GTCBD - GTC Biotherapeutics (Nasdaq GM) - Page 71

Thanx DT. I am glad to hear that. I am just glad to see it has been holding steady here for a couple of days now. Seems like the sell off is over. I think I will hold at least until I break even. We know these Pharmas have the 30+% random runs occasionally. Waiting for that. Like I said, do not need the money right now. Midterms, too much school work to follow along so attentively.

^ You need less volume so all the shorts start cashing in and this can breath again. Thats not to say it won't see high 0.30's but I highly doubt it.

I think there is more potential for this than risks, seeing that its the first of its kind and there is still alot to be done with the drug. This company does not release Bullshit PRS (cough, CTIC, cough) so expect the next one to be Suhweeeeeeeeeeeet.

Just make sure you put a limit order to cover your ass and sell incase of a massive PR or a random 30% spike. We all know what happens when PRs hit, lol.

We were 0.0002 away from finishing in the green today

wow

ya..this is a bloody one at this point. I just seen it and was going to post and you had already posted.

well we are back to pre-hype levels...I hope this is a bottom and we can start some sort of uptrend.

What is funny is that one guy that thought, this would not return to this level. If you go through all these pharms, they all do this. I looked @ Epix today, and it is back @ .55 and it went up to 1.80 on approval.

I don't believe we're at the bottom yet. Pre-hype was 0.11. With the approval it should be worth more, however just having an approval doesn't generate money. We need some good news to come out so I can finish getting out.

Looking at the chart for the last year, I believe its going to sub-pennies with out news.

They seem to be running out of money which may occur in the 2nd quarter if they don't get a partner.

In June LFB's stock becomes active also.

I'm hoping but right now it looks grim, at least in the short term.

I don't fully understand the process yet. Why would a stock be worth 1.80 at approval but not hold at least most of the gain. Is it because it really has nothing to do with the stock itself and is based purly on trading it? In other words there is a set deadline and the traders race to see who can get in the lowest/quickest without waiting months on end and ride it to the top without losing or being a bagholder.

I understand that approval is good but it doesn't generate money right off, but it would seem the approval is at least worth something and the price should stay up some and not go to pre-approval levels. Otherwise its no different than if there was no approval, but there was and the company has something.

Anyway thats the end of my rambling.

I agree with you that is does not make sense. In theory, an approval would mean a stock would step up in value and trade there or near that new range, because an approval should eventually generate revenue and profit, and the company shares should go up.

In reality, these pharms just run on rumor of approval, or good news on a trial of the next wonder drug, and you either hold for the one of the spikes or get in before an FDA due date, watch it run, and pick your exit point. Now eventually, when the product or drug in this case starts making reportable money, and that info gets out, the stock should rise, but the timeframe on that could be a long time. Or sometimes a partnership or buy out can occur that can be worth some $$$. None of this is generally predictable and charting these stocks is sometimes tough, since they do not obey all the general rules, sometimes.

The short version is, playing these stocks is semi-educated speclative gambling.

Exactly... Sometimes you just never know. Do all the DD you want and you can still get stuck holding a bag or losing moolah. The market is a mess right now and will be for a bit. So much volatility that it makes me just wanna go do something else.

x2

For all you people who wanted this under .40 ..............

FYI.

GTC Biotherapeutics, Inc. Earnings Conference Call (Q4 2008)
Scheduled to start Fri, Feb 27, 2009, 10:00 am Eastern
http://biz.yahoo.com/cc/7/101657.html

Thanks for the heads up DT.

Hoping for green today, so close. Looks like it may hang in the high 30s until news. But knowing my luck, it will probably drop another 10% tomorrow now that I said that.

Any guess on their Q4 earnings?

GTC Biotherapeutics Enters Follow-On Biologic Founder Development Collaboration with AgResearch
Thursday February 26, 2009, 8:00 am EST
Yahoo! Buzz Print Related:GTC Biotherapeutics, Inc.
FRAMINGHAM, Mass.--(BUSINESS WIRE)--GTC Biotherapeutics, Inc. ("GTC", Nasdaq: GTCB) has entered into a collaboration agreement with AgResearch Limited of New Zealand to develop transgenic founder animals to produce two follow-on biologic, also referred to as biosimilar, monoclonal antibodies. The establishment of a production capability outside of the United States is an important step in GTC’s long term biosimilar strategy. This approach will enable earlier sales of the products in territories such as Europe where the relevant patents expire before the associated patents in the United States.


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

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

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

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

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

About AgResearch

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

About GTC Biotherapeutics

GTC Biotherapeutics develops, supplies, and commercializes therapeutic proteins produced through transgenic animal technology. ATryn®, GTC’s recombinant human antithrombin, has been approved for use in the United States and Europe. ATryn® is the first and only transgenically produced product to be approved for therapeutic use anywhere in the world. In addition to ATryn®, GTC is developing a portfolio of recombinant human plasma proteins with known therapeutic properties. These proteins include recombinant forms of human coagulation factors VIIa, VIII, and IX, which are being developed for the treatment of hemophilia, and alpha-1 antitrypsin. GTC is developing a monoclonal antibody to CD20 with enhanced ADCC (antibody-dependent cell-mediated cytotoxicity), and a proprietary monoclonal antibody to CD137 with potential indications in oncology and autoimmune disease. GTC is also developing a portfolio of follow-on biologic monoclonal antibodies. GTC’s intellectual property 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, http://www.gtc-bio.com.

GTC BIOTHERAPEUTICS REPORTS FOURTH QUARTER AND YEAR END 2008 FINANCIAL RESULTS

GTC BIOTHERAPEUTICS REPORTS FOURTH QUARTER AND YEAR END 2008 FINANCIAL RESULTS


FRAMINGHAM, MA – February 27, 2009 -- GTC Biotherapeutics, Inc. ("GTC", Nasdaq: GTCB) reported today its financial results for the fourth quarter and year ended December 28, 2008. Revenues were $1.0 million for the fourth quarter of 2008, compared with $3.1 million for the fourth quarter of 2007. Revenues for 2008 increased to $16.7 million from $13.9 million for 2007. Revenues for the full year increased primarily due to the increase in services provided to PharmAthene for development of their recombinant human butyrlcholinesterase program, Protexia®. The reduction in revenues for the fourth quarter was primarily a result of the timing of completion of work on external programs and completion of shipments of ATryn® to LEO Pharma A/S in earlier quarters during 2008.

The net loss for the fourth quarter of 2008 was $6.2 million, or $0.06 per share, compared to $9.8 million, or $0.13 per share for the fourth quarter of 2007. The net loss for the 2008 financial year was $22.7 million, or $0.23 per share, compared to $36.3 million, or $0.47 per share, for the 2007 financial year.

“The recent approval of ATryn® in the US is an historic milestone for GTC, marking the FDA’s first approval of a transgenically produced therapeutic protein after rigorous review of both the product and our animals,” stated Geoffrey F. Cox, Ph.D., GTC’s Chairman of the Board and Chief Executive Officer. “We look forward to building on this success as ATryn® is commercialized and developed further with our partner OVATION Pharmaceuticals and in expanding our partnering relationships in our recombinant plasma protein and monoclonal antibody portfolio.”

Significant product development events for the year and outlook for 2009:

ATryn® (recombinant human antithrombin)
ATryn® was approved by the Food and Drug Administration, or FDA, for the prevention of peri-operative and peri-partum thromboembolic events in patients with hereditary antithrombin deficiency.
Along with the approval of ATryn®, the FDA’s Center for Veterinary Medicine also approved GTC’s New Animal Drug Application, the first of its kind for the regulation of a genetic construct stably integrated into the genome of genetically engineered animals.
GTC established a collaboration with OVATION for the commercial launch and further clinical development of ATryn® in the US. OVATION is working to launch the product in the approved indication in the second quarter of 2009. GTC and OVATION will also be discussing plans with the FDA to perform a phase III study of ATryn® in the treatment of heparin resistance associated with cardiopulmonary bypass surgery.
LEO Pharma informed GTC in September 2008 that, as a result of an internal re-assessment of its strategic priorities, LEO wished to transfer the ATryn program to GTC or a third party. Pending any such transfer, further patients are not being enrolled in the DIC study at this time. While GTC has sought to conclude this matter by reaching agreements with LEO and a new partner for the transfer of the program, GTC has initiated International Chamber of Commerce (ICC) arbitration proceedings to resolve matters under the provisions of its agreement with LEO.
Other Recombinant Plasma Proteins
GTC developed production animals for the recombinant human coagulation factor VIIa program with LFB Biotechnologies. GTC has now established both transgenic rabbits and goats for this protein and is in the process of evaluating the best commercial production system. GTC remains on track for initiating clinical studies in 2010.
The production of factor IX in transgenic pigs established by ProGenetics is being developed in collaboration with LFB and remains on plan for entering the clinic in 2010.
GTC has successfully established alternatives for extending the half-life of alpha -1 antitrypsin, which is also being developed in the collaboration with LFB. GTC intends to discuss its clinical development plans with the FDA following the FDA’s March 2009 public meeting on alpha-1 antitrypsin deficiency and its treatment options.
Monoclonal Antibodies and Follow-on Biologics
GTC has begun collaborating with AgResearch Limited of New Zealand for the development of transgenic production of two of the monoclonal antibodies in GTC’s follow-on biologics portfolio. Production of these follow-on antibodies in New Zealand will enable an earlier market introduction in Europe. GTC’s portfolio of follow-on monoclonal antibodies is being designed to address markets with current sales of the innovator products aggregating approximately $16 billion. GTC plans to further support the development and commercialization of its potential follow-on products through additional partnership arrangements.
In collaboration with LFB, GTC continues developing large scale production for the monoclonal antibody to the CD20 immune system receptor. This antibody targets the same immune system receptor as Genentech’s Rituxan® and GTC believes this antibody has advantageous characteristics of antibody dependent cell cytotoxicity or ADCC.
External Programs
GTC continues to provide services to PharmAthene in its development of Protexia® as a biodefense product.
GTC entered into a contract with JCOM of the Republic of Korea, associated with Dong-A Pharmaceuticals, to develop transgenic production for JCOM’s recombinant human insulin products. In addition to receiving compensation for its services under this contract, GTC is entitled to payments for successful demonstration of the production system, a license fee, and a royalty.
Cash and Investment Position
GTC ended 2008 with approximately $11.6 million of cash and marketable securities.

Farm creates life saving drug from goat's milk: http://www.necn.com/Boston/SciTech/2...237242860.html