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June 5, 2003

Purdue, Lilly form international drug manufacturing partnership

WEST LAFAYETTE, Ind. – Eli Lilly and Co. announced today (Thursday, 6/5) at World Health Organization headquarters in Geneva, Switzerland, that it will team with Purdue University to teach other nations how to manufacture drugs to fight tuberculosis, an effort expected to bring high-paying jobs to Indiana.

Charles O. Rutledge
Download photo - Caption below

The partnership also involves the World Health Organization, the U.S. Department of Health and Human Services, the Centers for Disease Control and Prevention and Harvard Medical School.

The project will be Purdue's first foray into drug manufacturing and will yield the first contract for the School of Pharmacy's Good Manufacturing Practices facility, which will be located in the Purdue Research Park. When completed in late 2004, the facility will allow Purdue to teach students and professionals worldwide about commercial drug production and management.

As the facility grows, it will fill a neglected niche in world health.

"Purdue's manufacturing facility will be more than just a great place to receive training in drug manufacturing," said Charles O. Rutledge, director of Discovery Park. "By nature of its relatively small size, it will be able to produce drugs profitably in small quantities. Often, these drugs are needed only by a small segment of a population. With such small profit margins, this is something that larger manufacturers cannot do because of their larger overhead."

Purdue's first products will be antibiotics that cure multiple drug-resistant tuberculosis (MDR-TB). Lilly is the original manufacturer of the drugs, and the company is now assisting developing countries with manufacturing the drugs themselves, as the disease is far more prevalent outside the industrialized world.

"Our efforts will fill a shortage in the drug market, not only by manufacturing the drugs, but also by assisting other countries with their own manufacturing efforts," Rutledge said.

More than 400,000 new cases of MDR-TB were reported last year, spread among more than 100 countries.

"Few of these countries have significant drug manufacturing capabilities," Rutledge said. "Lilly has generously offered to assist several developing countries fight the disease by transferring the specific technology necessary to produce these two drugs and assist in their start-up efforts. Purdue will teach them how to manufacture the drugs, general manufacturing principles and quality standards through good manufacturing processes, and will offer business management education. Harvard has been instrumental in providing clinical training for the treatment of these diseases in developing countries. With this initiative, these efforts will be greatly expanded."

MDR-TB is a term for a number of TB strains that develop when an infected patient is not cured completely during treatment. This occurs commonly in developing countries where the combination of drugs needed to eliminate hardy TB bacteria from a patient's system are often not available – or when they are available, are not administered in the necessary quantities or for a sufficient period of time. The bacteria then become resistant to standard treatment, and two special antibiotics – capreomycin and cycloserine – are needed to defeat it.

"It is one goal of this project to provide these countries with the manufacturing infrastructure necessary to fight different strains of TB on their own terms," Rutledge said. "With Lilly's gifts, countries like India, China and South Africa can begin to produce the drugs they need domestically."

Purdue will produce Seromycin (the trade name of cycloserine), which Lilly will then distribute under its own brand name. Production of this drug will then serve as a training ground for both Purdue students and personnel from developing countries in proper drug manufacturing procedures.

"Purdue is the only university in the country that will have the facilities necessary to both train personnel and manufacture pharmaceuticals for worldwide distribution and use," Rutledge said. "The state of world health will benefit from our participation in the project."

Rutledge said the partnership also would provide multiple benefits for the university and the community in the long run.

"This program will provide a revenue stream for the manufacturing facility," he said. "This is what we hope will be the first of many contracts to produce drugs for the market. But we also think it will produce more well-rounded students who will be better prepared for the pharmaceutical business."

Rutledge said the combined efforts of the university and manufacturing facility will be necessary to produce these professionals, who should then be in a good position to make their mark in industry.

"Many industry personnel are well-trained in pharmacy and chemical engineering, but not in manufacturing processes," he said. "However, few are trained in implementing the policies and regulations necessary to produce drugs of the highest quality."

For more information on the other organizations involved in the partnership, see Eli Lilly and Co.'s Web site.

Established in 1961, Purdue Research Park is two miles north of Purdue's West Lafayette campus and also is home to the largest university-affiliated, state-of-the-art business incubator facility in the nation. The companies in the park employ more than 2,200 people.

Writer: Chad Boutin, (765) 494-2081, cboutin@purdue.edu

Source: Charles O. Rutledge, (765) 494-6209, chipr@purdue.edu

Purdue News Service: (765) 494-2096; purduenews@purdue.edu

NOTE TO JOURNALISTS: A satellite feed from today's announcement will be available from 2-2:30 p.m. (ET) from Telstar 5/Transponder 8 (c) band DL: 3860 (H).

 

PHOTO CAPTION:
Charles O. (Chip) Rutledge, program director for Purdue University's Discovery Park, discusses the implications of a new initiative between Eli Lilly and Purdue. The partnership will provide the international community with better access to drugs that can combat tough strains of tuberculosis.

A publication-quality photograph is available http://ftp.purdue.edu/pub/uns/rutledge.lilly.jpeg.


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