A Maryland company has won marketing approval in Sweden for a new, powerful vaccine to protect children against whooping cough and, as a result, now has an edge in the race to grab a share of the estimated $800 million U.S. and European market for the new-generation vaccines.
North American Vaccine, based in Beltsville, won approval yesterday to market its vaccine for whooping cough, the dreaded disease also known as pertussis.
On news of the approval, the company's stock rose $1.125 per share to $15.50, a 12-month high. Trading was heavy yesterday at 200,500 shares.
"This approval has enormous significance," said Ronald J. Stern, a vaccine and drug industry analyst with New York-based Buckingham Research Group. "It's confirmation that North American's vaccine is very safe, and it puts them a full step ahead of the competition."
"It's a very big deal for us," said Dr. Sharon Mates, president of North American Vaccine. "There's a healthy market for the vaccine."
North American Vaccine's new injection for pertussis was approved in Sweden for what are called primary shots -- injections given to protect infants -- and booster shots, given later to bolster the immune system against the disease. The vaccine is made from a highly purified antigen rather than the whole cell of the pertussis bacteria, as is used now for the vaccine.
Whooping cough is a highly contagious disease, affecting 50 million worldwide annually, according to health experts.
Fewer than 6,000 of those cases occur in the United States, but in Sweden the disease is considered endemic because the country hasn't allowed vaccinations for it since 1979.
Dr. Mates declined to project how much of the pertussis vaccine market North American expects to gain, but she said that with just four companies vying for the market, building market share should not be difficult.
Still, the other companies are all formidable, industry analysts note.
The three well-known and well-healed players in the drug industry who also have developed effective, new pertussis vaccines are: California-based Chiron; British-based SmithKline Beechum PLC; and Connaught Laboratories, based in Pennsylvania and owned by Rhone Poulec SA of France.
Safety factor stressed
They and North American all argue that their new vaccines are safer than the one currently used and could potentially replace it.
All are seeking approval for their new pertussis vaccines in the United States and abroad.
Indeed, SmithKline has also received approval by Swedish authorities to market its new pertussis vaccine in that country.
Dr. Mates declined to estimate whether the vaccine, if approved in the United States and by additional European countries, would put her 5-year-old company in the black. North American has not turned a profit since 1990; it posted a $10.7 million loss in 1994, and posted a $2.4 million loss in the first three-quarters of its current year.
Dr. Mates said the company expects to be able to emerge as a significant competitor in the pertussis vaccine market because it plans to market its new vaccine for adult protection, particularly in Europe where many adults have never been vaccinated.
The company, she said, is also working on developing what are called "combination" vaccines, which would allow physicians to give one shot for protection against several diseases at once, including polio.
Mr. Stern, the analyst at Buckingham Research Group, said the development of a combination vaccine would greatly enhance North American's position in the market.
"It would bring down the cost of vaccinating kids and it would reduce the number of times you had to inoculate a kid, making the whole process a lot easier on everyone," said Mr. Stern.
North American's new whooping cough vaccine was shown in a recent clinical study among 1,700 infants to be 71 percent effective in preventing the disease. Today's commonly used pertussis vaccine is considered 40 percent to 90 percent effective, said health experts.
Fewer side effects
Moreover, the new vaccine was shown to have a low incidence of causing side effects compared with the vaccine used today. It also had a much lower incidence of causing side effects than competitors' new vaccines, noted Mr. Stern, the analyst.
And, say industry experts, safety is the issue that could determine which companies that have developed new whooping cough vaccines emerge with strong market shares.
"Mothers know about the safety issue when it comes to vaccines," said Mr. Stern. "They are going to ask their pediatrician, 'Are you giving my kid a vaccine that is safe?' Pediatricians are going to want the safest product."
The company hopes to win Food and Drug Administration approval by summer to market the vaccine in the United States. The company submitted its application for final FDA approval in late September.
North American Vaccine has struck an agreement with a Danish medical supply company to market and distribute its new vaccine in Sweden, which is among a small group of European countries that banned use of the pertussis vaccine in the 1970s and 1980s out of concern about its potential rare adverse side effects, including high fever, brain damage and convulsions.
In the United States, the currently available pertussis vaccine is first administered to 2-month-old infants as part of a childhood-immunization program that involves inoculating against diphtheria and tetanus. Despite its side effects, the vaccine is widely credited with nearly eliminating the disease in the United States.
Before the vaccine's introduction in 1947, the disease was considered the No. 1 childhood killer in the United States.