One from Egypt

Old idea, new contraceptive

After researchers at the Syntex Corp. produced the first oral contraceptive in 1951, the small pharmaceuticals maker grew within a few years into a large conglomerate (fiscal year 1982 revenues: $813 million). A host of other companies has made fortunes supplying what is now a huge U.S. contraceptives market. A small firm in California called V.L.I. hopes to join their ranks with a new kind of contraceptive that is likely to be approved by the Food and Drug Administration within a month.

Invented by Bruce Vorhauer, 41, a biomedical engineer, the new product is a soft polyurethane sponge 5.5 cm wide and 2 cm thick, permeated with a common spermicide, nonoxynol 9, that has been on the market for 20 years. The product combines the barrier aspects of the diaphragm with the principal advantages of the less effective male condom. In tests, the sponge has proved to be as effective as the diaphragm: studies for one year of thousands of women, some of whom may not have used contraception diligently or properly, have shown that both methods prevent pregnancy in 90% of those tested. Like the condom, the sponge is handy to use, and women will be able to buy it with ease and privacy, since no prescription will be required.

Inserted any time up to 16 hours before intercourse, the sponge releases its spermicide gradually, killing and absorbing sperm before they can reach the cervix. Unlike the diaphragm, the device--called Today--stays effective for 24 hours (hence the name) regardless of how many times the user has intercourse, and there is said to be nothing messy or awkward about it. A small polyester loop attached to the sponge makes removal easy. Vorhauer, the president of V.L.I., expects to start selling the contraceptives this fall, at about $1 apiece.

Vorhauer got the idea for the sponge in 1975, when he was an executive with Chicago-based American Hospital Supply Corp. The notion actually dates back more than 3,000 years to the Egyptians, who used sea sponges soaked in citrus juices, which are slightly spermicidal, as contraceptives. When American Hospital showed little interest in Vorhauer's idea, he resigned and set up a tiny office in Newport Beach, Calif. Says he: "My kitchen was my first lab."

Start-up funding of $400,000 from a friend enabled Vorhauer to begin clinical testing in Mexico City in 1977. But when the money ran out, Vorhauer was hard-pressed to keep his company afloat. He recalls one point when he had just $3.50 in the bank. During his seven-year wait for FDA approval, he was inspired by the inscription on a statue of Buddha that stands on his desk: "Those who cannot wait never win."

Each time he was almost out of business, an angel appeared. In 1980 a local gynecologist persuaded several fellow doctors to pitch in $500,000. Since then, a $5 million infusion by a group of investors, including Golder Thoma & Co., a Chicago venture-capital firm, and Donaldson, Lufkin & Jenrette's aptly named Sprout Investment Group, has enabled Vorhauer to hire 40 employees. V.L.I. will soon move into a 50,000-sq.-ft. manufacturing facility in nearby Irvine. Vorhauer expects to hire 80 more workers by year's end as production gears up. The United Kingdom and four other countries have already approved Today for sale, though it is not yet on the market. Says Rick Kroon, chief of the Sprout venture-capital operation: "The potential market for the product is tremendous."

Physicians who participated in clinical tests of more than 2,000 women conducted in the U.S. and six foreign countries during the past four years report that the sponge drew few complaints from users. Says Dr. Richard Soderstrom, a partner in the Mason Clinic in Seattle who is also a member of the FDA panel on toxic shock: "There are no systemic side effects, and no risk of infection."

Testing specifically addressed the risk of toxic shock, since some research indicates that barrier devices like the diaphragm may encourage the development of the bacteria believed to cause the deadly illness; Soderstrom reports that the spermicide in the sponge seems to kill the bacteria. Nevertheless, as an added safeguard, the FDA will require a label advising women to remove the sponge within 24 hours to reduce that risk. This is a bonus for V.L.I. Initially the company planned to advertise Today as a 48-hour protection. Before it even hits the shelves, the potential market has doubled. This file is automatically generated by a robot program, so viewer discretion is required.