of the heart quiver and do not pump blood effectively to the lower chambers. Patients were given either 300 milligrams or 600 milligrams of RSD1235 or a placebo intraveneously.

In the 300 milligrams group, 61 percent of patients had a normal heartbeat by the end of the study, compared with 43 percent taking placebo. This difference was statistically significant, the type of difference the Food and Drug Administration looks for in a drug application.

However, in the 600 milligram group, the difference was not statistically significant even though the percentages were the same, because fewer people participated in the higher-dose group.

When both dose groups were combined, the difference was statistically significant.

Cardiome Pharma shares fell $1.25, or 9.4 percent, to $12.06 in morning trading on the Nasdaq.

International Coal Group, Inc. (ICO)

Last Trade:4.54
Trade Time:11:59AM ET
Change:Down 0.99 (17.90%)

International Coal Group Inc. on Tuesday cut its 2006 outlook due to idling of its Sycamore 2 mine and continued cost pressures at operations in the central and northern Appalachian regions.

The company now expects a net loss of $10 million to $15 million, or 7 cents to 10 cents a share, on revenue or $900 million.

International Coal had previously forecast net earnings of $23 million to $33 million, or 15 cents to 21 cents a share, on revenue of $1 billion.

Analysts on average expect the company to earn 30 cents a share, before items, on revenue of $1 billion for the year, according to Reuters Estimates.

The company said its results to date were hit by $15 million due to the Sago mine accident and the Viper mine fire.

International Coal now expects 2006 coal production of 17 million tons and sales of 20 million tons, down from its earlier production forecast of 18 million tons and sales of 22 million tons.

For 2007, the company forecast 2007 coal production of 17 million to 19 million tons, with sales of 18 million to 20 million tons, compared to its previous forecast of 22 million to 24 million tons of production and 23 million to 25 million tons sold.

Napco Security Systems Inc. (NSSC)

Last Trade:6.20
Trade Time:12:07PM ET
Change:Down 1.31 (17.44%)

Napco Security Systems Profit Rises in 2006, but Results Below Analyst Expectations

Napco Security Systems Inc., a supplier of electronic security equipment, said Wednesday fiscal 2006 profit grew 9 percent, but results missed Wall Street expectations.

Profit for the year ended June 30 totaled $6.1 million, or 30 cents per share, versus $5.6 percent, or 28 cents per share, a year ago.

Analysts expected a profit of 37 cents, according to a poll by Thomson Financial.

Revenue grew 7 percent to $69.5 million from $65.2 million last year.

Napco did not provide quarterly earnings results.

The company is working with security company ADT to develop a security system called SafeWatch EZ by ADT and expects it to be a "significant contributor" to revenue in the future.

In a statement, Richard Soloway, Napco chairman and president, said the company was "cautiously optimistic" that it would improve shareholder value in fiscal 2007.

Shares fell 58 cents, or 7.7 percent, to $6.93 during morning trading on the Nasdaq. The stock has traded between $4.44 and $11.84 during the past 52 weeks.







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