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Celgene (NASDAQ: CELG ) got a solid base hit but no home run. The company announced Tuesday evening that its phase 3 study of Abraxane in combination with gemcitabine for treating metastatic pancreatic cancer showed significant improvement in overall survival. However, shares were down slightly in after-hours trading. Here's why.
What it means
Relatively speaking, Abraxane plus gemcitabine blew the doors off use of gemcitabine alone. The median overall survival rate for patients taking the Abraxane combination was 8.5 months, compared to 6.7 months for those taking gemcitabine by itself. The one-year survival rate for pancreatic cancer patients using gemcitabine alone in the study was 22% compared to 35% for those who took the combination of both drugs. That equates to a 59% improvement, which is quite good.
Even better statistical improvement was found with two-year survival rates. Only 4% of patients taking gemcitabine alone survived for two years, while more than double the number of patients -- 9% -- survived two years when taking Abraxane with gemcitabine.
As for safety concerns, the most common adverse event related to the treatment was neutropenia, which is a reduction of white blood cells that fight infection. Thirty-eight percent of patients taking the Abraxane treatment experienced neutropenia versus 27% taking gemcitabine alone. The other top two adverse reactions were fatigue and neuropathy, with 17% of the Abraxane patients suffering from both conditions compared to 7% and 1%, respectively, for patients taking only gemcitabine.
Why didn't this good news score a home run? The company announced last November that the primary endpoint of the study was met, but no specifics were revealed at that time. That left investors and observers speculating about how good the results could be. Based on the market reaction, it appears that some might have been a little disappointed by the numbers.
Part of that disappointment likely stems from an even better median survival rate of 11.1 months achieved in a clinical study of Folfirinox, a combination of four different generic drugs. It should be noted, though, that no head-to-head studies of Abraxane vs. Folfirinox have yet been undertaken. Also, many oncologists have been hesitant to prescribe Folfirinox because it is highly toxic.
Despite the ho-hum initial market reaction to the Abraxane results, things look pretty good for the drug. Celgene will file for approval in the U.S. and Europe within the next few months. The company plans to seek approval in other countries in the second half of this year.
Assuming Abraxane gains approval for pancreatic cancer, it should find a receptive market because there are few good alternatives. With prior approvals for treating breast cancer and non-small-cell lung cancer and another indication possibly on the way with pancreatic cancer, Celgene projects that annual sales for the drug could top $1 billion by 2015.
Celgene's shares have risen 22% so far this year. The company perhaps hasn't hit a home run with Abraxane's pancreatic cancer results, but its shareholders certainly aren't striking out.
With Celgene's broad portfolio of drugs and a strong pipeline to boot, many investors see it as a smarter way to play the biotech investing game. While Celgene might be a safer stock than its small biotech brethren, investors need to know about the key opportunities and risks facing the company. We run through them all in The Motley Fool's brand-new premium report on Celgene. To claim your copy today, simply click here now.