NEW YORK ? Bristol-Myers Squibb Co. and AstraZeneca?s new diabetes pill will probably face increased scrutiny from regulators and doctors after two rivals were tied to cancer and heart risks.
The drug, dapagliflozin, works differently than Takeda Pharmaceutical?s Actos, linked to cancer last week, and GlaxoSmithKline?s Avandia, tied to heart risks in 2007. While those drugs adjust the hormone that regulates sugar, the new pill helps patients excrete sugar through their urine.
?Increasingly, people are on the lookout for problems with these drugs,? said Laurence Kennedy, chairman of Cleveland Clinic?s department of endocrinology, diabetes and metabolism, in a telephone interview. ?There will always be a market for finding newer and different ways to help control blood sugar, but the newest ways will be under increasing scrutiny.?
Some analysts say they won?t project sales for dapagliflozin because of the risks posed by Avandia and Actos. Even if approved after a regulatory panel next month, doctors say they will be slow in using the new drug until more is known about long-term safety. A one-year study reported last year found no cancer or heart risks. Two years of data will be reported Sunday at the American Diabetes Association meeting.
An estimated 25.8 million Americans have diabetes, mostly the Type 2 variety linked to being overweight and sedentary, according to the National Institutes of Health. The disease is caused by an inability to use insulin to break down blood sugar into energy and can increase the risk of heart disease, stroke and kidney damage. Medicines are used to lower sugar levels.
The new drug is being developed jointly by New York-based Bristol-Myers and London-based AstraZeneca. The earlier trial showed it worked better than insulin plus a placebo, and that patients using it lost weight. This is particularly noteworthy because insulin drugs frequently trigger weight gain.
If approved, dapagliflozin would be the first in a new class of medications, called SGLT2-inhibitors. Similar drugs are also being developed by Johnson & Johnson, of New Brunswick, N.J., Indianapolis-based Eli Lilly and the German drugmaker Boehringer Ingelheim, Tokyo-based Astellas Pharma, Isis Pharmaceuticals Inc., based in Carlsbad, Calif., and Lexicon Pharmaceuticals, of The Woodlands, Texas.
The companies, analysts and investors will be closely watching the safety results and a panel of Food and Drug Administration advisers that is set to review dapagliflozin on July 19, said Les Funtleyder, a portfolio manager at Miller Tabak in New York, in a telephone interview.
Concerns about potential side effects of all diabetes medications leave analysts little room to assess the sales potential of dapagliflozin, he said.
?With these type of drugs, we don?t model until they?re approved because so much can go wrong,? Funtleyder said. ?We know it?s a new class in diabetes, which is often not well- controlled. The downside is people are nervous about possible infections and other side effects, and you have to take the good with the bad.?
Bristol-Myers referred comment to AstraZeneca. AstraZeneca?s spokeswoman Kirsten Evraire declined to comment.
In May, federal regulators restricted use of London-based Glaxo?s Avandia, ordering the drug to be pulled from pharmacy shelves and made available only through a special program. Sales of Avandia fell to $680 million last year from $1.8 billion in 2007 after a study that year showed a 43 percent increased risk of heart attacks among patients taking the medicine.
On June 15, a five-year analysis from a decade-long company-sponsored study of Takeda?s Actos showed an increased risk of bladder cancer. Actos is the world?s biggest-selling diabetes drug. The FDA had required the study under new guidelines for diabetes drug approvals.
Bristol-Myers?s and AstraZeneca?s Onglyza and Kombiglyze, a version of the drug combined with metformin, a standard treatment, generated $158 million last year. Those two drugs are projected to make $1.6 billion by 2017, according to estimates from Seamus Fernandez, an analyst for Leerink Swann.
Even after approval, ?we still have an obligation to conduct studies carefully and properly just to make sure nothing major has been missed? said Kennedy, of the Cleveland Clinic.
The number of Americans with diabetes is expected to rise to as many as 1 in 3 adults if trends continue, according to the Atlanta-based Centers for Disease Control and Prevention.
This explosion in cases has spurred the development of at least nine classes of diabetes drugs, some oral and some injectable. Today there are more than 39 diabetes drugs on market, generating about $16.8 billion in U.S. sales in 2010, according to data from research firm IMS Health.
Only half of diabetes patients have their blood sugar under control, so there?s a need for new medications, said Martin Abrahamson, the chief medical officer of Joslin Diabetes Center, an affiliate of Harvard Medical School in Boston.
?Type 2 diabetes being a progressive disease, one drug, a single drug, is unlikely to be a control for glucose levels over many years,? Abrahamson said in a telephone interview. ?Usually you add more medications to achieve glucose targets.?
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