12/05/2010

AgResearch GE-Animal Funding Threatened by FDA Fine

 

The parent company of GTC which has funds in AgResearch’s development of GE animals is facing a fine by the FDA of US$175 million for "up front disgorgement" of past profits, and has reported a first quarter loss of US$115 million.

The financial instability of GTC and its US parent company Genzyme Corporation [1] puts the New Zealand government and Crown Research Institute AgResearch in a vulnerable position as they are the biggest overseas investors in GE animals. AgResearch contracts with GTC have include GE animals to produce recombinant (GE) proteins such as human Follicle Stimulating Hormone, lacto ferrin and myelin basic protein (MBP), all with un-acceptable animal mutations and deformities.

“The Minister must take action to protect New Zealand from any fall out from the financial woes of AgResearch’s partners,” says Jon Carapiet from GE- Free NZ in food and environment. “There is a lack of due diligence by ERMA on the financial position of AgResearch’s programme, as liability and responsibility for an overseas company’s collapse could fall to the New Zealand taxpayer".

“The partnership on the creation of GE animals is extreme science verging on voyeuristic sadism,” said Claire Bleakley of GE Free NZ in Food and Environment. "AgResearch's overseas partners in this venture also present a serious financial risk to New Zealand. There is already fall-out from this failing GE project in the loss of other science jobs at AgResearch which will impact the farming sectors that are most important to New Zealand".


ENDS:

Claire Bleakley 06 3089842 / 027 348 6731

Jon Carapiet 0210507681

References:

[1]FDA crackdown on Genzyme, Nature Biotechnology 28, 388 (2010) doi :10.1038/nbt0510-388 http://www.nature.com/nbt/journal/v28/n5/full/nbt0510-388...html

[2] GTC Biotherapeutics, Inc, FORM 10-K March 2010, US Securities And Exchange Commission http://www.faqs.org/sec-filings/100312/GTC-BIOTHERAPEUTICS-INC_10-K/#tx90471_8
GTC have revealed some of the products being targeted in their Annual report

Working with our collaboration partner, AgResearch, in New Zealand we have initiated the generation of transgenic animals that are expected to produce an anti-EGFR MAb. We anticipate that the first transgenic animals will be born in 2010. New Zealand provides advantages with respect to earlier patent expiries in ex-U.S. territories that will allow earlier marketing of certain products, such as an anti-EGFR MAb, than would be possible if the product was produced in the U.S. A significant portion of the funding for this program is provided by the New Zealand government as part of our research collaboration with AgResearch (p7 & 8)

[3] GTC Biotherapeutics enters follow on Biologic Founder Development collaboration with AgResearch, 2009 http://www.transgenics.com/pressreleases/pr022609.html

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