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[genet-news] ANIMALS & REGULATION: Biotech animals case goes to High Court in New Zealand



                                  PART 1


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TITLE:  BIOTECH ANIMALS CASE GOES TO HIGH COURT

SOURCE: Scoop Independent News, New Zealand

AUTHOR: GE Free NZ, New Zealand, Press Release

URL:    http://www.scoop.co.nz/stories/PO0903/S00070.htm

DATE:   08.03.2009

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BIOTECH ANIMALS CASE GOES TO HIGH COURT

The High Court case taken by GE Free NZ in food and environment against the Environmental Risk Management Authority (ERMA) and AgResearch a Crown Research Institute (CRI) is being heard on Monday 9th March, 2009.

GE Free NZ took the action after AgResearch made a series of four applications that seek to develop, import and commercialise genetically modified animals from nine species of animals (alpacas, buffalo, cows, deer, goats, horses and donkeys, sheep, pigs). The generic applications seek approval at any location and for an indefinite period to allow commercial production of biopharmaceuticals, nutraceuticals and diseased animals for research.

?These four generic applications seek the right to use animals as bio factories anywhere, anytime, and in any way that the applicant wants. They are so broad that they make it impossible for people to know if, and how they will be affected now or at any time in the future? said Claire Bleakley president of GE Free NZ in food and environment.

?Because there are no specifications this makes it impossible for the public or scientific experts to know what they are being asked to comment on. The assessment of risks to the environment and any alternative methods to a GE one, cannot also be considered.?

?Previous applications for genetic modification have been continually stretching all the statutory boundaries, which ERMA carries out. The international best-practice approach of case by case risk assessment is being abandoned as applications are getting broader and broader with no ability to know what kind of risk is being produced,? said Jon Carapiet, spokesperson for GE Free NZ in food and environment .

To date the trials on GE animals in New Zealand have been plagued with deformities, well as sudden death from congenital heart and organ failure. Early abortions are common with many foetuses suffering from excessive abdominal fluid (hydrops) resulting in a very low to zero birth rate. New Zealand as also been exposed to the commercial risks of the 9-year GE sheep trial conducted by Scottish company PPL in which some 3000 GE animals had to be destroyed after the product failed in clinical trials and caused severe immune reactions in subjects.

GE Free NZ believes that applications are so universal in scope but lacking in detail that it is impossible to reasonably assess the risks or allow any New Zealand farmer, food producer, exporter or concerned member of the public to make a submission on how they will be impacted- for good or for worse.

The case being taken before the High Court seeks for all the applications to be withdrawn by ERMA and returned to the applicant.



                                  PART 2

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TITLE:  GTC BIOTHERAPEUTICS ENTERS FOLLOW-ON BIOLOGIC FOUNDER DEVELOPMENT COLLABORATION WITH AGRESEARCH

SOURCE: GTC Biotherapeutics, USA

AUTHOR: Press Release

URL:    http://www.gtc-bio.com/news.html

DATE:   26.02.2009

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GTC BIOTHERAPEUTICS ENTERS FOLLOW-ON BIOLOGIC FOUNDER DEVELOPMENT COLLABORATION WITH AGRESEARCH

FRAMINGHAM, MA ? February 26, 2009 -- GTC Biotherapeutics, Inc. has entered into a collaboration agreement with AgResearch Limited of New Zealand to develop transgenic founder animals to produce two follow-on biologic, also referred to as biosimilar, monoclonal antibodies. The establishment of a production capability outside of the United States is an important step in GTC?s long term biosimilar strategy. This approach will enable earlier sales of the products in territories such as Europe where the relevant patents expire before the associated patents in the United States.

Working in collaboration with GTC scientists, AgResearch will establish appropriate transgenic founder production lines, with a majority of the funding provided by a grant awarded by the New Zealand government. AgResearch will receive a royalty on future sales of the products.

?We are pleased to build on our relationships in New Zealand to leverage their scientific expertise and strong record of animal husbandry,? stated Geoffrey F. Cox, PhD, GTC?s Chairman and CEO. ?We see AgResearch as a natural research partner in our goal to develop biosimilar monoclonal antibodies and we look forward to working with them to develop production herds for these programs.?

AgResearch has significant experience and expertise in pioneering transgenic techniques and has successfully developed transgenic animals in a number of other programs. New Zealand is an ideal location for the production of transgenic animals due to its strong animal health record, and due to its significant commercial expertise in animal husbandry and the dairy industry. AgResearch currently has applications before New Zealand?s Environmental Risk Management Authority in which it seeks approval to expand and extend its research on transgenic animals.

GTC has successfully produced transgenically-derived monoclonal antibodies that possess similar activity to the innovator products, based on data generated with in vitro and in vivo assays as well as animal disease models. In 2008, GTC initiated the first of several research programs to develop biosimilar versions of marketed monoclonal antibodies that will begin to come off patent in the US from 2014 onwards. The products targeted had combined sales in 2008 of greater than $17 billion. GTC is seeking development partners to help commercialize its portfolio of biosimilar monoclonal antibodies.

Follow-on biologics, referred to as biosimilars in Europe, are therapeutic products that have the same or similar amino acid structure and are produced utilizing an expression system separate from that originally approved by the appropriate regulatory agencies. Transgenic production technology is able to generate large volumes of products such as monoclonal antibodies at lower costs, contributing to the benefit of establishing lower market prices while retaining a significant profit margin. A regulatory pathway for approving biosimilars is established in the European Union. Similar enabling legislation is under consideration in the United States.

About AgResearch

AgResearch Limited, based in New Zealand, is a government owned research institute specializing in research for the pastoral agriculture industry. AgResearch aims to apply the depth of experience and expertise it has in every aspect of biotechnology and in pastoral farming to continue to build substantial competitive advantage throughout the value chain. Through biosciences and genetics its research is focused on improving productivity and market success from forage to the supermarket shelf. The outputs of those endeavours directly benefit farmers, agribusiness and those involved in the food and health sectors. Additional information is available on the AgResearch web site, http://www.agresearch.co.nz

About GTC Biotherapeutics

GTC Biotherapeutics develops, supplies, and commercializes therapeutic proteins produced through transgenic animal technology. ATryn®, GTC?s recombinant human antithrombin, has been approved for use in the United States and Europe. ATryn® is the first and only transgenically produced product to be approved for therapeutic use anywhere in the world. In addition to ATryn®, GTC is developing a portfolio of recombinant human plasma proteins with known therapeutic properties. These proteins include recombinant forms of human coagulation factors VIIa, VIII, and IX, which are being developed for the treatment of hemophilia, and alpha-1 antitrypsin. GTC is developing a monoclonal antibody to CD20 with enhanced ADCC (antibody-dependent cell-mediated cytotoxicity), and a proprietary monoclonal antibody to CD137 with potential indications in oncology and autoimmune disease. GTC is also developing a portfolio of follow-on biologic monoclonal antibodies. GTC?s intellectual property includ
 es a patent in the United States through 2021 for the production of any therapeutic protein in the milk of any transgenic mammal. GTC?s transgenic production platform is particularly well suited to enabling cost effective development of proteins that are difficult to express in traditional recombinant production systems as well as proteins that are required in large volumes. Additional information is available on the GTC web site, http://www.gtc-bio.com


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