New Multibillion Blockbuster Obesity Drug Coming From Traditional African Plant And Healing Knowledge

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Researched by Industrialinfo.com (Industrial Information Resources, Incorporated; Houston, Texas). Traditional African healers and desert nomads are crucial elements in the efforts of two major pharmaceutical companies who, along with all pharma companies, are intensifying and broadening their techniques to find winners in the new generation of bio-based drugs. These are needed to replace the current generation of market leading proprietary products that have a limited patent lifespan before giving way to generic products. The pharmaceutical industry's output of new drugs has been sluggish in the last 20 years despite a 1,500% increase in research and development spending over the period.

Pfizer (NYSE:PFE) has just opened a Botanical Supplies Unit (BSU) in partnership with Phytopharm (LSE:PYM.L) (London, United Kingdom) at the state funded CSIR's (Council for Scientific and Industrial Research) Chemtek division near Pretoria in South Africa. In 1999 the two companies built the multi-million dollar Clinical Supplies Unit (CSU) at the CSIR/Chemtek. The CSU will enable the early clinical validation of patented botanicals, prior to licensing to multinational pharmaceutical companies. It will develop and supply small quantities of pharmaceutical raw material based on indigenous plants. The BSU will transform current traditional medicines into products that can be validated scientifically and are of acceptable quality and proven safety and efficacy. These units and their applications are unique in the world.

Both units form part of the CSIR's bioprospecting program, which has successfully developed the P57 obesity drug as a pathfinder project for the unit's advance on the international market. P57 is classified as a blockbuster drug with potential sales exceeding $1 billion a year. P57 is derived from the hoodia plant, which was first noted by a Dutch anthroplogist in 1937. He recorded that the San people (the original nomad 'bushmen' inhabitants of the south east Cape coastal and north-south eastern interior desert regions of South Africa and Botswana) used the hoodia plant to substitute for water and food consumption.

After a trail of stops and starts, the elusive molecule, which is the active compound in the plant, was indentified and patented in the 1990's by the CSIR using the latest technology. Like all scientific discoveries and advances, the breakthrough was based on generations of development. In 1960 the National Food Research Institute of SA at the CSIR investigated the properties of local edible plants, including the hoodia, as possible new food sources.

While having the intellectual ownership and the international patent on the novel P57 molecule and all derivatives, the CSIR could not find a local company to fund the estimated $400 million needed to produce a US Food and Drug Administration (FDA) approved drug. The exploitation rights went to Phytopharm who then sublicensed them to Pfizer. The CSIR has retained its patented asset and the platform to advance their bioprospecting program, which is on the verge of revealing the development of a second possible blockbuster drug.

The bioprospecting program aims to develop innovative medicinal products based on South Africa's plant biodiversity and history of traditional medicines. The program will be working through sections of the country's 24,000 indigenous botanical species. They have also struck an agreement with 200 sangomas (traditional healers) who will receive compensation and have their knowledge protected. The CSIR's aim has been to see benefits from the programs flow back into South African hands. The San people, who are struggling to maintain their traditional habitat, will receive a percentage of the development milestones and royalties from P57. In the process of the commercialization of the product, they may be involved in the management and conservation of a seed bank. The sangomas will be crucial in filtering and pinpointing the possibilities of plants using their inherited and indigenous knowledge.

The CSIR will receive three product development milestone payments and an annual royalty payment over the 20-year life of the patent. P57 is currently in the third phase of clinical study in the United Kingdom and the United States but the date when it will hit the multibillion-dollar obesity drug market is yet to be scheduled. Although P57 was only licensed in 1998, it is expected to have a faster run to final approval than the usual eleven-year cycle.

In addition to the next 'blockbuster' under development, the unit is also working on mosquito repellant and antimalarial and anti cancer products. New contracts with foreign companies will include technological transfer and manufacturing rights. The contract with Pfizer includes South African manufacturing rights for the local market. Bringing the benefits home and boosting the country's innovation profile are part of the CSIR's game plan.