Aviron Inc., a privately held company, signed an agreement withSouth Korea-based Sang-A for development of vaccines, includingan influenza vaccine administered by nasal spray.

Leighton Read, chairman and CEO of Aviron, said the deal involvesan equity investment giving Sang-A, a subsidiary of the Hanbo Groupin South Korea, less than a 25 percent ownership interest in hisBurlingame, Calif.-based company.

In return, Sang-A gets rights to manufacture Aviron's vaccines formarkets in South Korea and elsewhere and to sell the products inKorea.

This is very important to us because it's our first corporate deal,"Read said, "and it provides us with a manufacturing facility."

Aviron, founded three years ago, is developing vaccines for herpessimplex virus, cytomegalovirus, respiratory syncytial virus andvaricella zoster virus, in addition to influenza.

The potential flu vaccine is Aviron's lead product. It was licensedfrom the University of Michigan and is being developed andmanufactured under a collaborative research and developmentagreement with the National Institutes of Health (NIH) in Bethesda,Md.

Read said the company is spending more than $20 million developingthe vaccine, including expenses for clinical trials, scale-upmanufacturing and regulatory filings.

The vaccine is derived from a cold-adapted, modified livinginfluenza virus that triggers antibodies to the disease in the nasalpassages, which is where the flu normally infects its victims. Currentvaccines, which are administered by injection, are made from killedinfluenza viruses.

"It's a live attenuated virus that has been changed and doesn't makeyou sick," Read said.

Phase I/II trials are expected to begin this fall in the U.S., he said,followed by Phase III challenge studies at the end of the year. In thechallenge studies, about 100 to 200 people receive the vaccine andare exposed to the disease to see if they are protected.

Broader Phase III studies, involving more than 2,000 people, will beconducted during the winter flu seasons over two years, 1996 to1998.

The agreement with Sang-A, Read said, marks the first time theSouth Korean pharmaceutical maker has delved into the prescriptiondrug market. Sang-A has focused exclusively on over-the-counterproducts.

The vaccine being developed by Aviron is not new. It was introducedin the 1960s and the NIH-sponsored clinical trials began in 1975.Wyeth-Ayerst Laboratories, of King of Prussia, Pa., licensed thevaccine in 1989 and conducted trials of its own before dropping it in1993.

Read said that after Wyeth-Ayerst, a subsidiary of Madison, N.J.-based American Home Products Corp., discontinued development,the NIH sought new licensees for the vaccine and Aviron wasselected.

Read said the vaccine has been studied in more than 7,000 peopleand the data, including that from Wyeth-Ayerst, shows it is safe andeffective. n

-- Charles Craig

(c) 1997 American Health Consultants. All rights reserved.