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Calypte Biomedical Signs Exclusive Agreement to Distribute Urine-based HIV Testing Products in Brazil.


Business Editors & Health/Medical Writers

ALAMEDA, Calif.--(BUSINESS WIRE)--May 11, 2000

Calypte Biomedical bi·o·med·i·cal
adj.
1. Of or relating to biomedicine.

2. Of, relating to, or involving biological, medical, and physical sciences.
 Corporation (Nasdaq:CALY) today announced that it has entered into an exclusive distribution agreement with Biobras S.A. (Biobras) of Brazil to distribute its HIV HIV (Human Immunodeficiency Virus), either of two closely related retroviruses that invade T-helper lymphocytes and are responsible for AIDS. There are two types of HIV: HIV-1 and HIV-2. HIV-1 is responsible for the vast majority of AIDS in the United States.  urine-based testing products throughout Brazil.

Biobras is a privately held company privately held company

A firm whose shares are held within a relatively small circle of owners and are not traded publicly.
 headquartered in Belo Horizonte Belo Horizonte (bəl'rēzôN`tĭ) [Port.,=beautiful horizon], city (1996 pop. 2,091,770), capital of Minas Gerais state, E Brazil. , a city located directly north of Rio de Janeiro Rio de Janeiro, city, Brazil
Rio de Janeiro (rē`ō də zhänā`rō, Port. rē` thĭ zhənĕē`r
. Employing 500 people in four divisions, it is the fourth largest producer of insulin worldwide and one of the leading Brazilian manufacturers and distributors of reagents for clinical, food, and human identification laboratories. Biobras is very active in pharmaceutical and diagnostic markets, with annual sales of approximately $30 million.

Nancy Katz, president, chief operating officer Chief Operating Officer (COO)

The officer of a firm responsible for day-to-day management, usually the president or an executive vice-president.
 and chief financial officer of Calypte Biomedical, said, "We believe that the favorable characteristics that distinguish urine-based HIV testing are particularly well-suited for countries outside the U.S., like Brazil, that are seeking ways to encourage more people to be tested. Urine-based testing has proven to be safer, cheaper and easier to administer than traditional testing methods, and we believe that the Brazilian population will benefit from the introduction of alternative testing procedures.

"A critical part of the process, of course, is to identify the right distributor, one with sufficient scope and strong, national relationships, so that our test will get into the appropriate hands. We entered into many conversations in Brazil with a variety of companies, and Biobras suited our needs better than any other distributor. We look forward to working with Biobras and expect the relationship to be mutually beneficial Adj. 1. mutually beneficial - mutually dependent
interdependent, mutualist

dependent - relying on or requiring a person or thing for support, supply, or what is needed; "dependent children"; "dependent on moisture"
."

Ms. Katz added, "This agreement marks a significant milestone in Calypte's development. It is the first agreement Calypte has signed with a major international distributor and we are hopeful other countries will recognize the benefits our testing method can bring to underserved populations like Brazil's."

The announcement follows an April meeting held in Brasilia, which was attended by Brazilian health and regulatory officials, and featured a presentation by Professor Luc Montagnier Luc Montagnier (born 1932 in Chabris, France) is a French virologist. In 1982 he was asked for assistance with establishing the possible underlying retroviral cause of a mysterious new syndrome, AIDS, by Dr. , discoverer of the virus that causes AIDS. In that meeting, Professor Montagnier described his vision of the HIV epidemic and his view of the world's diagnostic and therapeutic priorities.

During the meeting, Professor Montagnier said, "Data from my own clinics, and others around the world, clearly demonstrate that the antiretroviral therapies available today can have a dramatic and favorable impact on the management of HIV disease. Our most urgent task is to adapt such therapies in order to make them accessible to all patients in developing countries. Therefore, it is important to conduct new epidemiological studies by HIV testing."

Professor Montagnier continued, "I believe that several unique aspects of urine testing, including its safety, painless sample collection and sample stability, make it a desirable -- if not preferable -- option for our expanded testing efforts."

Humberto Decerega Mendez, Director of the Diagnostics Division of Biobras, noted that the Calypte test will be the first test of its type available in Brazil. "We are moving forward with Brazilian registration of the Calypte products as quickly as possible. Brazil, with its large population and vast geography, poses logistical problems in HIV testing that we believe are perfectly addressed by the Calypte urine products. The simple and painless sampling method used by the Calypte products also makes them ideally suited for large scale testing of special groups, such as pregnant women and drug abusers. The Calypte products will be sold nationwide through a distribution network already established by Biobras, as well as to special screening programs operated by the federal government in regions where centralized laboratories do not exist."

Recent statistics from Brazilian health officials point to a significant HIV prevalence in Brazil, with up to 650,000 people already infected. Brazil accounts for roughly half of the AIDS cases in Latin America Latin America, the Spanish-speaking, Portuguese-speaking, and French-speaking countries (except Canada) of North America, South America, Central America, and the West Indies.  and the Caribbean.

Calypte Biomedical Corporation (Nasdaq:CALY) is a health care company dedicated to the development and commercialization of urine-based diagnostic products and services for Human Immunodeficiency Virus human immunodeficiency virus
n.
HIV.


Human immunodeficiency virus (HIV)
A transmissible retrovirus that causes AIDS in humans.
 Type 1 (HIV-1), sexually transmitted diseases Sexually transmitted diseases

Infections that are acquired and transmitted by sexual contact. Although virtually any infection may be transmitted during intimate contact, the term sexually transmitted disease is restricted to conditions that are largely
 and other chronic illnesses. Carter-Wallace (NYSE NYSE

See: New York Stock Exchange
:CAR) has the exclusive U.S. sales and marketing rights for Calypte's HIV products in the hospital, public health and reference lab markets. Calypte's tests include the screening EIA (Electronic Industries Alliance, Arlington, VA, www.eia.org) A membership organization founded in 1924 as the Radio Manufacturing Association. It sets standards for consumer products and electronic components.  and supplemental Western Blot tests Western blot test
n.
A serum electrophoretic analysis used to identify proteins.
, the only two FDA-licensed HIV-1 antibody tests that can be used on urine samples. The company believes that accurate, non invasive urine-based testing methods for HIV and other chronic diseases may make important contributions to public health by helping to foster an environment in which testing may be done safely, economically, and painlessly.

Statements in this press release that are not historical facts are forward-looking statements, including statements regarding market adoption of the HIV-1 urine testing products and the serum Western Blot test and statements regarding marketing and distribution arrangements and plans. Actual results, events, or performance may differ materially from the above forward-looking statements due to a number of important factors, and will be dependent upon a variety of factors, including the Company's ability, directly or through third parties, to successfully manufacture and market the HIV-1 urine testing products and the serum Western Blot test and the ability of the Company to continue to finance its operations and to enter into distribution and marketing arrangements. The Company undertakes no obligation to publicly update these forward-looking statements to reflect events or circumstances that occur after the date hereof or to reflect the occurrence of unanticipated events. Factors which may impact the Company's success are more fully discussed in the Company's most recent periodic report on Form 10-K Form 10-K

A report required by the SEC from exchange-listed companies that provides for annual disclosure of certain financial information.


Form 10-K

See 10-K.
.
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Publication:Business Wire
Date:May 11, 2000
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