West Coast Editor

Wasting no time after reporting preclinical success with its bird-flu vaccine, Novavax Inc. teamed up with Wave Biotech LLC to make commercial-scale supplies of that product and others.

Novavax's stock (NASDAQ:NVAX) closed Tuesday at $1.72, up 21 cents, or 13.9 percent.

The first push for the companies is Novavax's H9N2 Virus-Like Particle vaccine, which the company and government collaborators last month said was effective in animals challenged with the live virus. Results were published in the online Aug. 15, 2005, edition of Vaccine, and Novavax's stock jumped more than 30 percent on the news. (See BioWorld Today, Aug. 26, 2005.)

Under the terms, Somerset, N.J.-based Wave will provide process and equipment expertise for the proprietary technology based on disposable equipment for making biologicals, and Novavax scientists will work with the engineering team at Wave to further develop the vaccine-producing methodology.

Financial details were not disclosed, and company officials could not be reached.

Novavax's aseptic, high-yield VLP vaccine approach uses recombinant DNA technology to design components of the flu virus in 3-dimensional structures to give protection without the risk of infection or need for chemical adjuvants.

The H9N2 product incorporates VLP vaccines put together from the proteins HA, NA and M1, made from genes cloned from avian H9N2 influenza virus. Animals given shots of low-dose VLP developed antibodies after the first subcutaneous hit, and immune responses increased after a booster.

Novavax also has VLP vaccines in the works for AIDS, closing out the second year in a five-year program, and for severe acute respiratory syndrome, which just got under way. Both of those efforts also have government backing.

Already approved is the company's estradiol emulsion product, Estrasorb, for vasomotor symptoms in post-menopausal women. Androsorb, a topical testosterone emulsion, has completed two Phase I trials. Both were devised by way of the micellar-nanoparticles platform.

This summer, the transdermal technology yielded positive preclinical data in studies with a pair of other drugs, NX-303 oxybutynin, for urinary and bladder complications, and NX-401, an antihistamine. The approach also has shown promise in proof-of-principle studies with NX-300 (fentanyl) for pain management, NX-301 (nicotine) for smoking cessation and NX-302 (clonidine) for hypertension, as well as hormone candidates, such as NX-200 (norethindrone) for female hormone replacements and NX-201 (ethinyl estradiol) combined with norethindrone as a contraceptive.

In July, the Malvern, Pa.-based firm completed a financing that raised gross proceeds of $4 million through the sale of 4 million shares at $1 per share, pursuant to a shelf registration. Novavax said proceeds will be used for product development and working capital.

No Comments