Diabetes Article:
CNNMoney.com) -- America's 20 million-plus diabetics mean dollar signs for drug companies that sell a slew of new products, including a successful drug based on the saliva of a Gila monster, and a failed inhalation device that's been compared to a "bong."
Glaxo's blockbuster drug Avandia came under fire in May after a report linked it to an increased risk of heart attacks.
The diabetes epidemic is expanding in step with the nation's aging population and its widening waistlines. Obesity is a leading cause of the disease and more than 60 percent of Americans are considered obese, giving rise to a new word in doctor slang: "diabesity."
Weight loss can be an effective way to prevent and treat type II diabetes, the most common form of the disease. But many diabetics instead fight the disease with drugs.
Some of the drugs treat heart conditions that are related to diabetes, such as high cholesterol. Among the most popular are cholesterol-cutting statins like Pfizer's Lipitor, the top-selling drug in the world with nearly $13 billion in 2006 sales.
But other drugs, such as the pills Actos from Takeda and Avandia from GlaxoSmithKline, and the injectable drug Byetta from Amylin and Eli Lilly & Co., treat the disease more directly by controlling blood-sugar levels.
Diabetics have difficulty producing insulin or processing the insulin that their bodies produce, or both. Insulin is a hormone that helps the body convert blood-sugar into energy. Diabetics have been injecting insulin as a tried-and-true treatment since the 1920s.
Newer products help diabetics control blood-sugar levels. Byetta works by signaling the pancreas to produce the right amount of insulin after eating. Not only do diabetics sometimes have trouble producing insulin naturally, but they also develop resistance to it. Actos and Avandia work by reducing that resistance.
But Glaxo's blockbuster drug Avandia, which totaled $3 billion in 2006 sales, came under fire in May. That's when The New England Journal of Medicine published a report from Dr. Steve Nissen, chief cardiologist of the Cleveland Clinic, that linked Avandia to an increased risk of heart attacks. Much of Nissen's data was based on studies conducted by Glaxo.
The British drugmaker Glaxo attacked the integrity of the study for being a "meta-analysis" of previous studies, rather than a study in its own right. Nonetheless, the company's stock has dropped 11 percent since the journal report, and Avandia sales have disintegrated, with a 38 percent plunge in the third quarter to $460 million.
When Glaxo announced plans to shut down a plant in Puerto Rico and reduce staff by 250 workers, the company blamed the hemorrhaging sales of Avandia.
Despite the negative flap, a panel of experts advising the Food and Drug Administration backed Avandia in July. In a nonbinding vote, panelists voted 22 to 1 to keep it on the market.
Actos and Avandia share many characteristics because they're members of the same drug class, known as thiazolidinedione, or TZD. In August, the FDA said that Glaxo and Takeda agreed to strengthen the heart failure warnings on their diabetes drugs.
Nonetheless, the Japanese drugmaker Takeda has emphasized that its Actos is a separate product from the competition and doesn't share the same risks.
Takeda found fuel for its defense in two more studies published in The Journal of the American Medical Association in September that compared the cardiovascular risks of the two drugs.
One of the studies was co-authored by Nissen, and the other study was from Dr. Sonal Singh of the Wake Forest University School of Medicine in Winston-Salem, North Carolina. Both studies concluded the same thing: that Actos is safer than Avandia.
Glaxo disputes the findings. Glaxo spokeswoman Mary Anne Rhyne said her company has conducted 42 studies of Avandia, tracking more than 5,000 patients, and found no difference in risk between the Glaxo product and Actos.
Fortunately for diabetics, they have other choices for controlling blood-sugar. Since it was approved for the U.S. market in 2005, diabetics have been injecting Byetta, a drug based on the saliva of the Gila monster, a rare venomous lizard from the American Southwest and Mexico.
In its two years on the market, Byetta has yet to be hit by a firestorm of allegations over side effects. Byetta sales are growing rapidly, with Eli Lilly & Co. reporting a 30 percent jump in the third quarter to $165 million. (Lilly splits U.S. sales with its partner, Amylin.) Also, the companies are working on a more advanced version of the drug, called Byetta LAR, in the effort to keep sales growing.
Januvia, a pill from New Jersey-based Merck & Co., Inc., is the newest entrant to the diabetes field. Like the other drugs, it controls blood-sugar levels and is only used by diabetics with type II diabetes, which generally emerges in adults as a result of obesity.
Januvia's growth has been rapid since the drug was launched into the U.S. market in October 2006. Sales for Januvia (and the similar drug Janumet, which is much smaller) totaled about $200 million in the third quarter of 2007. Some analysts believe Januvia has billion-dollar blockbuster potential. John Boris, an analyst at Bear Stearns, has projected $740 million in sales for 2007, Januvia's first full year on the market.
Januvia could someday compete with the diabetes drug Galvus from the Swiss drugmaker Novartis. Both drugs are members of the same class, known as DDP-4 (dipeptidyl peptidase-4) inhibitors. Both work by allowing diabetics to increase insulin when their blood sugar is high, and reduce sugar produced by the liver after eating when the body doesn't need it.
Galvus was approved by European authorities in September, but the FDA wants more data from Novartis before it deems the drug good enough for the United States. Producing fresh data requires more tests -- a costly and time-consuming endeavor for Novartis.
So the market is brisk for diabetes drugs that control blood-sugar levels. But it hasn't been so hot for inhaled insulin. This concept of inhaling powdered insulin, rather than injecting it in a liquid form, became a reality in 2006. That's when Pfizer Inc., the New York drug giant, launched Exubera, the very first device for inhaled insulin.
But Exubera is no more. Pfizer and its new device failed to win the hearts and minds of diabetics and their doctors. In October, Pfizer announced that it had yanked the product off the market, taking a $2.8 billion hit as a result of closing down manufacturing facilities.
Pfizer is the largest seller of pharmaceutical drugs in the world, as measured by annual sales, so it's big enough to take a hit and survive. Pfizer is 250 times the size of Mannkind Corp., a California company that is developing a device for inhaled insulin called Technosphere.
With Exubera off the market because of lack of popular demand, the future is uncertain for Technosphere, and the stakes are high for the relatively small company, which has no products on the market. But the aspiring product Technosphere does have a potential edge over its failed rival: convenience.
Technosphere is the size of a cell phone and fits easily into the palm of one's hand. Exubera was considerably larger.
And that's not all. When in use, Exubera is a transparent tube filled with white mist, resembling -- in the words of one diabetic -- a "bong."
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