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Wow Bios will move now...and will collect royalty from Abbot. good move !!!
Press Release
FDA Advisory Committee Recommends Approval of Abbott?s XIENCE? V Drug Eluting Stent System
Abott Park, Illinois, November 29, 2007 ? Abbott announced today that the Circulatory System Devices Advisory Panel to the U.S. Food and Drug Administration (FDA) recommended approval for the XIENCE? V Everolimus Eluting Coronary Stent System. XIENCE V is a next-generation drug eluting stent intended for use in the treatment of coronary artery disease.
The FDA advisory committee voted to recommend the XIENCE V stent system for approval with conditions related to post-marketing study requirements and language related to dual antiplatelet therapy. The FDA is not required to, but usually follows the recommendations of its advisory committees.
"The clinical and angiographic benefits of the XIENCE V stent compared to the most widely used drug eluting stent available in the U.S. have been consistent and significant across the SPIRIT trials,? said Gregg W. Stone, M.D., of Columbia University Medical Center and the Cardiovascular Research Foundation, New York and principal investigator of the SPIRIT III clinical trial. ?The robust body of safety and efficacy data support approval of XIENCE V as an important new technology that will enhance the lives of millions of patients with heart disease.?
Abbott filed its Premarket Approval (PMA) submission for XIENCE V with the FDA on June 1, 2007. The PMA for XIENCE V is the first to include data demonstrating superiority of one drug eluting stent over another in the primary endpoint of in-segment late loss in a randomized controlled head-to-head trial with a market leading product.
"The outcome of today?s advisory committee meeting is very encouraging,? said John M. Capek, Ph.D., executive vice president, Medical Products, Abbott. ?We look forward to bringing this important new treatment for coronary artery disease to physicians and patients in the U.S.?
XIENCE V was launched in Europe and other international markets in 2006. XIENCE V is currently an investigational device in the United States and Japan.
About Abbott Abbott is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics. The company employs 65,000 people and markets its products in more than 130 countries.
Thank you "poiuyt" for your kind assistance. Appreciate it. My interest in Abbott is due to something that I read before that there is some relational tie-up with Biosensor. Cheers and have a great weekend.
Boston Scientific Welcomes FDA Panel Recommendation to Approve
PROMUS? / XIENCE? V Everolimus-eluting
Coronary Stent System
November 29, 2007 -- Natick, Massachusetts -- Boston Scientific Corporation (NYSE: BSX - News) today welcomed the recommendation of a U.S. Food and Drug Administration (FDA) advisory panel to approve with conditions the PROMUS? / XIENCE? V everolimus-eluting coronary stent system. The PROMUS and XIENCE V stent systems are identical products, sold respectively by Boston Scientific and Abbott in international markets. Both stent systems would be covered by the same FDA approval.
Factors that may cause such differences include, among other things: future economic, competitive, reimbursement and regulatory conditions; new product introductions; demographic trends; intellectual property; litigation; financial market conditions; and, future business decisions made by us and our competitors. All of these factors are difficult or impossible to predict accurately and many of them are beyond our control. For a further list and description of these and other important risks and uncertainties that may affect our future operations, see Part I, Item 1A- Risk Factors in our most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission, which we may update in Part II, Item 1A - Risk Factors in Quarterly Reports on Form 10-Q we have filed or will file thereafter. We disclaim any intention or obligation to publicly update or revise any forward- looking statements to reflect any change in our expectations or in events, conditions, or circumstances on which those expectations may be based, or that may affect the likelihood that actual results will differ from those contained in the forward-looking statements. This cautionary statement is applicable to all forward-looking statements contained in this document.
"Today's recommendation is a significant step toward making Boston Scientific's two-drug program a reality in the United States," said Hank Kucheman, Senior Vice President and President of Boston Scientific's Cardiovascular business. "Once approved in the United States, the PROMUS stent system -- together with our proven and market-leading TAXUS stent technology -- will enable Boston Scientific to offer physicians and their patients a choice of two distinct drugs, each on a highly deliverable stent platform."
The PROMUS and XIENCE V stent systems are investigational devices in the U.S. and not yet approved for sale. PROMUS is a private-labeled XIENCE V everolimus-eluting stent system manufactured by Abbott and distributed by Boston Scientific.
TAXUS and PROMUS are trademarks of Boston Scientific Corporation or its affiliates. XIENCE is a trademark of the Abbott Laboratories group of companies.
Boston Scientific is a worldwide developer, manufacturer and marketer of medical devices whose products are used in a broad range of interventional medical specialties. For more information, please visit: www.bostonscientific.com.
Cautionary Statement Regarding Forward Looking Statements This press release contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934. Forward-looking statements may be identified by words like "anticipate," "expect," "project," "believe," "plan," "estimate," "intend" and similar words. These forward- looking statements are based on our beliefs, assumptions and estimates using information available to us at the time and are not intended to be guarantees of future events or performance. These forward-looking statements include, among other things, statements regarding clinical trials, regulatory approvals, product performance and competitive offerings. If our underlying assumptions turn out to be incorrect, or if certain risks or uncertainties materialize, actual results could vary materially from the expectations and projections expressed or implied by our forward-looking statements. These factors, in some cases, have affected and in the future (together with other factors) could affect our ability to implement our business strategy and may cause actual results to differ materially from those contemplated by the statements expressed in this press release. As a result, readers are cautioned not to place undue reliance on any of our forward-looking statements.
http://www.ptca.org/news/2007/1129_ABBOTT.html
FDA Advisory Panel Recommends Approval for Abbott's XIENCE? V Drug Eluting Heart Stent
9-1 Vote May Mean 4 Drug-Eluting Stents Will Be Available in the U.S. Next Year
November 29, 2007 -- Gaithersburg, Maryland -- The FDA Circulatory System Devices Advisory Panel, which met today to hear data and opinions from the manufacturer, as well as outside experts, on the safety and efficacy of Abbott's XIENCE V Drug-Eluting Stent, has voted 9-to-1 to recommend approval. The FDA is not required to follow the Panel's recommendation, but usually does.
The single dissenting vote came from Dr. John C. Somberg, a professor of Clinical Pharmacology at Rush University Medical Center, who had previously expressed concern that Abbott's clinical trials had not yet provided sufficient safety assurance for the period beyond 12 months. The issue of late stent thrombosis, or blood clots forming more than 12 months after stent implantation, surfaced last year around the previously-approved drug-eluting stents: the CYPHER, made by Cordis / Johnson & Johnson, and the TAXUS, from Boston Scientific. The safety issue became paramount and was the subject of a much-reported on two-day meeting of this same FDA Panel on December 7-8, 2006, so the Panel members were already quite sensitive to these concerns.
Post-Market Follow-up Required -- No Delay Seen
The Panel recommended approval, based to a great extent on Abbott's promise to do a long-term post-market follow-up to track the safety. Some financial analysts expressed concern that the time needed for Abbott to design this longer term follow-up study might delay approval of the XIENCE. However, Abbott currently has several larger XIENCE studies in process and recently announced the hiring of Dr. Charles Simonton as Chief Medical Officer for the cardiac group at Abbott Vascular. While at the Carolinas Heart Institute in North Carolina, Dr. Simonton headed up the STENT Registry, currently one of the largest data sets of stent patients which has regularly issued long-term follow-up reports since its inception 4 years ago. His expertise and experience, along with clear indications that the FDA was going to require all stent manufacturers to include much larger and longer term post-market studies than the Agency had in the past, would indicate that Abbott already is far along in designing such a study, and this should not represent a significant delay.
"Stent Wars" Expand
For the past 3-4 years, the U.S. drug-eluting stent market has been under the sole purview of the CYPHER and TAXUS stents, both of them first generation devices. Last month Medtronic's Endeavor received unanimous FDA Panel approval -- along with today's vote, there may soon be four stents in the U.S. market, with two of them being newer designs. According to many cardiologists, these new DES are based on a more advanced and better-performing stent platform. Prior to the introduction of drug-eluting stents, Abbott's (formerly Guidant's) Multi-Link and Medtronic's Driver bare metal stents, were thinner, stronger, more deliverable and showed a lower restenosis rate than other bare metal stents. Additionally, both manufacturers claim to have developed more biocompatible coatings.
The safety profile of Medtronic's new stent has been borne out in large studies, with some data going out to five years. Abbott's XIENCE V, while it doesn't have as large a data set, has shown significantly improved results and in a recent study, demonstrated a 43% reduction in MACE (Major Adverse Cardiac Events, such as heart attacks, death, re-intervention) over its chief rival, Boston Scientific's TAXUS.
The size of the drug-eluting stent market worldwide has shrunk considerably over the past year, as safety concerns drove a switch back to bare metal stents and as other studies even questioned the need for some stent procedures. However, most observers of the interventional cardiology scene agree that, if approved, Medtronic and Abbott will be taking major market share from Cordis and Boston Scientific -- although Boston, as part of its acquisition agreement with Guidant, has the right to sell Abbott's XIENCE under its own brand name PROMUS, so it will in effect share in the fruits of its own flagship stent's demise.
Good morning Mr. Bengster68. Thank you for the article from
Washington Post and on Abbott in particular. Do you by chance have an update on this? Sorry to impose and thanks again. Cheers
Thank You Bengster68. i remembered you mentioning the panel outside the FDA was meeting on the 29th November . You are amazing and let's really hope for the best that xience gets the recommendation for approval as the FDA normally follows the recommendation and this will be a BIG STEP for BIG.
WASHINGTON, Nov 27 (Reuters) - Patients treated with Abbott Laboratories Inc's (ABT.N:
Quote,
Profile,
Research) experimental drug-coated heart stent had low rates of blood clots, heart attacks and cardiac-related deaths up to two years later, U.S. medical device reviewers said in documents released on Tuesday.
Food and Drug Administration staff also said Abbott's Xience device had "favorable" outcomes on a key measure of effectiveness, when compared with Boston Scientific Corp's (BSX.N:
Quote,
Profile,
Research) Taxus stent.
Heart-related deaths were comparable between Xience and Taxus after one year, the FDA staff said in a summary released ahead of an advisory panel review on Thursday.
Stents are tiny mesh tubes used to prop open arteries after doctors clear them of blockages. Some versions have a drug coating meant to keep the vessels from reclogging.
Blood clots that may develop in some patients months later, and potentially cause heart attacks, are a major concern with drug-coated stents. The market for the devices once stood at $6 billion a year but has dropped over the clotting issue.
Abbott provided data to the FDA on a subset of 603 patients followed for two years. FDA reviewers said rates of blood clots, heart attacks and heart-related deaths were "low," but cautioned that the analysis had several limitations.
For example, the cut-off date was chosen arbitrarily, and the data may not have included problems in patients who had not yet reached the two-year follow-up point.
Phil Nalbone, an analyst with RBC Capital, said the two-year data were impressive, although not a great surprise, and signal that Xience likely will become the best-selling U.S. stent about a year after approval. The product is already sold overseas.
"Xience after two years continues to show the robust superiority to Taxus that we learned about in March, when most of the data only went out to 9 months," Nalbone said.
"We think it will dominate the U.S. market after about a year, capturing over one-third (of market share) and will ultimately claim at least 40 percent of the market," Nalbone said.
"It will be a multibillion-dollar product and support Abbott's future earnings," he said.
A panel of experts from outside the FDA is expected to decide on Thursday whether to recommend Xience for approval. The FDA usually follows panel recommendations.
JP Morgan analyst Michael Weinstein, in a note to clients, said the chance of a positive panel vote was 60 percent. He said it was "by no means a slam-dunk," as data beyond one year remained "limited" and panel members could decide more are needed.
At the moment, Johnson & Johnson's (JNJ.N:
Quote,
Profile,
Research) Cypher and Boston Scientific's Taxus are the only two U.S.-approved drug-coated stents. Abbott and Medtronic Inc (MDT.N:
Quote,
Profile,
Research), with its Endeavor stent, are seeking to join the field.
Abbott has said it expects to launch Xience in the first half of 2008 should the product win FDA clearance.
In a statement issued on Tuesday, Abbott Executive Vice President John Capek said Xience was "the only drug-eluting stent that has demonstrated clinical superiority over another drug-eluting stent in a randomized clinical trial."
Abbott acquired Xience from Guidant Corp when Boston Scientific bought Guidant in 2006 and divested the Guidant vascular business. As part of the deal, Boston Scientific would market the Xience stent alongside Taxus, but would call the new product Promus and return 40 percent of gross profits from Promus to Abbott.
In October, an FDA advisory panel unanimously urged approval for Medtronic's Endeavor stent. A final decision is pending.
Abbott shares were up $1.62 or 3 percent to $55.85 in late afternoon trading on the New York Stock Exchange. (Reporting by Lisa Richwine and Ransdell Pierson, editing by Gerald E. McCormick/Jeffrey Benkoe
26/11
Cashier... :)
You are right that TA is a "double edge sword" of sorts... this is because TA is nothing but a 'map' of
the price... it is not a forcasting tool by itself... it just show where price were and what is happening...,
and nothing more.
By the way, TA people are snooked by a
bull-trap for
SPC on the 26 Nov (2 days ago)...
Cashier...
:)Many will be scratching their heads and saying... "so cheap still don't buy?" ... hehehe...
Is it a good entry point yet?
why u keeping dropping biosensor, i want to buy u but y dun let me buy.. sian
Maybe we should start afresh a new topic on biosensors so all the animosity and anger be forgotten ???? Also better fong sui?
no need to pity them, i am glad i didnt buy it when i m saved by my TA, i must admit i am very tempted to enter when it cross my entry sign for this stocks. however, regret didnt buy noble yesterday. lol. TA is double sided sword. got good and bad.
I pity those selling to the BBs cheap now. Soon they will realise it is a big mistake to sell BIG at this price. Someone's loss is another man's gain.
Seemed weak. Maybe 0.735 will be a touch and drop
once it go up to 73.5 today can buy again. jusy fyi only, not for inducement to trade
Hi friends!
Wake-up!!!!
BIG LAI LIAO
The best thing i like about BIG is that there are no more lab test or paper to submit. Just waiting for CE Mark.
Lets say we have to wait 3 mths and the price eventually rise 50% from 70c to $1+. 3 mths, 50% return; for me that is a very good risk reward.
[Dow Jones] Biosensors ( B20.SG) +6.6% at S$0.725 as investors accumulate on recent weakness after 33% fall since start of November. Market may also be buying on expectation drug eluting stent maker may finally secure coveted CE Mark. Firm expecting response early next year from EU Competent Authority, which recently sought more data on its stents. Citigroup tips CE Mark award by early next year. On charts, negative MACD suggests buying momentum still weak, while Bollinger Bands show stock still far from overbought levels. Resistance at 10-day moving average of around S$0.78.
opss it dip below... lets see on monday
