Celgene's Swiss Army Knife

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Celgene (Nasdaq: CELG  ) could have the pharmaceutical equivalent of a Swiss army knife with its drug Abraxane. The biotech company announced today (in Switzerland, of course) the latest results from phase 3 studies of Abraxane in treating metastatic melanoma. Patients receiving Abraxane showed statistically significant improvement in progression-free survival compared with patients receiving dacarbazine chemotherapy.

What it means
The positive results from the phase 3 studies related to metastatic melanoma mean that Celgene will likely submit another NDA for Abraxane in the near future. If the company gains approval, Abraxane appears to be on its way for potential blockbuster status.

Celgene made $214 million from Abraxane sales in the first six months of this year for its use in the second-line treatment of metastatic breast cancer. Citi Investment Research analyst Yaron Werber estimates that use of the drug in treating melanoma could garner more than $1 billion in annual revenue in the U.S. alone.

The company would first need to get past a couple of drugs already approved for treating melanoma. Bristol-Myers Squibb (NYSE: BMY  ) sells Yervoy, which helps the body's immune system fight against the cancerous cells. Roche (through its Genentech subsidiary) and Daiichi Sankyo market Zelboraf, the first treatment for BRAF mutation-positive metastatic melanoma approved by the Food and Drug Administration.

Looking ahead
Several major announcements for Abraxane loom large in the days ahead.

The FDA is due to announce its decision on approval of the drug for first-line treatment of advanced non-small-cell lung cancer by Oct. 12. A positive decision could catapult Celgene into competing against the likes of Pfizer (NYSE: PFE  ) , with its Xalkori lung cancer drug.

Many investors also eagerly await the phase 3 pancreatic cancer study for Abraxane. At the European Society of Medical Oncology conference held last weekend, Threshold Pharmaceuticals (Nasdaq: THLD  ) hoped to make an impression on additional analysis about the performance of TH-302 compared with gemcitabine, a drug originally sold by Eli Lilly (NYSE: LLY  ) . However, attendees were more anxious to talk about forthcoming results for the Abraxane study.

Abraxane also has phase 2 trials under way for the treatment of bladder cancer, ovarian cancer, and first-line treatment of breast cancer. Positive results from any of these studies could further boost Celgene's momentum.

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Fool contributor Keith Speights has no positions in the stocks mentioned above. The Motley Fool has no positions in the stocks mentioned above. Try any of our Foolish newsletter services free for 30 days. We Fools may not all hold the same opinions, but we all believe that considering a diverse range of insights makes us better investors. The Motley Fool has a disclosure policy.

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  • Report this Comment On October 03, 2012, at 3:51 PM, CoraSchlesinger wrote:

    This has been a top performer since I bought it in 1995-6 @ split equivalent 70 cents/shr/ 30M MC. In my brag book. Current highest tp is $91. Other tp was raised from $64 to $75 yest, when stock was trading at $78.

    If Revilimid is successful for CLL, and in particular for non-Hodgkins lymphoma, both in phase III, it would take the roof off.

    MDS indication would compete with Vidaza, I suppose as one stop for 1st and 2nd line drugs.

    Abraxane is as you described, w/ 3 indications in phase III, and looking like NSCLC is about ready to submit.

    Plus Celg has been hiring like crazy lately, as you can observe:

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