By Matthew Willett

Aviron Inc. submitted a biologics license application Tuesday with the FDA for its FluMist influenza vaccine, signaling, company officials said, the transition from a development focus to a focus on commercialization.

The submission, when accepted for filing by the FDA, will trigger a $15.5 million milestone payment from marketing partner Wyeth Lederle Vaccines, a division of Wyeth-Ayerst Laboratories, in turn a division of American Home Products Corp., of Madison, N.J.

That agreement with Wyeth Lederle potentially is worth more than $400 million for Mountain View, Calif.-based Aviron. (See BioWorld Today, Jan. 13, 1999.)

Boyd Clarke, Aviron president and CEO, said the submission represents a maturation for his company. The jump to commercialization is a goal the company set in the spring.

"Three things are fundamental to what this represents," Clarke told BioWorld Today. "One is that we fulfilled the objective we set for ourselves. I believe we can say to our investors that we delivered on time as we said we would. The second is that it's a hallmark of our shift from a development company to one focused on commercialization, which we've seen in the transition in management, our company's size and re-establishing control of all the facets of our manufacturing facilities. And it's consistent with the time frame for a potential 2001 launch."

The road to filing hasn't been without bumps. Pivotal trials for the vaccine began in 1996, and positive results from a two-year Phase III trial prompted the company to submit the vaccine to the FDA for approval in 1998.

That submission in 1998 for FluMist was rejected by the FDA, which cited a need for manufacturing data. (See BioWorld Today, Sept. 2, 1998.)

Little more than a year later Aviron decided not to re-file with the FDA. Plagued by manufacturing issues with contract manufacturer Medeva Pharma Ltd., the company set the goal of 2001. (See BioWorld Today, Nov. 16, 1999.)

Now Clarke considers it personally gratifying to have hit the mark Aviron set for itself.

"It is a significant achievement from Aviron's perspective, and the one I take the most pleasure in is that in March of this year we established for ourselves an objective of a fourth-quarter BLA," he said. "We knew it had to be a high-quality BLA, and there's no guarantee. But we believe we've done that. We hit that objective dead on the nose, and I think that's something to derive some amount of pleasure from."

Clarke said his company now will focus on commercializing FluMist, a unique intranasally delivered attenuated live vaccine, in time for the 2001 flu season. Production of the vaccine already has begun.

Wyeth has exclusive worldwide marketing rights for up to 11 years, co-promoting FluMist with Aviron in the U.S. and collaborating on regulatory, clinical and marketing programs. Excluded from the deal are Korea, Australia, New Zealand and certain South Pacific countries. Aviron, which would receive a $20 million milestone upon approval, also is entitled to royalties on sales and transfer payments for manufacturing.

"I believe there are two fundamental differences in this vaccine compared to all other flu vaccines," he said. "The first and most obvious to people who see the vaccine and the delivery system is that it is an intranasal, and therefore painless. Whether you're a child, or an adult, like me, who's not particularly enamoured of needles, that delivery system is an attractive one.

"Further, unlike traditional flu vaccines it's not an inactivated virus, it's an attenuated live vaccine administered intranasally, and many observers have postulated it will provide a type of immunity much more like natural immunity."

But as important as the next step in the vaccine's development, if not more important for Aviron, is the next step for the company.

"The company is moving toward commercialization, and we have sincerely taken our own destiny in our hands. In the early days we were to work with contract manufacturers, and as recently as a few weeks ago we secured from PowderJect control of our manufacturing facility in the UK. What it boils down to is that in 1998 the company was a typical small biotech company, and now we're much more focused on commercialization. We're much more robust."

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