Purdue Research Park Center to Manufacture Lilly Drug

PharmaManufacturing.com
05/17/2007

The Chao Center for Industrial Pharmacy & Contract Manufacturing in the Purdue Research Park will become the sole U.S. provider of an Eli Lilly and Co. pharmaceutical drug that will help fight MDR-TB, or multidrug-resistant tuberculosis.

The agreement, announced May 16, states that the Chao Center will gain exclusive rights to manufacture, distribute and sell the multidrug-resistant tuberculosis drug Seromycin. The drug will be made available to consumers in the United States, Canada, Puerto Rico, Guam and the U.S. Virgin Islands.

"This agreement places the Chao Center among the first university-affiliated contract manufacturing organizations to receive rights to a commercially available pharmaceutical drug product," said Purdue president Martin C. Jischke. "It enables Purdue's Chao Center to join Lilly in its initiative with the World Health Organization to fight multidrug-resistant tuberculosis."

Highly contagious, difficult to treat and a growing threat to global public health, multidrug-resistant tuberculosis strikes about 450,000 people each year, with the highest rates of prevalence in China, India, South Africa and the countries of the former Soviet Union. The World Health Organization estimates that the average multidrug-resistant tuberculosis patient infects up to 20 other people in his or her lifetime, and cases have been found in nearly every country surveyed by the organization. When drugs used to treat multidrug-resistant tuberculosis are misused or mismanaged, the even more virulent extreme drug-resistant tuberculosis can develop.

"One of the centerpieces of Lilly's MDR-TB partnership is the transfer of technologies and expertise needed to manufacture Lilly antibiotics used to treat MDR-TB," said Dr. Gail Cassell, vice president of scientific affairs and a distinguished research scholar at Eli Lilly and Co. "Since 2003 Lilly has successfully transferred its technology, formula and trademark to generic drug makers in South Africa, China, India and Russia to increase the supply of these important medicines. We are pleased that the Chao Center has joined us in the global fight against multidrug-resistant tuberculosis."

Lilly will provide the Chao Center with the intellectual property and associated analytical, regulatory, quality and technical support, including all necessary and related regulatory materials. Lilly also has agreed to donate equipment and supplies to the Purdue Research Foundation, the Chao Center's parent organization, which will be used to support the Seromycin® manufacturing process. Until the Chao Center completes the process of securing regulatory approval from the U.S. Food and Drug Administration to manufacture Seromycin, Lilly will supply the center with the drug for sale and distribution.

"The collaboration between Lilly and the Chao Center is an excellent example of the strategic mission of the Purdue Research Park," said Joseph Hornett, Purdue Research Foundation senior vice president, treasurer and chief operating officer. "That is to provide a university model of entrepreneurship and economic development through the commercialization of science and technology."

The 12,000-square-foot facility that houses the Chao Center opened in the fall of 2005. The center will produce drugs, known as "rare legacy drugs," for which small demand makes production by large pharmaceutical manufacturers cost prohibitive. Rare legacy drugs often are not manufactured profitability by large companies but can still generate significant revenue for smaller firms.

"These drugs, such as Seromycin, are still needed by thousands of patients, both here and abroad," said Chao Center director Craig Davis. "The Chao Center has the capability to manufacture these drugs in an economical manner."

The Chao Center also will work with the Purdue College of Pharmacy, Nursing and Health Sciences, which is a center partner.

"We have an ongoing partnership with the Chao Center, which provides excellent training opportunities for students, and have collaborated on several research projects and studies," said Craig Svensson, dean of the College of Pharmacy, Nursing and Health Sciences. "The college is a leader in industrial pharmacy innovation. This agreement with Lilly will draw on the strengths of the college and the Chao Center."