InvestorsHub Logo
Boards
News
Market Data
Markets
Discover
Discover
Subscribe Login/Register
S&P 500
5,537.02
(
0.51%
)
US TECH 100
19,641.60
(
0.83%
)
Dow Jones
39,308.00
(
-0.06%
)
Brent Oil
86.92
(
-0.48%
)
Bitcoin
54,548.16
(
-4.27%
)
Post# of 19309
Next 10
Reply Private New
Public Reply Private Reply New Post
Keep Last Read
Replies (1) Keep Next 10 Report Keyboard Shortcuts
Replies (1) Next 10 Prev Next

DewDiligence

Send PM Follow Ignore
Followers 832
Posts 119978
Boards Moderated 17
Alias Born 09/05/2002

DewDiligence

Member Level

Re: DewDiligence post# 3584

Thursday, 05/24/2007 2:35:50 PM

Thursday, May 24, 2007 2:35:50 PM

Post# of 19309
GTCB Raises ATryn Sales Projection

[This is pretty big news because the projection is being raised a lot, not a little. GTC now says that ATryn can achieve $1B in annual sales for just the DIC/sepsis indication in the U.S. (This is up from the prior guidance of $500-700M for all indications, worldwide.)

Why the greatly increased guidance? Please see #msg-19905539.]

http://biz.yahoo.com/bw/070524/20070524005878.html?.v=1

>>
GTC Biotherapeutics Reports Results of 2007 Annual Meeting

Thursday May 24, 2:27 pm ET

Updates of ATryn® Clinical Development and Market Estimates

FRAMINGHAM, Mass.--(BUSINESS WIRE)--GTC Biotherapeutics, Inc. ("GTC", Nasdaq: GTCB ) held its annual meeting of shareholders yesterday. Directors Robert W. Baldridge, James A. Geraghty, and Michael J. Landine were elected to three year terms on the board of directors. In addition, the proposed amendment and restatement of GTC's 2002 Equity Incentive Plan was approved.

During a presentation to shareholders following the business portion of the meeting, GTC updated its progress in the ATryn® program, including updating the estimated market in the acquired deficiency indication of disseminated intravascular coagulation, or DIC, in severe sepsis.

"ATryn® has the potential to become an effective treatment to reduce the current mortality rate, which can be up to 50% in patients with disseminated intravascular coagulation associated with severe sepsis," commented Suzanne Groet, Vice President of Therapeutic Development for GTC. "The needs of the approximately 500,000 patients spread equally between the U.S. and Europe who develop DIC associated with severe sepsis each year are not well met by current treatments. The opportunity for ATryn® is to ultimately demonstrate a significant reduction in mortality and displace the costs associated with current treatment options."

ATryn® is GTC's recombinant form of human antithrombin. Antithrombin, produced in the liver and circulated in blood plasma, has both anticoagulant and anti-inflammatory properties. The recombinant form is able to be produced using GTC's transgenic production platform, enabling large volume supply. ATryn® has been approved for use in Europe for the prophylactic treatment of deep vein thrombosis in hereditary antithrombin deficient patients undergoing surgical procedures. LEO Pharma A/S, GTC's partner in the development and commercialization of ATryn® in Europe, Canada, and the Middle East, is initiating a Phase II dose ranging study in the DIC indication to establish an optimum dose to be used in a subsequent Phase III study. Recruitment into the Phase II study is anticipated to begin this quarter and is planned to take about 12 months.

In evaluating the clinical and commercial opportunities in DIC in the U.S., GTC has determined that existing treatment options for severe sepsis are priced at a benchmark of approximately $10,000 per treatment, which if applied to DIC indicates a total potential U.S. market of $2 to 3 billion per year. GTC believes that ATryn® has the potential to achieve in excess of $1 billion of this potential DIC market in the U.S. alone, if successfully developed and approved for DIC associated with severe sepsis.

GTC is also nearing completion of the clinical studies necessary to support the filing of a Biologics License Application for ATryn® in the HD indication planned for the first quarter of 2008. These studies include an evaluation of the incidence of deep vein thrombosis and thromboembolisms in 17 additional hereditary antithrombin deficient patients undergoing surgical and pregnancy procedures that will be treated with ATryn® and a non-inferiority comparison to a total of 35 historical records of patients undergoing similar procedures that have been treated with plasma-derived antithrombin products. GTC plans on releasing top line data from these studies in the fourth quarter of 2007. GTC is in discussions for potential commercial partnering in the US market for ATryn®.

The full presentation from the annual shareholder meeting can be accessed at the GTC web site, www.gtc-bio.com.

About GTC Biotherapeutics

GTC Biotherapeutics develops, produces, and commercializes therapeutic proteins through transgenic animal technology. In August 2006, ATryn®, GTC's recombinant form of human antithrombin, was approved by the European Commission for use in patients with hereditary antithrombin deficiency undergoing surgical procedures. This was the first approval anywhere in the world of a therapeutic protein produced from a transgenic animal. We have developed goats that have the human antithrombin gene linked to a milk-protein promoting gene so that they express this protein in their milk. This transgenic approach provides the opportunity to produce recombinant forms of proteins, such as antithrombin, that are difficult to express in economically viable quantities in conventional production systems. In addition, GTC has established a strategic collaboration with LFB Biotechnologies of France to jointly develop recombinant forms of human plasma proteins and monoclonal antibodies. The first program of the collaboration will be to develop recombinant human factor VIIa as a potential treatment for hemophilia in patients with antibodies to other coagulation factors.

In 2006, GTC was granted 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 those that are required in large volumes. Additional information is available on the GTC web site, http://www.gtc-bio.com.
<<

“The efficient-market hypothesis may be
the foremost piece of B.S. ever promulgated
in any area of human knowledge!”

Public Reply Private Reply New Post
Keep Last Read
Replies (1) Keep Last Read Next 10 Report Keyboard Shortcuts
Replies (1) Next 10 Prev Next

Join the InvestorsHub Community

Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.

Sign Up