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Biopirates: Bayer earns $379m from diabetes drug

CBGnetwork | 19.02.2006 09:48 | Bio-technology | Globalisation | Health | Cambridge | World

Bacteria harvested from Kenya are being used by a global pharmaceutical company to manufacture a multi-million dollar diabetes drug, although the country is not making a shilling from the entire enterprise, a dossier prepared by a respectable American think-tank says.



East African, February 13, 2006

Biopirates: Bayer earns $379m from diabetes drug

Bacteria harvested from Kenya are being used by a global pharmaceutical company to manufacture a multi-million dollar diabetes drug, although the country is not making a shilling from the entire enterprise, a dossier prepared by a respectable American think-tank says.

Sale of the drug, Glucobay, hit $379 million in the 12 months to December 31, 2004, making it one of the leading brands in the world. Glucobay, scientifically known as acarbose, is sold by the German pharmaceutical giant Bayer.

According to the report Out of Africa: Mysteries of Access and Benefit Sharing - published jointly by the Washington-based Edmonds Institute and the African Centre for Biosafety, in 1995 - five years after Glucobay first hit the European market but one year before it was sold in the lucrative American market, Bayer filed for a patent on a new way to manufacture the drug. The patent was subsequently approved in Europe, America and Australia.

Perusal of the patent application for the new method of manufacturing Glucobay revealed that it involved the use of a bacterium called Actinoplanes SE 50, which is found in water masses around Ruiru, near Nairobi.

"In 2001, in an article in the Journal of Bacteriology, a group of Bayer scientists and German academics confirmed that SE 50 was being used to manufacture acarbose," the report by the Institute says. "Although their paper did not mention Kenya, it did say that 'the oral antidiabetic agent is produced by fermentation of actinomyecete Actinoplanes species strain SE 50.'"
Apart from Kenya, the Edmonds report details extraction of natural resources from sub-Saharan Africa that have been commercialised for medicinal or cosmetic purposes, earning their patent holders hundreds of millions of dollars without compensating the communities from where they were extracted, even though the communities had been using them for centuries.

The companies involved read like a roll-call of the top players in the global medicines and cosmetics market, and include GlaxoSmithKline, Merck Sharp & Dohme, Pfizer and French cosmetic giant Dior. (By DAGI KIMANI)


Excerpt from "Out of Africa: Mysteries of Access and Benefit Sharing", page 11
Diabetes Drug Produced by a Microbe

Many of those who suffer from Type II diabetes can thank a microbe from Kenya's Lake Ruiru for a drug that improves their lives. Type II diabetics frequently take acarbose, a drug better known by its trade names Precose (in the US and Canada) and Glucobay (in Europe and elsewhere). (3)
The drug is an "alpha glucosidase inhibitor", meaning that it works by regulating absorption of glucose into the bloodstream, thereby preventing potentially dangerous spikes of glucose ("blood sugar").
Acarbose is sold by the German pharmaceutical giant, Bayer. How is it made? In 1995, five years after Glucobay was commercialized in Europe and one year before it was released in North America, Bayer filed for patent on a new way to manufacture the product. The patent application, which subsequently issued in Europe, the US, and Australia, (4) reveals that an Actinoplanes sp. bacteria strain called SE 50 had unique genes that enable the biosynthesis of acarbose in fermentors. The strain comes from Kenya's Lake Ruiru.
In 2001, in an article in the Journal of Bacteriology, a group of Bayer scientists and German academics confirmed that SE 50 was being used to manufacture acarbose. (5) In the article, they described manufacture of acarbose and related compounds. Although their paper did not mention Kenya or Africa, it did say that "The oral antidiabetic agent [acarbose] is produced by fermentation of the actinomycete Actinoplanes sp. strain SE50."
SE50 is the same strain that was identified as Kenyan in the patent application filed six years before.
In 2004, Bayer sales of acarbose totaled €278 million (US $379 million, as of 31 Dec 2004). (6) I could find no evidence of a benefit-sharing agreement related to this extremely valuable microbe.

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