David A. Edwards, Ph.D.

David A. Edwards
Gordon McKay Professor of the Practice of Biomedical Engineering
School of Engineering and Applied Sciences
Harvard University
322 Pierce Hall
Cambridge, MA 02138
Phone: (617) 495-1328
Fax: (617) 495-9837
dedwards@deas.harvard.edu

MORE EFFICIENT WAYS TO TAKE YOUR MEDICINE MIT SPURS TECHNOLOGY TO DELIVER DRUGS OVER PERIOD OF TIME

Author(s): Lori Valigra, Globe Correspondent
Date: February 24, 1999
Page: D1 Section: Business

Imagine walking into a drugstore and ordering all of your prescriptions in a single pill. That pill, or microchip, could include your heart medicine, cholesterol-lowering drug, aspirin, and vitamins -- all in precise doses to be delivered at specific times over a period of days, weeks, months, or even years.

Such futuristic technology to develop drug cocktails and the systems by which to deliver them already exist, much of it the result of Massachusetts Institute of Technology research that is finding its way into companies around the corner and around the country. Robert Langer, professor of chemical and biomedical engineering at MIT, is spearheading much of the development of new polymers and drug-delivery systems -- implantable wafers, osmotic-pump pills, microchips, aerosols, and low-frequency ultrasound devices -- all aiming to make drug doses more effective, safer, and easier to take.

"What's intriguing is the potential of truly long-term dosing," said Terry McGuire, a general partner with Polaris Venture Partners LLC of Waltham. "The applications and potential are enormous. It's going to redefine the way we deliver drugs."

Polaris, a $270 million venture fund, will put $1.5 million into a new company currently being formed in Cambridge to commercialize MIT-developed microchip technology. The microchip, which could be swallowed or implanted, and activated by remote control, holds a drug or drugs in tiny wells throughout its surface. The drugs can be released by an electrical impulse or a biochemical interaction.

The company, tentatively called Microchip Inc. (Micro Chemically Integrated Products), is the result of a growing type of collaboration between academia, financiers, and industry. Polaris will found the company along with Langer and two other codevelopers of the microchip: Michael Cima, an MIT professor of ceramic processing; and John Santini Jr., an MIT graduate student in chemical engineering.

Santini will become the first employee of the company after completing his doctorate in June.

It's rare for a venture capital firm to help found a company, said McGuire. Instead, venture capitalists usually fund start-ups and other existing companies.

"The partnership with Langer and MIT made for a very supportive environment," he said.

Langer's influence extends far beyond the new company. Langer, who has 353 patents issued or pending, figures 70 former students and colleagues from his MIT laboratory are now at other universities researching drug-delivery and related technologies. And, he figures, 70 to 80 of his former students are at pharmaceutical, biotech, or medical device companies.

Among them is David Edwards, a chemical engineer who is founder and president of Advanced Inhalation Research Inc. of Cambridge, which also got its initial financing from Polaris Venture Partners.

His company is developing a magic marker-size mouth inhaler for estrogen, allergy, and other medications based on technology conceived by Edwards and codeveloped with MIT and Pennsylvania State University.

Edwards said the new inhaler can get 70 percent or more of an asthma drug dose into a patient's lungs vs. about 10 percent with today's inhalers. The rest typically stays in the person's mouth. The company's first product is several years away.

Privately held Advanced Inhalation Research started in 1997. It received $2 million in four rounds of financing from Polaris Venture Partners, and has an undisclosed amount of additional financing from research funding and equity from three corporate partners.

Advanced Inhalation Research was acquired Feb. 1 by publicly held Alkermes Inc. of Cambridge, which now has six drug-delivery technologies in its stable. The stock deal was for 3.68 million shares of Alkermes stock, worth about $90 million based on a 30-day average share price, according to BancBoston Robertson Stephens.

Another Cambridge company using MIT technology is Sontra Medical Inc., which is building low-frequency ultrasound devices to get medicines through the skin more easily and to monitor glucose levels for diabetics. Privately held Sontra, which started in the second quarter of last year, received $7 million from three companies: Essex Woodlands Health Ventures, Hambrecht & Quist Health Technology Investor's Venture Fund, and Vanguard Venture Partners.

"We're trying to turn this concept into a handheld device for doctors and patients," said Shawn Stovall, general manager of Sontra. He added that the first commercial product is at least two years away.

These local firms are among the dozens of emerging companies nationwide eyeing a drug-delivery market that topped $14 billion in sales in 1998, according to estimates by Langer and industry analysts.

"New drug-delivery systems moved quickly from no market 20 years ago to $14 billion now in the United States alone," Langer said. "And there's still so much that needs to be done. For example, delivery of gene therapy." Langer and his colleagues are developing concepts, but it takes several million dollars for companies to turn them into products, he said.

Large pharmaceutical companies are becoming ready investors in and partners with new drug-delivery ventures. One reason: The start-ups take on the R&D risk. The start-ups also generally apply their technology to reformulate drugs going off-patent after 17 years, thus extending the patent life of some multimillion-dollar drugs, with better versions expected to be priced the same or less. And the start-ups have promising technology for future drugs that might need new drug-delivery systems to get into the right area of the body.

"New drug-delivery technologies create a lot of value for pharmaceutical companies," said Jay Silverman, pharmaceutical industry analyst for BancBoston Robertson Stephens. "The risks are low and the rewards are high."

Early examples of these new ways to administer drugs include patches such as Nicoderm for smoking cessation, implants such as Norplant for birth control, and time-release cold tablets and vitamins. The emerging delivery methods promise better controlled release of drugs, safer dispersion of toxic chemotherapies, and organ-specific treatments.

Langer said the new drug-delivery systems reduce side effects because they put out steadier doses. Current drugs, such as pills that must be taken every four hours, have peaks and valleys of effectiveness.

Cima added that the dosage in any pill currently purchased at a pharmacy may vary by about 15 percent of the labeled content, because conventional manufacturing technologies are not as precise as the emerging ones. Therics Inc., a Princeton, N.J. company that licensed the three-dimensional printing technology devised at MIT, is now making test pills within 1 percent of the labeled dosage, Cima said.

Three-dimensional printing technology prints one or more drugs in layers into a pill or implant. Precise drug doses can be delivered at variable intervals.

Cima, who codeveloped three-dimensional printing technology, predicted that vaccine tablets made using the technology could have a big impact in Third World countries, where it is hard to get a nurse to all areas to administer injections.

"I believe we can make printed tablets cost-competitive against current pressed tablets," Cima said. He added that Therics is getting close to the one-cent-per-tablet cost that would make printed pills competitive with today's pressed tablets.

Even in developed countries, it is sometimes hard to get patients to take their medications regularly. That's particularly true of people with chronic diseases and the elderly, who might forget to take a dose. A controlled-dose drug that needs to be taken less often is more convenient and gives the person a better quality of life.

Langer said the companies turning the new drug-delivery technologies into products can have a great impact on people's lives. So, too, can the researchers. Langer recalled a ceremony last year during which he received the $500,000 Lemelson-MIT award, a prestigious prize for inventing and engineering that is akin to the Nobel Prize. One man who attended the event to meet Langer was George Ferraiuolo of Hagerstown, Md., a 34-year-old who had a brain tumor removed and a wafer containing chemotherapy implanted in his brain.

"He thanked me for everything I had done," said Langer. "That is great satisfaction. I write a chemical structure on a blackboard, and years later see it as a drug that is saving someone's life."

For Cima, the process has been more personal. He wanted to see three-dimensional printing technology commercialized so his grandmother, who had to take a handful of pills each day, could use it.

"Grandma died two years ago," Cima said. "But I know I'll be taking these tablets someday.

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