Forum: Pharming » GTC en EMEA

kers 27 februari 2004 14:29

GTC Biotherapeutics Announces EMEA
Accepts MAA Submission for Review Of ATryn

FRAMINGHAM, Mass.--Feb. 27, 2004--GTC Biotherapeutics, Inc.
("GTC", Nasdaq: GTCB) announced today that the European Medicines
Evaluation Agency (EMEA) has accepted for review GTC's Market
Authorization Application (MAA) submission of ATryn(R), its
recombinant human antithrombin. With the acceptance of the MAA, the
EMEA begins its review process to determine if ATryn(R) is acceptable
for use in Europe as a treatment of hereditary antithrombin
deficiency.
"We are very pleased that the EMEA will begin the review process
for ATryn(R)," stated Geoffrey F. Cox, Ph.D., GTC's Chairman of the
Board and Chief Executive Officer. "We are looking forward to what we
believe will be a successful conclusion in the review of ATryn(R)."
GTC recently completed a multinational safety and efficacy study
of ATryn(R) in the prophylactic treatment of hereditary antithrombin
deficiency during high risk situations such as surgery and childbirth.
The MAA submission includes data from this trial as well as data from
high risk patients treated under a compassionate use program.
Antithrombin is a plasma protein with anticoagulant and
anti-inflammatory properties. GTC expresses this protein in the milk
of goats that have the human antithrombin gene linked to a
milk-protein promoting gene. This transgenic approach provides the
opportunity to produce recombinant forms of proteins, such as
antithrombin, that are difficult to express in conventional production
methods.
GTC Biotherapeutics is a leader in the development, production,
and commercialization of therapeutic proteins through transgenic
animal technology. GTC has three internal proprietary products in its
pipeline and a portfolio of external program production opportunities.
In addition to the ATryn(R) program, GTC is developing a recombinant
human serum albumin and a malaria vaccine. In its external programs,
GTC's technology is used to develop transgenic production of its
partners' proprietary products, including both large-volume protein
therapeutics as well as products that are difficult to produce in
significant quantities from conventional bioreactor systems. GTC's
external program collaborations are developing transgenic versions of
products such as monoclonal antibodies and immunoglobulin fusion
proteins for conditions such as rheumatoid arthritis, HIV/AIDS and
cancer. One of the external programs recently entered clinical trials
with a transgenically produced product. Additional information is
available on the GTC web site, www.gtc-bio.com.
This press release contains forward-looking statements as defined
in the Private Securities Litigation Reform Act of 1995, including
without limitation statements regarding the expected outcomes of
regulatory submissions for the ATryn(R) program. Such forward-looking
statements are subject to a number of risks, uncertainties and other
factors that could cause actual results to differ materially from
future results expressed or implied by such statements. Factors that
may cause such differences include, but are not limited to, the risks
and uncertainties discussed in GTC's most recent Annual Report on Form
10-K and its other periodic reports as filed with the Securities and
Exchange Commission, including the uncertainties associated with
conducting clinical studies, and the risks and uncertainties
associated with dependence upon the actions of regulatory agencies.
GTC cautions investors not to place undue reliance on the
forward-looking statements contained in this release. These statements
speak only as of the date of this document, and GTC undertakes no
obligation to update or revise the statements, except as may be
required by law.

[verwijderd] 27 februari 2004 15:40

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Mooi bericht, Kers ! Dank je wel.
Deze acceptatie voor review vormt ook voor Ph., dat immers dezelfde techniek gebruikt, een belangrijke stap.
Gr. Jan

[verwijderd] 28 februari 2004 09:39

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Het is anders niet af te zien aan de koers van GTCB aan de Nasdaq:

February 27, 2004 16:01 22:01 -0.52 (-14.94 %)
Volume 1'231'850
Prev. close 3.48
Last 2.96

Als iemand hier een verklaring voor heeft mag hij het zeggen...

[verwijderd] 28 februari 2004 12:01

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Deze daling van GTC is met name het gevolg van geruchten. Aan de ene kant bestaat er de kans dat de testgroep te klein is en dat er meer onderzoek/ informatie wordt geeist door de EMEA, wat natuurlijk weer meer tijd gaat kosten. Ook zijn er geruchten van mogelijke bijwerkingen, waardoor er ook meer onderzoek moet plaatsvinden.

Ghostly 28 februari 2004 14:16

tnx penny stocks voor de info.
dat verklaart tenminste de daling van 14% gisteren.

ghostly

Aandeel Pharming Group AEX:PHARM.NL, NL0010391025

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