 By LEONARD ZEHR Toronto Globe and Mail December 26, 2005
As governments around the world scramble to stockpile the antiviral Tamiflu, generic drug maker Biolyse Pharma Corp. plans to begin next month making shikimic acid, the main ingredient in the manufacture of oseltamivir, commonly known as Tamiflu, from the needles of discarded Christmas trees. Tamiflu, as almost everybody knows by now, treats seasonal influenza and is also being championed as a first line of defense against a possible pandemic outbreak of bird flu, which has been devastating chicken populations across Southeast Asia and parts of Europe.
So far, the H5N1 virus, which usually strikes people in close contact with diseased fowl or their droppings, has infected an estimated 130 people, killing 70. The worry is that H5N1 will undergo a genetic mutation with a human seasonal influenza virus, morphing into a deadly strain that could jump between people like the common cold. After being rejected as a Tamiflu supplier by Swiss drug maker F. Hoffmann-La Roche Ltd., which has a monopoly grip on the manufacture of the drug, Biolyse turned its sights to making shikimik acid. The reason: the price of shikimik acid has soared to more than $500 a kilogram from $45 in the past 12 months on shortages of Tamiflu and skyrocketing demand. Biolyse specializes in extracting chemicals from plants and biomaterials at its plant in St. Catharines, Ontario, and now makes a generic version of the cancer drug paclitaxel from yew trees. "Our research has shown that 2-to-3 percent of the biomass from various pine, spruce and fir trees is extractible shikimic acid," Biolyse principal Claude Mercure said. As the process moves to the commercial stage from the laboratory, he said the company is aiming to eventually produce one-to-three tons of shikimic acid a month. To get started, next month it will receive some 500,000 Christmas trees to be donated by Toronto-based Gro-Bark, a forestry recycling company. Most shikimic acid is now extracted from star anise, the fruit of a slow-growing evergreen in China, which is harvested for several months each year. That's why Roche's production of Tamiflu takes about 12 months and there isn't nearly enough of the drug to go around for government stockpiling. "What makes our process more viable is the fact that the particular species of pine, spruce and fir that we are working with are far more abundant than the seedlings of star anise," said John Fulton, Biolyse's vice-president for new product development. Mercure said Biolyse has no plans to make Tamiflu unless Ottawa grants compulsory licenses under the Patent Act in a national emergency. In such a case, he said the company could produce the drug in five weeks. In countries where Roche's patents on Tamiflu aren't recognized, like the Philippines and Thailand, he said Biolyse is in discussions to sell shikimic acid and provide technical assistance so the drug can be manufactured for use in that country.
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