Pharming company has been promoting genetic modified cows
in Finland in Northern Savo area for several years. The aim of the project is to
produce human lactoferrin for the company by means of 2000 transgenic cows in
local farms. The project has continued with a very low profile until last year
when a local peoples' action group started to debate and investigate the plans.
One of the concerns has been the regional strategy of agriculture. Organic
farmers have maintained that the region is the centre of milk production in
Finland.
We want to develop organic farming and have a clean
image without any bioreactors in our region, says Antti Hamalainen, organic milk
producer from Lapinlahti community. Also ethical reasons have been raised under
debate.
This cow project is the first time in the world when
big mammals are so put for production. Before starting to invest in Pharming's
business there should have been a deep discussion of the future development.
People's Biosafety Association in Finland has tried to raise the discussion, but
Pharming has answered with silence.
This is the first step to the new relation between
human beings and animals. When speaking of animal rights we should see that
genetically modified cows mean the beginning of the era of genetic slavery, says
Hannu Hyvönen, chairman of People's Biosafety Association.
Has the risk
analysis been withheld from the investors?
People's Biosafety Association is claiming that while
Pharming was pushing the project forward and obtaining significant finance and
support, it concealed from decision makers, farmers and citizens the kind of
information, which it was obliged to tell investors in its explanatory
prospectus in its listing on the Dutch stock exchange. The company has also left
unsaid that in Holland the Dutch Minister for Agriculture in 1998 banned the
genetic transfer techniques used by Pharming, reminds Asko Ali- Marttila an
investigator from People's Biosafety Association.
Further all sorts of uncertainties as to the future
activities of the company are causing raised eyebrows. On one hand there is talk
of medicinal purposes and on the other of "clinical food additives".
Also the possibility of producing baby food has been mentioned. Although the
project is unclear and has lots of risks the farmers, who should invest totally
the costs in their farms are not told anything about the problems and possible
risks. According to the information available to People's Biosafety Association
nothing has been mentioned of risk even to the Finnish public investors. At
least Lapinlahti Council, The Northern Savo Employment Office, industrial
ministry and Sitra, an entrepreneurial Finnish financial support foundation have
supported Pharming«s project to the tune of at least 10,000,000 Finnish marks.
The role of Kuopio
University under closer look
The beginning of the cow project started in the 90s
when Dr Juhani Jänne with his group developed the first transgenic cow, named
as Huomen (Tomorrow). The study group founded the company FinnGene Ltd which has
been sold to Pharming.
The role of the professors of Kuopio University and
A.I.Virtanen Institute should be clarified, says Hannu Hyvonen and reminds that
for example Dr. Juhani Jänne has been one member in Pharming's organisation.
It is questionable if scientists who are themselves
beneficiaries in Pharming«s business matters can present themselves as neutral
experts for the governmental and provincial investors.
People's Biosafety Association comment on the latest
news of the resignation of the managing director of Pharming in Finland (see
news below) by saying that the whole project should now be stopped and put under
examination.
We wonder how the investor has been carrying money for
this multinational medicine company and at the same time there is deep and
serious need for supporting organic agriculture. The future for Finnish
agriculture is in organic not in genetically modified crops or animals.
More information:
People's Biosafety Association in Finland
bioturva@bioturva.org
Appendix
1
Summary of prospectus for the Dutch stock exchange
Prospectus
Summary Prospectus
dated June 7, 1999
The following summary is qualified in its entity by,
and should be read in conjunction with, the detailed information and the
consolidated financial statements, including the notes thereto, appearing
elsewhere in this Prospectus. This Prospectus contains forward-looking
statements which involve uncertainties. The company's actual results could
differ materially from those anticipated in these forward-looking statements as
a result of certain factors, including those set forth under 'Risk Factors' and
elswhere in this Prospectus.
The Company Pharming was established in Nowember 1988
and started operations in Leiden, the Netherlands. Pharmin, which was a
wholly-owned subsidiary of US-based GenPharm International, Inc ('GPI') during a
period from April 1989 until April 1995, has raised approximately NLG 91 million
in private placements after it was spun off from GPI. In July 1998, the Company
raised NLG 141 million in an initial public offering on EASDAQ.
RISK FACTORS
Technological Uncertainty
... The transgenic production methods and all of the
therapeutic product candidates which the Company is developing will require
significant additional research, development and testing, and will require
regulatory approval and the expenditure of substantial additional capital
resources prior to commercialization. It will be a number of years, if ever
before the Company will recognize any revenues or royalties from product sales.
The use of transgenic production methods is relatively new and untested and has
not yet resulted in any approved therapeutic products. Accordingly, product
development utilizing the Company's transgenic technologies involves a high
degree of risk, is highly uncertain, and could result in unanticipated
developments, clinical or regulatory delays, or inadequate therapeutic efficacy,
any of which have a material adverse effect on the Company's business, financial
condition and results of operations. There can be no assurance that Company's
technologies will lead to the discovery and development of any commercially
viable product, that the Company's or it's collaborators'research and product
development efforts as to any particular product candidate will be succesfyully
completed, that any such product candidate will be proven to be safe and
efficacious, or that required regulatory approvals will be obtained on a timely
basis if at all. The Company or its collaborators may encounter problems and
delays relating to research and development, regulatory approval, manufacturing
and marketing. The failure by the Company to succesfully address such problems
and delays would have a material adverse effect on the Company's business,
financial condition and results of operations.
No assurance of
Succesfull Product Development ...
No assurance can be given that the results of
preclinical testing or early clinical trials will support the commencement of
further clinical trials on any of the Company's product candidates, that the
results of the preclinical studies or the clinical trials will support the
Company's application for regulatory approval, or that regulatory authorities
will not require the Company to conduct additional clinical trials either prior
to, or after, regulatory approval is obtained.....
Appendix
2
Report from local Savon Sanomat on 13.2.2001
KUOPIO
The producer and cultivator of Lapinlahti's genetically altered cow's
medicinal milk, Pharming Ltd's managing director Pauli Seppänen has tendered
his resignation. Officially Seppänen and Pharming parted company a week ago.
"Yes, that is correct but I do not wish to make any comment" stated
Seppänen and referred the matter to Pharming in accordance with agreed
procedure. He nonetheless denied that last month's heated public discussion on
the risk of genetically altered cattle had anything to do with his personal
decision. "I won't speculate on what I will do next. The Sonera management
(Finnish IT-company) don't comment, it's a fair game between one and other. Seppänen
managed Pharming Ltd for five years before which he was employed in Kemira's
biotechnic division for ten years. Deputy Managing Director, Dutchman Erik Smahl
is presently responsible for Pharming's management. He has earlier been engaged
in cooperation work as project leader of the Kuopio medicinal milk project.
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