Whooping Cough

North American Vaccine Inc. said yesterday that it had won a key regulatory approval in Europe for a vaccine for children, and expects the vaccine's sales to help fuel revenue growth this year.The Columbia-based vaccine developer said German regulatory authorities gave marketing approval to the company's combined injectable vaccine for diphtheria, tetanus, pertussis -- or whooping cough -- and polio.The DTaP-IPV vaccine was approved for use in infants and children up to six years of age, and will be marketed and distributed in Germany under an agreement with Chiron Behring, one of the largest vaccine distributors in Germany.

Columbia-based North American Vaccine Inc. reported yesterday that its fourth-quarter net loss almost doubled to $23.4 million, or 73 cents per share, on revenue of $3.3 million.In comparison, the company had a net loss of $13.1 million, or 41 cents per share, on revenue of $612,000 for the same period in 1997.The company said that its fourth-quarter loss included a $12 million interest charge. Without the charge, the loss would have been $11.5 million, or 36 cents per share, North American said.

Beltsville-based North American Vaccine Inc. said yesterday that its net loss grew to $43.8 million, or $1.39 per share, for the year ended Dec. 31, 1997, from a net loss of $19.5 million, or 63 cents a share, the previous year.For the fourth quarter, the vaccine developer reported a net loss of $13.1 million, or 41 cents a share, compared with a net loss of $199,000, or 1 cent a share, posted for the corresponding period a year earlier.The company attributed the 120 percent increase in the 1997 loss in part to increased operating expenses, which jumped 48 percent to $49.9 million, compared with $33.1 million in 1996.

In an effort to bring new life to its operations, North American Vaccine Inc. replaced its president of the past eight years with an executive from one of its competitors yesterday.Randal Chase, president of Canadian operations for vaccine maker Pasteur Merieux Connaught, will assume the top job at the Beltsville company by the end of the year, replacing Sharon Mates, who has departed."The company felt it was time for a management change because its needs have changed. North American Vaccine is shifting from an emerging biotechnology company to an operating company.

North American Vaccine said yesterday that it has turned over to the Food and Drug Administration all of the additional information the agency had requested about its new whooping cough vaccine for children and is confident the drug will win U.S. marketing approval soon.Shares in the Beltsville-based vaccine developer closed higher yesterday at $18.125, up $2.375, on the news."We feel very confident we'll have approval very soon," said Stephen M. Keith, vice president for sales and marketing for North American Vaccine.

Baltimore County has a new idea to get reluctant parents to immunize infants: It's offering a free, weeklong trip to Walt Disney World and other Florida attractions for one family.County officials hope publicity about the prize, worth more than $5,000, will boost the number of immunizations for hepatitis, diphtheria and other childhood diseases. Only 62 percent of the county's children have received their state-required shots by the proper age, the local health officer estimates."It's an interesting concept," R. Barry Trostel, assistant chief of Maryland's Center for Immunizations, says -- and an original one."

Here's a sampling of what's ahead for some of Maryland's better known biotechnology companies:* MedImmune Inc. -- This Gaithersburg-based biotechnology company is one of the state's best positioned and could move into the black if the federal Food and Drug Administration approves its Synagis, a powerful drug to treat a potentially life-threatening respiratory infection in infants. MedImmune plans to seek European regulatory approvals for the drug this year.The company also hopes to land FDA clearance early this year to launch human clinical trials for vaccine candidates it's developing for human papilloma virus, or HPV. The company is seeking regulatory approvals to market one vaccine for the viral infection, a leading cause of cervical cancer.

North American Vaccine Inc. yesterday won a long-awaited Food and Drug Administration approval to market its new whooping cough vaccine for children in the United States.The approval, which took the Beltsville-based company almost two years to land, marks the first U.S. product approval for the 12-year-old biotechnology company."This is really big for us," said Stephen M. Keith, vice president for sales and marketing for North American. "Clearly, the U.S. is a big market, and we're confident the vaccine will do well gaining market share."

Drug giant Abbott Laboratories said yesterday that it has begun marketing Certiva, a child vaccine developed and manufactured by North American Vaccine Inc. of Beltsville, to pediatricians and other health care providers.Certiva is the first North American Vaccine product to hit the U.S. market.Abbott has rights to market the vaccine, which provides protection against diphtheria, tetanus and pertussis, or whooping cough, to the private physician and managed-care markets in the United States under an agreement with North American Vaccine.

Shares in North American Vaccine Inc. tumbled more than 16 percent yesterday as word hit Wall Street that the Food and Drug Administration has requested more information about its whooping cough vaccine, Certiva.The stock closed at $18.56, down $3.62 a share.Neither the FDA nor the Beltsville-based company would disclose what information has been requested. But Dr. Sharon Mates, the company's chief executive officer, said the company wasn't asked to conduct additional costly and time-consuming human clinical trials to show that the drug is safe or effective.

When an unvaccinated child in Dr. Daniel Levy's practice came down with whooping cough this year, the Owings Mills pediatrician made a decision: He would no longer see patients whose parents refused to have them immunized against that disease or others, such as measles and meningitis. The risks posed to his other patients were too great, Levy reasoned. And he felt he couldn't give adequate care to children whose parents rejected some of his most basic advice: That routine childhood vaccines are safe and are the key to preventing diseases that used to kill many before they could reach adulthood.

Whooping cough sounds like one of those old-fashioned diseases that only the heroines of Victorian novels get. But whooping cough, or pertussis, is a serious and sometimes fatal illness that has been on the rise in the United States in recent years, says Virginia Keane, associate professor of pediatrics at the University of Maryland School of Medicine and president of the Maryland chapter of the Academy of Pediatrics. What is whooping cough? A bacterial infection caused by the bacteria Bordetella pertussis.

It sounds like some medieval baby-killer that must have disappeared when husbands first began boiling water as their wives went into labor. But 25 percent of pregnant women in the United States carry a common, potentially deadly bacterium called group B streptococcus (or GBS) that can infect their babies during childbirth or soon after. Although doctors frequently administer antibiotics during labor to prevent them, GBS infections kill or injure several thousand babies each year - within hours or weeks of their birth.

It started out much like any winter cold. But, soon enough, 16-year-old Zachary Graham couldn't stop coughing. And coughing. When doctors finally diagnosed Zach a few weeks later, they told him that his hacking fits - which sometimes made it hard to breathe and sleep - were caused by a disease the teenager thought he couldn't get: whooping cough. "When I was diagnosed, my parents and I were surprised that I had it because I had been vaccinated against the disease," said Graham, a high school junior from Sunapee, N.H., whose illness kept him off the ski slopes and away from his friends.

Vaccine shortages are forcing pediatricians to delay giving shots against diseases from tetanus to whooping cough, raising concerns that the nation could lose ground in the fight against childhood illnesses. The trouble started last summer when doctors had difficulty replenishing supplies of tetanus vaccine. Production problems have since triggered shortages of immunizations against chickenpox, diphtheria, whooping cough, measles, mumps, German measles and pneumococcal disease. For now, pediatricians say the shortages have bedeviled staffers who have had to keep track of patients who did not get shots during scheduled visits, and parents who have had to bring their youngsters back to make up missed shots.

North American Vaccine Inc. said yesterday that it had won a key regulatory approval in Europe for a vaccine for children, and expects the vaccine's sales to help fuel revenue growth this year.The Columbia-based vaccine developer said German regulatory authorities gave marketing approval to the company's combined injectable vaccine for diphtheria, tetanus, pertussis -- or whooping cough -- and polio.The DTaP-IPV vaccine was approved for use in infants and children up to six years of age, and will be marketed and distributed in Germany under an agreement with Chiron Behring, one of the largest vaccine distributors in Germany.

Columbia-based North American Vaccine Inc. reported yesterday that its fourth-quarter net loss almost doubled to $23.4 million, or 73 cents per share, on revenue of $3.3 million.In comparison, the company had a net loss of $13.1 million, or 41 cents per share, on revenue of $612,000 for the same period in 1997.The company said that its fourth-quarter loss included a $12 million interest charge. Without the charge, the loss would have been $11.5 million, or 36 cents per share, North American said.

In an effort to bring new life to its operations, North American Vaccine Inc. replaced its president of the past eight years with an executive from one of its competitors yesterday.Randal Chase, president of Canadian operations for vaccine maker Pasteur Merieux Connaught, will assume the top job at the Beltsville company by the end of the year, replacing Sharon Mates, who has departed."The company felt it was time for a management change because its needs have changed. North American Vaccine is shifting from an emerging biotechnology company to an operating company.

Drug giant Abbott Laboratories said yesterday that it has begun marketing Certiva, a child vaccine developed and manufactured by North American Vaccine Inc. of Beltsville, to pediatricians and other health care providers.Certiva is the first North American Vaccine product to hit the U.S. market.Abbott has rights to market the vaccine, which provides protection against diphtheria, tetanus and pertussis, or whooping cough, to the private physician and managed-care markets in the United States under an agreement with North American Vaccine.

North American Vaccine Inc. yesterday won a long-awaited Food and Drug Administration approval to market its new whooping cough vaccine for children in the United States.The approval, which took the Beltsville-based company almost two years to land, marks the first U.S. product approval for the 12-year-old biotechnology company."This is really big for us," said Stephen M. Keith, vice president for sales and marketing for North American. "Clearly, the U.S. is a big market, and we're confident the vaccine will do well gaining market share."