FDA to decide on Bristol breast cancer drug

Bristol waiting on FDA review for chemotherapy treatment; decision expected by mid-October.

By Aaron Smith, CNNMoney.com staff writer

NEW YORK (CNNMoney.com) -- Bristol-Myers Squibb faces a moment of truth this month when the FDA decides whether its experimental chemotherapy for breast cancer is good enough for the U.S. market.

The Food and Drug Administration is expected to make its decision on the experimental chemo - called ixabepilone - by mid-October, said New Jersey drugmaker Bristol (Charts, Fortune 500).

If ixabepilone is approved, it would be used to prolong the lives of women with advanced stages of metastatic breast cancer. The FDA is reviewing this drug for use only by women who have tried - without success - two prior types of treatment.

Ixabepilone would not be a billion-dollar-a-year blockbuster, analysts say, but annual sales would still reach several hundred million dollars. Robert Hazlett of BMO Capital Markets and Joseph Tooley of A.G. Edwards project that annual sales will peak between $400 million and $500 million sometime after 2010.

"There's not much room for [new] chemotherapy when you have all the biologics [cancer drugs] out there," said Hazlett.

Ixabepilone is a "first-in-class" drug, according to Bristol, meaning that it works differently from other forms of chemotherapy on the market. It also works differently from non-chemo breast cancer drugs such as Herceptin from Genentech (Charts), Tykerb from GlaxoSmithKline (Charts), Xeloda from Roche, Taxotere from Sanofi-Aventis (Charts), and the generic drug tamoxifen.

Chemotherapy side effects typically include nausea and vomiting. Hazlett said the FDA will scrutinize the side effects related to ixabepilone and its toxicity levels.

Drug companies are often criticized for producing "me-too" drugs, which aren't much different from drugs that are already on the market.

Les Funtleyder, analyst for Miller Tabak, said Bristol has managed to buck this trend by producing completely new molecular compounds with therapeutic effects, such as Orencia for rheumatoid arthritis and Baraclude for Hepatitis B. These drugs work differently from anything else on the market.

Even though ixabepilone is unlikely to achieve blockbuster status, Funtleyder said the creation of yet another "first-in-class" drug demonstrates to investors that Bristol has strong research capabilities.

The analysts interviewed for this story do not own stock in Bristol. Top of page