MedImmune Inc. said yesterday that the Food and Drug Administration has approved a refrigerated version of its FluMist vaccine to soon replace the current frozen formulation, which has been criticized for having difficult storage requirements.
Wall Street reaction to the news was tepid. MedImmune shares closed down 7 cents, or 0.2 percent, to $34.25 in moderate trading on the Nasdaq yesterday.
Securing the approval means the Gaithersburg company has cleared the first of at least three significant hurdles analysts say are hampering the nasally inhaled vaccine's success. MedImmune's vaccine has struggled to make inroads against the traditional flu shot that many people receive annually.
Distribution of the original frozen FluMist, first approved in 2003, is limited to those willing to meet the storage needs, locking out some schools, pharmacies and grocery stores. The refrigerated version should encourage more flu vaccine providers to offer FluMist, said Frank M. Malinoski, a senior vice president for medical and scientific affairs at MedImmune.
The company is awaiting word on whether it can expand the dosage label to include older adults and the very young, and, anticipating a positive result, plans to ramp up production of the vaccine this year. Currently, the second-generation vaccine - temporarily known as CAIV-T - is only approved for healthy people ages 5 to 49.
In July, MedImmune asked the FDA to approve CAIV-T for children between the ages 1 and 5 with no history of wheezing or asthma - thought to be a key group.
"As MedImmune hopes to make CAIV-T the gold-standard pediatric influenza vaccine, the success of [that] filing is just as important to CAIV-T's potential as today's approval," biotechnology analyst Philip Nadeau, who works for Cowen & Co. in New York, wrote in a report issued yesterday.
Last summer, state officials announced plans to vaccinate elementary school children ages 5 to 11 with 250,000 free doses of FluMist, giving the vaccine a public relations boost among Maryland families.
MedImmune is also hoping to one day distribute the vaccine to adults 50 and older, but hasn't yet gathered the data needed to support this.
Such factors have kept FluMist sales relatively low in comparison to its injectable counterpart, the flu shot. In 2005, FluMist revenue was $21.3 million, which some blamed for MedImmune's loss that year. And while sales for 2006 are expected to be higher, the company has said the vaccine is exerting "downward pressure" on last year's margins.
In a report issued last month, analyst Joel Sendek of Lazard Capital Markets said CAIV-T will likely have a tough time penetrating the adult market, particularly given new data released in December that showed the current standard - the flu shot - performs better in adults than FluMist.
Sendek said the company predicted peak FluMist sales of about $400 million down the line.
The newly approved version should be available for next winter's flu season.