Important note: Information in this article was accurate in 1999. The state of the art may have changed since the publication date.
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Reuters NewMedia - Thursday May 6, 1999
Ransdell Pierson
In a Reuters interview, Peter Ringrose said the bolstered drug R&D budget was necessary to compete with aggressive research rivals such as Pfizer Inc. (PFE - news) and to develop the growing number of early and late-stage compounds in its pipeline. Wall Street analysts had expected R&D budget growth in the mid-teens. Ringrose said he would encourage his company to also increase drug R&D spending "more than 20 percent," in the year 2000.
Bristol-Myers in late 1996 hired Ringrose, who had been head of Pfizer's European drug discovery team, where he helped develop Pfizer's flagship hypertension drug Norvasc.
Bristol-Myers in 1998 spent about $1.6 billion in overall -R&D -- about $1.25 billion of which was for pharmaceutical research. The remainder was for research on the company's medical devices and consumer products.
Ringrose declined to predict what the company's overall corporate R&D would be in 1999.
"The (Bristol-Myers') drug pipeline is demanding that we spend more," on research, he said, referring to the growing number of its products in development.
Sol Rajfer, head of Bristol-Myers' clinical research, said in a separate interview that the company had twice as many compounds in Phase III, or late-stage, trials as it did three years ago and had twice as many compounds entering early-stage human testing as it did four years ago.
"We need to be competitive with industry peers," Ringrose said. "Some companies like Pfizer are clearly in an aggressive growth strategy." Pfizer recently announced it was boosting its company R&D in 1999 to $2.8 billion from $2.3 billion in 1998.
Ringrose said the company was on track to meet his previously promised goal of tripling by 2003 the number of new significant drugs launched each year to three from one.
Ringrose in 1997 said the promised tripling of drug launches was necessary if Bristol-Myers was to increase its earnings by 15 percent a year -- the annual earnings growth rate expected by Wall Street in that period for the pharmaceuticals industry.
The company is now awaiting approval for two drugs that analysts say could each have potential annual sales of $400 million or more. The drugs are Orzel, an oral drug for colorectal cancer, and Tequin, a quinolone antibiotic that would compete with Pfizer drug Trovan.
But the most promising drug in the near-term pipeline, Ringrose said, is Omapatrilat, a hypertension drug in Phase III, which some analysts say could become a $1 billion-a-year drug.
Ringrose said that Bristol-Myers expects to seek U.S. marketing approval for Omapatrilat by December.
"When I first joined Bristol-Myers I though Omapatrilat had the potential of being a blockbuster. Now I'm more convinced," Ringrose said, noting that Phase II data will be unveiled later this month.
Wall Street has expressed concern that Bristol-Myers could lose its U.S. patent protection by next year on three key drugs already on the market. They include Type II diabetes drug Glucophage, cancer drug Taxol, and BuSpar for anxiety. But Ringrose said he was "reasonably confident we will protect Glucophage," beyond the year 2000. He declined to stipulate how, but added that Bristol-Myers was testing an extended-release form of the drug in late-stage trials.
Analysts have said they thought the company was developing that form of the drug to extend the patent life of the Glucophage franchise.
An extended-release form would allow patients to take the drug once a day, an improvement over the current twice-a-day pill. That would be a potential major marketing advantage over any generic form of Glucophage that rivals may eventually make, analysts have said.
Ringrose said that the company also had high hopes for a Protease inhibitor against the HIV virus that causes AIDS.
The company may file for U.S. marketing approval for the drug by late 2000, Ringrose said. He added that if approved the once-daily Protease inhibitor, BMY-232632, might be combined with two other once-daily Bristol HIV drugs. Those HIV drugs are Zerit and Videx, which are in the other leading class of AIDS drugs known as reverse transcriptase inhibitors (RTIs).
Zerit is now the best selling RTI in the United States, with sales of $152 million in the first quarter of 1999.
Ringrose said that Bristol-Myers last week filed for U.S. marketing approval of a once-a-day form of Videx and was "working on" a once-a-day formulation of Zerit.
He said that with a cocktail of once-a-day forms of Videx, Zerit, and the Protease inhibitor, "patients would literally have to take just three pills a day versus up to 30 tablets a day," on some current cocktail regimens.
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