Finding ways to make drugs go down easier

From lollipops to nasal sprays, companies develop new delivery systems for old medicines

August 27, 2006|By Tricia Bishop | Tricia Bishop,Sun reporter

Anyone who has ever tried to give a 5-year-old an antibiotic can appreciate where Edward M. Rudnic is coming from.

As the founder of Advancis Pharmaceutical Corp. in Germantown, one of his goals is to take amoxicillin and convert it to a taste-free powder that could be sprinkled on anything - even ice cream - and tots would be none the wiser.

His plans are not quite a reality yet, having run into a snag in clinical testing, but Rudnic hasn't stopped trying. And he is not alone.

Ever since there were drugs, science has looked for ways to improve their delivery to better satisfy doctors and patients. They've turned injections into pills, cut daily dosing amounts and enhanced flavors, hoping it would all add up to happier patients, safer medication and more profit.

But efforts have ramped up recently as advances in technology have made more things possible, and businesses have had to get increasingly creative to find a competitive edge.

It can take a dozen years and $1 billion to create a drug from scratch, which often means a long wait before new companies see any sales.

By taking proven drugs and repackaging them with new delivery systems, entrepreneurs can potentially cut years off the timeline and maybe millions off the price tag.

And along the way, they just might solve a problem that has vexed physicians for decades: People aren't very consistent when it comes to taking their meds.

Some patients are afraid of needles. Others forget to take their pills every four hours. And parents struggle with squirmy children who often hate to take any kind of medicine.

"A better delivery system is a clear way of remedying that, especially if you're talking about a patch or something that [doesn't require] remembering to open up a vial and take X number of pills," said Kenneth I. Kaitin, director of the Tuft's Center for the Study of Drug Development.

With that in mind, companies are developing patches that deliver Alzheimer's treatments and birth control hormones, edible strips that release cough medicine, lollipops that yield a pain reliever for cancer patients and nasal sprays that dispense insulin and anti-obesity drugs.

Diabetes treatments are a hot area, with many companies working on new ways to deliver insulin or check glucose levels. An associate professor at the University of Maryland Biotechnology Institute, for example, has invented a contact lens meant to measure blood sugar.

Elsewhere in Maryland, where biotechnology is considered a key industry, Baltimore's Guilford Pharmaceuticals (which was acquired by a Minnesota company last year) developed an implantable wafer that treats brain cancer.

And at least three Gaithersburg companies are working on unusual ways to deliver drugs: MedImmune Inc. has its inhaled FluMist vaccine, Iomai Corp. is creating vaccine patches, and Panacos Pharmaceuticals Inc. is working on an HIV pill meant to replace a current therapy that has to be injected.

The drug delivery field is among the fastest-growing areas in the pharmaceutical industry. Sales of medications with novel delivery systems are increasing by 15 percent every year, according to market analysts Scrip Reports. By 2009, the drug delivery products and services market is expected to top $67 billion - more than double the $24 billion figure of 2003 - says a study from analysts NanoMarkets.

But a new way of dispensing a drug does not always mean it's better for a patient. Businesses still need to show their replacement versions are as good as or better than the old to get Food and Drug Administration approval.

Norplant was developed as a contraceptive that could be implanted once and protect against pregnancy for five years - unlike birth control pills, which require daily dosing. But it was pulled from the U.S. market in 2000 after women developed serious side effects, including severe headaches and depression.

A similar, but ostensibly safer, birth control implant called Implanon was approved for sale last month.

And not all new versions are as well received as their counterparts. Relatively few people have picked MedImmune's nasal flu vaccine over the traditional shot. The company is working on a new formulation it hopes will sell better.

There are always risks in drug development, but that shouldn't stop the search for improvements, said Stanley C. Erck, president and chief executive of Iomai. His company's goal is no less than changing "the entire way vaccination is practiced."

Iomai was founded by a scientist at the Walter Reed Army Institute of Research, where he discovered that you could deliver proteins through the skin and stimulate a powerful response from the immune system.

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