US biotech Novavax has initiated a pivotal two-stage study for its H1N1 influenza vaccine in Mexico. Novavax’s strategy of pursuing approval for the vaccine in smaller markets before targeting the US represents an alternative and faster route to market. Given the many benefits of this strategy, Datamonitor believes that it may be adopted by other small vaccine companies in the future.

Novavax has initiated the two-stage Phase IIb/III study of its virus-like-particle (VLP) H1N1 influenza vaccine in Mexico in collaboration with Avimex Laboratories (Avimex) and GE Healthcare (a unit of General Electric Company).

In its first stage, the blinded, placebo-controlled clinical trial will evaluate the safety, immunogenicity and efficacy of the VLP vaccine in 1,000 healthy adults. Pending the favorable outcome of stage one, stage two of the study will examine the safety of the vaccine in a larger cohort of 3,000 subjects. Primary safety and immunogenicity results are expected within three months of the start of the study, in January 2010, and could form the basis for the registration of the pandemic flu vaccine in Mexico and other countries, including the US.

Mexico-based Avimex will be providing financial support for the trial and will distribute the vaccine in Mexico if it gains approval. GE Healthcare, meanwhile, is supporting this program by providing its single-use bio-processing technologies for vaccine production. GE Healthcare and Novavax have worked together since December 2007, focusing on vaccine production strategies using GE Healthcare’s manufacturing technologies.

Partnering with local manufacturers and first commercializing the vaccine in smaller markets such as Mexico is a smart strategy, allowing Novavax to gather additional data to strengthen its application in the US where market entry barriers are higher due to larger competition. Novavax is pursuing a highly regional strategy with its H1N1 program: the biotech has also established a collaboration with the Spanish company Rovi Pharmaceuticals to market the vaccine in Spain, if it is successfully approved. In addition, clinical trials for the vaccine will be conducted in joint collaboration with Indian drug major Cadila Pharmaceuticals.

Novavax is not the only company looking across the US border for accelerated progress on its H1N1 program. In May 2009, its Connecticut-based rival Protein Sciences also closed a deal with authorities in Mexico to operate a vaccine manufacturing facility there, which could be used for the production of the company’s H1N1 vaccine.

In Datamonitor’s opinion, targeting smaller or emerging markets first represents an interesting and potentially faster route to commercialization for H1N1 influenza vaccines. Since this strategy lowers market entry barriers and preserves cash, Datamonitor predicts that other smaller vaccines developers may adopt it in the coming months.

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