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Abraxane's Approval for Pancreatic Cancer Is a Major Milestone for Celgene

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The Food and Drug Administration's recent approval for Celgene's (NASDAQ: CELG  ) Abraxane as a treatment for pancreatic cancer is good news for the patient community. However, it also makes the pancreatic cancer treatment market highly competitive. For Celgene, the approval is a major milestone that is expected to boost sales of Abraxane, which has already been approved for the treatment of breast and lung cancers.

FDA approval
Earlier this month, the FDA approved Celgene's supplemental New Drug Application, or sNDA, for Abraxane as first-line treatment for patients with metastatic adenocarcinoma of the pancreas, in combination with gemcitabine.

The approval is also a milestone for the pancreatic cancer treatment market as Abraxane is the first new treatment approved for metastatic adenocarcinoma of the pancreas in nearly eight years. The approval came after a study showed that Abraxane in combination with gemcitabine delivered an overall survival of 8.5 months, compared with 6.7 months for patients who received only gemcitabine.

The pancreatic cancer treatment market
According to estimates from the American Cancer Society, around 45,220 people (22,740 men and 22,480 women) will be diagnosed with pancreatic cancer in the U.S. this year. Around 38,460 die each year from the disease.

Despite the high prevalence of pancreatic cancer, the global market for pancreatic cancer treatment is valued at only $700 million, according to research firm Decision Resources. However, the research firm expects the treatment market in the U.S. to grow to $829 million by 2019. The focus currently is on the development of novel drugs for treatment along with chemotherapy.

Existing treatment options for advanced pancreatic cancer include Sutent, Afinitor, Tarceva, and Gemzar. Pfizer's (NYSE: PFE  ) Sutent already has a strong base in the treatment of pancreatic cancer. The drug is also used as treatment for advanced renal cell carcinoma, including metastatic renal cell carcinoma, or mRCC, and gastrointestinal stromal tumors. Sutent had sales of $615 million in the first half of 2013, with U.S. sales totaling $176 million and international sales totaling $438 million. While Sutent and Abraxane are approved to treat different types of pancreatic cancers, Pfizer's success in this market may give Celgene investors a glimpse into how this expanded approval can help boost its sales.

Novartis' (NYSE: NVS  ) Afinitor has been approved in the U.S. and EU for five indications, including advanced pancreatic cancer. In the first half of 2013, the product registered sales of $611 million, up 94% on a constant currency basis.

Despite the available treatment options, there has been a need for treatment advances to improve patient outcomes as noted by Julie Fleshman, who serves as president and CEO of the Pancreatic Cancer Action Network. Abraxane's approval is a major development for Celgene, as well as the overall pancreatic cancer treatment market.

Approval to boost Abraxane sales
Abraxane sales had totaled $427 million in 2012, representing an increase of 11% over the previous year. Abraxane sales accounted for around 8% of the company's net product sales in 2012. In the second quarter of 2013, Abraxane sales totaled $155 million, up 41% on a year-over-year basis. Abraxane sales accounted for approximately 10% of the company's total net product sales.

With the latest approval, Abraxane's contribution to Celgene's top line is likely to increase. Of course, the approval will also boost Celgene's top-line growth.

A major development for Celgene
As the numbers suggest, the approval of Abraxane as a first-line treatment for metastatic pancreatic cancer is a major development for Celgene. Abraxane sales account for around 10% of the company's net product sales, and its contribution is expected to increase even further with the latest approval.

In addition, the pancreatic cancer treatment market in the U.S. is expected to grow significantly over the next few years. Given all these factors, Abraxane could provide a significant boost to Celgene's top line.

Editor’s Note: A previous version of this article did not clearly distinguish between drugs that treat metastatic adenocarcinoma of the pancreas and pancreatic neuroendocrine tumors. This article has been edited and the Fool regrets the error.

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