Sunday, June 10, 2012

(BN) J&J Diabetes Drug Seen Challenging Merck’s Market Leader

J&J Diabetes Drug Seen Challenging Merck's Market Leader

Johnson & Johnson (JNJ) has turned one of diabetes' most worrisome warning signs into a treatment that lowers dangerously high levels of blood-sugar before the disease can cause blindness, kidney damage and heart disease.

The demand for novel diabetes drugs is soaring as rising obesity rates push the condition to epidemic levels, affecting nearly 347 million people worldwide. While 10 different types of drugs are sold to treat diabetes, physicians still struggle to control their patients' blood-sugar levels.

The spotlight is now on J&J's canagliflozin, which is designed to expel excess sugar from the body, something that doesn't normally occur until after glucose rises to critical levels. The pill may reach pharmacies next year, competing with Merck & Co.'s $3.3 billion market leader Januvia.

While it's not a cure, the approach "is a beautiful example" of treating a serious disease by managing blood sugar levels in a new way, said Laurence Kennedy, a specialist at the Cleveland Clinic in Ohio, who hasn't been involved in researching the therapy, in a telephone interview.

Data on canagliflozin, to be reported at the American Diabetes Association meeting this weekend, shows the pill regulates blood sugar levels better than Januvia, according to Derrick Sung, a Sanford C. Bernstein & Co. analyst in New York.

Manipulating Insulin

Diabetes occurs when the body is unable to properly use or produce enough of the hormone insulin to convert blood sugar into energy. Most medicines for the illness, including Januvia, work by manipulating insulin production to control glucose levels.

The novel strategy developed by J&J sheds sugar through the urine, after it's filtered from the blood by the kidneys and before it can be reabsorbed into the body.

The New Brunswick, New Jersey-based drugmaker plans to unveil data from trials done in the final stages of testing normally needed for U.S. marketing approval during the diabetes meeting in Philadelphia. Last week, the company filed for regulatory clearance to sell the pill in the U.S.

Still, the drug has drawn skepticism from some physicians, and concerns about possible unknown risks. As a result, Larry Biegelsen, an analyst at Wells Fargo Securities in New York, estimates the drug's sales may be limited to $122 million in 2013, growing to $667 million in 2016.

'Unconventional' Treatment

"Using a side effect of uncontrolled diabetes as a primary mode of treatment is unconventional, to say the least," said Adrian Vella, an endocrinologist at the Mayo Clinic in Rochester, Minnesota, by telephone. "We still need to understand how severe and how frequent the potential side effects associated with these medications are."

J&J gained less than 1 percent to $62.98 at the close in New York. The shares have declined 4.8 percent in the past 12 months.

Many diabetics also have kidney disease, and it's not clear if the drug's action may further damage those organs over a longer time period.

The most unusual side effect thus far stems from having a urinary tract that is constantly flooded with excreted glucose. As many as 20 percent of women given canagliflozin develop fungal or bacterial genital infections, said Biegelsen.

The FDA has been tough on diabetes drugs since Avandia, from London-based GlaxoSmithKline Plc (GSK), was linked to heart attacks in 2007, and subsequent studies showed blood sugar control medicines may have harmful effects. Dapagliflozin, a drug from New York-based Bristol-Myers Squibb Co. (BMY) and London- based AstraZeneca Plc (AZN) that works the same way as the J&J drug, failed to win U.S. approval because of concerns about bladder and breast cancer.

Cancer Risk

The data on J&J's drug shows no signs of cancer, Biegelsen wrote in a May 31 note to investors.

Diabetes drugs that have been approved were the third fastest growing medications in the U.S. last year, with sales rising 10.7 percent to $19.6 billion, led by Januvia, according to IMS Health, a Norwalk, Connecticut-based health-care information and services.

One "welcome benefit" of the J&J therapy is that early results showed it doesn't lead to low blood sugar when used alone, said Tom Donner, director of the diabetes center at Johns Hopkins University School of Medicine in Baltimore, who wasn't involved in the research.

Still, the risk of urinary tract infections, and the resultant frequent trips to the bathroom, with the J&J therapy could prove to be a hurdle, said the Mayo Clinic's Vella.

"To me or you it might be a nuisance factor, but to someone who is unstable on their legs, or might not be mobile, getting up repeatedly at night might be a problem," he said, suggesting it will be key to whether the drug is used by physicians.

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