By Karen Pihl-Carey

Aviron has filed a shelf registration statement with the SEC to offer up to $100 million of securities over a two-year period as it prepares to market its influenza drug, FluMist.

"We said $100 million, but it doesn't necessarily mean we'll raise or need to raise $100 million," said Fred Kurland, senior vice president and chief financial officer for Mountain View, Calif.-based Aviron. "It just provides us with the ability to take advantage of market opportunities."

The company chose this financing route for the flexibility of raising the money when it is needed either through stock, debt or a convertible-type security. If all of it is raised through stock, it would involve approximately 4 million shares at the stock's current price. But it does not have to be raised through stock. The shelf registration allows Aviron to raise money on favorable terms at its leisure. It may include one $100 million deal or multiple deals that do or do not add up to $100 million, Kurland said.

The company has not announced any particular financing deal as of yet. No underwriters are involved in the shelf registration.

For the quarter ended June 30, Aviron reported a net loss of $15.1 million and revenues of $2.9 million. It had $71.1 million in cash at the end of the second quarter, and approximately 15.7 million shares outstanding.

Aviron's stock (NASDAQ:AVIR) closed Thursday at $23.937, down $2.562.

The company intends to use the money raised through the financing primarily for its nose-spray influenza vaccine, FluMist, as well as for development of a second-generation formulation of FluMist and research and development of other pipeline products.

"It basically has to do with FluMist," Kurland told BioWorld Today. "We're going through a phase in which we hope to engage in the regulatory process real soon and build the infrastructure to commercialize FluMist."

While Aviron is still on track to file a biologics license application (BLA) for FluMist this fall, Kurland said the company now expects it to happen later in the fall than originally anticipated.

In a double-blind, placebo-controlled Phase III study, FluMist reduced febrile illness, severe febrile illness and upper respiratory tract illness in adults aged 18 to 65. The patients missed fewer days of work and made fewer visits to their health-care provider over the course of the study. (See BioWorld Today, July 15, 1999, p. 1.)

Aviron and Wyeth Lederle Vaccines, a business unit of Wyeth-Ayerst Laboratories, share U.S. marketing rights of FluMist in a $400 million deal signed earlier this year.

Other companies have similar products in the clinic or on the market, including Birmingham, Ala.-based BioCryst Pharmaceuticals Inc., with its RWJ-270201, a small-molecule neuraminidase inhibitor, which demonstrated positive results in a Phase II trial. Glaxo Wellcome plc's inhaled neuraminidase inhibitor flu therapy, Relenza, received marketing approval in July. Gilead Sciences Inc., of Foster City, Calif., and Hoffmann-LaRoche Inc., of Nutley, N.J., have a neuraminidase inhibitor in pill form, GS4104, which is expected to be approved by the FDA sometime this year.

In its pipeline, Aviron has a live intranasal vaccine for parainfluenza virus type 3 (PIV-3) to protect against croup, which completed a Phase II trial and will likely progress to a Phase III. In collaboration with SmithKline Beecham Biologicals SA, the company also is developing a subunit vaccine for Epstein-Barr virus to protect against infectious mononucleosis, which completed a Phase I trial and will continue in the clinic in 2000. Aviron hopes to bring its vaccine for cytomegalovirus to the clinic in a Phase I trial early in 2000. The company also is trying to develop vaccines for herpes simplex virus type-2 and respiratory syncytial virus.

"We are working with potential vaccine candidates, but we have not made firm plans for entry into the clinic," Kurland said.