Chiron Corp. announced Friday that it has completed its Phase III U.S.-based Menjugate trial, but will not be filing a biologics license application as planned.

The company gave no details as to what the pivotal trial showed, but said it intends to focus its resources on the Phase II meningococcal ACWY vaccine, instead.

"The decision is not in any way a reflection on the vaccine itself," said John Gallagher, Chiron's media relations manager. "The results looked good."

While he would not detail the results, he said they most likely would be presented at a scientific conference. Chiron initiated the Phase III trial in the first half of last year. (See BioWorld Today, Feb. 28, 2003.)

Despite the data and the fact that Menjugate is approved in more than 20 countries, Chiron sees no future for the product in the U.S. The Emeryville, Calif.-based company is backing away from Menjugate because of competition from Aventis Pasteur and other companies.

"With the changing landscape of competitors with quadravalent vaccines, it seemed like the opportunities for Menjugate were smaller," Gallagher told BioWorld Today. "So it made more sense to put our resources into developing our own quadravalent."

Aventis Pasteur, part of the Sanofi-Aventis Group, filed a BLA in December for its quadravalent vaccine, Menactra, which offers protection against four serogroups of meningococcal disease, including A, C, Y and W-135. (See BioWorld Today, Dec. 29, 2003.)

Likewise, Chiron's quadravalent vaccine offers protection against those four serogroups, while Menjugate offers protection against one, serogroup C.

Chiron said it has collected a lot of safety and immunogenicity data from the Phase III study, and will apply that knowledge as it moves the ACWY vaccine forward. The ACWY vaccine is being studied in a Phase II trial in infants, and should move into Phase III work sometime in 2005. It could reach the market by 2008, Gallagher said.

In vaccination campaigns in the UK and Quebec City, Chiron said Menjugate helped reduce disease-related deaths by 80 percent.

But according to Chiron's quarterly results, sales for Menjugate slipped. Chiron reported $9 million in sales of meningococcus vaccines for the third quarter of 2004, compared to $11 million for the third quarter of 2003. The decrease primarily was due to lower sales of Menjugate as a result of the timing of tenders and an increased price competition.

"It's a tender-driven business," Gallagher said. "It really has a lot to do with the timing of tender offers. Various countries will say they will put a tender offer in for meningococcal C vaccines. There are fluctuations in the revenue as a result of that. And there's been an increased competitive market."

The decrease in Menjugate sales, however, was offset last quarter by sales from MeNZB meningococcal B vaccine, which was approved in July in New Zealand. Chiron developed the vaccine in collaboration with the New Zealand Ministry of Health and the Norwegian Institute of Public Health to protect against the specific meningococcal B strain responsible for a 13-year epidemic in the country.

With news that Menjugate will not reach the U.S. market, Chiron has had a busy few months. The company submitted a new drug application for Pulminiq inhalation solution for lung transplant patients in October, about a month after it acquired Prion Solutions Inc., of La Jolla, Calif., to complement its blood-safety program. (See BioWorld Today, Sept. 1, 2004, and Oct. 15, 2004.)

And about six weeks ago, Chiron announced that it would not be providing flu vaccine this season after the UK banned production at its Liverpool facility over safety concerns. The company's stock fell 16.4 percent that day, to close at $37.98. (See BioWorld Today, Oct. 6, 2004.)

On Monday, the stock (NASDAQ:CHIR) dropped 8 cents, to close at $31.87.