FDA approval boosts CyDex

KU expected to profit from pharmaceutical research

An Overland Park pharmaceutical company with Kansas University ties has won an important victory from the Food and Drug Administration.

CyDex Inc. said Monday the FDA had given its first-ever approval to a drug using a chemical compound developed by the company.

The FDA approval is expected to generate additional revenue for both the company and KU, which owns a part of CyDex. Officials with the company and KU declined to comment on how much revenue the new deal, which involves pharmaceutical giant Pfizer, is expected to generate.

But company officials said the approval should open the door for CyDex technology to be used in several other drugs.

“This is an important and big milestone for the company,” said Karl Strohmeier, vice president of corporate development. “One of the key issues when you are introducing a new technology is people are always asking whether it has been proven by someone else. Now we can definitely say that it has.”

The technology CyDex developed is a chemical compound called Captisol that makes the drug it is combined with more easily absorbed by a patient’s body. CyDex has partnered with Pfizer on a drug called Vfend, which is used to treat patients who have a fungal infection that attacks the blood.

Strohmeier, though, said Captisol can be used with a wide variety of drugs. Now that the company has been involved with a drug that has been successfully launched in the United States, he said, many more companies will be seeking to partner with the firm.

“I think this really will bring us a lot of attention from companies that weren’t aware of us or weren’t sure about us,” Strohmeier said.

Much of the research used to create Captisol was conducted by KU professors Valentino Stella and Roger Rajewski, who also own a portion of CyDex. Because of their involvement, KU was able to negotiate an agreement that calls for the university to be paid a portion of any royalties generated from Captisol.

“This could be a very big deal for the university,” Stella said. “It’s tough to say because it depends on future sales, but over the next 10 years it should be millions of dollars for sure.”

Charles Decedue, executive director of the Higuchi Biosciences Center where the research was conducted, said the benefit to the university would grow as the company grows.

“There definitely will be a financial return to the university, and I think it will be significant because I’m sure this will be the first of many approvals for the company,” Decedue said.

CyDex, founded in 1993, employs 30 people in Overland Park. Strohmeier said the company may be looking to expand its work force depending on whether it reaches future deals with other pharmaceutical companies.