RE: RE: Free publicity for Medicago!TORONTO (Dow Jones)--If there was a lesson Medicago Inc. (MDG.V) learned from the swine-flu scare, it's that the company is in the right business.
While the H1N1 strain wasn't as aggressive as previous pandemic flu viruses, likely because it's been around for a while and the community had some basic immunity, it should serve as a wake-up call that current vaccine-production methods aren't adequate, says Andy Sheldon, president and chief executive of Medicago.
"Had this been the avian flu, had this been the H5 strain, this would have been a different ballgame," Sheldon told Dow Jones. "We would have had severe infections across the planet."
He said it took about six or seven months before the first H1N1 vaccine was delivered because current vaccine-production methods use egg-based technology. It's a system that's worked okay for 50 years, but in the case of a pandemic, it's not fast enough.
Enter Medicago, whose unique production method can do the same job in a month using tobacco plants, which are known to be efficient producers of proteins.
A key difference between the egg method and the plant method is that the former requires working with the live virus, which can add months to the production process. "All we need is the genetic sequence. We take it, synthesize it in a DNA fragment, clone it, and modify our plants to produce this strain," Sheldon explained. When the next pandemic comes along, Medicago's method could have a vaccine ready in a month, and the capital costs associated with a plant-based facility are about 10% of those of a conventional facility, he said.
The company is going into a Phase II trial of its pandemic influenza vaccine, with results expected late this year or in early 2011. The trial will likely enroll 400-600 patients and test for safety and development of antibodies.
"It will show that we have a product that can work and that our platform can actually produce vaccines and other proteins," he said. Once Medicago has the results, it will talk to regulators about whether it needs to do a Phase III trial. Its aim is to have its first products on the market by 2013.
Paradigm Capital analyst Claude Camire said agreements that Medicago has signed with companies in France, Japan, India and Saudi Arabia recognize the value of the technology and the time-sensitive nature of flu vaccines. He said similar deals will follow soon given the positive Phase I data released in December.
Camire added that the technology is versatile, resulting in a contract with the U.S. Army to explore production of industrial enzymes used in biofuels.
Medicago is also eyeing the seasonal-flu business, which will require very expensive clincial trials. One advantage is that the company can wait longer to ensure the correct strains are selected for the vaccine because of its faster production method.