Amgen bets on risky field of diabetes
New warnings were slapped on two of the nation’s most popular diabetes drugs Wednesday as Thousand Oaks biotech giant Amgen Inc. jumped into the booming market.
The biotech giant agreed to buy Massachusetts-based Alantos Pharmaceuticals for $300 million in cash. The closely held company does not yet have a drug on the market but is known for drugs under development to treat diabetes and other diseases.
As the world’s population ages and obesity rates rise, sales of diabetes medications and treatments are booming and new drug research holds promise of limiting or even preventing the disease in certain patients.
“There is a lot of exciting developments in basic diabetes research right now,” said Dr. Ping Wang, an endocrinologist and director of Joslin Diabetes Center at UC Irvine.
But these drugs carry risks and, in some cases, new warnings. The Food and Drug Administration on Wednesday placed its most serious safety warning, a so-called black box label, on the drug Avandia and similar medication Actos, which were taken by more than a million people last year.
Packaging on both drugs will now warn of increased risk of heart attacks in some patients. The move followed a high-profile study last month in the New England Journal of Medicine that raised safety questions about Avandia.
Doctors are expected to significantly reduce prescriptions for the medications. Some may switch patients to a batch of newer medicines recently approved for Type 2 diabetes. Sales of all diabetes drugs in the U.S. were $10 billion last year.
These newer medicines take a different approach, helping the body better stimulate insulin secretion and control blood-sugar levels. Amylin’s Byetta, an injectable drug approved in 2005, is a synthetic version of a substance found in the saliva of a Gila monster, a stout reptile that takes its name from Arizona’s Gila River. A side effect can be significant weight loss, which has helped fuel sales.
In October, the FDA approved a class of diabetes drugs that research showed avoids some of the common side effects of earlier treatments, such as dangerously low blood sugar.
They include Merck & Co.’s Januvia, a once-daily tablet. Galvus, a similar drug by Novartis, is expected to receive approval soon.
The leading drug candidate by Alantos, the company being purchased by Amgen, also is in this category.
The move is the latest example of Amgen’s recent strategy of buying companies with new drugs rather than developing them on its own. On Monday, it bought a company that is developing a drug to treat chronic kidney disease.
Andrew Drexler, director of UCLA’s Gonda Diabetes Center, said the real promise of some of the new diabetes drugs was that they might be able to spur the growth of insulin-producing cells, possibly reversing the effects of the disease.
Still, doctors advise caution in evaluating the drugs’ safety and effectiveness because the longest clinical trials involved a few thousand patients and lasted no more than two years, not large enough or long enough to observe rare side effects.
“We need to follow these and continue to evaluate them,” Drexler said.
More than 16 million Americans have diabetes and an estimated one-third of them have not been diagnosed and do not know they have the disease.
The most common type of diabetes, Type 2, occurs in adults, often as the result of obesity, leading some to refer to the condition as “diabesity.”
Type 1, a more serious form of diabetes, is often diagnosed in children and young adults.
Experts say drug companies and researchers have made gains in recent years in understanding the science involved in the disease, with some believing that they may be able to retard or reverse it if caught early. Several clinical trials are underway.
Martha Keates of Claremont, whose 13-year-old daughter Bailey was diagnosed with Type 1 diabetes last year, said she was realistic enough to know that her daughter might not benefit even if any of the research proved successful. But she is enthusiastic that it may help the next generation of diabetics. “Anything they can do would be a godsend,” she said.
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Recent Amgen deals
Dec. 14, 2005: Agrees to buy Abgenix Inc. for $2.2 billion.
Sept. 29, 2006: Announces plans to acquire Avidia Inc. for $290 million.
Monday: Agrees to buy Ilypsa Inc. for $420 million.
Wednesday: Agrees to buy Alantos Pharmaceuticals for $300 million.
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Source: Times research
