Post Reply
5741-5760 of 10899
Comparing with other RCT against Cypher, I would say that only Biomatrix's clinical data figures are actually lower than Cypher for all the measurements and no other DES has done it before. Looking at Endeavor's clinical data, I would say all the clinical data figures of Endeavor are much higher than Cypher's. I believe for LEADERS 12 month and 2 years data, we should see some wider margin of difference with advantage to Biomatrix. Spirit III trial is against Taxus, NOBORI trials are also against Taxus. Both stents uses Biosensor's DES technology and both slam dunked Taxus. Sirolimus, Everolimus and BiolimusA9 are all very potent limus drugs (most experts feel Zotarolimus is the least potent limus drug among the 4 main limus drugs). I feel among all the 4 main limus drugs, BiolimusA9 is definitely the best. We need OCT endothelial recovery scan and longer data to see the positive aspects of ablumenal coating and biodegradable polymer DES technology. So far there is no RCT of Xience VS Cypher because there is a chance Xience's data may be also "non-inferior" to Cypher but somewhere around Cypher's data or slightly lose to Cypher. Why risk challenging Cypher when Taxus is a easier stent to beat? All of Biomatrix's clinical data manage to beat Cypher in all areas but not wide enough to show statistical "P value" superiority.
Biomatrix's FDA IDE was submitted years ago. I suspect the FDA Medical Device Mafia Inc is giving BIG is hard time. The Master Drug File took so long to be approved as safe. I heard BiolimusA9 is now approved by FDA for DES purposes. With the LEADERS results, BIG will actively seek for FDA IDE approval as it has been delayed for years. Under the old FDA rules, Biomatrix proving "non-inferiority" in 1,700 patient trial against an existing approved DES would have warrant an unaminous FDA panel of jury for Biomtaix's FDA PMA approval. I think the FDA has no more reason to further Biomtrix's IDE after BIG's submission of further clinical evidence of positive LEADERS results. This is just like CE Mark. Never in the history of CE approval they need to see RCT against an approved DES. Only after NOBORI trial submission then CE has no more reason to delay Biomatrix's CE approval. Drug / medical device is a "Mafia" game and only a powerful American MNC with good connections can handle such matters without much hiccups.
I think there is definitely a chance of JNJ buying over BIG. JNJ may want to look at 12 month data, endothelial scan, further subgroup data analysis, etc which will be available very soon. Of course if JNJ's NEVO stent is not working well in clinical trials, another M&A is the only option for JNJ and BIG is a very obvious and best target. Biodegradable polymer and totally polymerless ablumenal coating DES has a very good potential to answer the late thrombosis problem. We know that BMS is the safest bet against late thrombosis. In Endeavor IV trial, Endeavor had even more late-thrombosis cases than Taxus!!! Endeavor's one and only key selling point is their durable polymer technology is seems to be slightly better than the first generation DESs with regards to late-thrombosis cases and Endeavor is perceived to be a safer DES. Look at how well Endeavor is selling even though they flopped end-point measurements against both Cypher and Taxus. MNC style of marketing also plays a key role in sales of DESs. There is a very good marketing platform and attraction of PLA Biodegradable polymer and Totally Polymerless DES that Biosensors is using. Its novel, revolutionary and it is proven to work very well. The potential to overcome late-thrombosis is the most powerful marketing tool for DES right now.
JNJ don't have good DES R&D and technology now. If JNJ is technically strong in their internal R&D, why their scientists and stent engineers cannot even spot a stent (Costar) that is about to be proven a flop (3 months after acquisition) and still want to buy over Conor? All the stent engineers think that reservoir holes stent strut technology is a stupid idea but JNJ think it is novel and brilliant. The "Conor / NEVO Show" must go on until proven failure again. You cannot buy something for US$1.4B cash and just thrash away the whole thing immediately. How to answer to shareholders why the management bought Conor in the first place? Why not just play along the game and pray it will somehow work? If it still doesn't work, blame it on the previous guys that were already sacked because they were the ones that bought Conor. This is a typical MNC management / employee mentality.
If JNJ use Sirolimus on biodegradable polymer, they will be caught in BIG's limus drug on biodegradable polymer patent. So technically, NEVO stent is in breach of BIG's patent. Before NEVO is proven to be a failure, JNJ would probably have bought another stent developer (most likely Biosensors). This was exactly what happended to Abbott in 2006. Abbott knew their own in-house Zomaxx DES R&D program is not going anywhere and bought Xience R&D program from Guidant (Boston Scientific) for US$4.1B cash. 2 months after the Xience M&A, Abbott then announce their own Zomaxx R&D clinical trial failure, will scrap the whole Zomaxx R&D program and focus on developing and commercialising Xience DES which looks more promising.
I think that a lot of people have under-estimated the importance of the Leaders trial. Let me explain.
First, the trial will remove doubts that the Bio-matrix does not have the critical mass of patients to prove its efficacy and safety. In fact, the 'real world' patients in the trial actually 'OUTDO' most of the existing trials.
Secondly, the fear of STENT THROMBOSIS is very real, and a lot of patients are on drug therapy (probably for the rest of their lifes). THe theory behind this problem is that when the drug are taken off, inflammation due to the residual drug/polymer will cause blood clots (stent thrombosis).
WIth the 'Leaders trial', physicians can finally have a DES that applies the drug when needed during the first 6-9 mths, and revert back to a bare metal stent after that !.
ANd that is why the subsequent results, that is the 1 yr (at TCT2008), the 2 yrs, etc will be of utmost importance to show that the clinical results obtained with the bio-matrix (especially in the area of stent thrombosis) will remain similar.
I recall Patrick Serruys (cannot remember the exact spelling), Eberhad Grube saying that the general trend of the DES industry is going towards a 'polymerless' one, and the Bio-matrix actually fits the bill !
I would classify Bio-matrix to be up there with the Xience DES, as being the top 2 DES, with Cypher, Taxus and Endeavour being in the 2nd tier.
Just a personal opinion - Not a call to buy/sell.
The Leaders results are exactly as I cautioned they would be in my earlier post. Of course we all
wanted a knockout punch from Biomatrix, but there was no way that 9
month data would be able to deliver one. The true value of the Biomatrix stent
design will hopefully be revealed in the longer term follow-ups at 2-3
years. The Leaders trial has definitely enhanced the credibility of Biosensors and sales should increase as a result.
Unfortunately, Biosensors is still years away from FDA approval and the lucrative North American market and is also years away from potentionaly showing superiority against Cypher. Meanwhile, the target has moved and the new gold standard DES will not be Cypher, but Xience. I think the so called 'catch up problem' for Xience is a non-issue as the 2 year clinical data from the SPIRIT studies was excellent.The verdict on Xience's Very Late Thrombosis result is not clear yet, but the endothelialization studies done by Dr. Virmani suggest quicker and better healing.
While we wait years for these studies, technology improves and the
target may yet move again. Does a MNC (JnJ) risk billions on a takeover
and clinical trials for a device that may not show superiority?
PensionAlterEgo ( Date: 02-Sep-2008 20:57) Posted:
|
Biosensors' heart stent matches J&J rival in study
MUNICH (Reuters) - A new heart stent from Biosensors International made with a biodegradeable drug coating appears as safe and effective as an older industry standard from Johnson & Johnson, researchers said on Monday.
The news is a boost for Singapore-based Biosensors, which believes its product may avoid some of the problems seen with conventional drug-coated stents -- tiny scaffolds used to prop open clogged coronary arteries.
Its BioMatrix product represents a novel approach because it is made with a bioabsorbable polymer.
After nine months, the drug and polymer dissolve completely, leaving patients with bare metal that should be less likely to cause late stent thrombosis -- a rare condition in which blood clots form inside stents a year or more after implantation.
In a clinical study involving 1,700 patients followed for nine months, no significant difference was seen in the performance of BioMatrix compared with J&J's Cypher, Stephan Windecker of Bern University Hospital, Switzerland, told the annual meeting of the European Society of Cardiology.
A total of 9 percent of patients given the new stent suffered cardiac death, experienced a heart attack or needed reopening of arteries. That compared with 11 percent of those using Cypher.
LONGER STUDIES NEEDED
Cardiologists said the results were encouraging but they pointed out that the study had followed patients for less than a year and BioMatrix had simply shown "non-inferiority" to an existing drug stent, rather than proving itself better.
"Before we become overly enthused with new-generation drug-eluting stents, we should call for new-generation trial designs that will enable us to assess whether or not these new stents are necessarily better," Ron Waksman of the Washington Hospital Center wrote in the Lancet journal, which published the trial results online. (*This guy must be supporter of JNJ)
Windecker acknowledged longer-term follow-up studies were needed to confirm the theory that BioMatrix could reduce the risk of late blood clots.
Biosensors won approval to sell BioMatrix in Europe at the beginning of this year -- a key step in the company's planned return to profitability. It is also on sale in Asia but a new clinical trial will be needed before it can be approved in the United States.
Chief Executive Mike Kleine said there would be a series of further pivotal studies that could eventually make BioMatrix a new industry standard.
Biosensors is a relative minnow in the stent market, which is dominated by big U.S. companies like J&J, Boston Scientific, Medtronic and Abbott Laboratories.
That has led to speculation the Singapore company might be a takeover candidate -- something Kleine said he did not rule out but was not actively pursuing.
"Everything is on the table, as long as it meets the value that we feel the company is at the time of the conversation," he told Reuters.
heavy short by bb,,,,,,,,,,,,,,believe or ignore,,,,,,,take ur own risk,,,,,,retail buyer be careful,,,,,,,,,,
I have mixed feeling about the Leaders results. A part of me wanted a clear knockout results from Biomatrix on Cypher.. but in reality I think we have to be pleased with the results. If you listen to Michael Kliene's briefing, he says that this trial was arranged/designed in a unique way. It was all planned, executed and tabulated by physicians unlike trials done by other companies. So no "kelong" unlike other trials with company's involvement. Said that many commended Bio for this and for taking on Cypher..!
And by now, most of us have heard that this trial is an all comers off label trial. Overall it enhances the credibility of the Biosensors as a company. I am very positive that sales figure will be enhanced with the LEADERS results.
Michael Kliene also was quite upbeat about the upcoming 1 year results. I think he might have a point there. As he mentioned, from now on (9 months onward), the stent has transformed to BMS but Cypher will start eluding its drug and expose its polymer. Then the problem will start to be more apparent.
I think there will be some parameters that will start to show superiority in the long run. I think there is chance for Biomatrix to show superiority in TLR and late lumen loss. It's like a marathon. Currently Biomatrix is still slightly ahead only. Lets wait for the 1 year and 2 years results. I believe, the gap between the two stents will grow wider..
Remember Xience has a late catch up problem which starts to become apparent in 2 years. Its late lumen loss catches up to the same value as Taxus. The verdict on Xience's Very Late Thrombosis result is not clear yet.
bro...49 not likely....after getting all this results still 49.... bengster already say ....59..... har...
craps... 0.57... better drop to 0.49, collect again !
People just profit take since the news is out. No more reason to keep at the moment until the next good news......
some body have been collecting since the last 10 days....
Kena profit taking. Sianz.......... There is a collector at around 59ct region.
Don't believe this, i thought the price should shoot up instead of profit taking. Isn't the Leaders trial a strong show of BIG's products?
"JI PA BAN"
Dun listen to those eat "SAI" analyst there only know how to eat "MONEY".
BIG !!!!!!!!!!!!Cheong!!!!!!!!!!!!!!!!!!!!Cheon!!!!!!!!
DJ MARKET TALK: Biosensors Off 4.8% On Profit-Taking Post Trial (2008/09/02 09:39AM)
0139 GMT [Dow Jones] Biosensors (B20.SG) heads lower as encouraging trial results for its flagship drug-eluting stent BioMatrix likely already priced in following recent strong performance; shares down 4.8% at S$0.59. Stock had risen 18.1% in previous 6 sessions, so now likely seeing profit-taking. "We believe the positive results are largely expected by the market," says Credit Suisse; adds, trial results should serve as good marketing tool for BioMatrix but not likely to increase Biosensors'' likelihood of being acquired as uncertain economic environment, worries over intellectual property deterring potential buyers. Nevertheless, broker says if BioMatrix sales growth remains strong next quarter, shares should get a boost; maintains Outperform rating, unchanged S$0.90 target price. Charts show stock overbought on RSI, stochastic oscillator, decent number of shares traded; suggests shares may have tad more downside with support tipped at converging 10-, 30-day moving averages at S$0.56-S$0.57. (KIG)
Contact us in Singapore. 65 64154 150; MarketTalk@dowjones.com
(END) Dow Jones Newswires
September 01, 2008 21:39 ET (01:39 GMT)
Copyright (c) 2008 Dow Jones & Company, Inc.
once bitten twice shy.. so, what's the price we are talking about today? 0.69 ?
DJ MARKET TALK: Biosensors May Rise Tad On Positive Trial (2008/09/02 08:42AM)
0042 GMT [Dow Jones] Biosensors (B20.SG) may head tad higher after medical products firm says trial that pitted its BioMatrix stent against Johnson & Johnson''s rival Cypher stent showed BioMatrix stent was as safe and effective as Cypher''s. "We think that this puts the BioMatrix stent in good stead to contest more market share in an accelerated fashion," says OCBC Investment Research. Adds, "while waiting for greater scrutiny of its data, we maintain our positive view on Biosensors as the promising results should enhance its claim of a superior 2nd-generation stent technology"; maintains Buy rating, S$1.02 target price. Pre-open quotes show heaviest selling interest at S$0.65 so that may act as cap; shares closed flat at S$0.62 yesterday. (KIG)
Summary from OCBC Research
Biosensors International Group: Milestone clinical trials results
Summary: Results of a key clinical trial were announced at the European Society of Cardiology on 1 Sep 08 that had direct impact on Biosensors. The Biosensors' LEADERS trial had pitted its BioMatrix stent against J&J's Cypher stent, the long established leader in the Drug Eluting Stent field. In essence, the LEADERS trial is the first to have achieved all its primary end goals and showed that the BioMatrix stent was of equivalence to Cypher. We think that this puts the BioMatrix stent in good stead to contest more market share in an accelerated fashion. This 9-month old data will be updated again in a presentation in Oct 08 at another key medical conference and will continue for another 4 years. We are of the view that future follow-up data would yield good results that should address concerns of Drug Eluting Stents (i.e. late stent thrombosis) as the BioMatrix stent is now essentially a Bare Metal Stent. While waiting for greater scrutiny of its data, we maintain our positive view on Biosensors as the promising LEADERS results should enhance its claim of a superior 2nd-gen stent technology. Maintain BUY with fair value of S$1.02.
this morning, radio "93.8 live" mentioned about the results..... similar to news from web just minus the data
so much about the results....is time to move forward .......i think what is important next for BIG is to have to increase both their sales and market shares.
then suitor will be line up in front of their door steps...........
Let me magnify it so that it is easier to have a closer look:
LEADERS (Biomatrix VS Cypher):
*Late-loss : 0.13mm VS 0.19mm
*Binary restenosis : 5.5% VS 8.7%
*Overall TLR : 5.4% VS 5.9%
*Overall TVR : 5.7% VS 7.3%
*MACE (9 months) : 9.2% VS 10.5%
*Late stent thrombosis - Definite cases at > 30 days (0.2% VS 0.5%)
ENDEAVORIII (Endeavor VS Cypher):
*Late loss : 0.34mm VS 0.13mm
*Binary Restenosis: 11.7% VS 4.3%
*Overall TLR : 9.8% VS 3.5%
*MACE (30 days) : 7.6% VS 7.1%
*Late-thrombosis : Nil for both DESs
Biomatrix clearly beat Cypher and potentially can slam dunk Endeavor like the way Biomatrix slam dunked Taxus in NOBORI trials.
LEADERS (Biomatrix VS Cypher):
*Late-loss : 0.13mm VS 0.19mm
*Binary restenosis : 5.5% VS 8.7%
*Overall TLR : 5.4% VS 5.9%
*Overall TVR : 5.7% VS 7.3%
*MACE (9 months) : 9.2% VS 10.5%
*Late stent thrombosis - Definite cases at > 30 days (0.2% VS 0.5%)
ENDEAVORIII (Endeavor VS Cypher):
*Late loss : 0.34mm VS 0.13mm
*Binary Restenosis: 11.7% VS 4.3%
*Overall TLR : 9.8% VS 3.5%
*MACE (30 days) : 7.6% VS 7.1%
*Late-thrombosis : Nil for both DESs
Biomatrix clearly beat Cypher and potentially can slam dunk Endeavor like the way Biomatrix slam dunked Taxus in NOBORI trials.