Investors to Get $300M as FDA Approves Celgene Drug For Pancreatic Cancer

9/6/13Follow @benthefidler

Celgene’s 2010 buyout of Abraxis Bioscience is about to pay some more dividends for a whole lot of patients and investors.

The FDA today approved the Summit, NJ, company’s chemotherapy drug, protein-bound paclitaxel (Abraxane), to treat patients with advanced pancreatic cancer. The Celgene (NASDAQ: CELG) drug—which it acquired when it snared Abraxis three years ago—is already FDA approved to treat breast cancer and non-small cell lung cancer, but today’s decision gives it a presence in one of the toughest areas of cancer to break into.

Pancreatic cancer is the fourth-leading cause of cancer death in the U.S., despite the fact that it accounts for just over 2 percent of the cancers diagnosed annually. It is extremely fast-moving—by the time it is detected, the cancer typically can’t be surgically removed, and patients typically die within months.

This year, an estimated 45,220 patients in the U.S. will be diagnosed with the disease, and some 38,460 will die, according to the National Cancer Institute.

The FDA has cleared the Celgene drug to be used in combination with another chemotherapy drug, gemcitabine, in patients with pancreatic cancer that has spread to other parts of the body. In a late-stage clinical trial of 861 patients that Celgene wrapped up in January, that regimen helped a group of patients, on average, live 1.8 months longer than a group randomly dosed with gemcitabine alone. The combination regimen also helped slow the growth of patients’ tumors, on average, when compared to those on gemcitabine alone.

While that’s good news for patients, it also marks another payday for investors who bought into the contingent value rights, or CVRs, Celgene issued as part of the Abraxis deal. Those CVRs are tied to a stock that trades on the NASDAQ under the symbol CELGZ. Celgene initially paid $2.9 billion in cash and stock for Abraxis, but promised big payments to CVR holders down the road if the drug succeeded in clinical trials.

As part of the transaction, for example, Celgene agreed to pay those shareholders another $250 million if the drug was approved to treat non-small cell lung cancer—Celgene checked that box last year. That pot included a further $300 million payout upon approval of protein-bound paclitaxel as a pancreatic cancer therapy. The CVR holders will also start getting royalties on the Celgene drug if sales top $1 billion—something that is now possible given it’s approved for pancreatic cancer. The drug generated $427 million in 2012.

The CVR stock jumped about 3 percent in trading this afternoon, to $7.75 apiece as of 1:08 p.m. ET.

Some common side effects experienced by patients taking the drug were lower counts of white blood cells and platelets, vomiting, diarrhea, and nerve damage in the arms and legs, according to the FDA.

Ben Fidler is Xconomy's Deputy Biotechnology Editor. You can e-mail him at bfidler@xconomy.com Follow @benthefidler

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