Weathering the Storm - Pharmaceutical Executive


Weathering the Storm
Out from financial scandal, CEO Peter Dolan is steering BMS' most productive pipeline yet.

Pharmaceutical Executive

R&D investment will be directed toward increasing support for the company's late-stage development pipeline, which will begin to tilt the revenue toward products developed in-house. Wood Mackenzie forecasts BMS' business development index in 2009 to decrease to 71.5 percent.

"But we are still highly dependent and very interested in the in-licensing strategy because of attrition," says Sigal. "Attrition is the Achilles heel of the pharmaceutical industry. And it only makes sense that you keep a balanced portfolio of in-house and out-of-house discoveries in your pipeline."

Growth Drivers

BMS is a company in transition. Although new products fit in with the specialty strategy, it will be a few years before it completely sheds its old skin.

"In April of 2006, we lose exclusivity on Pravachol [pravastatin] in the United States, but that's the last major product up through 2012 that we're offsetting major exclusivity losses in any given year," says Dolan, "By contrast, 70 key US products that accounted for more than $70 billion in sales in 2004 are going off patent across the industry in the next five years."

BMS expects its 10 target disease areas to account for about half of all the company's pharma sales by the end of 2005, partially spearheaded by new products.

Abilify Abilify (aripiprazole), an anti-schizophrenic co-developed and co-marketed with Otsuka Pharmacuetical, was introduced in the United States in November 2002. From 2003 to 2004, its sales grew 110 percent to $593 million, the best start of any new drug in the company's history. In 2004, BMS launched Abilify in Europe, and FDA approved it for treatment of acute bipolar mania, as well as a new formulation.

Baraclude More than one million US patients have chronic hepatitis B infection. Datamonitor estimates that, globally, two billion people have been exposed to the hepatitis B virus and almost 400 million are chronically infected. Baraclude sales are expected to peak between $300 and $500 million in 2009.

Reyataz BMS launched HIV treatment Reyataz (atazanavir) in June 2003. In 2004, the company began marketing the drug in Europe. Total sales for the brand in 2004 were more than $400 million, and in the first quarter of 2005, nearly $150 million. Reyataz now has a 30 percent share of the weekly new US prescriptions in the protease inhibitor class, and has already exceeded that threshold in certain European countries.

Erbitux In 2000, Dolan charged a group to develop a biologics strategy. But it wasn't until February 2004 that BMS, along with partner ImClone Systems, received FDA approval for its first biologic Erbitux, indicated for the treatment of advanced refractory colorectal cancer. Sales since launch through the first quarter of 2005 were nearly $350 million.

In addition, the company has also submitted the following compounds for regulatory approval:

Pargluva BMS and partner Merck are awaiting word from FDA on the compounds' status. Sigal says it "lowers blood sugar better than most, if not all, compounds that we have tested against." But Pargluva needs to obtain the dual indication to treat diabetes and heart disease if BMS is to maintain its legacy in the cardiovascular disease and metabolics area.

Abatacept This compound—also known as CTLA4Ig—is BMS' first internally discovered biologic, and would be the first in a new class of agents called selective T-cell co-stimulation modulators for the treatment of rheumatoid arthritis. The company completed the rolling Biologics License Application in March, and expects to hear from FDA later this year.

Challenges Ahead

In the company's office in Princeton, New Jersey, there is a gallery dedicated to the history of BMS. Along the walls hang the brands and boxes of Sal Hepatica laxative and Ipana toothpaste—reminders of the "Bristol-Myers" part of the organization—and graying photos of Edward Robinson Squibb in front of his pharmaceutical plant in Brooklyn, New York.


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