Sheep-cloner PPL says five years to market

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Reuter / Maggie Fox

Mar 24, 1997, 3:00:00 AM3/24/97

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<H1><CLARI-ITEM HEADLINE>Sheep-cloner PPL says five years to market</CLARI-ITEM></H1>
<I><B><CLARI-ITEM COPYRIGHT>Copyright 1997 by Reuters</CLARI-ITEM></B></I> / <I><CLARI-ITEM DATE>Mon, 24 Mar 1997 14:42:33 PST</CLARI-ITEM></I><P>
<P> LONDON (Reuter) - Sheep-cloner PPL Therapeutics Plc said
Monday it will be five years before it brings a product to
market but said it was turning its sights on even more
controversial technology : animal-to-human transplants.</P>
<P> PPL Managing Director Ron James said the small biotechnology
company, which stunned the world by helping clone an adult sheep
named Dolly, would continue to concentrate on creating animals
genetically engineered to produce human proteins, including
sheep, cattle, rabbits and pigs.</P>
<P> But he warned the technology was still clumsy and
unreliable, although he was confident this would improve.</P>
<P> Asked how long before PPL would have a cloning or other
biotechnology product on the market, James answered, ``It's at
least five years away.''</P>
<P> Announcing its first annual results since the company was
listed on the stock market last year, PPL reported a pretax loss
of 6.2 million British pounds ($10 million). Revenues hit 2.5
million pounds ($4 million).</P>
<P> ``I think we might see this level of turnover continue,''
said PPL Finance Director Richard Cruse. ``We will also expect
to see the 8.25 million (pounds) sterling ($13.2 million) (in
development costs) increase again.''</P>
<P> James said the company was looking for new ventures. One
possibility would be producing genetically engineered pigs for
use in xenotransplants, or tranplants of organs from animal to
human. The most likely are pig's hearts because they are a good
match for humans in terms of size and function.</P>
<P> Researchers led by embryologist Dr. Ian Wilmut at the Roslin
Institute in Edinburgh, Scotland, announced late last month they
had created a lamb using DNA from the sheep Dolly. PPL sponsored
the research and has applied for patents.</P>
<P> The company has no immediate plans to use its cloning for
any marketable product. The technology is still experimental and
the company has yet to create a cloned, genetically engineered
<P> James, briefing reporters on the annual results, said the
same technology could be used to create pigs that produce human
sugars on the surfaces of their organs. These sugars help the
immune system identify foreign agents, so pig organs that
produced human sugars would theoretically be recognized as
<P> Such pigs have already been created by other companies. But
PPL's cloning technology could be used to create cloned,
genetically engineered pigs -- saving a step in production.</P>
<P> Britain's government has declared a moratorium on
xenotransplants until all the dangers, such as introducing an
unknown virus into people, are studied. But James said this
would not affect PPL.</P>
<P> ``By the time we get around to (clinical) trials, either the
moratorium will have been lifted or we will be able to do them
somewhere else,'' he said. James said he suspected another
company, such as Cambridge, England-based Imutran, owned by
Novartis, would be in trials first anyway.</P>
<P> James said he admired the U.S. approach, which would allow
for experimental transplants to go ahead, with patients kept in
isolation until it was clear whether they were infected with any
strange new animal viruses. ``That seems to me to be the more
logical approach,'' he said.</P>
<P> PPL's revenues fell from 4 million pounds ($6.4 million)
when Germany's Bayer AG withdrew its support for the British
company's lead product, alpha anti-trypsin (AAT), a human
protein produced in milk from genetically engineered sheep.</P>
<P> AAT is about to begin Phase II clinical trials for use in
treating cystic fibrosis. In the United States, Phase II trials
are generally the first test of a drug on humans to determine
whether they work and precede the final Phase III test that
comes before a drug is submitted for regulatory approval.</P>
<P> James said PPL hoped to find a partner for AAT by the middle
of next year. ``Our plan here is to get a partner on board at
the end of the Phase II trial,'' he said. ``We obviously need to
start talking to them before then and we are talking to
potential partners now.''</P>
<P> Commercial arrangements are under way for marketing AAT,
fibrinogen for wound healing and other products with Novo
Nordisk A/S of Denmark, as well as products with Euro Pharma Co.
and Wyeth Laboratories Ltd.</P>
<P> James said product development was on schedule.</P>
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