Health and Human Services Secretary Mike Leavitt awarded more than $1 billion in government contracts to five companies for cell-based production of seasonal and pandemic flu vaccines, with a $170 million contract going to MedImmune Inc.
Under the terms of the five-year agreement, MedImmune will "work toward establishing a cell-based manufacturing facility in the U.S.," said Clarencia Stephen, a spokeswoman for Gaithersburg, Md.-based company, adding that the facility will be designed to produce "150 million doses of monovalent intranasal vaccine within six months of the declaration of an influenza pandemic."
Shares of MedImmune (NASDAQ:MEDI) gained 84 cents Thursday to close at $31.89.
The funding is part of a federal $3.3 billion plan aimed at improving the efficiency of flu vaccine production, an objective outlined in the president's National Strategy for Pandemic Influenza. The government's goal is to be able to produce at least 600 million doses within a six-month period, if needed.
In addition to MedImmune, contracts also went to GlaxoSmithKline plc for $275 million, Novartis Vaccines and Diagnostics (comprising Novartis Vaccines and Chiron) for $221 million, DynPort Vaccine Co. LLC for $41 million and Solvay Pharmaceuticals for $299 million.
Work at all those companies will focus on developing a process for manufacturing flu vaccines using cell-based methods. For the past 50 years, flu vaccine production has relied on a technique involving virus strains grown in chicken eggs, but that method likely would not yield enough doses in the event of a pandemic. That process also is dependent upon egg supplies, and cannot be administered to patients with egg allergies.
For instance, MedImmune's marketed intranasal flu vaccine, FluMist, which is manufactured using chicken eggs, has a capacity to scale up to 45 million bulk doses per month. With a cell-based manufacturing process, which involves the introduction of the virus into a container of mammalian cells, the company anticipates producing between 300 million and 400 million doses of a pandemic version of the vaccine on an annual basis.
MedImmune already has the cell-based manufacturing technology in place. The company uses it to manufacture Synagis (palivizumab), a monoclonal antibody for preventing respiratory syncytial virus in high-risk infants.
"So we plan to use that technology and expertise in developing an intranasal pandemic vaccine," Stephen said.
Besides FluMist, MedImmune has filed a biologics license application for CAIV-T, a next-generation, refrigerator-stable trivalent vaccine that has demonstrated equivalence to frozen FluMist.
Next month, the company intends to submit a supplemental application to expand the CAIV-T label to include children from 6 months to 5 years, based on Phase III data reported earlier this week showing that MedImmune's vaccine was 55 percent more effective in infants than the standard injectable inactivated flu vaccine.
If it's approved, "we'll be one step closer to bringing a next-generation vaccine to the market," Stephen said, adding that the company anticipates producing CAIV-T for commercial use during the 2007-2008 flu season.
This summer, the company also expects to begin Phase I testing of its avian flu vaccine against the H5N1 strain under a collaboration with the National Institutes of Health.
MedImmune isn't the only firm planning to use funds from its HHS contract award to establish manufacturing capabilities. London-based GlaxoSmithKline anticipates using about $100 million to create a domestic cell-culture flu vaccine production site at its facility in Marietta, Pa. The company expects to use other funds to support clinical development of a trivalent seasonal influenza vaccine, and complete Phase II studies of an H5N1 pandemic flu vaccine. Both of those will be formed using cell-based technologies.
Basel, Switzerland-based Novartis will focus on setting up a U.S. manufacturing site that could produce 150 million doses of flu vaccine within six months after a pandemic hits.
The contract awarded to Solvay covers the development and design costs for establishing another U.S. manufacturing facility. Solvay, of Marietta, Ga., also intends to use funds to support the submission of an investigational new drug application, clinical testing and the filing for regulatory approval for vaccines.
DynPort Vaccine, part of El Segundo, Calif.-based Computer Sciences Corp., intends to use its funding to develop cell culture-derived vaccines and seek FDA licensure on a split virus vaccine for seasonal flu and a modified whole virus vaccine designed to protect against H5N1 pandemic flu. DynPort has partnered with Deerfield, Ill.-based Baxter Healthcare Corp.
Last year, HHS awarded its first contract for developing cell-based vaccines. That $97 million contract went to Paris-based Sanofi-Pasteur for commercial-scale production of influenza vaccine production technology.