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However, the big market potential for some of the new drugs makes it worth the effort, said the executives at the BIO International conference in Boston.
Drugs from natural substances, known as botanicals, that target Parkinson’s disease, ALS — known as Lou Gehrig’s disease — debilitating diarrhea and pollen allergy are expected on the market within about seven years.
In fact, plant extracts are increasingly attractive weapons in the war on obesity, industry representatives said.
Hoodia gordonii, an appetite suppressant from a rare, cactus-like South African succulent, will probably be added to Slim-Fast, a diet drink sold by Unilever, and be on the market in 2009, said Daryl Rees, chief executive officer of Phytopharm, the company that isolated Hoodia.
“Plants are a rich source of chemicals” that are active against disease, said Rees, whose company is based in Cambridgeshire, England.
But when tapping into this emerging market, addressing supply issues up front is critical, Rees said.
“You need to ask early on, ‘Can we supply enough botanical raw material? Can we scale up into the tons?’” he said. If not, the development can take years, as was the case with Hoodia, Rees warned.
Hoodia, a plant used for years by the San people in the Kalahari Desert as an appetite suppressant during times of hunger or long hunts, is protected and so rare in South Africa that the only way to have enough just for testing was to cultivate the plant.
“This required a lot of work up front,” Rees said. “We had to find good farmers and train them.” The product’s development hit another snag when local African farmers sued for a share of the company’s profits, he added.
Hoodia cultivation took from 1999 to about 2004, he said. But the work paid off. Hoodia proved effective when given to humans, within about 15 days, Rees said.
He estimated the global market for diet products at about $2.3 billion.
Rees said his company will begin clinical trials next year of potential ALS therapy Myogane, made from a Chinese plant, which appears to protect neurons that are damaged by the disease; and Cogane, which is being developed for Parkinson’s disease and Alzheimer’s. Cogane shows promise in boosting healthy proteins necessary for memory.
Jakob Knudsen, CEO of ALK-Abello A/S, which specializes in allergy products, stressed the need for companies to keep thorough records of all processes related to the natural substance used to make a new drug.
He noted that, last year, British regulatory authorities asked for a declaration about any pesticides that were used on plants that are the basis for drugs.
“You need to think of all these things from the get go,” said Knudson, whose company is based near Copenhagen, Denmark.
ALK-Abello’s product, Grazax — which treat grass pollen allergy and works the same way as allergy shots — is currently available in the United Kingdom and parts of Europe.
Stateside, California-based Napo is currently testing Crofelemer, which is derived from a rainforest plant and targets severe diarrhea associated with irritable bowel syndrome and HIV.
Napo CEO Lisa Conte said the firm is also pursuing approval of the drug in global markets to treat pediatric diarrhea.
“We add a higher volume to the equation, the 80 percent of people
in the world who are usually ignored,” she said.
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