A Billion-Dollar Needle-Exchange Program

NJBIZ, Jul 25, 2005 by Daks, Martin C

HAMILTON

The search is on for a way to give insulin that doesn't require a painful jab

DR. HOWARD GOLDSTEIN faces a challenge in treating some of his diabetic patients: making sure they inject themselves with insulin, the hormone that enables their cells to absorb the glucose building up in their blood. Goldstein's problem may be a multibillion-dollar opportunity for pharmaceutical companies.

Insulin-dependent diabetics not only have to inject the drug at least once a day, most have to poke themselves regularly to get drops of blood to measure how well the insulin is controlling their disease. "A lot of people with diabetes are suffering unnecessarily," says Goldstein, a partner with Diabetes and Endocrinology Associates in Hamilton. "Many need to take insulin, but one of the biggest roadblocks to effective insulin therapy is the needle."

Insulin is normally produced and released as needed by the pancreas. But among an estimated 21 million Americans, and 180 million people worldwide, the pancreas either produces little or no insulin, a condition known as Type 1 diabetes, or, as is more common, the body has become resistant to insulin, a malady known as Type 2 diabetes. Depending on the severity of the disease, left untreated the effects can range from dehydration to organ damage to death.

In those cases where a change in diet, activity level or the use of oral medications to increase insulin production haven't relieved the symptoms, insulin must be injected to control a user's blood sugar. And as Goldstein, a past president of the Eastern Region of the American Diabetes Association knows, it can be tough to get people to stick themselves. If some local drugmakers have their way, however, patients may soon have more choices.

"Today, pharmaceutical companies are trying to get away from injections," Goldstein says. "They're exploring alternative delivery systems, including inhalants, patches, pills and even suppositories."

The market they are chasing is already estimated to exceed $3 billion a year, and is expected to grow fast as sedentary lifestyles lead more people to gain weight, putting them at greater risk for diabetes.

Researchers at companies like Novo Nordisk in Princeton, Sanofi-Aventis in Bridgewater and Pfizer in Morris Plains are looking at a lot of different ways to deliver insulin, but right now three approaches-skin patches, inhalants and pills-lead the pack, according to the American Diabetes Association.

Transdermal methods-patches that deliver medication through the skin-work well with anti-smoking products because nicotine is a small molecule that easily enters the bloodstream. But according to an ADA report titled "Alternative Insulin Delivery Systems," insulin molecules are too large to get through without the help of minute electrical currents, ultrasound waves or chemicals. "Either way," says the report, "we have a while to wait before insulin patches might be available in pharmacies."

Taking insulin orally, perhaps in a pill form, is another option. The problem is that insulin, a protein like those in one's morning eggs, is broken down in the stomach before it can be absorbed. Possible solutions include developing coatings that would slow the dissolution of the pills or altering the very structure of the molecule to get it through the stomach. But the ADA notes that a lot of insulin may still be wasted with these alternatives.

A system permitting insulin to be inhaled may be the most promising new method. "Due to the lungs' large surface area, the pulmonary route has long been considered a good method of drug delivery," says Amy Ba, a Sanofi-Aventis spokeswoman. Her company is working with Pfizer on an inhaler called Exubera. "Inhaled insulin may encourage earlier use and greater compliance." Despite concerns that inhaled insulin may damage lung tissue over time, Exubera, which delivers a powdered form of the drug, has advanced through trials and is being evaluated by the FDA.

The FDA is also evaluating an insulininhaler system called AERx, which was developed by Novo Nordisk and Aradigm, a California company that specializes in needle-free drug-delivery systems.

Goldstein, other doctors and millions of diabetics are waiting as avidly as the drug companies' investors for good news about these tests. "Wall Street money is backing up these and other efforts," says Goldstein. "Investors wouldn't be committing money unless they thought there was a market for these products."

E-mail to mdaks@njbiz.com