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ludwig mack 1 augustus 2008 12:31

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GTC BIOTHERAPEUTICS TO ANNOUNCE SECOND QUARTER 2008 EARNINGS ON THURSDAY, AUGUST 7, 2008

Framingham, Mass., July 31, 2008-- GTC Biotherapeutics, Inc. (Nasdaq: GTCB) (“GTC”) will release its second quarter 2008 financial results on Thursday, August 7, 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 webcast on GTC’s website www.gtc-bio.com, or access the conference call as follows:

Live Call – In the United States, dial 1-877-391-6849
Outside the United States, dial 617-597-9298

Reference call ID: when prompted 69521428

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

Outside the United States, dial 617-801-6888
Reference call ID: when prompted 53798560

Participants may pre-register for the call at:

www.theconferencingservice.com/prereg...

Pre-registrants will be issued a pin number to use when dialing into the live call which will provide quick access to the conference by bypassing the operator upon connection.

NOTE: the audio archive replay of the call will be available one hour following the end of the call and will be accessible until August 14, 2008.

The earnings webcast is also being distributed over CCBN's Investor Distribution Network to both institutional and individual investors. Individual investors can listen to the call through CCBN's individual investor center at www.earnings.comor by visiting any of the investor sites in CCBN's Individual Investor Network. Institutional investors can access the call via CCBN's password-protected event management site, StreetEvents (www.streetevents.com).

ludwig mack 7 augustus 2008 17:59

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GTC BIOTHERAPEUTICS REPORTS SECOND QUARTER 2008 FINANCIAL RESULTS

FRAMINGHAM, MA – August 7, 2008 -- GTC Biotherapeutics, Inc.’s ("GTC", Nasdaq: GTCB)total net loss for the second quarter ended June 29, 2008, was $2.2 million, or $0.02 per share, compared with a net loss of $10.6 million, or $0.14 per share, for the second quarter of 2007. The total net loss for the first six months of 2008 was $10.4 million, or $0.11 per share, compared to $18.1 million, or $0.23 per share, for the first six months of 2007.

“We have had an excellent quarter, achieving strong cash receipts from our partnering activities,”stated Geoffrey F. Cox, Ph.D., GTC’s Chairman of the Board and Chief Executive Officer. “In addition, we have completed preparation of our application to the Food and Drug Administration for licensure of ATryn® in the United States and entered into a strategic collaboration agreement with OVATION Pharmaceuticals for ATryn®’s further U.S. commercialization and development. In addition, we are engaged in further partnering discussions for our recombinant plasma proteins and monoclonal antibodies.”

ATryn® Update

GTC has completed preparation of the Biologics License Application (BLA) of ATryn®, a recombinant form of human antithrombin, for the prophylactic treatment of hereditary antithrombin deficient patients undergoing surgery or childbirth. GTC has requested a 6-month Priority Review. If granted, GTC expects a determination by the FDA on the BLA in the first quarter of 2009. Inspections of GTC’s U.S.-based production and manufacturing facilities to support this review have already been completed.

GTC and OVATION Pharmaceuticals have signed a strategic collaboration agreement with $257 million of potential milestone payments to commercialize and further develop ATryn® in the U.S. The agreement includes provisions for OVATION to fund clinical studies of ATryn® as a treatment for heparin resistance during cardiopulmonary bypass surgery, including paying for the product used in the studies. GTC will receive a $3 million payment associated with the closing of the agreement and anticipates $2 million of additional milestone payments in 2008.

LEO Pharma A/S, GTC’s partner for ATryn® in Europe, Canada, and the Middle East, continues recruitment into a phase II dose ranging study for prophylactic treatment of disseminated intravascular coagulation associated with severe sepsis. In addition, LEO continues expanding the number of European countries where pricing has been set for the approved EU indication of prophylactic treatment of hereditary antithrombin deficient patients undergoing surgical procedures. LEO has reported initial sales in the United Kingdom.

Other Partnering Update

In the second quarter, GTC received $3 million of a total $6 million funding commitment from LFB Biotechnologies for GTC’s share of the 2008 expenses for the collaboration programs in recombinant human coagulation factor VIIa, recombinant human alpha-1 antitrypsin, recombinant human coagulation factor IX, and a monoclonal antibody to the CD20 human immune receptor. GTC retains the opportunity to reimburse LFB at a premium for these expenses to restore 50/50 profit sharing under the terms of the existing collaboration agreement.

Cash and Investment Position

Cash and marketable securities at June 29, 2008 totaled $12.2 million, a $3.6 million decrease compared to $15.8 million at December 30, 2007 and a $0.5 million increase from the $11.7 million at March 30, 2008. The second quarter cash flow reflects in excess of $10 million of cash receipts from our partnering programs, including $4.2 million from LEO for the clinical supply of ATryn product, $3 million from LFB to fund GTC’s portion of the collaboration programs, $1.6 million from PharmAthene for product development and purification services and $550,000 from Pharming Group NV, for a license to fibrinogen. We estimate our net cash use for the remaining six months of 2008 to be approximately $14 million, not including any payments from potential partnering agreements under discussion.

Other Financial Results

Revenues for the second quarter of 2008 were $9.1 million, a $6.3 million increase from the $2.8 million recorded in the second quarter of 2007. Revenues totaled $12.7 million for the first six months of 2008 compared to $8.3 million in the first six months of 2007, an increase of $4.4 million. The revenue increases in 2008 were primarily driven by the supply of ATryn® to LEO and our work for PharmAthene.

Costs of revenue and operating expenses totaled $11 million in the second quarter of 2008, approximately 19% lower than $13.5 million in the second quarter of 2007. Costs of revenue and operating expenses totaled $22.7 million for the first half of 2008, approximately 15% lower than $26.7 million for the first half of 2007. The lower expenses are primarily due to decreased costs in the ATryn® program combined with the $3 million received from LFB for funding GTC’s share of the collaboration programs. The decrease in costs of revenue and operating expenses compared to the prior periods were offset by a $2.9 million charge to cost of revenue recorded in the second quarter of 2007 in connection with the write-off of ATryn® inventory that had been rendered unusable by a contractor. We continue to pursue recovery of our losses, but we make no assumption of the recovery, if any, in our financial statements or projections. The lower expenses in the ATryn® and LFB programs were partially offset by higher costs supporting revenues in the PharmAthene program and due to the timing of shipment for the ATryn® product sold to LEO.

The per share results were affected by an increase in the weighted average number of shares outstanding from 77.9 million shares for the second quarter of 2007 to 102.8 million shares in the second quarter of 2008. The weighted average number of shares outstanding increased from 77.7 million shares for the first six months of 2007 to 93 million shares in the first six months of 2008. The increases in the weighted average shares outstanding primarily reflect the conversion by LFB of most of its preferred stock of GTC into 14,500,000 common shares of GTCB, which occurred near the end of the first quarter of 2008. GTC had approximately 102.8 million common shares outstanding as of June 29, 2008.

Conference Call Information

GTC Biotherapeutics will discuss these results and expectations with financial analysts in a web cast conference call at 10:00 a.m. (Eastern) today. The dial-in number from inside the United States is 1-877-391-6849. The dial-in number from outside the United States is1-617-597-9298. The participant passcode is 69521428. The webcast may be found at www.gtc-bio.com.

ludwig mack 8 augustus 2008 19:55

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GTC BIOTHERAPEUTICS COMPLETES BLA SUBMISSION FOR ATryn®

FRAMINGHAM, MA – August 7, 2008 – GTC Biotherapeutics, Inc. ("GTC", Nasdaq: GTCB) has completed its submission of the final portion of the Biologics License Application, or BLA, for ATryn® in the United States. The final portion of the BLA submission includes all of the clinical safety and efficacy data generated from studies of ATryn®, including the pivotal study supporting product licensure. ATryn® is GTC’s recombinant form of human antithrombin, a plasma protein with anticoagulant and anti-inflammatory properties. The BLA requests market authorization for the use of ATryn® in the prophylactic treatment of deep vein thrombosis and other thromboembolisms in patients with hereditary antithrombin deficiency who are undergoing high risk surgical and childbirth procedures. There are no other recombinant forms of antithrombin available to treat this patient population.

GTC has requested Priority Review. Priority Review is a procedure the U.S. Food and Drug Administration, or FDA, reserves for products that are intended to treat serious and/or potentially life threatening events and have the potential to fulfill an unmet medical need. ATryn® has already been granted Orphan Drug designation, as well as Fast Track status by the FDA. Assuming that Priority Review is granted, GTC anticipates the FDA reaching a decision on the BLA filing in the first quarter of 2009. A definitive agreement has been signed with OVATION Pharmaceuticals, Inc. for commercialization and development rights in the U.S.

ATryn® has been approved for use in a similar indication in the European Union. LEO Pharma A/S is marketing ATryn® in Europe and is conducting further clinical development

ludwig mack 13 augustus 2008 03:02

1

Edited Transcript from 2Q08 Conference Call:

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

ludwig mack 14 augustus 2008 16:44

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GTC Biotherapeutics and OVATION Pharmaceuticals Close Agreement to Market and Develop ATryn(R) in the U.S.
Thursday August 14, 8:00 am ET

FRAMINGHAM, Mass.--(BUSINESS WIRE)--GTC Biotherapeutics, Inc. ("GTC", Nasdaq: GTCB) announced the closing of its previously announced collaboration agreement with OVATION Pharmaceuticals, Inc. (“OVATION”) to develop and market ATryn® in the United States. ATryn® is GTC’s recombinant form of human antithrombin, a plasma protein with anticoagulant and anti-inflammatory properties. The agreement includes $257 million in potential payments to GTC for meeting clinical, regulatory, and sales milestones, including a $3 million payment from OVATION to GTC at the closing, $2 million in payments anticipated for regulatory milestones in 2008, and up to an additional $4 million in milestone payments through a successful approval of ATryn® in 2009 for the hereditary antithrombin deficiency, or HD, indication.

spyfly 4 september 2008 14:09

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FDA Assigns Priority Review to GTC Biotherapeutics' ATryn(R)
Thursday September 4, 8:00 am ET

FRAMINGHAM, Mass.--(BUSINESS WIRE)--The US Food and Drug Administration, or FDA, has assigned Priority Review to GTC Biotherapeutics, Inc.’s ("GTC", Nasdaq: GTCB) Biologic License Application, or BLA, for ATryn®. Priority Review is granted to applications for products that, if approved, would provide a significant improvement in the safety or effectiveness of the treatment, diagnosis or prevention of a serious or life-threatening disease. Under Priority Review, the FDA’s target date for action on the BLA is February 7, 2009.

“We are pleased that the FDA has recognized the inherent advantage of ATryn® as the only recombinant antithrombin product that may become available to patients with hereditary antithrombin deficiency who are at risk of developing serious or potentially life-threatening venous thromboembolic events,” stated Geoffrey F. Cox, PhD, GTC’s Chairman and CEO. “We look forward to continuing our collaborative efforts with the FDA during the review process.”

The FDA’s goal for completing review of applications assigned Priority Review is six months from receipt of the complete application. GTC filed the last section of the BLA on August 7, 2008.

ATryn® is GTC’s recombinant form of human antithrombin, a plasma protein with anticoagulant and anti-inflammatory properties. The BLA seeks a license to sell ATryn® in the United States for the prophylactic treatment of deep vein thrombosis and other thromboembolisms in patients with hereditary antithrombin deficiency who are undergoing high risk surgical and childbirth procedures. There are no other recombinant forms of antithrombin available to treat this rare patient population. GTC has licensed ATryn® to OVATION Pharmaceuticals, Inc. to develop and market it in the United States.

ludwig mack 19 september 2008 16:09

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met dank aan
jasverstoppen - 18 sep 08, 17:45

Genetically Engineered Animals May Get U.S. Rules (Update1)

By Jamie McGee

Sept. 18 (Bloomberg) -- Genetically engineered animals would be regulated by the U.S. Food and Drug Administration under rules proposed today.

The agency would use its existing authority over animal drugs to regulate genetic engineering, the addition of genes to animals to improve food quality, build disease resistance or produce medicines for humans, the FDA said in a statement. Producers would have to demonstrate that altered animals, if intended for use as food, are safe to eat.

Plants that are genetically engineered are already regulated by government agencies. The FDA said it would continue to exempt from its pre-approval review altered animals that pose little risk, as it did with an aquarium fish that was genetically engineered to glow in the dark.

``Genetically engineered animals hold great promise for improving human medicine, agriculture, the environment, and the production of new materials, and the FDA has long been involved in their scientific evaluation,'' said Randall Lutter, the agency's deputy commissioner for policy, in the statement. ``Our guidance provides a framework for both GE animals and products made from them to reach the market.''

jasverstoppen - 19 sep 08, 00:29 | Reageer | Quote | Zoek | Aanbevolen: 0

FDA to review genetically engineered animals
Meat industry wants to sell such products as human food
updated 3:39 p.m. ET Sept. 18, 2008
WASHINGTON - Super Chicken strutted a step closer to the dinner table Thursday.

The government said it will start considering proposals to sell genetically engineered animals as food, a move that could lead to faster-growing fish, cattle that can resist mad cow disease or perhaps heart-healthier eggs laid by a new breed of chickens.

The rules will also apply to drugs and other medical materials from genetically engineered animals, a field with explosive potential.

U.S. supermarkets currently sell no meat from genetically engineered animals. But a Boston-area company called Aqua Bounty Technologies hopes to win approval next year for its faster-growing salmon and make the fish available by 2011. "It tastes just like any other farm-raised salmon," said vice chairman Elliot Entis, who has sampled it.

Reaction from consumer groups was mixed. They welcomed the government's decision to regulate genetically altered animals, but they cautioned that crucial details remain to be spelled out. For example, the Food and Drug Administration does not plan to require that all genetically engineered meat, poultry and fish be labeled as such. It would be labeled only if there was a change in the final product, such as low-cholesterol filet mignon.

"They are talking about pigs that are going to have mouse genes in them, and this is not going to be labeled?" said Jean Halloran, director of food policy for Consumers Union. "We are close to speechless on this." Consumers Union publishes Consumer Reports magazine.

Nonetheless, Gregory Jaffe, who heads the biotechnology project at the Center for Science in the Public Interest called the FDA's move a "good first step."

"This is the first time the federal government is announcing a comprehensive regulatory system that addresses the concerns from these animals," said Jaffe. "But it may not have addressed all the environmental concerns."

What would happen if a genetically engineered animal escaped and started reproducing with wild animals of the same species? asked Jaffe. The FDA said it would address that issue.

On Thursday, the FDA released a proposed legal framework for how it would resolve such questions as whether the altered animals are safe for human consumption and whether they pose any serious environmental risk. FDA officials said they were focusing on animals that will be used as food, or to produce medications that would then be consumed by people or by other animals. The agency is not interested in reviewing genetically engineered mice already widely used in lab experiments.

"Genetic engineering of animals is here and has been here for some time, " said Larisa Rudenko, a science policy adviser with the FDA's veterinary medicine center. "We intend to provide a rigorous, risk-based regulatory path for developers to follow to help ensure public health and the health of animals."

Genetic engineering is already widely used in agriculture to produce higher-yielding or disease-resistant crops. But it's unclear how consumers will react to altered animals, even if they come with a government seal of approval.

Genetically engineered — or GE — animals are not clones, which the FDA has already said are safe to eat. While clones are exact copies of an animal, genetically engineered animals are manipulated by scientists to bring about a change in their characteristics. In years past, this was done by crossbreeding animals with desirable traits.

GE animals are created when scientists insert a gene from one species of animal into the DNA of another animal to reprogram some of its characteristics. For example, fish could be made to grow faster, or pigs might be re-engineered to produce less waste.

To engineer Aqua Bounty's faster-growing salmon, scientists took a snippet of DNA from an eel-like fish and stitched it into the genes of salmon. Normally, Atlantic salmon produce growth hormone only in the summer months. But with the change, salmon produce growth hormone all year long, allowing them to grow to full size in about 18 months instead of three years, Entis said.

"This is like tuning up your car," he said. GE salmon would be kept in enclosed pens, to prevent their escape into the wild, and sterilized to keep them from reproducing.

While the introduction of GE animals by food companies will probably get the most attention from the public, it's the pharmaceutical industry that seems poised to reap the greatest benefits.

Barbara Glenn, an animal science expert with the Biotechnology Industry Association, said research is under way that could lead to the development of vaccines, transplant organs, replacement tissues, and other medically useful materials from genetically engineered animals.

For example, one company is experimenting with GE cows to produce human antibodies against such diseases as smallpox and pandemic flu. Another is trying to produce a pig liver that would be suitable for transplanting into a human patient.

Glenn said there is currently only one drug on the market derived from a genetically engineered animal, and it is not approved in the U.S. Available in Europe, the medication is an anti-blood clotting factor produced from the milk of GE goats.

"We are issuing this draft guidance now because the technology has evolved to a point where the commercialization of these animals is no longer beyond the horizon," said Randall Lutter, FDA deputy commissioner for policy. The agency's proposal will be open for public comment for 60 days.

Copyright 2008 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.

ludwig mack 19 september 2008 16:17

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dank saffi

FDA News
FOR IMMEDIATE RELEASE
September 18, 2008
Media Inquiries:
Siobhan DeLancey, 301-827-0857
Michael Herndon, 301-827-9182
Consumer Inquiries:
888-INFO-FDA

FDA Issues Draft Guidance on Regulating Genetically Engineered Animals
Public comment invited on application of new animal drug provisions of the Federal Food Drug and Cosmetic Act
The U.S. Food and Drug Administration, part of the Department of Health and Human Services, today released for public comment draft guidance on the regulation of genetically engineered (GE) animals. The guidance document is intended to clarify the FDA's regulatory authority in this field, as well as the requirements and recommendations for producers of GE animals and products derived from GE animals.

The comment period for the draft guidance, titled "The Regulation of Genetically Engineered Animals Containing Heritable rDNA Constructs," runs for 60 days and closes Nov. 18, 2008. The 25-page document is available online at www.fda.gov/cvm/GEAnimals.htm.

"Genetically engineered animals hold great promise for improving human medicine, agriculture, the environment, and the production of new materials, and the FDA has long been involved in their scientific evaluation," said Randall Lutter, Ph.D., deputy commissioner for policy. "Our guidance provides a framework for both GE animals and products made from them to reach the market."

Genetic engineering generally refers to the use of recombinant DNA (rDNA) techniques to introduce new characteristics or traits into an organism. When scientists splice together pieces of DNA and introduce a spliced DNA segment into an organism to give the organism new properties, it's called rDNA technology. The spliced piece of DNA is called the rDNA construct. A GE animal is one that contains an rDNA construct intended to give the animal new characteristics or traits.

GE animals can be divided into several classes, based on their intended use. They include animals that produce human or animal pharmaceuticals (biopharm animals); animals that serve as models for human diseases; animals that produce high-value industrial or consumer products, such as fibers; and food-use animals with new traits such as improved nutrition, faster growth or lower emission levels of environmentally harmful substances (such as phosphate in their manure).

Genetic engineering already is widely used in agriculture to make crops resistant to pests or herbicides. In medicine, genetic engineering is used to develop microbes that produce drugs and other therapeutic products for use in humans. In food, genetic engineering is used to produce microorganisms that aid in baking, brewing, and cheese-making.

Using the animal drug provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act), the FDA's Center for Veterinary Medicine (CVM) has been working with developers of GE animals to make them aware of their responsibilities to ensure that food from these animals does not enter the U.S. food supply unless the FDA has authorized such use.

The FD&C Act classifies "articles (other than food) intended to affect the structure or any function of the body of man or other animals" as drugs. An rDNA construct that is in a GE animal and intended to affect the animal's structure or function meets the definition of a new animal drug, whether the animal is intended for food, or used to produce another substance. Developers of these animals must demonstrate that the construct and/or any new products expressed from the inserted construct are safe for the health of the GE animal.

Under the draft guidance, in those cases in which the GE animal is intended for food use, producers will have to demonstrate that food from the GE animal is safe to eat. The FDA will review this information as part of its food safety assessment, consistent with that recommended in the recently adopted Codex Alimentarius Guideline for the Conduct of Food Safety Assessment of Foods Derived from Recombinant-DNA Animals. Codex is a worldwide food safety organization sponsored by the United Nations.

The draft guidance also describes a sponsor's responsibility in meeting the requirements for environmental assessment under the National Environmental Policy Act.

Depending on the species of animal and its intended use, the FDA will coordinate with agencies in the U.S. Department of Agriculture (USDA) and with other federal departments and agencies, such as the Environmental Protection Agency, in regulating GE animals. The draft guidance indicates the areas in which the FDA will be working with those agencies to develop a coherent policy under the Coordinated Framework for the Regulation of Biotechnology. USDA has published in the same issue of the Federal Register a "Request for Information" that seeks input on what types of actions and approaches it should consider under the Animal Health Protection Act (AHPA) that would complement FDA's guidance. The AHPA gives the Secretary of Agriculture authority to take specific actions to prevent the spread of diseases and pests of livestock.

"This is a cutting-edge technology that has significant implications, including real benefits, not just for human health, but also for animal health, such as developing disease-resistant animals," said CVM Director Bernadette Dunham, D.V.M., Ph.D. "We look forward to the public comments to help refine our thinking and approach."

The draft guidance describes how the FDA may exercise enforcement discretion, that is, not require premarket approval, for some GE animals depending on potential risk, as we did after reviewing information about Zebra danio, aquarium fish genetically engineered to glow in the dark. For example, the draft guidance states the FDA's intent to exercise enforcement discretion for laboratory animals used for research and kept in confined conditions. The agency does not expect to exercise enforcement discretion for animal species traditionally consumed as food and expects to require approval of all GE animals intended to go into the human food supply.

The draft guidance describes how the FDA regulates heritable rDNA constructs, that is, constructs inherited from one generation to the next. Non-heritable constructs, such as those used for gene therapy to treat individual animals, may be the subject of a subsequent guidance.

For more information, see www.fda.gov/cvm/GEAnimals.htm.

[verwijderd] 6 oktober 2008 14:12

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FDA ACCEPTS ATRYN® BLA FILING ; GTC RECEIVES $2 MILLION IN MILESTONE PAYMENTS

FRAMINGHAM, MA – October 6, 2008 – The US Food and Drug Administration, or FDA, has accepted for review GTC Biotherapeutics, Inc.’s ("GTC", Nasdaq: GTCB) Biologics License Application, or BLA, for ATryn®. FDA’s Blood Products Advisory Committee intends to review the BLA for ATryn®during a meeting that is being planned for January 2009. Based on the achievement of these milestones, GTC has received $2 million in additional milestone payments from OVATION Pharmaceuticals, Inc.

As previously announced,ATryn® has been designated an Orphan Drug and FDA has determined that the product fulfills the criteria for Fast Track status. TheATryn® BLA will also receivePriority Review. Priority Review is granted to only to those products that, if approved, would provide a significant improvement in the safety or effectiveness of the treatment, diagnosis or prevention of a serious or life-threatening disease. Under Priority Review, the target date for FDA action on the BLA is February 7, 2009. This action date was affirmed by the FDA following preliminary review of the BLA performed in accepting the BLA.

ATryn®is GTC’s recombinant form of human antithrombin, a plasma protein with anticoagulant and anti-inflammatory properties. The company seeks regulatory approval ofATryn®in the United States for the prophylactic treatment of deep vein thrombosis and other thromboembolisms in patients with hereditary antithrombin deficiency who are undergoing high risk surgical and childbirth procedures. There are no other recombinant forms of antithrombin available to treat this rare patient population. GTC has licensedATryn®to OVATION Pharmaceuticals, Inc. to develop and market it in the United States.

Ghostly 6 oktober 2008 14:25

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quote:
wous_ schreef:
strong buy - 18 jun 05, 13:38 | Reageer | Quote | Zoek | Aanbevolen: 15

Beste GTCB friends,

Nu GTCB aan de vooravond staat om geschiedenis te gaan schrijven

///////////////////////////////////
a.s woensdag alweer 3 jr geleden ,
dat bovenstaand werd geschreven .

het blijkt een lange vooravond te zijn geworden .

nu dan eindelijk??
ik hoop het.

ludwig mack 3 november 2008 14:44

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GTC BIOTHERAPEUTICS REPORTS THIRD QUARTER 2008 FINANCIAL RESULTS

FRAMINGHAM, MA – November 3, 2008 -- GTC Biotherapeutics, Inc.’s ("GTC", Nasdaq: GTCB)total net loss for the third quarter ended September 28, 2008 was $6.1 million, or $0.06 per share, compared with $8.4 million, or $0.11 per share, in the third quarter of 2007. The total net loss for the first nine months of 2008 was $16.5 million, or $0.17 per share, compared to $26.5 million, or $0.34 per share, for the first nine months of 2007.

“GTC has made great strides this quarter by completing the Biologics License Application, or BLA, for ATryn® and obtaining Priority Review designationin the United States,” stated Geoffrey F. Cox, Ph.D., GTC’s Chairman and Chief Executive Officer. “We recently entered into a partnership with OVATION Pharmaceuticals for the commercialization and development of ATryn® in the US. We are also taking action to transfer the ATryn® program from LEO Pharma to LFB Biotechnologies, already an important strategic partner of ours, to provide a positive impetus to commercial and clinical development of ATryn in Europe and the Middle East. These activities are all buttressed by today’s announcement of LFB’s commitment to lend us financial support, which provides the runway for us to meet significant milestones in the development of ATryn® in the US.”

ATryn® Commercial and Clinical Progress

ATryn®is GTC’s recombinant form of human antithrombin, a plasma protein with anticoagulant and anti-inflammatory properties. The collaboration agreement with OVATION Pharmaceuticals, Inc. includes $257 million in potential payments to GTC for meeting clinical, regulatory, and sales milestones, including a $3 million payment from OVATION to GTC that was made at the closing, $2 million in payments made for regulatory milestones in 2008, and up to an additional $4 million in milestone payments through a successful approval ofATryn®in 2009 for the hereditary antithrombin deficiency, or HD, indication. GTC has completed the BLA forATryn® to be reviewed for this indication by the US Food and Drug Administration, or FDA. The FDA has accepted the filing, granting GTC’s request for Priority Review and assigning an action date of February 7, 2009 with an advisory panel planned for January 2009. The FDA previously designated ATryn® as an Orphan Drug.

GTC has entered into negotiations for the transition of the program for the commercialization and clinical development ofATryn® for Europe and the Middle East from LEO Pharma to LFB. This follows an internal strategic review and reprioritization by LEO. LEO has confirmed that there are no safety or efficacy issues with theATryn® product either commercially or in the Phase II clinical study for the potential treatment of disseminated intravascular coagulation, or DIC, associated with severe sepsis.

LFB, currently a 20% shareholder in GTC, has expressed a significant interest in commercializingATryn® in Europe and the Middle East for its existing indications. LFB is also interested in continuing the development ofATryn® in the ongoing Phase II DIC study and for other clinical indications. Further patients are not being recruited into the Phase II study until completion of the transition to LFB. LFB has additional strategic commercialization and development programs with GTC in recombinant plasma proteins, including factor VIIa, factor IX and alpha-1 antitrypsin, and also an anti-CD20 monoclonal antibody.

Cash Position

Cash and marketable securities at September 28, 2008 totaled $8.8 million, a $7 million decrease compared to $15.8 million at December 30, 2007. GTC recently signed an agreement with LFB for $15 million of convertible debt financing. The convertible debt, which matures on June 30, 2012, will be subordinated to the current term debt with GE Capital, and will become convertible into GTC common stock at LFB’s option if the debt is not repaid by June 1, 2009. As a condition of the financing, $4 million of the proceeds will be placed in escrow to secure the existing debt to GE Capital. The financing, which is subject to approval by GTC shareholders, consent by GE Capital and other closing conditions, is scheduled to close in mid-December 2008.We expect net proceeds after transaction costs and the escrow amount to be approximately $10 million. With successful completion of the $15 million financing from LFB, GTC projects that its cash resources will be sufficient to support its operations into the second quarter of 2009.

Other Financial Results

Revenues were approximately $2.9 million for the current quarter, a $300,000 increase from approximately $2.6 million in the third quarter 2007. The revenues in the third quarter 2008 were primarily from the program with PharmAthene for the services provided for their Protexia® product and from the completion of the production program for Merrimack Pharmaceuticals for their MM-093 product. Third quarter revenues in 2007 were primarily from the services provided to PharmAthene and Merrimack. Revenues for the first nine months of 2008 totaled $15.6 million, a $4.8 million increase compared to the $10.8 million in the first nine months of 2007. The increase in revenues for the nine-month results were primarily due to the sale of ATryn® product to LEO as well as revenue derived from the PharmAthene program.

Costs of revenue and operating expenses were $8.8 million in the current quarter, a 19% decrease from the $10.9 million in the third quarter 2007. Costs of revenue and operating expenses were $31.5 million in the first nine months of 2008, a 16% decrease from the $37.6 million in the first nine months of 2007. The decrease in the quarter and nine month costs were primarily due to lower costs in the ATryn® program and funding provided by LFB to offset GTC’s costs in the joint venture collaboration programs. These lower costs were partially offset by the increased activity to support the PharmAthene program. The decrease in expenses for the ATryn® program is primarily due to the higher costs in 2007 from the write-off of inventory that was rendered unusable as a result of a fill/finish process at a US-based contractor.

The per share results were affected by an increase in the weighted average number of shares outstanding from 78 million shares in the third quarter 2007 to 102.9 million shares in the third quarter 2008. The weighted average number of shares outstanding increased from 77.8 million shares in the first nine months of 2007 to 96.6 million shares in the first nine months of 2008. The increases in the weighted average shares outstanding primarily reflect the issuance of shares of common stock in a registered direct offering in February 2008 and the conversion from preferred stock to common stock by LFB in March 2008. GTC had approximately 102.9 million common shares outstanding as of September 28, 2008.

NASDAQ Staff has informed GTC that the date for meeting compliance with the minimum $1.00 bid price requirement for continued listing has been extended to April 20, 2009. This extension conforms to NASDAQ’s recently instituted policy to suspend action on the minimum bid price and market value rules between October 16, 2008 and January 16, 2009. GTCcan regain compliance, either during the suspension or during the compliance period resuming after the suspension, by achieving a $1 clo

ludwig mack 3 november 2008 14:45

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GTC SIGNS AGREEMENT FOR $15 MILLION CONVERTIBLE DEBT FINANCING FROM LFB /FINANCING SUBJECT TO SHAREHOLDER APPROVAL

FRAMINGHAM, MA – November 3, 2008 – GTC Biotherapeutics, Inc.’s ("GTC", Nasdaq: GTCB) signed an agreement with LFB Biotechnologies, its collaboration partner for a number of recombinant plasma protein and monoclonal antibody development programs, for a $15 million financing in which GTC will issue convertible debt and warrants to purchase shares of GTCB common stock. The financing, which will be for GTC’s corporate purposes across all programs, is subject to approval by GTC shareholders, consent by GE Capital and other closing conditions. It is scheduled for a stockholder vote and closing in mid-December 2008. GTCexpects net proceeds at closing, after transaction costs and establishment of a restricted cash account, to be approximately $10 million.

Under the agreement, the convertible debt will mature on June 30, 2012,and will bear interest at an annual rate of 8%. The debt may be converted into GTC common stock at $0.31 per share at LFB’s discretion at any time after June 1, 2009. GTC has the right to redeem the debt on or before June 1, 2009. GTC will also issue to LFB 5-year warrants to purchase approximately 23.2 million shares of GTCB common stock at $0.31 per share. If the debt is repaid in full, LFB will have the right to require GTC to redeem the warrants for an aggregate price of $1.5 million. As a condition of the financing, $4 million of the proceeds will be placed in a restricted cash account to secure GTC’s existing debt to GE Capital.

“Our collaborative relationship with LFB is one of GTC’s most important strategic relationships as we navigate these difficult financial markets,” stated Geoffrey F. Cox, Ph.D., GTC’s CEO and Chairman of the Board. “This financing will enable GTC to complete the significant regulatory and partnering milestones for ATryn® in the US in the first quarter of 2009. In addition, we will continue to pursue our overall strategy of developing collaborative strategic partnerships across the full range of our development pipeline.”

The convertible debt will be secured by a first lien on GTC’s intellectual property and a second lien on all of GTC’s other assets except for the restricted cash account for GE Capital. In addition, the debt will be secured by a grant of rights and licenses with respect to certain products, including GTC’s co-exclusive rights under its collaboration agreement with LFB. The convertible debt will be subordinated to the current term debt with GE Capital.

The LFB financing is subject to a vote of GTC shareholders and completion of an intercreditor agreement between LFB and GE Capital.

ludwig mack 5 november 2008 16:25

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GTC BIOTHERAPEUTICS TO WEBCAST CORPORATE PRESENTATION AT THERODMAN & RENSHAW 10TH ANNUAL HEALTHCARE CONFERENCE

FRAMINGHAM, MA, November 5, 2008—GTC Biotherapeutics, Inc. (“GTC”, Nasdaq: GTCB) announced today that Geoffrey Cox, Ph.D., GTC’s Chairman and CEO, is scheduled to present on Tuesday, November 11, 2008 at 10:20 a.m. during the Rodman & Renshaw 10th Annual Healthcare Conference. The conference is being held at the New York Palace Hotel in New York, New York from November 10 - 12, 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 11 november 2008 13:14

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GTC BIOTHERAPEUTICS RECEIVES NASDAQ NOTICE

FRAMINGHAM, MA – November 11, 2008 -- GTC Biotherapeutics, Inc. ("GTC" or “the Company”, Nasdaq: GTCB) received notice from the Listing Qualifications Staff (“Staff”) of The NASDAQ Stock Market indicating that GTC no longer satisfies the minimum $2.5 million stockholders’ equity requirement for continued listing on The NASDAQ Capital Market, as set forth in Marketplace Rule 4310 (c)(3).

“We will be submitting our plan to regain compliance tothe NASDAQ Staff and we look forward to engaging in this discussion through the review and, if necessary, appeal process,” stated Geoffrey F. Cox, GTC’s Chairman of the Board and CEO. “Our strengths in expected near term news flow as well as the financial support from current and potential future partners leaves GTC well positioned to regain compliance.”

The NASDAQ Staff requested that the Company provide a plan to achieve and sustain compliance with all requirements for continued listing, including the time frame for completion of the plan. The Company anticipated receipt of the NASDAQ notice and is preparing its plan for timely submission to NASDAQ. If, after the conclusion of the NASDAQ Staff’s review, the Staff determines not to accept the Company’s plan of compliance, then the NASDAQ Staff will provide the Company with written notification that its securities are subject to delisting from The NASDAQ Capital Market. At that time, the Company would be afforded the opportunity to request a hearing before a NASDAQ Listing Qualifications Panel. In such an event, the Company’s securities would remain listed on NASDAQ pending a decision by the Panel following the hearing.

ludwig mack 10 december 2008 20:36

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GTC SHAREHOLDERS APPROVE PROPOSALS FOR $15 MILLION CONVERTIBLE DEBT FINANCING FROM LFB

FRAMINGHAM, MA – December 10, 2008 – Shareholders of GTC Biotherapeutics, Inc. ("GTC", Nasdaq: GTCB) have approved three proposals required to complete an agreement with LFB Biotechnologies for a $15 million financing in which GTC will issue convertible debt and warrants to purchase shares of GTCB common stock. The financing, which will be for GTC’s corporate purposes across all programs, is scheduled to close upon completion of an intercreditor agreement between LFB and GE Capital and satisfaction of other customary closing conditions. GTCexpects net proceeds at closing, after transaction costs and establishment of a restricted cash account, to be approximately $10 million.

The proposals approved by a special meeting of GTC shareholders, and described more fully in the proxy statement, include:

The issuance to LFB of a $15 million secured convertible note and a warrant to purchase shares of common stock.
An increase of 2,000,000 in the number of shares of common stock reserved under GTC’s 2002 Equity Incentive Plan.
An increase of 10,000,000 in the number of GTC’s authorized shares of common stock.

Under the agreement with LFB, the convertible debt will mature on June 30, 2012,and will bear interest at an annual rate of 8%. The debt may be converted into GTC common stock at $0.31 per share at LFB’s discretion at any time after June 1, 2009. GTC has the right to redeem the debt on or before June 1, 2009. GTC will also issue to LFB 5-year warrants to purchase approximately 23.2 million shares of GTCB common stock at $0.31 per share. If the debt is repaid in full, LFB will have the right to require GTC to redeem the warrants for an aggregate price of $1.5 million. As a condition of the financing, $4 million of the proceeds will be placed in a restricted cash account to secure GTC’s existing debt to GE Capital.

The convertible debt will be secured by a first lien on GTC’s intellectual property and a second lien on all of GTC’s other assets except for the restricted cash account for GE Capital. In addition, the debt will be secured by a grant of rights and licenses with respect to certain products, including GTC’s co-exclusive rights under its collaboration agreement with LFB. The convertible debt will be subordinated to the current term debt with GE Capital.

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 Europe and has begun the review process in the United States under a 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 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 is collaborating with LFB on the factor VIIa, factor IX, alpha-1 antitrypsin, and CD20 monoclonal antibody programs. 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.

Forward-Looking Statement

This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, including without limitation statements regarding GTC’s ability to satisfy any of the other conditions to completing the LFB financing, the timing of the financing, and the potential for further success in GTC’s continuing partnering strategy. 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 dependence upon the actions of 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.

CONTACT:
GTC Biotherapeutics, Inc.
Thomas E. Newberry
Vice President, Corporate Communications & Government Relations
(508) 370-5374 or tom.newberry@gtc-bio.com

ludwig mack 23 december 2008 17:27

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FRAMINGHAM, Mass.--(BUSINESS WIRE)--GTC Biotherapeutics, Inc. ("GTC", Nasdaq: GTCB) has closed on the agreement with LFB Biotechnologies for a $15 million financing in which GTC issued convertible debt and warrants to purchase shares of GTCB common stock on the terms previously disclosed. The net proceeds at closing, after transaction costs and establishment of a restricted cash account, were approximately $10 million.

finance.yahoo.com/news/GTC-Closes-15-...

ludwig mack 7 januari 2009 15:26

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www.reuters.com/article/marketsNews/i...

WASHINGTON, Jan 7 (Reuters) - GTC Biotherapeutics Inc's (GTCB.O) anti-clotting drug Atryn works and appears safe, U.S. health regulatory staff said in an analysis released on Wednesday.

The Food and Drug Administration released the report ahead of a public meeting on Friday to discuss whether to approve the biological drug for patients with a inherited clotting disorder when they undergo surgery or give birth.

GTC has licensed Atryn to Ovation Pharmaceuticals Inc [OVAPH.UL] for U.S. marketing. (Reporting by Susan Heavey, editing by Gerald E. McCormick)

ludwig mack 7 januari 2009 21:37

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ludwig mack 7 januari 2009 21:43

0

met dank aan:

beur - 7 jan 09, 18:56 | Reageer | Quote | Zoek | Dit is niet OK | Aanbevolen: 0

WRAPUP 2-U.S. FDA staff backs CSL, GTC blood clot drugs
Wed Jan 7, 2009 12:25pm EST

By Susan Heavey and Lisa Richwine

WASHINGTON, Jan 7 (Reuters) - Two proposed therapies to treat rare blood disorders appear safe and effective for U.S. approval, including one made from genetically engineered goats, Food and Drug Administration staff reviewers said in documents released on Wednesday.

GTC Biotherapeutics Inc's (GTCB.O) anti-clotting drug Atryn, made from human proteins inserted into goat milk, and CSL Ltd's (CSL.AX) clot disorder treatment Riastap appeared to work in company studies, the FDA staff said in reports prepared for an advisory panel that meets on Friday.

Both products would need further study after they begin sales, the agency reviewers said.

On Friday, a panel of outside advisers will make a recommendation to the FDA on whether the two therapies are safe and effective. The agency usually takes their advice.

Shares of GTC soared 28 percent to 73 cents on the Nasdaq at midday on Wednesday.

The drug is GTC's first product to be submitted for approval in the United States and is part of a series of anti-clotting drugs that the Framingham, Massachusetts-based company is developing, officials said.

"This is an important tipping point for us," the company's chief executive, Geoff Cox, told Reuters on Tuesday. He added that Atryn, if approved, could bring in between $40 million and $50 million in the next four to five years.

Atryn treats hereditary antithrombin deficiency, in which irregular protein levels can cause excessive clotting. The treatment is made using a human protein produced in milk from genetically engineered goats.

While patients usually take traditional blood thinners such as warfarin, such drugs are not suitable for high-risk surgeries or giving birth, company officials have said.

In its review, the FDA said company data showed Atryn helped prevent clotting in patients and had an "acceptable" level of risks.

GTC is also developing further studies to test the drug in patients at risk for clots in non-hereditary conditions such as coronary bypass surgery, which if approved later by the FDA could also boost sales, Cox said.

To make Atryn, company scientists injected human DNA into goat cells to breed about 200 genetically modified goats at its Massachusetts facility. Females then express the human anti-clotting protein in their milk when they begin lactating after giving birth.

The drug is licensed to Ovation Pharmaceuticals Inc [OVAPH.UL] in the United States.

The other product under FDA review, Riastap, made by the company's CSL Behring unit, is intended for patients with congenital fibrinogen deficiency, which limits the blood's ability to clot

ludwig mack 7 januari 2009 21:46

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met dank aan sappas:

www.telegram.com/article/20090107/FRO...

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