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Gene therapy speeds transgenic animal production
http://tinyurl.com/39gsc7
Grtz CV
"GTC is making significant progress, both in the near-term with ATryn(R), our recombinant form of human antithrombin, and strategically with the development of portfolios of recombinant plasma proteins and monoclonal antibodies, including follow-on biologics," stated Geoffrey F. Cox, Ph.D., GTC's Chairman and CEO. "We are confident in our ability to reach significant milestones in our clinical and commercialization programs and will consider actions as appropriate to address compliance with the continued listing requirements of the Nasdaq Global Market."
http://www.pharmalive.com/News/index.cfm?articleid=507026&categoryid=36%2C61
Grtz CV
First transgenic kids with the human Lactoferrin gene
http://www.alphagalileo.org/index.cfm?_rss=1&fuseaction=readrelease&releaseid=525910
Grtz CV
Newberry speaks again,
http://wbjournal.com/j/index.php?option=com_content&task=view&id=2949&Itemid=139
Grtz CV
National electronic Library for Medicines
http://www.nelm.nhs.uk/Record%20Viewing/viewRecord.aspx?id=587566
Grtz CV
Transgenics Advance
http://contractpharma.com/articles/2007/10/bio-news-views
and
Gene therapy breakthrough at Penn
http://www.upenn.edu/pennnews/current/research/101807.html
Grtz CV
Franco-American Alliance Targets Hemophilia Market
By John Brosky
BioWorld International Correspondent
LILLE, France - At least one player in France has the muscle to swim against the tide in biotechnology financings and buy into an American firm to achieve its strategic goals - the French government.
A state-owned company, the Laboratoire Francais du Fractionnement et des Biotechnologies SA (LFB) in October 2006 purchased a 20 percent share of GTC Biotherapeutics Inc., of Framingham, Mass., for $25 million in three installments as part of a strategic agreement for joint product development and exclusive distribution rights.
France is now the largest shareholder in publicly traded GTC (NASDAQ:GTCB). The status of the collaboration and LFB's longer-term strategy for international development were discussed at the EuroBIO conference last week, as part of a presentation on biotech-to-biotech alliances as an alternative to the dominant biotech-to-pharma deals.
The deal gave GTC exclusive marketing rights in the U.S. and Canada for products emerging from joint development while LFB holds exclusive marketing rights in the European Union. GTC and LFB hold co-exclusive marketing rights to the rest of the world.
According to Marc Pennacino with LFB, each partner gave to the other exclusive licenses to relevant intellectual property and know-how for development and commercialization of products.
The partners also agreed to share costs, investments and profits "under rules for each area and governed by principles that I can not disclose," he said.
LFB's investment in GTC stock "is not part of the joint project but an outright stock purchase to give GTC the capital it needs to grow the company," he said.
The first program in the collaboration is development of a transgenically produced recombinant form of human factor VII a (rhFVIIa), a clotting factor for the X-linked (male) genetic disorder that will treat Type A hemophilia and may treat Type B with potential secondary uses for trauma and uncontrolled bleeding.
LFB has demonstrated production of FVII in transgenic rabbits, and GTC's transgenic production platform is capable of larger volumes than cell culture bioreactor facilities.
LFB and GTC said they intend to become the low-cost producer of rhFVIIa, noting that the current product on the market, NovoSeven, from Bagsvaerd, Denmark-based Novo Nordisk A/S, is high in price yet enjoys strong market growth. Sales doubled from $400 million in 2000 to $800 million in 2005, and the estimate is for $2 billion in 2012, Pennacino said.
Another product announced by the partners is a transgenically produced CD20 monoclonal antibody. The resulting product is expected to have a target specificity similar to Rituximab but with a relatively higher antibody dependent cell-mediated cytotoxicity.
The CD20 antibody may be considered for clinical development as a follow-on biologic in the U.S. and a biosimilar in the EU as the appropriate legislation is enacted and regulatory guidance is established.
LFB created a subsidiary, LFB Biotechnologies (LFB-B) in September 2006 as a legal framework, allowing it to operate outside of France and to enter into agreements, such as setting up a production facility in Brazil for plasma-derived proteins.
LFB supplies 20 plasma-derived products, 50 percent of which have trauma applications, to 1,000 hospitals in France and 40 hospitals in the UK and Germany. LFB reported 2006 sales of €310 million (US$432.2 million) and employs 1,300 people. The state-owned laboratory reports to both the French ministries of health and the economy.
"This strategic alliance between GTC and LFB assembles all the assets and skills for a worldwide success for transgenically derived blood factors and monoclonal antibodies, and this collaboration offers a unique opportunity to meet worldwide expanding patient needs with a technological breakthrough," said Evelyne Nguyen, director of financial affairs for LFB-B, during the Lille presentation.
The LFB-B subsidiary has 28 employees and a research and development budget of €40 million that is being boosted to €50 million for 2008, she said. The subsidiary expects to have 200 employees.
"The challenge to LFB is international growth," Nguyen said. "Our goal is to double the current level of sales over two years and then to reach €150 million by 2012."
GTC develops, produces and commercializes therapeutic proteins through the production of recombinant proteins in the milk of transgenic animals.
"Transgenic production offers potentially critical advantages in the production of recombinant proteins," Rick Finnegan, GTC vice president of commercial development, told the EuroBio audience.
He said creating a herd and providing appropriate dairy facilities can be accomplished with substantially less cost than building a bioreactor. In addition, expanding to meet future needs can be accomplished with a higher degree of flexibility in the timing of the deployment of capital.
GTC consistently has achieved high expression rates with recombinant proteins, he said. High protein expression levels in transgenic animals, concentrated raw materials, efficiency in purification and efficient capital spending all contribute to a highly cost-effective transgenic equation. As a result, the cost of a transgenically derived product is, in most cases, substantially lower than that of a cell culture product.
The subsidiary LFB-B also announced at EuroBio that it has acquired 51 percent control of MAbgène, a biotech company based in Alès, France, to scale up its biomanufacturing capacity for the production of recombinant proteins and monoclonal antibodies through cell culture techniques.
LFB-B said it will scale up the site, which features a pilot development unit and a clinical batch production facility, to "a truly industrial dimension and manufacture commercial batches of biomolecules." LFB-B said its long-term objective is to acquire all the capital in MAbgène.
Published October 3, 2007
Last Year i send Newberry an email about this issue and well this was his answer,
I apologize for taking so long to reply. We have now had a couple of pieces of news this week that have consumed much of my time.
The military had shifting priorities and did not finish pursuing the program plan. The mechanism of action in Ebola and Marburg is thought to be similar to what we expect to see in the DIC study that is planned to start around the end of the year. It is possible that this research effort may take on a higher priority as we establish data in the DIC studies.
Best regards,
Tom
Thomas E. Newberry
Vice President, Corporate Communications
Phone: 508-370-5374
Fax: 508-370-3797
-----Original Message-----
From: L.H.Mulderij [mailto:l.h.mulderij@home.nl]
Sent: Monday, October 02, 2006 4:47 PM
To: Newberry, Thomas
Subject: CRADA
Dear Sir,
Can you tell me maby a bit more about two-year CRADA with the USAMRIID to evaluate the potential therapeutic application of ATryn to hemorrhagic diseases resulting from infections of the Ebola and Marburg viruses.
I ask this because the 2 year contract almost comes to an end and i can't remember that there was any news about this item recently, maby i mist something.
Sincerely,
L.H.Mulderij
Netherlands.
FDA Should Draft Rules to Take Biotech Industry to Higher Realms, Say Experts
Genetically engineered pigs, cows and goats are waiting for the butcher’s knife in the US.
But the knife remains suspended in the air as the regulatory body, Food and Drug Administration (FDA) is yet to make up its mind on whether and how such meat or milk could be allowed to enter the nation’s food supply.
Pigs whose manure causes less pollution and which make fatty acids, normally found in fish, and hence good for health, disease-resistant cows, goats whose milk might help ward off infection in children and catfish needing fewer antibiotics are among the wonders chiseled by US bioengineers.
Genetically engineered animals are often created by injecting the gene of interest into a single-cell embryo. A more recent technique that is more efficient is to put the gene into a skin cell and create an embryo from that cell by cloning.
In both cases, the embryo with the foreign gene is then implanted into the womb of a surrogate mother. After some transgenic animals are born, additional ones can be made by conventional breeding, because the foreign gene generally will be passed on to some of the offspring, as would any other gene.
But even 15 years after it started sifting the data available to it, the FDA will not say when its rules for this sector would be ready.
“We want to get it out, but we also want to get it right,” insisted Julie Zawisza, a spokeswoman for the agency.
The FDA is turning to transgenic animals after having tentatively declared in December that milk and meat from livestock that is cloned — but not otherwise genetically manipulated — was safe for people to eat.
It considers clones to be less biologically radical than genetically engineered animals — which instead of being mere replicas of naturally occurring animals are given foreign DNA, usually from another species.
Larisa Rudenko, a senior biotechnology adviser in the FDA’s veterinary drug division, said in a May presentation at the biotechnology industry’s annual convention that each new type of genetically engineered animal would require approval for use in the food supply. That will be done, she said, under the umbrella of existing rules for drugs used in treating animal diseases.
The fast-growing salmon is the transgenic animal that has been swimming upstream the longest at the FDA. Its developer, Aqua Bounty Technologies of Waltham, Massachusetts, has been working to win agency approval for about 10 years.
Elliot Entis, Aqua Bounty’s chief executive, said the company had already given the FDA. studies showing that the fish were healthy and that the implanted gene remained stable over generations.
He said the company also had tests done to show that its fish contained the same level of fats, proteins and other nutrients as other farmed salmon and would not set off unexpected allergic reactions in people who eat them. The fish also taste the same as other farmed Atlantic salmon, Entis said.
“Nobody has ever analyzed salmon as closely as we have had done,” he said. But the FDA is asking for more data on safety and potential environmental effects on wild salmon.
Industry executives say the Enviropigs would be the next candidate for FDA approval.
Less far along in the approval pipeline are pigs that contain a gene from the roundworm allowing them to produce omega-3 fatty acids, a nutrient normally found in fish that is good for the heart. That, in theory, could make eating pork or bacon healthier, although that has yet to be tested.
If only the FDA finalizes its rules on the issue, big money would come in pouring for the transgenic livestock industry, experts say.
“Right now, it’s very hard to get any corporate investment,” said James D. Murray, a professor at the University of California.
But some experts caution that even if the FDA clears the regulatory path in coming months, investors and agribusiness companies might still shy away. Many fear that consumers would shun foods from transgenic animals, sometimes referred to as genetically modified organisms, or GMOs.
“The companies we have spoken to have gone organic, and they are very concerned, at least up to the present time, of having GMO associated with their name,” said Cecil W. Forsberg, a professor at the University of Guelph in Ontario, Canada, who helped developed the “Enviropig” with cleaner manure. Smithfield Foods, for one, the world’s largest hog producer and pork processor, says it is doing no research on genetically engineered animals.
But critics say changing the genes of animals could lead to potentially harmful changes in the composition of milk or meat, like the introduction of a protein that could cause allergic reactions. They say there could also be risks to the environment if, for example, extra-large salmon were to escape into oceans and out-compete wild salmon for food or mates. Some also say that some of the processes used to create transgenic livestock can harm the animals themselves.
Carol Tucker Foreman, director of the Food Policy Institute at the Consumer Federation of America, a consumer advocacy group in Washington, said regulations might not assuage consumers, many of whom object to the genetic engineering of animals on humane or ethical grounds, more than on safety concerns.
“The fact that the FDA has a powerful regulatory process for reviewing genetically engineered animals, far greater than they apply to genetically engineered crops, may not make any difference at all,” Ms. Foreman said. “Because that’s not what it’s all about.”
Source-Medindia
GPL/B
http://tinyurl.com/yv3cpu
Thanks great read.
I did post it on a Dutch board to.
Grtz CV
That's right the trial fore Psoriasis hasn't been updated but NCT00105976 did,
(Study ID Numbers: MM-093-02-200
Last Updated: October 25, 2005
Record first received: September 6, 2005
ClinicalTrials.gov Identifier: NCT00147329)
(Study ID Numbers: MM-093-01-200
Last Updated: January 17, 2007
Record first received: March 18, 2005
ClinicalTrials.gov Identifier: NCT00105976)
So I'm a little bit confused now.
Grtz CV
Efficacy Study of MM-093 in Rheumatoid Arthritis Patients on Methotrexate has been completed.
http://www.clinicaltrials.gov/ct/show/NCT00105976?order=2
And they are looking for a Protein Chemist/Formulation Scientist
http://www.merrimackpharma.com/careers/form_scientist.html
Seems all good news 2 me.
Grtz CV
Transgenic Drug Production Heads Back to the Farm
The use of transgenic goats to produce a recombinant form of human antithrombin is much more efficient than using mammalian cell cultures.
http://www.managedcaremag.com/archives/0611/0611.biotech.html
Grtz CV
And how about this are they talking about i think it is or what.
Is there a difference between CD137 and CDw137?
http://clinicaltrials.gov/ct/show/NCT00309023?order=1
Please can someone fill me in
Grtz CV
2006 Nov 17
A Randomised double-blind, placebo-controlled trial of a recombinant version of human alpha fetoprotein (MM-093) in patients with active rheumatoid arthritis.
Pollard LC, Murray J, Moody MD, Stewart EJ, Choy EH.
King's College London, United Kingdom.
OBJECTIVE: RA tends to remit during pregnancy, with more patients achieving remission in the third trimester, coinciding with an increase in levels of alpha fetoprotein (AFP). In vitro and animal studies have shown that AFP has immunomodulatory properties. MM- 093 is a non-glycosylated, recombinant version of human AFP. METHODS: The safety, tolerability and clinical effects of MM-093 were assessed in this 12-week, randomised, double-blind, placebo-controlled study. Twelve patients with RA, who had active disease and were on stable doses of methotrexate, received weekly subcutaneous injections of placebo or 21mg of MM-093. Assessments were carried out at baseline and weekly thereafter.
RESULTS: Baseline characteristics were similar in both groups. There was one dropout in the placebo group due to flare of disease. Treatment with MM-093 was well tolerated. No serious adverse event was observed. By day 85 MM-093 produced a statistically significant mean improvement from baseline in DAS28 (0.913 vs 0.008, p=0.033) and patient's global assessment (28.9% vs - 36.3%, p=0.02) compared to placebo.
CONCLUSION: This is the first randomized, controlled trial of MM-093, a recombinant version of human AFP, in patients with RA. MM-093 was well tolerated. Evidence of efficacy was observed, suggesting that MM-093 may have therapeutic potential in RA.
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?CMD=search&DB=PubMed
search for MM-093
Grtz CV
I completely agree with that.
Who will fill in the blanks?
Grtz CV
O I'm sorry i used the question from message #1918
I was watching Top Gear on the TV and reading this board, as well the board in the Netherlands where someone posted the link to this report.
It seems that I'm not so good at doing two things at once -))
But it's the whole report.
Grtz CV
$3 Target confirmed via the wires. If anyone has access to the report please post it.
http://www.unterberg.com/research/news/111706GTCBInitiationWEB.pdf
Grtz CV
Europäische Akademie Newsletter October 2006
http://www.europaeische-akademie-aw.de/susanis/global/download.php/news/pdf/id/33/Newsletter_66_www....
Grtz CV
Thank you Mblimon for this great post, not that it makes me happy at the contrary it made me very concerned and i gonna send this link forward to everyone i know to who i think can make a little difference.
Grtz CV
So you may think now, now that it is approved, that this programs are pushed forward again.
There's a lot to look out for.
Grtz CV
Who, where, and when will be the next partner voor Gtcb??
http://www.pharmafocusasia.com/currentedition/manufacturing_processing2.htm
Or will the US come first?
Grtz CV
Generic Threat Puts Biologic Firms On The Defensive
http://biz.yahoo.com/ibd/061013/health.html?.v=1
Grtz CV