GTCB had some intersting news out after hours on Friday. Its soewhat overbought but still could take off. I will get the L2 up and watch the volume and sales to see if I can determine if its trigger time.
GTC Biotherapeutics Enters Into $257 Million Agreement with Ovation Pharmaceuticals to Develop and Market ATryn in the U.S.
GTC Biotherapeutics Enters Into $257 Million Agreement with Ovation Pharmaceuticals to Develop and Market ATryn in the U.S. - Drugs.com MedNews
ROCKVILLE, Md., Jan 9 (Reuters) - The first drug made using genetically engineered animals to near U.S. approval won key support on Friday from an advisory panel that judged it safe and effective despite concerns from groups worried about the genetic tinkering.
GTC Biotherapeutics Inc's (GTCB.O) experimental anticlotting therapy, called Atryn, is made using a human protein gathered from female goats bred to produce it in their milk.
GTC is seeking approval to sell the intravenous therapy to prevent excessive blood clots in patients with an inherited disorder.
Company data showed the drug was safe and effective, a majority of the Food and Drug Administration's 19-member panel voted. The FDA will consider the advice in making its decision, expected by Feb. 7.
"This will... set a precedent for what will happen in the future," said Dr. Richard Colvin, the panel's consumer representative and a clinical assistant in medicine at Massachusetts General Hospital.
But some genetic-safety and animal advocates at the meeting expressed concern about the use of so-called transgenic animals despite the drug's benefits, saying more information is needed from the agency about genetically engineered animals.
The FDA issued preliminary guidelines in September about how it would regulate animals whose DNA has been altered and called for public comment, but it has not yet issued final details.
Approving Atryn "would be a back door way to approve transgenic animals," said Jaydee Hanson, a policy analyst for the nonprofit group Center for Food Safety.
Still, FDA officials said they were seeking advice on the specific product, not the larger issue of generically-altered animals. They added that the final regulations on such animals would be released soon.
Several patients and family members at the advisory meeting urged the FDA's approval of Atryn regardless of the transgenic issue.
Karen Janes, whose daughter died after a 7-inch-long clot, said it could help her remaining daughter live longer and have children. "I don't care how it's made," the New Mexico resident told the panel.
Between 60,000 and 600,000 people in the United States have the excessive clotting disorder, known as hereditary antithrombin deficiency, according to GTC.
GTC has estimated Atryn could generate up to $40 million to $50 million in U.S. annual sales in its first five years on the market. Shares of the company were halted Friday for news pending.
The goats used to make Atryn are bred using cells injected with human DNA. The company has a herd of about 200 at its Massachusetts facility, which are otherwise normal and screened for viruses, GTC said.
UPDATE 2-US advisers back 1st drug from DNA-altered animals | Markets | Markets News | Reuters
Tue, Dec 23, 2008
• GTC Closes $15 Million Convertible Debt Financing from LFB
BUSINESS SUMMARY
GTC Biotherapeutics, Inc. develops, supplies, and commercializes therapeutic proteins produced through transgenic animal technology. The company?s recombinant human antithrombin, ATryn, 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, it also develops a portfolio of recombinant human plasma proteins with known therapeutic properties. These proteins include recombinant forms of human coagulation factors VIIa and IX, which would be used for the treatment of hemophilia; and alpha-1 antitrypsin. The company also has a monoclonal antibody portfolio that includes a monoclonal antibody to CD20 and a monoclonal antibody to CD137. Its intellectual property includes a patent in the United States for the production of therapeutic proteins in the milk of transgenic mammals. GTC Biotherapeutics? transgenic production platform enables the development of proteins that are difficult to express in traditional recombinant production systems, as well as proteins that are required in large volumes. The company was founded in 1993 and is headquartered in Framingham, Massachusetts.
Share Statistics
Average Volume (3 month)3: 689,403
Average Volume (10 day)3: 2,791,290
Shares Outstanding5: 102.92M
Float: 81.37M
% Held by Insiders1: 29.90%
% Held by Institutions1: 15.10%
Shares Short (as of 10-Dec-08)3: 154.18K
Short Ratio (as of 10-Dec-08)3: 0.5
Short % of Float (as of 10-Dec-08)3: 0.20%
Shares Short (prior month)3: 113.06K
Profitability
Profit Margin (ttm): -141.06%
Operating Margin (ttm): -136.95%
Management Effectiveness
Return on Assets (ttm): -39.61%
Return on Equity (ttm): -315.42%
Income Statement
Revenue (ttm): 18.67M
Revenue Per Share (ttm): 0.203
Qtrly Revenue Growth (yoy): 13.70%
Gross Profit (ttm): 2.34M
EBITDA (ttm): -22.79M
Net Income Avl to Common (ttm): -26.33M
Diluted EPS (ttm): -0.286
Qtrly Earnings Growth (yoy): N/A
Balance Sheet
Total Cash (mrq): 8.77M
Total Cash Per Share (mrq): 0.085
Total Debt (mrq): 8.89M
Total Debt/Equity (mrq): N/A
Current Ratio (mrq): 0.581
Book Value Per Share (mrq): -0.006
Cash Flow Statement
Operating Cash Flow (ttm): -16.21M
Levered Free Cash Flow (ttm): -13.09M
GTCB GTC Biotherapeutics Inc Biotechnology
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