Calypte Shares Soar on Chinese Approval for HIV Test 8/25/00 2:56:00 PM
Source: Bloomberg News
Alameda, California, Aug. 25 (Bloomberg) -- Calypte Biomedical Corp. nearly tripled after the HIV test specialist said it won approval to sell its HIV urine test in China.
Calypte rose 2 7/8, or 191 percent, to 4 3/8 in Nasdaq trading of 21.8 million shares, about 155 times its three-month daily average. The stock was the No. 2 percentage gainer and the second-most-active stock on U.S. markets after Microsoft Corp.
The State Drug Administration of the People's Republic of China approved Calypte's HIV-1 antibody urine test, making it the only urine-based test approved for Chinese distribution, the company said. In studies, the test appears to work alone or in combination with blood tests too boost the HIV detection rate. Tests cost as little as $3 each.
''This is just the beginning of the company's penetration on a worldwide basis,'' said Morton Cohen, chairman of the Clarion Group, which manages a $125 million hedge fund and holds about 800,000 shares of Calypte. ''This stock, at four dollars, is really cheap.''
About half a million people in China are infected with HIV, according the United Nations' UNAIDS program, and officials from China's National Center for AIDS Prevention and Control have said HIV infections in China could reach 10 million by 2010 if screening and prevention measures aren't taken.
The Calypte test could prove particularly useful in China, where according to the National Center, roughly one-third of people who were to be tested refused to have blood drawn during a recent screening effort, Calypte said.
U.S. Setbacks
The Chinese approval could be a boon to the company, which has struggled to build sales for the test in the U.S., where it has been approved since mid-1998.
The company has had regulatory struggles in recent years. In 1998, Calypte received two FDA warning letters for lapses in manufacturing quality control. According to regulatory filings, the FDA has said the company's responses to both letters appeared adequate; still, Calypte must wait for an FDA re-inspection of its plants before the agency considers the matter closed.
In October, the company replaced its top two executives. Board member David Collins, a former executive at drugmaker Schering-Plough Corp., was named chief executive, and Nancy Katz, who had run marketing and sales for Johnson & Johnson's LifeScan diabetes testing unit, became president, chief operating officer and chief financial officer.
Other Agreements
Since then, Calypte has signed agreements with governments including South Africa and other sub-Saharan African nations where HIV and AIDS are taking their greatest toll.
''The company has just had trouble marketing'' the test, Cohen said. ''New management has come in and has executed almost every deal,'' he said.
Calypte's test is safer than a blood test because it's free of the risk of HIV transmission when needles used to draw blood are reused. The test also is cheaper and easier to handle than a blood test, with comparable accuracy, and can be administered by people without special training.
In South Africa, for example, the company is developing a mobile screening program where shipping containers are transformed into basic clinics and moved by truck or train to remote areas. The urine test also doesn't require refrigeration and other stabilizing measures necessary for tested blood.
HIV screening tests, whether on blood, urine or saliva, look for antibodies to HIV -- an indication that the patient's immune system is fighting an infection. Since they all sometimes give so- called false positive results, or indications patients are infected when they really aren't, another test that looks for parts of the virus itself is used to confirm positive results. |
