MedImmune licensed its proprietary reverse genetics technology to Novartis, marking the third time in a year the biotech has licensed the technology for development of influenza vaccines.

Under the terms of the deal announced Aug. 23, Gaithersburg, Md.-based MedImmune will receive an up-front payment and royalties on "certain vaccine stockpiles or sales of other influenza products" developed using the technology.

The company inked a similar deal with Sanofi Pasteur in March and one with Australia's CSL in December. "As the owner or exclusive licensee of the key patent estates for use of the reverse genetics technology in human influenza vaccines, MedImmune remains committed to making sure that the technology is accessible to government institutions and industry manufacturers," the company said.

The licenses are for development and construction of new vaccine strains to produce inactivated human seasonal, pre-pandemic and pandemic influenza vaccines.

Also on Aug. 23, the firm announced positive results from a second Phase III study of its next-generation respiratory syncytial virus therapy Numax (motavizumab). The biotech had said it would hold off submitting a BLA for the Synagis (palivizumab) follow-on until it received data from the study, which tested the vaccine in Native American infants. That submission is planned by the end of the year, with a launch during the 2008-2009 RSV season (¹ Also see "MedImmune Delays Numax BLA Pending Additional RSV Trial Data" - Pink Sheet, 7 February, 2007.).

In the study, motavizumab was shown to reduce hospitalizations due to RSV by 83 percent, as compared to placebo (8.3 percent in placebo arm versus 1.4 percent in treatment arm; p<0.001), the trial's primary endpoint. On the secondary endpoint of reduction in RSV-specific lower respiratory infections, the treatment group showed a 71 percent reduction in LRIs requiring outpatient management (9.5 percent in placebo group and 2.8 percent in the motavizumab group; p<0.001).

In November, MedImmune released top-line data from a Phase III study in which Numax met the non-inferiority endpoint of reducing RSV hospitalizations by 26 percent compared to Synagis.

MedImmune is now a wholly owned subsidiary of AstraZeneca, which completed its acquisition of the company for roughly $15.6 billion on June 18 (² Also see "AstraZeneca Accelerates Biologics Strategy With Acquisition Of MedImmune" - Pink Sheet, 23 April, 2007.).

-Shirley Haley (s.haley@elsevier.com)

MedImmune Inks Third Reverse Genetics Licensing Deal For Influenza Vaccines

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