Berna Wins First Approval for Inhaled Flu Vaccine
(Update1)
By Chantal Pfenniger
Bern, Oct. 3 (Bloomberg) -- The Swiss Serum and Vaccine Institute, or Berna,
won the first approval to sell a nasal-spray influenza vaccine, beating bigger
rivals Glaxo Wellcome Plc and Roche Holding AG in the race to bring new
entries to market.
Berna said it won marketing approval from the Federal Office for Health to sell
Nasalflu on the Swiss market. The closely held company said the treatment is
the world's first preventive flu drug absorbed by the mucous membrane in
patient's nose.
``Berna, which is already the top supplier of intravenous flu vaccines in
Switzerland, hopes Nasalflu will appeal to new groups of the population,''
Berna said in a faxed statement. ``The drug is now available to Swiss
doctors.''
After 10 years of research, the Swiss biotechnology company with annual
sales of 183 million Swiss francs ($105 million) won the race against much
larger pharmaceutical rivals such as Glaxo, the world's fourth-biggest
drugmaker, and Roche, No. 5 in Europe.
Both Glaxo and Roche are seeking U.S. approval of drugs for use in preventing
the flu. The companies already have clearance to sell their medicines as
treatments for the illness. Glaxo's Relenza is inhaled, while Roche's Tamiflu is
a pill.
Spray Bursts
The Berna vaccine is applied through a burst of the spray into each nostril,
which will produce antibodies against a strain of virus in the blood and in the
nose, where the germs usually enter the body, Berna said. Clinical studies
have proven the safety and effectiveness of the medicine, the company said.
Berna has plans to sell its products in Germany and extend sales to the rest
of the European Union. The company also wants to enter the U.S. market,
said Bernhard Wegmueller, a sales representative at Berna.
``We've filed for approval in Germany and expect to have it on the market for
next year's flu season,'' Wegmueller said. ``In the U.S., we're in talks with
various companies to license our products.''
Wegmueller declined to name the companies. Aventis SA, SmithKline
Beecham Plc and Merck & Co. are among the major vaccine makers with
extensive operations in the U.S. American Home Products Corp., meanwhile,
is working with the U.S. biotechnology company Aviron in its own nasal spray
flu vaccine. |
