Pharmed animals go to market

Pharmaceutical firms could soon be making a fortune from cloning, writes Charles Arthur
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The Independent Online
What sheep and goats can produce

Product: Human Factor IX

Use: blood clotting factor

Company: PPL Therapeutics

Value: pounds 2m per sheep

Available: if clinical trials succeed, within 10 years

Product: human alpha-1-antitrypsin

Use: to treat cystic fibrosis

Company: PPL Therapeutics

Value: probably thousands per sheep

Available: in clinical trials

Product: Human fibrinogen and factor VII

Use: blood clotting factors

Company: PPL Therapeutics

Value: pounds 500,000 per sheep

Available: within 10 years

Product: Human Factor VIII

Use: the essential blood clotting element for the majority of haemophiliacs

Company: licensed to Baxter Healthcare and Bayer

Value: pounds 10m per sheep or goat

Available: unknown

Product: Human antithrombin III

Use: blood plasma protein for accident victims and organ recipients

Company: Genzyme

Value: probably many thousands per goat

Available: in human trials

IN THE new world of "pharming" - using farm animals to produce pharmaceutically useful products - there was no bluster in the announcement this week by PPL Therapeutics that 50 cloned sheep could satisfy the pounds 100m world market for the Factor IX blood clotting protein.

It is only the start of a huge industry, made possible by the twin technologies of genetic engineering and cloning.

Where once the most valuable capital item a technology company owned was a factory, in future it will be a living, breathing animal. It will naturally generate enough of some valuable protein to make it a better wage-earner than any City slicker. And it won't even demand a company car: a big enough field with nice grass will suffice.

But for the companies, defending their property - and trying to extend it - will become an ever bigger business. PPL has already been thwarted in its wish to produce transgenic animals which produce the far more valuable Factor VIII clotting protein. That is used to treat the majority of haemophiliacs (unlike Factor IX, which is used to treat those with the rarer form, haemophilia B). The world market for Factor VIII is worth half a billion pounds. But the Scripps Institute, in La Jolla, California, has the patent on the gene that encodes the production of the protein. And it has licensed its use to Baxter Healthcare and Bayer - but not PPL.

Other companies are developing pigs whose organs are coated with human proteins, so that their kidneys, lungs and hearts could be transplanted into humans, where the numbers on waiting lists typically outnumber donors by three to one.

How much could the involuntary organ donors be worth? Presently there are just 45,000 human transplants annually. But there is no official market in organs. However, a recent estimate by analysts at Salomon Brothers reckoned that if we could use pig organs, they would create a $6bn (pounds 3.75 bn) market, in which 455,000 transplants from animals would be performed. That would make each animal worth just pounds 25,000 - implying that the figures are probably underestimates.

Given the choice between dying and paying huge amounts for a pig organ, rich people would surely choose the latter.

The technology underlying the implementation of all these methods, though, is cloning. Breeding a transgenic animal with another, normal one always carried the risk that the money-making gene would be lost. By cloning from the embryo or the adult of the transgenic animal - techniques that PPL has demonstrated are feasible - the companies can rest assured that their investments will continue for generations.

What cattle can produce

Product: Human growth hormone

Use: treatment of dwarfism and AIDS-related illnesses

Company: Genzyme

Value: up to pounds 6m per cow

Available: soon in human clinical trials

Product: beta-interferon

Use: treatment of multiple sclerosis

Company: Genzyme

Value: up to pounds 1m per cow

Available: approaching human clinical trials

Product: Human serum albumin

Use: in blood transfusions

Company: Advanced Cell Technology

Value: pounds 150,000 per cow

Available: just announced

What pigs produce

Product: "humanised" hearts, kidneys, lungs

Use: transplant operations to replace failing human organs

Company: Imutran, Alexion, Novartis, Nextran

Value: if legalised, a $6bn industry by 2010

Available: depends on medical studies on associated risks