Alpha Therapeutic Obtains Patent on Testing Method for Plasma Donations, Signs Licensing Agreement With National Genetics Institute.

Business Editors & Health-Care Industry Writers

LOS ANGELES--(BUSINESS WIRE)--June 12, 2000

Alpha Therapeutic Corp. today announced that the company has obtained a U.S. patent for a method of efficiently and rapidly testing large numbers of plasma donations for viruses using the highly sensitive Polymerase Chain Reaction (PCR) testing technology.

Alpha also announced that it granted an exclusive license to National Genetics Institute (NGI) to use this method, known as the "efficient algorithm" to provide services in the United States with the opportunity to expand the exclusive license to other countries.

"This discovery is especially important because it enables us to use the most sensitive and specific tests which are currently being studied to increase the safety profile of the source plasma donations we use to manufacture life-saving blood products," said Ralph M. Galustian, president and CEO of Alpha.

A leading producer of plasma derived therapies, Alpha collects plasma from donors across the United States and processes it into a variety of products to treat life-threatening conditions, including intravenous immune globulin for primary immune disorders, coagulation factors for hemophilia, and albumin for shock and trauma.

Plasma donations are currently screened for the human immunodeficiency viruses (HIV) Types 1 and 2 and hepatitis viruses using serologic tests approved by the U.S. Food and Drug Administration (FDA). These tests detect either protein components of these viruses (antigens) or antibodies to the virus, which are produced in response to infection.

PCR detects very small amounts of the genetic material (DNA or RNA) in the viruses themselves. It has the potential to detect a virus early in the process of infection, during the "window" of time before an infected person develops detectable levels of viral antigens or antibodies to the virus. PCR screening of plasma donations is currently being studied in clinical trials, which are intended to support the addition of PCR to current testing methods.

Efficient Algorithm Method Makes

PCR Testing of Plasma Donations a Reality

The complexity of PCR testing makes it difficult to apply to the millions of individual plasma donations collected each year. To make it practical to use this highly sensitive, but logistically complicated procedure for plasma screening, Alpha has patented this method in which "mini pools" of up to 512 donations are tested by PCR, under Investigational New Drug Applications (IND) filed with the FDA in 1997 and 1999.

If a mini pool tests positive, then the efficient algorithm is applied to determine the order of further testing, so that the reactive sample(s) in the pool can be identified with a minimum of 26 tests, rather than the 512 tests needed to screen each sample individually. Thus, the efficient algorithm provides the industry with a way of improving the ability to detect and remove reactive plasma donations and also shortens the time required for PCR screening.

In February and May 1999, Alpha submitted applications to the U.S. Food and Drug Administration (FDA) for approval to supplement its Product Licenses with the addition of PCR testing of source plasma for HIV and hepatitis C virus (HCV).

"Our clinical studies under investigational use may show that PCR testing using the efficient algorithm method may detect HIV and HCV in plasma donations during the window period earlier and more accurately than currently approved testing methods," said Charles Heldebrant, Ph.D., director, technical affairs at Alpha.

Investigational testing is being performed to determine the effectiveness of PCR testing to detect low levels of viral material. The significance of a negative result is unknown since the effectiveness of the test has not been established.

Alpha Licenses Efficient Algorithm Method to

National Genetics Institute

On May 16, 2000, Alpha was granted U.S. Patent 6,063,563 for the efficient algorithm method and subsequently entered into a license agreement with NGI, which grants NGI the right to use the method in connection with PCR testing services it performs. NGI has rights in the United States and an option for additional rights in other countries. Alpha retains all rights in Asia.

NGI currently conducts PCR testing of plasma donations for Alpha. The plasma is pooled into the 512 sample mini pools at the Alpha Testing Laboratory in Memphis, Tenn., and is shipped to Los Angeles for PCR testing at NGI.

NGI was founded in 1991 and has focused its expertise to develop PCR technology for testing AIDS/HIV, hepatitis and cancer. The company has developed a proprietary clinical assay system based on PCR technology. NGI is based in Los Angeles, and is licensed and approved as a clinical laboratory provider by both state and federal agencies. More information is available at www.ngi.com.

Alpha is a leading developer of plasma derived biopharmaceutical products including coagulation factors, immune globulins and albumin. With headquarters in Los Angeles, the company has more than 3,000 employees. Alpha is committed to providing high-quality, safe and cost-effective therapeutics for improved patient care worldwide. Additional company information is available at www.alphather.com.