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Bristol facing two key FDA panel votes
Advisory panels to review two drugs next month in moves that could reshape drugmaker's future.
August 23, 2005: 3:03 PM EDT
By Aaron Smith, CNN/Money staff writer

NEW YORK (CNN/Money) - Bristol-Myers Squibb faces votes by FDA advisory panels on two key drugs in its pipeline, decisions that could affect the company's financial future for years to come.

"It's going to be a big week for Bristol," said Al Rauch, analyst for A.G. Edwards. "These products are going to be very important for its turnaround. After Pravachol goes off patent in 2006, these would be the products that would really help the company."

Bristol-Myers' drug abatacept, a potential treatment for rheumatoid arthritis, goes before a Food and Drug Administration panel of experts on Sept. 6. Three days later, a separate FDA panel will review muraglitazar, a dual-use diabetes drug developed by Bristol-Myers (down $0.25 to $24.49, Research) with partner Merck (down $0.22 to $27.67, Research) as the marketer.

Abatacept, also known by its trade name Orencia, is designed to reduce swelling and pain and to treat structural damage in joints gnarled by rheumatoid arthritis.

Bristol-Myers spokesman Jeff McDonald said there is an "unmet medical need" for abatacept, because "there's clearly a number of patients who do not respond to the available biological treatment."

The drug would be used to treat patients who are not responding to competing drugs like Enbrel by Amgen (down $0.10 to $79.09, Research), Immunex Corp. and Wyeth, Remicade, made by Centocor, and Humira produced by Abbott Laboratories (down $0.03 to $45.93, Research).

Rauch was reluctant to call abatacept a potential blockbuster because it treats a relatively small portion of the population, but Merrill Lynch analyst David Risinger has projected that sales could reach $1.1 billion in 2009, pending FDA approval.

The FDA granted the drug a fast-track review process, which typically takes six months. Abatacept was submitted in March, so if it's approved it could enter the market as early as September.

Muraglitazar, also know by its trade name Paragluva, has been shown to do two things in clinical studies: lower blood sugar in type 2 diabetics and reduce the risk of heart disease. Type 2, the most common type of diabetes, and heart disease affect millions of Americans and are seen as growing areas for the health care industry.

The FDA typically follows the advice of its panels of experts, which also draw up suggestions for warning labels. FDA spokeswoman Suzanne Trevino said the FDA bucked the panel's advice only about a dozen times during more than 100 reviews over the last two years.

A lot is riding on the potential revenue from these two drugs.

Bristol-Myers' blockbuster drug for cholesterol, Pravachol, a statin with $2.6 billion in annual sales, will go off patent in 2006.

Bristol-Myers could use some good news, considering that the company has paid out hundreds of millions of dollars to the Securities and Exchange Commission and the attorney general's office in New Jersey, where the $19.4 billion company is based, to settle investigations for fraudulent behavior.

On Monday, the SEC charged two of its employees with deceiving investors about the company's financial performance. (For more on Bristol-Myers' troubles with the SEC, click here and here).

Rauch said the key to having both drugs approved is whether the FDA panel believes that both of them are safe.

"They both could be key products," said Rauch.

"With Muraglitazar, if they can prove they don't have a cancer risk and they're clean, then they're in a position where they can compete effectively with Actos and Avandia," said Rauch, naming two other diabetes treatments by Takeda Pharmaceuticals (up $0.96 to $53.00, Research) and GlaxoSmithKline (down $0.57 to $47.73, Research), respectively.

For more on Muraglitazar, click here.  Top of page

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