Shares of vaccine makers including Vical Inc. ((Nasdaq: VICL), Novavax Inc. (Nasdaq: NVAX) and BioCryst Pharmaceuticals Inc. (Nasdaq: BCRX) all are up strongly Monday after Europe’s version of the FDA decided to fast-track swine flu vaccine testing, making producers of the yet-to-be-approved inoculations potentially closer to bringing their products to market.
According to the Associated Press, The European Medicines Agency is greenlighting swine flu vaccine approvals; Britain, Greece, France and Sweden say they’ll start using the vaccines possibly within weeks.
Amid criticism from some doctors who warn about the potential for unknown side effects, the agency has decided that flu vaccines have been around for four decades, and the type of extensive testing reserved for most new drugs is not needed for swine flu vaccines. It would be using well-tested technology.
Speeding the vaccines to market in Europe may be a numbers game. The World Health Organisation has provided a guesstimate that only 900 million doses of swine flu vaccine may be able to be produced annually on a worldwide basis, for a world population of more than 6.5 million. In a pandemic scenario, that may pit rich countries versus poorer ones for vaccine access. Rich countries appear to want a jump-start.
That already appears to be happening. President Obama earlier this year set aside about $1 billion to buy needed vaccines.
But Europe is moving more aggressively. The U.K., for example, hopes to protect at least half its population from swine flu with vaccines by the start of next year.
For companies such as Vical Inc., the news may create a revenue opportunity for the company’s experimental H1N1 swine flu vaccine much quicker than expected. The company late last month showed strong efficacy data for its vaccine in animal models. The company said that at least 75% of vaccinated animals achieved or exceeded the protection threshold after a single dose of vaccine. The company said it is ready to advance directly to large-scale manufacturing for human clinical trials, subject to external funding.
Novavax, Inc. is another big play. The company last month signed a deal with Spain’s health ministry and ROVI Pharma, a specialty drug maker in Spain, to license its genetically engineered technology to produce pandemic and seasonal flu vaccines and build that country’s first vaccine-making plant.
BioCryst, meanwhile, made strides with its anti-flu program earlier this month. A study sponsored by BioCryst partner Shionogi & Co Ltd. in Japan showed that its Peramavir candidate was not inferior in terms of efficacy and safety to the anti-flu standard, Roche’s Tamiflu. The study involved a total of 1,099 patients at 146 centers. BioCryst now says it is planning late-stage studies of Peramivir, in hopes of winning an FDA approval.
Analysts covering all three companies are not expecting much, if anything in terms of swine flu revenue this year. But that could soon change, with the timetable for vaccines to market in Europe moving up rapidly.
It’s appears to be a race to get ready for the winter flu season. The Centers for Disease Control and Prevention (CDC) today said parents should have their children ages 6 months to 18 months vaccinated for flu this fall as soon as the flu vaccine becomes available. And the FDA wants to test swine flu vaccines among several thousand volunteers in August, in preparation for some vaccinations being available in October.
Europe, meanwhile, is not willing to wait that long.
Mike Tarsala, BioHealthInvestor and 24/7 Wall St.
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