UBI Press Release

Release Date: December 9, 2002

Contact: Ms. Francine Volz

Public Relations

Tel: (631) 273-2828

Fax: (631) 273-1717


Web Page: www.unitedbiomedical.com

Success at Long Last: Development of a Safe Synthetic Vaccine for Foot-and Mouth Disease by United Biomedical, Inc.

Scientists have been trying to develop a safe synthetic vaccine for Foot-and-Mouth

disease for more than 20 years. Foot-and-Mouth Disease is an extremely infectious

disease of cattle, sheep, and swine. Outbreaks have caused recent devastating losses

in the U.K., Taiwan, and Argentina. The virus remains a constant threat throughout

much of Asia, Africa, the Middle East, and South America and the market for vaccines

exceeds US$500 million. North America and other FMD-free regions fear both

accidental introduction and intentional introduction through bioterrorism

(www.reuters.com/newsArticle.jtml?type=topNews&storyID=1777664 ). Current vaccines

are produced from killed viruses and present biohazard risks both in manufacture and

use. Most attempts to produce a safer vaccine have focused on reproducing by

chemical synthesis a small subunit of the virus that is responsible for evoking antibodies

that inactivate the virus. However, up until now these efforts have resulted in synthetic

vaccines that either were not protective in livestock, or that required doses too large to

be economically feasible.

United Biomedical, Inc. (UBI) of Hauppauge NY, along with its subsidiary UBI Asia, has

been working on this problem since 1997 with an in-house team headed by Dr. Chang Yi

Wang, and international collaborators at the USDA Plum Island Animal Disease Center,

the Animal Technology Institute Taiwan, the National Institute of Animal Health Taiwan,

and commercial animal health companies. UBI has successfully developed a synthetic

Foot-and-Mouth Disease vaccine for swine using its unique UBITh . synthetic peptide

technology. The synthetic vaccine has been designed to confront a broad array of

pandemic FMD viruses from serotype O and can be readily re-designed for potency

against the other six serotypes of FMD virus. The UBI vaccine for FMD virus has

protected over 200 swine from experimental infection during laboratory vaccine trials.

UBI has recently reported on one of these studies in the journal Vaccine. In this.publication, "Effective synthetic peptide vaccine for foot-and-mouth disease in swine" by

CY Wang, TY Chang, AM Walfield, et al. (Vaccine, 2002; 20: 2603-2610) 20 out of 21

peptide-immunized pigs were protected from infection. The vaccine was effective at

small doses in formulations that can be readily manufactured at low cost, comparable to

those of the killed virus vaccines. Field and regional trials have recently been completed

for the UBI FMD vaccine as part of the procedure to receive official registrations by

national regulatory agencies. The company is now perfecting other formulations of its

synthetic vaccine for potency and efficacy in cattle.

UBI expects that its synthetic FMD vaccine will encourage wider use of vaccination for

control of FMD due to the vaccine’s advantages: 1) as a completely safe chemically

defined product and, 2) as a marker vaccine whose immunogenic footprint can be

readily distinguished from the immune responses that result from FMD virus infection.

The company also produces a series of synthetic-peptide based diagnostic tests for

FMD that work particularly well as a system together with its vaccines. The UBI

diagnostic kits detect infected animals and distinguish them from vaccinated animals.

An unprecedented relaxation of the guidelines that restrict the export of vaccinated

animals was issued by the Office International des Epizooties earlier this year, in

response to the new technical developments in FMD control. The new rules are

expected to result in more widespread use of FMD vaccines and diagnostics. The UBI

peptide-based vaccine/diagnostic system will be particularly attractive to FMD-free

countries for defensive serosurveillance and for contingency plans for emergency

vaccination in the event of an outbreak.