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ludwig mack 5 december 2007 15:09

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GTC BIOTHERAPEUTICS OBTAINS LICENSES TO FACTOR IX, FACTOR VIII AND FIBRINOGEN

FRAMINGHAM, MA – December 5, 2007 -- GTC Biotherapeutics, Inc. ("GTC", Nasdaq: GTCB) has entered into a definitive agreement with ProGenetics, LLC, a private company based in Blacksburg, Virginia, to obtain an exclusive license to develop and commercialize ProGenetics’ recombinant human factor IX, recombinant human factor VIII, and recombinant human fibrinogen for North America, Europe and Japan. ProGenetics is developing production of the human coagulation factors IX and VIII in the milk of transgenic pigs and has patents that cover the transgenic production of human fibrinogen. ProGenetics will receive a non-exclusive license to GTC’s patent in the United States for the transgenic expression of therapeutic proteins in milk to enable the commercial development of these products outside of North America, Europe and Japan. ProGenetics received $500,000 from GTC upon signing of the agreement and will receive approximately $500,000 from GTC in the second quarter of 2008. GTC will also receive a small equity interest in ProGenetics.

“We are very pleased to work with ProGenetics to add factor IX, factor VIII, and fibrinogen to our portfolio of recombinant coagulation factors,” stated Geoffrey F. Cox, Ph.D., GTC’s Chairman and Chief Executive Officer. “Together with our program for recombinant human factor VIIa, GTC has a leading position in developing recombinant versions of all the major coagulation factors used to treat hemophilia and potentially other bleeding conditions. Our strategic portfolio of recombinant plasma proteins also includes ATryn®, our recombinant form of human antithrombin, and recombinant human alpha-1 antitrypsin, establishing a broad franchise in hematology and associated genetic disorders.”

ProGenetics will be responsible for the production of the proteins in the milk of their transgenic pigs. GTC will be responsible for manufacturing, clinical development, regulatory affairs, and commercialization activities in its territories.

Hemophilia is caused by genetic conditions in which the patients’ failure to express enough coagulation factors may lead to excessive bleeding. Type A hemophilia is due to the lack of factor VIII. Type B hemophilia is due to the lack of factor IX. The preferred treatment strategy is to provide supplemental coagulation factors prophylactically to avoid episodes of excessive bleeding. The price and availability of current recombinant coagulation factors often allows for use in only limited indications and markets. The aggregate market for plasma-derived and recombinant factor IX, factor VIII, and fibrinogen products in North America, Europe and Japan is currently estimated to be greater than $3 billion annually.

[verwijderd] 6 december 2007 20:26

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Mary Ann Gray Elected to GTC Biotherapeutics Board of Directors
Last update: 12/6/2007 8:45:01 AM
FRAMINGHAM, Mass., Dec 06, 2007 (BUSINESS WIRE) -- GTC Biotherapeutics, Inc. (GTCB) announced that Mary Ann Gray, Ph.D. of Gray Strategic Advisors, LLC has been elected to its Board of Directors. GTC's Board now has a total of eleven directors. "We are very pleased to welcome Dr. Mary Ann Gray to our Board of Directors," stated Geoffrey F. Cox, Ph.D., GTC's Chairman of the Board and Chief Executive Officer.
"Dr. Gray has established a reputation as an influential voice in the biotechnology and healthcare industry. Her extensive experience as an investor, analyst, consultant, and scientist will be a valuable contribution to our board." Background on Dr. Gray Dr. Gray is President of Gray Strategic Advisors, LLC, a strategic planning and advisory firm for biotechnology companies. She also is a member of the boards of Telik, Inc., Dyax Corp., and Acadia Pharmaceuticals. Previously, Dr. Gray was Portfolio Manager of Federated Kaufmann Fund and was responsible for over $1 billion in health care investments. Dr. Gray has also been a senior biotechnology analyst at Raymond James & Associates, Warburg Dillon Read, and Kidder Peabody & Company. Dr. Gray served as a senior scientist at Schering-Plough Research and NeoRx Corporation. Dr. Gray received her Bachelor of Science degree from the University of South Carolina and her Ph.D. in pharmacology from the University of Vermont. She was a postdoctoral associate at Northwestern University School of Medicine and Yale University School of Medicine.

ludwig mack 10 december 2007 16:19

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GTC Obtains FDA Orphan Drug Designation For ATryn(R)
Last update: 12/10/2007 8:00:14 AM
FRAMINGHAM, Mass., Dec 10, 2007 (BUSINESS WIRE) -- GTC Biotherapeutics, Inc. (GTCB) announced today that the US Food and Drug Administration, or FDA, has designated ATryn(R) an orphan drug for the treatment of patients with hereditary antithrombin deficiency, or HD. "ATryn(R) is the only recombinant human antithrombin product being developed to address the needs of this rare patient population who are at risk of developing serious and potentially life-threatening venous thromboses," stated Geoffrey F. Cox, PhD, GTC's Chairman and CEO. "The orphan drug designation is recognition of the importance of our developing a unique therapeutic for this rare patient population. We are close to completion of the Phase III comparative study to treat HD patients at risk for developing deep vein thrombosis or thromboembolism while undergoing surgery or childbirth. We plan to have top line results of the comparative study available in late December to early January, depending on final patient scheduling. The FDA recently granted fast track designation for ATryn(R) and provided permission for a rolling Biologics License Application, or BLA, submission. We will complete the submission after all clinical data is gathered, analyzed, and available for the BLA, which is planned to be in the first half of 2008." ATryn(R) is GTC's recombinant form of human antithrombin, a protein with anticoagulant and anti-inflammatory properties that is normally present in human plasma. ATryn(R) is produced in the milk of goats that have incorporated the human antithrombin gene such that it is only expressed during lactation. This technology enables an alternative supply of antithrombin that is unconstrained by the limited availability of plasma-derived product. ATryn(R) has been approved for sale in the European Union for the treatment of HD patients undergoing surgical procedures, marking the first time that any transgenically produced therapeutic protein had been approved anywhere in the world. LEO Pharma A/S, GTC's commercial and development partner in Europe, Canada and the Middle East, has initiated commercial sales in Europe in the approved indication and initiated a Phase II study of ATryn(R) in the treatment of patients with disseminated intravascular coagulation, or DIC, associated with severe sepsis. DIC is a large unmet medical need with approximately 500,000 patients in the US and EU each year and up to 50% mortality. Orphan drug designation provides GTC with seven years of marketing exclusivity upon product licensure and automatic waiver of the FDA's application user fee. The Orphan Drug Act is intended to encourage companies to develop therapies for the treatment of diseases that affect fewer than 200,000 individuals in the United States. About GTC Biotherapeutics GTC Biotherapeutics develops, produces, and commercializes therapeutic proteins through transgenic animal technology. In addition to ATryn(R), GTC is working with LFB Biotechnologies to develop recombinant forms of human coagulation factor VIIa and a CD20 monoclonal antibody. Additional programs in the development pipeline include recombinant forms of human alpha-1 antitrypsin, human coagulation factors VIII and IX, and a monoclonal antibody to CD137. GTC's intellectual property includes 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, . This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, including without limitation statements regarding the timing of completion of GTC's current Phase III study of ATryn(R) and filing of the associated BLA. 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 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. SOURCE: GTC Biotherapeutics, Inc

ludwig mack 10 december 2007 17:07

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AP
GTC Blood Drug Gets Special FDA Status
Monday December 10, 8:31 am ET
GTC Biotherapeutics' Blood-Clot Drug Will Get 7 Years of Market Exclusivity in the U.S.

FRAMINGHAM, Mass. (AP) -- GTC Biotherapeutics Inc. said Monday its drug candidate aimed at treating a rare blood-clotting disorder will get seven years of market exclusivity if approved in the U.S.
The Food and Drug Administration granted the drug candidate, called ATryn, "orphan drug" status. The special status is granted to drugs being developed to treat rare conditions and includes the exclusivity benefit along with application fee waivers.

[verwijderd] 2 januari 2008 21:11

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Interesting view of a former FDA's Office of Biotechnology expert (He was the medical reviewer for the first genetically engineered drugs evaluated by the FDA and was instrumental in the rapid licensing of human insulin and human growth hormone).

WILL REGULATION PREVENT ANIMAL BIOTECH FROM BRINGING HOME THE BACON?

www.nbiap.vt.edu/news/2008/news08.jan...

Henry I. Miller, M.D.

Biotechnology is everywhere these days, from the production of pest-resistant crops to microorganisms that make biofuels to new drugs and vaccines. It’s even being used to produce animals with novel and valuable traits, but these applications in particular are suffering from inconsistent, uncertain regulation. After 20 years, the FDA has not yet published a policy statement, but a senior official in its Center for Veterinary Medicine recently gave a strong hint of the agency’s preferred approach. She said that every new genetic construction in an animal that employs recombinant DNA, or gene-splicing, technology would require approval for use in the food supply, and that the applicable procedures and regulations would be the same as for drugs used to treat animal diseases.

But the introduction of a gene is not the same as the administration of a drug. Moreover, the FDA’s approach represents a major shift in FDA’s regulation of biotechnology that will be hugely expensive to animal breeders and detrimental to consumers. John J. Cohrssen, who worked on FDA reform during the 1990’s as majority counsel of the House Commerce Committee, characterized the FDA’s new approach as "complex, arbitrary and dilatory."

Up till now, the FDA has not regulated farm animals or, for that matter, animals used for what might be termed "medical purposes." For example, if German shepherds or golden retrievers were bred to enhance traits that made them better seeing-eye or companion dogs, the FDA would not regulate them under its medical device or veterinary drug regulations. Nor would a leaner line of pigs be regulated differently from others under the FDA’s food regulations, unless some safety issue was raised. Even for transgenic animals used in research, the FDA has not asserted jurisdiction over the hundreds of rodent lines that are available (http://www.criver.com/research_models_and_ services/transgenic_services/tgresearchmodels.htm).

The only transgenic animal currently marketed to the public at large is a small, tropical, ornamental (aquarium) zebrafish that glows because of the insertion and expression of a gene that synthesizes a beautifully colored fluorescent protein (http://www.glofish.com). The fluorescent protein genes were obtained from another marine organism, the sea anemone. The FDA opted not to regulate them, under this rationale: "Because tropical aquarium fish are not used for food purposes, they pose no threat to the food supply. There is no evidence that these genetically engineered zebra danio fish pose any more threat to the environment than their unmodified counterparts which have long been widely sold in the United States. In the absence of a clear risk to the public health, the FDA finds no reason to regulate these particular fish."

That statement from the FDA would seem to weaken the argument for treating transgenic animals as though they were being treated with a "new drug." (It is noteworthy that in spite of the fact that the fluorescent fish are not eaten and would not survive outside an aquarium, they have been banned by regulators in California.) The most apposite models for gene-spliced or "transgenic" animals are the FDA’s oversight of traditional foods and food additives; and the production of livestock clones, or identical twins, which regulators decided last year were safe to eat.

A company called Aqua Bounty Technologies has been trying for about a decade to get FDA approval to market an Atlantic salmon that contains a newly introduced Chinook salmon growth hormone gene engineered to keep it turned on all year round (instead of during only the warmer months, as in nature). This cuts the time to marketable adult weight from 30 months to 18. The extra gene confers no detectable differences in the salmon’s appearance, taste, or nutritional value; it just grows faster. In spite of sufficient evidence that the fish is safe to eat and does not differ nutritionally from other Atlantic salmon, the FDA has kept the company treading water for almost a decade.

There are numerous other applications in various stages of R&D, including transgenic livestock with leaner muscle mass, enhanced resistance to disease, or improved use of dietary phosphorous to lessen the environmental impacts of animal manure. But if regulators don’t make appropriate regulatory decisions soon, the entire sector could virtually disappear.

One problem plaguing the FDA’s Center for Veterinary Medicine is that the "new drug" paradigm doesn’t fit transgenic animals well. A better model is the way that another FDA component, the Center for Food Safety and Nutrition, regulates other foods. The law places the burden of ensuring the safety of foods and food ingredients on those who produce them. It prohibits the adulteration (contamination) or misbranding (mislabeling) of food, but the agency does not inspect or evaluate food prior to its sale in shops, supermarkets, or restaurants. Rather, federal oversight relies on market surveillance, or post-marketing regulation, and the FDA takes action only if there is an apparent problem. This approach has worked quite well over many years.

The law does require a pre-marketing review for certain food-related products. These include most food additives — a class of ingredients that includes preservatives, emulsifiers, spices, sweeteners, and natural and synthetic flavors or colors, among others. In general, a food additive must be pre-approved if it becomes a component of or otherwise affects the characteristics of a food and it is "not generally recognized as safe (GRAS) by qualified experts for its intended use."

GRAS is an important concept: Before a new food additive is marketed, it is the responsibility of the producer to determine whether or not the substance is GRAS. The agency routinely reviews food additive applications for safety only when the substance in question has been determined not to be GRAS by the producer. If the producer determines that a substance is GRAS, only a notification of that decision to the FDA is necessary (which is then subject to agency review).

The FDA’s existing approach to biotechnology and to foods in general could be adapted easily to transgenic animals. Traditionally, in a logical application of transitivity, the combination of two GRAS substances is still GRAS. Similarly, because adding a GRAS gene to a GRAS organism is likely to yield a GRAS outcome, an FDA pre-marketing review would not be necessary for genetic constructions like the fast-growing salmon. But instead the FDA intends to treat every new animal as though it contains a "new drug," the evaluation of which can take many years even if there is minimal likelihood of harm.

The GRAS/food additive concept is relevant to "transgenic" animals because of the nature of the techniques. "Transgenic" animals usually are created by injecting the desired gene — which may be intended to confer an advantage in husbandry or nutrition, for example — into a single-cell embryo, or by inserting the gene into a skin cell and cre

[verwijderd] 7 januari 2008 14:48

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www.marketwatch.com:80/News/Story/Sto...
ATryn(R) Nears Completion of US HD Clinical Study

Last update: 8:30 a.m. EST Jan. 7, 2008Print E-mail RSS Disable Live Quotes

FRAMINGHAM, Mass., Jan 07, 2008 (BUSINESS WIRE) -- GTC Biotherapeutics, Inc. (GTCB:gtc biotherapeutics inc com announced today that it has completed recruitment into the historical arm of the comparative clinical study of ATryn(R) in the treatment of patients with hereditary antithrombin deficiency, or HD, undergoing high-risk surgical or childbirth procedures. This study is expected to support a Biologics License Application, or BLA, submission with the United States Food and Drug Administration, or FDA. Evaluable records for 37 patients were obtained, meeting the required minimum of 35 HD patients. The data from the historical records were gathered under a prospective clinical protocol observing patients who had been treated with plasma-derived antithrombin products.
A minimum of 31 evaluable HD patients are required for the ATryn(R) treatment trial. Results for 14 of these patients were already obtained from the study that supported ATryn(R)'s approval in the European Union for HD patients undergoing surgical procedures. Due to patient scheduling decisions, top line results of the clinical study are now expected to be available around the end of January. The ongoing study is designed to determine the non-inferiority of ATryn(R) to plasma-derived antithrombin products in reducing the incidence of deep vein thrombosis or other thromboembolisms in this challenging patient population.
"While the scheduling of patients into the active treatment arm of our comparative study has taken a little longer than originally forecasted, we have made good progress in working through the recruitment process, completing the historical arm, and moving the regulatory process forward," stated Geoffrey F. Cox, PhD, GTC's Chairman and CEO. "We are encouraged that we continue on track with our plans to commercialize and further develop ATryn(R) in the US, closely following its commercialization in Europe."
ATryn(R) was recently granted fast track status by the FDA and subsequently was designated an orphan drug for the HD indication. GTC has also been granted permission to submit the sections of the associated BLA on a rolling basis as the required sections are completed. The submission of the preclinical and manufacturing sections is anticipated shortly. The last section to be filed is expected to be the clinical study results, which are planned to support completion of the BLA by mid-year. GTC will be seeking priority review in conjunction with the BLA submission. On this basis, GTC anticipates approval of the BLA around the end of 2008.
Discussions with potential partners for the commercialization and further development of ATryn(R) in the US have continued through the end of 2007. GTC is planning to conclude an agreement during the first quarter of 2008.
ATryn(R) is partnered with LEO Pharma A/S in Europe, Canada, and the Middle East. LEO launched the product in the United Kingdom in the fourth quarter of 2007 and has also obtained pricing approval in Ireland and Greece. LEO is continuing to expand the commercial launch into additional European countries as pricing is established. LEO is also conducting a phase II dose ranging study in treating disseminated intravascular coagulation, or DIC, associated with severe sepsis. GTC retains rights to this indication in the US and the rest of the world. The US market opportunity for the DIC indication is estimated to be $2 - 3 billion.
About GTC Biotherapeutics
GTC Biotherapeutics develops, supplies, and commercializes therapeutic proteins produced through transgenic animal technology. In addition to ATryn(R), GTC is developing a portfolio of recombinant human plasma proteins with known therapeutic properties. These proteins include recombinant forms of human coagulation factor VIIa, factor VIII, factor IX, and alpha-1 antitrypsin. GTC also has a monoclonal antibody portfolio that includes a CD20 monoclonal antibody and a monoclonal antibody to CD137. GTC's intellectual property includes 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, 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 timing of completion of GTC's current Phase III study of ATryn(R), filing and review of the associated BLA, and timing of partnering and commercialization activities. 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 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 and potential collaboration partners. 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.
SOURCE: GTC Biotherapeutics, Inc.
GTC Biotherapeutics, Inc.
Thomas E. Newberry, 508-370-5374
Vice President, Corporate Communications
tom.newberry@gtc-bio.com

Copyright Business Wire 2008

[verwijderd] 10 januari 2008 14:55

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LFB Biotechnologies to Collaborate with GTC Biotherapeutics on Coagulation Factor IX Program
Thursday January 10, 8:00 am ET

biz.yahoo.com/bw/080110/2008011000547...

FRAMINGHAM, Mass.--(BUSINESS WIRE)--GTC Biotherapeutics, Inc. ("GTC", Nasdaq: GTCB) announced today that LFB Biotechnologies has agreed to include the recombinant human coagulation factor IX program in the existing collaboration between GTC and LFB. Under their collaboration, both the costs and profits of this program will be shared between GTC and LFB. LFB will fund the final $500,000 license fee payment due to ProGenetics, LLC in the second quarter of 2008. GTC retains exclusive marketing rights in North America for recombinant factor IX and LFB will receive exclusive marketing rights in Europe with co-exclusive marketing rights in Japan.

“GTC is building a significant and valuable portfolio of recombinant plasma proteins leveraging the unique characteristics of our production technology,” stated Geoffrey F. Cox, PhD, GTC’s Chairman and CEO. “Our collaboration with LFB is a significant enablement in this process, not only in the benefits of financial support, but very importantly in the experience and expertise with plasma fractionated products which LFB brings to our collaboration. The collaboration with the factor IX program is a further important example of the value of this relationship.”

Factor IX is used to treat Type B hemophilia. The preferred treatment strategy is to prophylactically supplement the patient’s deficient factor IX to establish normal coagulation. The high cost and limited availability of the recombinant factor IX product currently on the market often relegates its use to treating acute bleeding episodes, typically in the joints, which often irreversibly harms joint function and ultimately limits mobility.

GTC previously obtained from ProGenetics an exclusive license to a number of recombinant plasma proteins, including human coagulation factor IX, for North America, Europe and Japan. ProGenetics has developed production of recombinant human factor IX in the milk of transgenic pigs. ProGenetics received $500,000 from GTC upon signing of the agreement.

[verwijderd] 5 februari 2008 09:04

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ATryn® MEETS PRIMARY ENDPOINT / ROLLING BLA SUBMISSION INITIATED
www.transgenics.com/news.html

FRAMINGHAM, MA – February 4, 2008 -- GTC Biotherapeutics, Inc. ("GTC", Nasdaq: GTCB) announced today that ATryn® has met the statistical requirements for the primary endpoint in the pivotal study for the treatment of patients with hereditary antithrombin deficiency, or HD, undergoing high-risk surgical or childbirth procedures. The primary endpoint was demonstration of non-inferiority to plasma-derived antithrombin in preventing clinically relevant deep vein thromboses, or DVTs, or other thromboembolisms.

GTC also announced that it has initiated the filing of the associated Biologics License Application, or BLA, by submitting the preclinical and manufacturing sections. The last section to be filed is expected to be the full clinical study results around mid-year, once all reviews of the data have been completed. GTC is seeking priority review in conjunction with the BLA submission, and on that basis anticipates approval of the BLA approximately 6 months after submission of the last section. GTC previously received approval to commence the BLA filing on a rolling basis when ATryn® was granted fast track status by the Food and Drug Administration, or FDA. Separately, ATryn® has also been designated an orphan drug for the HD indication.

The completed comparator arm of the study is based on historical data gathered under a prospective clinical protocol from patients who had been previously treated with plasma-derived antithrombin products while undergoing similar high-risk procedures to those performed in the active arm. There were no clinically relevant DVTs or other thromboembolisms in these patients.

A minimum of 31 evaluable HD patients are required for the ATryn® treatment trial. Results for 14 of these patients were already obtained from the previous study that supported ATryn®’s approval in the European Union for HD patients undergoing surgical procedures. Seventeen additional patients have been treated, of which 16 are considered evaluable. One patient is considered unevaluable due to the course of treatment deviating from the clinical protocol. None of the additional patients had clinically relevant DVTs or other thromboembolisms during the evaluation period. On this basis, the study has already met the statistical requirements for non-inferiority. Although the primary endpoint has already been met, enrollment is being extended through February to include an additional patient to ensure that the minimum number of evaluable patient procedures agreed upon with the FDA is satisfied.

“We look forward to moving into the regulatory review process with the FDA on the basis of having met the primary endpoint for ATryn®’s clinical studies,” stated Geoffrey F. Cox, PhD, GTC’s Chairman and CEO. “We are grateful to the many physicians and clinical sites that supported the most robust clinical study in hereditary deficient patients ever attempted for any antithrombin product. ATryn® is also unique in being the only recombinant form of human antithrombin to be developed for therapeutic use.”

Complete safety and efficacy data will be available for the BLA submission after the last patient is enrolled. The completed clinical data package will include 90-day follow-up tests for antibody generation to ATryn® after the last patient is treated, which is a typical regulatory requirement and was also part of the approval process successfully completed for the European Union

[verwijderd] 8 februari 2008 14:54

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GTC Biotherapeutics to Raise $6 Million in Registered Direct Offering

Last update: 8:41 a.m. EST Feb. 8, 2008Print E-mail RSS Disable Live Quotes

FRAMINGHAM, Mass., Feb 08, 2008 (BUSINESS WIRE) -- GTC Biotherapeutics, Inc. (GTCB:gtc biotherapeutics inc com
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GTCB 0.87, -0.14, -13.9%) announced today that it has entered into a securities purchase agreement with institutional investors to purchase 6,896,550 million shares of GTC's common stock at a price of $0.87 per share for gross proceeds of approximately $6 million. Under the terms of the financing, GTC will also issue 7-year warrants to purchase an additional share of GTC's common stock for each share sold in the offering, at an exercise price of $0.87 per share. The closing of the offering is expected to take place on February 12, 2008, subject to the satisfaction of customary closing conditions. The net proceeds of the financing will be used for general corporate purposes.
The shares and warrants are being offered under a shelf registration statement previously filed with the Securities and Exchange Commission. Rodman & Renshaw, LLC, a wholly-owned subsidiary of Rodman & Renshaw Capital Group, Inc. (Nasdaq: RODM - News), acted as the lead placement agent and Dawson James Securities, Inc. served as co-agent for the offering.
This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state. Copies of the prospectus and the prospectus supplement can be obtained from Rodman & Renshaw, LLC, 1270 Avenue of the Americas, 16th Floor, New York, NY 10020, Fax: 212-581-5690.
About GTC Biotherapeutics
GTC Biotherapeutics develops, supplies, and commercializes therapeutic proteins produced through transgenic animal technology. GTC's lead program is ATryn(R), its recombinant form of human antithrombin that is approved for use in the European Union and met the primary endpoint of a pivotal study for the United States. In addition to ATryn(R), 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, and alpha-1 antitrypsin. GTC also has a monoclonal antibody portfolio that includes a CD20 monoclonal antibody and a monoclonal antibody to CD137. GTC's intellectual property includes 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, www.gtc-bio.com.
This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, including statements about the expected closing date of the offering and the amount of proceeds expected to be received from the offering. 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 filed with the Securities and Exchange Commission, including the risks and uncertainties inherent in satisfying the conditions to the closing of such a transaction. 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.
SOURCE: GTC Biotherapeutics, Inc.
GTC Biotherapeutics, Inc.
Thomas E. Newberry, 508-370-5374
Vice President, Corporate Communications
tom.newberry@gtc-bio.com

Copyright Business Wire 2008

ludwig mack 11 februari 2008 17:03

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met dank aan:

ohmygod - 11 feb 08, 14:49 | Reageer | Quote | Zoek | Aanbevolen: 0

Interview met Cox vandaag:

www.xconomy.com/2008/02/11/gtc-biothe...

ludwig mack 25 februari 2008 15:01

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LAST PATIENT ENROLLED IN ATryn® PIVOTAL STUDY

FRAMINGHAM, MA – February 25, 2008 -- GTC Biotherapeutics, Inc. ("GTC", Nasdaq: GTCB) announced today that ATryn® has completed enrollment in the pivotal study for the treatment of patients with hereditary antithrombin deficiency, or HD, undergoing high-risk surgical or childbirth procedures. As previously announced, the pivotal study has met the primary endpoint of demonstration of non-inferiority to plasma-derived antithrombin in preventing clinically relevant deep vein thromboses, or DVTs, or other thromboembolisms.

A minimum of 31 evaluable HD patients were required for the ATryn® treatment trial. Results for 14 of these patients were already obtained from the previous study that supported ATryn®’s approval in the European Union for HD patients undergoing surgical procedures. Seventeen evaluable patients have been treated to complete the pivotal study. There were no clinically relevant DVTs or other thromboembolisms during the evaluation period in any of the patients treated in the pivotal study.

The previously completed comparator arm of the study is based on historical data gathered under a prospective clinical protocol from patients who had been previously treated with plasma-derived antithrombin products while undergoing similar high-risk procedures to those performed in the active arm. There were no clinically relevant DVTs or other thromboembolisms in these patients.

“Completing enrollment in this pivotal study is another important stepping stone in validating the application of our transgenic production technology to the development of recombinant protein therapeutics. We look forward to completing our rolling Biologics License Application as planned around mid-2008, when we submit the full clinical data package,” stated Geoffrey F. Cox, PhD, GTC’s Chairman and CEO. “ATryn® is unique in being the only recombinant form of human antithrombin to be developed for therapeutic use, as recognized in its orphan drug status for the HD indication.”

The full clinical data package will include 90-day follow-up tests for antibody generation to ATryn®, which is a typical regulatory requirement and was also part of the approval process successfully completed for the European Union.

ludwig mack 28 februari 2008 21:33

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Press Release Source: GTC Biotherapeutics, Inc.

GTC Biotherapeutics to Webcast Corporate Presentation at the 10th Annual BIO CEO & Investor Conference
Wednesday February 6, 2:30 pm ET

FRAMINGHAM, Mass.--(BUSINESS WIRE)--GTC Biotherapeutics, Inc. ( GTC , Nasdaq: GTCB) announced today that Geoffrey Cox, Ph.D., GTC’s Chairman and CEO, is scheduled to present on Wednesday, February 13, 2008 at 11:00 a.m. during the 10th Annual BIO CEO & Investor Conference. The conference is being held at the Waldorf=Astoria in New York, New York from February 11-13, 2008.

The presentation will be webcast live and can be accessed by logging onto www.gtc-bio.com. The replay can be accessed from this same website and will be available within 24 hours of the presentation

ludwig mack 29 februari 2008 11:47

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GTC BIOTHERAPEUTICS TO HOST FOURTH QUARTER AND YEAR END 2007 EARNINGS CALL AND WEBCAST ON THURSDAY, MARCH 6, 2008

Framingham, Mass., February 28, 2008-- GTC Biotherapeutics, Inc. (Nasdaq: GTCB) (“GTC”) announced today that its financial results for the fourth quarter and year end 2007 will be released on Thursday, March 6, 2008 followed by a webcast conference call starting at 10:00 a.m. Eastern Time. You may access the live internet broadcast or the subsequent archived recording, on GTC’s website www.gtc-bio.com or access the conference call as follows:

Live Call – In the United States, dial 1-888-713-4216
Outside the United States, dial 617-213-4868

Reference call ID: when prompted 16913362

Audio Archive – In the United States, dial 888-286-8010

Outside the United States, dial 617-801-6888
Reference call ID: when prompted 63023748

Participants may pre-register for the call at: www.theconferencingservice.com/prereg...

ludwig mack 6 maart 2008 14:52

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GTC BIOTHERAPEUTICS REPORTS FOURTH QUARTER AND YEAR END 2007 FINANCIAL RESULTS

FRAMINGHAM, MA – March 6, 2008 -- GTC Biotherapeutics, Inc. ("GTC", Nasdaq: GTCB)reported today its financial results for the fourth quarter and year ended December 30, 2007. Revenues were $3.1 million for the fourth quarter of 2007, compared with $2.8 million in the fourth quarter of 2006. Revenues for 2007 more than doubled to $13.9 million, a $7.8 million increase from $6.1 million in 2006. Revenues increased primarily due to payments from LEO for the supply of ATryn® and the services provided to PharmAthene for the development of their Protexia® product.

The net loss for the fourth quarter of 2007 was $9.8 million, or $0.13 per share, compared to $7.4 million, or $0.10 per share in the fourth quarter of 2006. The net loss for the 2007 financial year was $36.3 million, or $0.47 per share, compared to $35.3 million, or $0.53 per share, for the 2006 financial year.

“During the last 12 months, we have successfully completed a rigorous comparative study of ATryn® that is key to our request for our first regulatory approval of a transgenic product in the U.S., and our revenues have more than doubled as we broadened our collaboration activities,” stated Geoffrey F. Cox, Ph.D., GTC’s Chairman of the Board and Chief Executive Officer. “We have also made significant progress in building a broad portfolio of recombinant plasma proteins and we have begun development of a portfolio of monoclonal antibodies as follow-on biologics exploiting the volume and cost advantages of our production technology. Based on these advances, we continue to expand our existing collaborations and seek to develop new collaborations to help provide the financial and technical resources to support the growth of these product portfolios.”

Significant achievements for the year:

ATryn® (recombinant human antithrombin)

ATryn® met the primary endpoint of a comparative study demonstrating non-inferiority to plasma-derived antithrombin in prophylactically treating hereditary deficient patients undergoing surgical or childbirth procedures with a high risk of developing deep vein thrombosis or thromboembolisms.
The initial sections of the Biologics License Application, or BLA, forATryn® were submitted to the US Food and Drug Administration, or FDA, under its designation for a rolling submission where sections are filed as they are ready. The final section is anticipated to be filed in mid-2008.
The FDA granted both Fast Track review and Orphan Drug status toATryn®, recognizing its unique characteristics as the only recombinant antithrombin product that may be available to the rare patient population with hereditary antithrombin deficiency.
We are in partnering negotiations for the commercial launch and further development ofATryn® in the US. Commercial launch is being planned for the first half of 2009 assuming a priority review and FDA approval of the BLA around the end of 2008.
LEO Pharma A/S, GTC’s marketing and development partner for ATryn® in Europe, Canada, and the Middle East, launched the product in the approved indication for hereditary deficient patients undergoing surgical procedures. Pricing was established in November in the United Kingdom and subsequently in Ireland and Greece. Commercial availability is being expanded as pricing is further established on a country-by-country basis.
LEO began enrolling patients in a phase II dose ranging study ofATryn® as a treatment for disseminated intravascular coagulation associated with severe sepsis.

Other Recombinant Plasma Proteins

We developed production animals for the recombinant human coagulation factor VIIa program with LFB Biotechnologies.
We licensed exclusive rights to North America, Europe, and Japan for recombinant human coagulation factors VIII and IX, as well as fibrinogen, from ProGenetics, LLC. The factor IX development program was subsequently added to our joint collaboration with LFB.

Monoclonal Antibodies and Follow-on Biologics

We have initiated the development of a portfolio of follow-on monoclonal antibodies addressing markets with current sales of the innovator products aggregating approximately $16 billion. We plan to support the development and commercialization of our potential follow-on products through partnership arrangements.
We began developing the production capacity under the joint collaboration with LFB for a monoclonal antibody to the CD20 immune system receptor, the same target as for Genentech’s Rituxan®.

External Programs

We increased revenue from our manufacturing and process development services work performed to support PharmAthene in their development of Protexia® as a biodefense product.

Cash and Investment Position

We ended 2007 with approximately $15.8 million of cash and marketable securities. We subsequently sold approximately 6.9 million shares of common stock at $0.87 per share for net proceeds of approximately $5.5 million.

We used $28 million of cash and marketable securities for 2007, net of the $4.4 million of financing proceeds received from LFB in January 2007. We expect a similar cash use for 2008, excluding any upfront payments from new or expanded partnerships not currently contracted. Any such payments from agreements that result from the ongoing partnering discussions will reduce the net cash use for 2008. We anticipate our current cash and contracted receipts to support our operations into the third quarter of 2008.

The financial report for the financial year ended December 30, 2007 to be filed on our Form 10-K with the Securities and Exchange Commission within the next few days will include an audit opinion from our auditors, PricewaterhouseCoopers LLP, which will refer to substantial doubt over our ability to continue as a going concern based on the amount of cash and marketable securities on our balance sheet and our expected cash use in 2008. Inclusion of this information in this release satisfies Nasdaq Marketplace Rule 4350 (b) (1) (B) for public announcement of the auditors’ statement of uncertainty and in no way alters our plans for addressing the underlying circumstances primarily through new and expanded collaborations.

Other Financial Results

Costs of revenue and operating expenses were $50.3 million for 2007, 20% higher than the $41.8 million in 2006. The year-to-year increase included the cost of additional inventory sold to LEO and the cost incurred in the programs in our collaboration with LFB, as well as the $2.9 million inventory write-off disclosed in the second quarter of 2007.

The weighted average number of shares outstanding increased from 73.6 million shares for the fourth quarter of 2006 to 78.1 million shares in the fourth quarter of 2007. The weighted average number of shares outstanding increased from 66.9 million shares in 2006 to 77.9 million shares in 2007. The increases in the weighted average shares outstanding primarily reflect the issuance of common stock in financing transactions.

Conference Call Information

GTC Biotherapeutics will discuss these results and its business outlook in a web cast conference call at 10:00 a.m. (Eastern) today. The dial-in number from inside the United States is 1-888-713-4216. The dial-in number from outside the United States is 1-617-213-4868. The participant passcode is 16913362

ludwig mack 7 maart 2008 19:57

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samenvatting c.c. van 6 maart 2008

investorshub.advfn.com/boards/read_ms...

ludwig mack 20 maart 2008 12:40

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Bru-m Bru-m - 20 mrt 08, 11:42 | Reageer | Quote | Zoek | Aanbevolen: 0

AMSTERDAM (Dow Jones)--De herhaalde afkeuring van Pharmings belangrijkste middel Rhucin door medisch toezichthouder EMEA zal de marktautorisatie van het middel met 1,5 tot 2 jaar vertragen, verwacht analist Kenn Curt Daniel van Fortis. De analist denkt dat Pharmings verzoek om een versnelde beoordelingsprocedure niet wordt gehonoreerd en dat meer klinisch onderzoek nodig zal zijn, naast de resultaten van de reeds afgeronde aanvullende placebogecontroleerde test waarvan de analyse binnenkort gereed is. De herhaalde afkeuring betekent volgens de Fortis-analist nog niet meteen het einde voor het biotechbedrijf, omdat dat voorlopig nog genoeg geld in kas heeft. De analist is wel van mening dat het bedrijf "iets radicaals" zal moeten doen, bijvoorbeeld fuseren met een Amerikaanse sectorgenoot, die al wel marktautorisatie heeft voor een vergelijkbaar product. De analist hanteert een sell-advies met een koersdoel van EUR0,70. Donderdag rond 11.30 uur noteert het aandeel Pharming 24% lager op EUR0,89. (AVR) Dow Jones Nieuwsdienst: +31 20 5890270, amsterdam@dowjones.com (END) Dow Jones Newswires March 20, 2008 06:31 ET (10:31 GMT)
© 2008 Dow Jones & Company, Inc.

[verwijderd] 26 maart 2008 15:30

0

quote:
ludwig mack schreef:

Bru-m Bru-m - 20 mrt 08, 11:42 | Reageer | Quote | Zoek | Aanbevolen: 0

AMSTERDAM (Dow Jones)--De herhaalde afkeuring van Pharmings belangrijkste middel Rhucin door medisch toezichthouder EMEA zal de marktautorisatie van het middel met 1,5 tot 2 jaar vertragen, verwacht analist Kenn Curt Daniel van Fortis. De analist denkt dat Pharmings verzoek om een versnelde beoordelingsprocedure niet wordt gehonoreerd en dat meer klinisch onderzoek nodig zal zijn, naast de resultaten van de reeds afgeronde aanvullende placebogecontroleerde test waarvan de analyse binnenkort gereed is. De herhaalde afkeuring betekent volgens de Fortis-analist nog niet meteen het einde voor het biotechbedrijf, omdat dat voorlopig nog genoeg geld in kas heeft. De analist is wel van mening dat het bedrijf "iets radicaals" zal moeten doen, bijvoorbeeld fuseren met een Amerikaanse sectorgenoot, die al wel marktautorisatie heeft voor een vergelijkbaar product. De analist hanteert een sell-advies met een koersdoel van EUR0,70. Donderdag rond 11.30 uur noteert het aandeel Pharming 24% lager op EUR0,89. (AVR) Dow Jones Nieuwsdienst: +31 20 5890270, amsterdam@dowjones.com (END) Dow Jones Newswires March 20, 2008 06:31 ET (10:31 GMT)
© 2008 Dow Jones & Company, Inc.

zonder namen te noemen GTCB dus!

ludwig mack 26 maart 2008 15:53

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daarom plaatste ik het artikel hier ;-)

ludwig mack 27 maart 2008 13:06

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GTC BIOTHERAPEUTICS AND PHARMATHENE EXTEND AGREEMENT FOR PROTEXIA®PROGRAM

FRAMINGHAM, MA– March 27, 2008 -- GTC Biotherapeutics, Inc. ("GTC", Nasdaq: GTCB) has entered into an extended agreement with PharmAthene, Inc. (Amex: PIP) under which GTC will provide continuing process development and clinical supply manufacturing services for PharmAthene’s Protexia®program. The manufacturing work is planned to conclude in the third quarter of 2008. Protexia® is a recombinant form of human butyrylcholinesterase (rBChE) produced in the milk of transgenic goats, which is being developed by PharmAthene as a pre- and post-exposure therapy for victims of a chemical nerve agent attack.

“We are pleased to continue to support PharmAthene as it develops Protexia®,” stated Geoffrey F. Cox, Ph.D., GTC’s Chairman and Chief Executive Officer. “The constraint in supplying BChE from either human plasma sources or other recombinant systems is an excellent example of transgenic production enabling development of otherwise difficult to express proteins.”

While the utility of human plasma derived butyrylcholinesterase (BChE) to protect against nerve agent toxicity is well documented, a major limitation hindering its commercial development has been the inability to produce commercial quantities due to a limited availability of appropriate blood supplies, low levels of the protein in plasma, and low production yields using traditional biotechnology methods. Protexia® overcomes these limitations by enabling substantially larger production yields than are possible using other expression systems or through purification of the native protein from human plasma. Transgenic production and manufacturing is estimated to be capable of supplying sufficient rBChE to make Protexia® available for use by the military and civilian populations.

About Nerve Agents

Organophosphate nerve agents, or anti-cholinesterase agents, cause toxicity by binding to and inhibiting acetylcholinesterase, an enzyme in the body that is essential for nervous system function. This leads to increases in acetylcholine and “cholinergic crisis” that can cause loss of muscle control, respiratory failure, paralysis, convulsions, permanent brain damage and eventually death.

These so-called nerve gases, which are actually all liquids at room temperature, are lethal in low quantities when inhaled or absorbed through the skin. Nerve agents can be classified as either G-agents (sarin, soman, tabun) or V agents (VX), both of which are exceedingly volatile and toxic.

About Protexia®: Recombinant Human Butyrylcholinesterase

Protexia® is a pegylated form of recombinant human butyrylcholinesterase (rBChE), a potent

organophosphate (OP) scavenger protein produced in the milk of transgenic goats, which is being developed for use as a prophylactic and therapeutic against acute organophosphate (OP) nerve agent toxicity. PharmAthene’s development of Protexia® is being funded by a multi-year contract from the Department of Defense (DoD) U.S. Army Space and Missile Command. For more information on PharmAthene, please visit www.PharmAthene.com.

About GTC Biotherapeutics, Inc.

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 Europe and has begun the review process in the United States under a rolling Biologics License Application. 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 used for the treatment of hemophilia, and alpha-1 antitrypsin. GTC also has a monoclonal antibody portfolio that includes a monoclonal antibody to CD20 and a monoclonal antibody to CD137. GTC’s intellectual property includes 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, www.gtc-bio.com.

[verwijderd] 9 april 2008 17:23

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PharmAthene's Protexia May Play a Neuroprotective Role in Alzheimer's Disease

biz.yahoo.com/prnews/080409/new002.ht...

>>
Wednesday April 9, 9:16 am ET

ANNAPOLIS, Md., April 9, 2008 /PRNewswire-FirstCall/ -- PharmAthene, Inc. (Amex: PIP ) a biodefense company specializing in the development and commercialization of medical countermeasures against chemical and biological threats, announced today that scientists from the Hebrew University of Jerusalem, one of PharmAthene's collaboration partners, have recently obtained new data suggesting that recombinant butyrylcholinesterase (rBChE), a non-pegylated form of Protexia®, may have neuroprotective benefits.

Recent research conducted by Dr. Hermona Soreq and co-workers at the Alexander Silberman Life Sciences Institute at The Hebrew University of Jerusalem, in collaboration with PharmAthene, examined the role of rBChE in the prevention of amyloid plaques, which are believed to play a role in the development of Alzheimer's disease.

"The role of amyloid plaques in the pathophysiology of Alzheimer's disease is well documented, and a number of approaches have been studied which attempt to block their formation by interfering at critical stages in this complex pathway," said Hermona Soreq, Ph.D., Professor of Molecular Biology and Dean of Sciences at The Hebrew University. "Our preliminary results are especially intriguing as they continue to suggest that rBChE is effective not only in inhibiting plaque formation, but also in potentially attenuating neurotoxicity. The accumulating data provide compelling evidence that rBChE may serve as a natural protector against amyloid toxicity. In view of the empirical evidence gathered to date, the role of rBChE in the pathogenesis of Alzheimer's disease merits closer scrutiny and understanding."

Recent in vitro data have demonstrated that rBChE effectively blocked the formation of amyloid fibrils, precursors to plaque formation in the brain. These data were substantiated by transmission electron microscopy studies, which showed that rBChE dramatically suppressed the formation of fibrils, resulting in thinner and less branched filaments than would normally occur in patients with Alzheimer's disease.

More recent studies have also demonstrated that this plaque inhibitory activity is still active when peptide fragments of rBChE are used, rather than the full length protein. This may be an advantage in developing a product that can cross the blood brain barrier.

The formation of amyloid plaques in Alzheimer's disease is theorized to involve a structural transition of the amyloid beta peptide. New data generated by Dr. Soreq corroborate earlier findings, and demonstrate that both rBChE and its peptide fragments could disrupt amyloid beta organization and potentially limit its neurotoxicity.

David P. Wright, President and Chief Executive Officer of PharmAthene commented, "The early research is certainly intriguing. While we are still a long way from understanding the utility of rBChE in patients with Alzheimer's disease, our next steps will include studying rBChE in a transgenic mouse model of Alzheimer's disease to evaluate its ability to inhibit or reduce amyloid plaque formation. If the results continue to be encouraging, it may allow PharmAthene to expand applications of rBChE to additional areas beyond organophosphorous nerve agent toxicity with potentially important benefits to society. Importantly, this is consistent with our strategy of developing dual-use applications for our biodefense programs in other commercial markets."

Alzheimer's disease is a progressive neurodegenerative disease which is estimated to affect more than 4.5 million Americans. One of the hallmarks of Alzheimer's disease is the accumulation of excessive amyloid plaques in areas of the brain that control memory and cognition. Amyloid multimers are believed to be neurotoxic and interfere with the normal communication between neurons. A growing body of scientific evidence suggests that the accumulation of amyloid plaques and neurofibrillary tangles in the brain may play an important role in the development and progression of Alzheimer's disease.

The work conducted under the Alzheimer's research program is based on a patent owned by Yissum (the technology transfer company of The Hebrew University of Jerusalem), entitled "Human BChE Variants as Protectors from Amyloid Diseases", which has been licensed to PharmAthene.

As part of the collaboration with Hebrew University, PharmAthene has an exclusive, worldwide license to the application of rBChE and its corresponding peptides for use in the field of Alzheimer's disease.

About Protexia®: Recombinant Human Butyrylcholinesterase (rBChE)

Protexia is a pegylated form of recombinant human butyrylcholinesterase (rBChE), a potent organophosphorous (OP) scavenger protein produced in the milk of transgenic goats, which is being developed for use as a prophylactic against acute organophosphorous (OP) nerve agent toxicity.

About Chemical Weapons

Organophosphorous nerve agents, or anti-cholinesterase agents, were discovered in the 1930s following intensive research into new insecticides. Their discovery represents the beginning of modern chemical warfare. These agents cause toxicity by binding to and inhibiting acetylcholinesterase, an enzyme in the body that is essential for nervous system function, leading to increases in acetylcholine and "cholinergic crisis" that can cause loss of muscle control, respiratory failure, paralysis, convulsions, permanent brain damage and eventually death.

These so-called nerve gases, which are actually all liquids at room temperature, are lethal far more quickly and in far lower concentrations than other classical chemical warfare agents such as vesicants, choking agents and blood agents, and are effective both when inhaled and when absorbed through the skin. Nerve agents can be classified as either G-agents (sarin, soman, tabun) or V-agents (VX), both of which are exceedingly toxic.

About PharmAthene, Inc.

PharmAthene (Amex: PIP - News) was formed to meet the critical needs of the United States and its allies by developing and commercializing medical countermeasures against biological and chemical weapons. PharmAthene's lead programs include Valortim(TM) for the prevention and treatment of anthrax infection and Protexia® for the prevention and treatment of morbidity and mortality associated with exposure to chemical nerve agents. For more information about PharmAthene, please visit www.PharmAthene.com.

About Yissum:

Yissum was founded in 1964 to protect the Hebrew University's intellectual property and commercialise it. An estimated $1 billion in annual sales are generated by products based on Hebrew University technologies licensed out by Yissum. Ranked among the top technology transfer companies in the world, Yissum has registered 5500 patents covering 1600 inventions; licensed out 480 technologies and spun out 65 companies. Yissum's business partners span the globe and include companies such as Novartis, Microsoft, Johnson & Johnson, Merck, Intel, Teva and many more.
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