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Is Biosensors a good buy?
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Centaur
Veteran |
30-May-2008 10:45
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Hey, i see BIG picking up again.. 
Maybe the BBs have digest BIG's info and is coming back in. Let's hope this time round, it can be sustain |
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bengster68
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30-May-2008 01:08
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During the first 50% takeover of JWMS, BIG said they will appoint the CEO of JWMS and take active role in managing JWMS. Is Jack Wang the original founder and owner of first 50% of JWMS? MDT is holding strategic stake in WeiGao for several reasons and MDT/WeiGao even formed a new JV company in China to do some other medical device business collaboration. I think BIG's new CEO can bring in more professional management expertise into BIG to achieve their mid-term goal of becoming the top DES player in Asia and a respectable player in CE approved markets. USA market will depend on potential licensing / JV partnership after LEADERS results. In case we get carried away by M&A possibilities (like me  ), takeover has always been a very interesting "side bet" for investing this stock but serious investors should always ask themselves whether can BIG become a respectable DES player in their own capacity. Invest into this stock only when you are convinced on BIG's potential as a respectable DES player in their own capacity. Takeover is a big bonus jackpot if it happens.
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investor
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29-May-2008 22:28
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Medtronics initial foray into Weigao was due to some of the other medical products that Weigao was manufacturing, rather than JWMS. Medtronics may or may not be interested in JWMS - I dont know. If Medtronics is interested in BIG, I think it is a convoluted way to do it thru Weigao - so I think that secnario may not be likely, OR if they expressed interest in the future, than it be be felt more directly. Dr. Jack Wang is employed by Biosensors to be the CEO of JWMS - So he is their man, so we should not read too much into it. (For confirmation, listen to the conference, when they announced the purchase of the inital 50 % of JWMS). I think we need time to let the CEO of Biosensors bring value to the company, when the sales starts coming in, this will be reflected in the instinsic value of the company. (I must say that the CEO's presentation in the video is quite inspring, and anyone seriously intending to invest (NOT SPECULATE) should listen to his speech and form their own conclusion). Having said that, there is no gaurantee that the CEO can bring out the value in Biosensors - the next 6-9 mths should be a good gauge of where the company is heading, including the Leader's trial results. Speculation of take-overs, if any should only be the icing on the cake. For discussion. Not a call to buy/sell |
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bengster68
Master |
29-May-2008 21:59
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From PAE's earlier article: <History suggests Cypher can recover from initial market-share losses, to an extent. When "Where physicians moved away, they are now returning to Cypher," Self-consolation statement from Cordis for not coming out with a better DES weapon. The Japs went back to Cypher because NOBORI 1 phase 1 and 2 clearly shows Taxus is one of the worst DES around and Endeavor III shows Cypher still has some competitive strength, esp their Sirolimus drug. By looking into these clinical trials, the Japs know that Taxus is probably more inferior compared to Cypher so they switched back to using more Cypher. When Terumo get their NOBORI DES Japan approval later this year, i think Cypher's sales will definitely drop very significantly. Japan is Terumo's stronghold with very strong branding there, very extensive and well connected sales channel, plus Japs tend to support Japanese products first. NOBORI will be the future market leader in Japan market and corner that US$600m market within 2 years after Japan approval. If LEADERS (Biomatrix VS Cypher) trial results at October TCT 2008 can show superiority of Bimatrix against Cypher, it will be the death knell for Cypher in Japan and LEADERS results will give NOBORI (a.k.a Biomatrix) a very good headstart for their Japan market launch. I believe within 2 years after product launch, NOBORI will be able to capture at least 50% of Japan's US$600m a year market. Thats US$300m of DES sales a year for Japan market for Terumo. If royalty to BIG is at around 40%, thats freaking US$120m cash royalty a year for BIG. Zero expense to BIG, pure cash royalty profit and its a yearly recurring profit. It will happen in year 2010 onwards. This is how BIG make money from their top class DES technology. |
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bengster68
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29-May-2008 21:32
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Forgot to add on that if MDT bought the WeiGao and Dr Jack Wang's combined 20% of BIG shareholdings, that is bad news for BIG's takeover situation. It will be difficult for JNJ to have full control of BIG and fully utilise BIG's DES technology, patents, etc to fit into JNJ's own own DES strategy. No point to launch a takeover if JNJ cannot have full control of BIG, unless MDT wants to sell to JNJ for a gain in investing into BIG's shares (which is unlikely to be the purpose of MDT's investment in BIG as MNCs normally do such investments for strategic reasons). If such a case happen, chances of JNJ takeover will be greatly diminshed. But i don't think MDT will be satisfied to invest 20% into BIG and just become a passive shareholder. I doesn't quite make much sense for MDT to hold 20% unless they want to launch a full takeover bid or hold a 20% strategic stake in BIG with the intention to do other types of DES collaboration or JV with BIG like Biomatrix USA market or future DES programmes like Biomatrix Freedom / Biomatrix ABSORB DES, etc. |
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bengster68
Master |
29-May-2008 16:51
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BIG's poker game smoke screen to get a better takeover offer will be to insist they want to remain independent as they want to become a big player independently. There are several method to create this smoke screen to JNJ, MDT or other potential buyer: 1. BIG can start to "source" for potential USA market licensee after LEADERS trial result as a smoke screen to show BIG is not a desperate seller for M&A possibilities. If BIG start to source for a USA licensee partner, this move effectively is sending a strong impression to JNJ that BIG wants to remain independent and not waiting aimlessly for a takeover to happen. BIG's normal business decisions have to move on and if BIG ever sign the USA licensing deal before JNJ can come out with a decent offer, thats too bad and too late for JNJ and Cordis' only "LAST HOPE" is also gone. 2. Build up huge cash level (at least US$250m) to show that you have the financial resources to capture global markets via intensify branding, clinical trials, marketing and distribution and selling operations like an MNC. BIG will be a bigger threat to existing player and has the financial capability to capture a large slice of market share from them. 3. Announce plans to list China JWMS after second 50% deal completion to expand further into China / Asia / 3rd world country markets. 4. Basically just do the best business decision as what an independent strong company will do to capture more market share. |
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bengster68
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29-May-2008 16:30
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Excellent article PAE posted. It gives an updated summary what i have been saying all along about JNJ. To analyse takeover possibility, we got to know all the potential buyers' situation and also know BIG's biggest asset and weakness. BIG's best assets now are strong IP, patents, top class DES technology, CE approval and China JWMS. BIG got to improve on those weakness like low cash level, low sales of Biomatrix (just launched on 01/04/08). JNJ did the right thing to forego their takeover bid for Guidant. Guidant's defibrillators kena a lot of recall problems and at that time Xience was still in clinical trial stage and no CE approval yet. Actually i think Xience is just slightly better than Cypher in terms of their drug and durable polymer. JNJ's biggest mistake is still acquiring Conor. Conor is a "Pian Chiak" company, a farce from the beginning to the end. Also, Boston offered way too high for Guidant and the company didn't manage to recover after their costly acquisition due to too heavy takeover cost/debt incurred. Luckily, Boston has got Abbott who paid them US$4.1B for Guidant's Xience DES program. And luckily for Abbott, Xience turned out very well at clinical trial results (not like Conor). Biosensors is definitely still on the radar screen of JNJ. Biosensors is JNJ's very last hope to revive their Cordis division. Read carefully again, I said "LAST HOPE". If JNJ miss this takeover chance after LEADERS results, Cordis got no hope left. When you see JNJ talking about "Cypher's track record" and no new selling points, you know they really got no selling points about Cypher left. As what Dr Renu said about JNJ's Cypher 4 years safety results presented at EuroPCR2008, she said : "I think it is thrash". If JNJ try to press down BIG's takeover price too much, BIG will reject their low offer, license out the Biomatrix USA market, remain independent and still can become a respectable global DES player. BIG still can become the number one DES player in Asia and a respectable player in Europe and USA market (via licensing). Cordis once made tons of profit from Cypher DES ( i think got at least US$1B a year) and JNJ know how lucrative it is to be the most dominant player in DES industry. They are selling Cypher for about US$2,400 but cost of manufacturing is only freaking less than 10% of their selling cost. This is how lucrative DES really is. But you need the scale of a top selling DES to really reap very handsome profits. A few percent market share will only make meagre profits because operating / R&D costs are very high. So its still a volume business game for DES. Also, i believe that MDT only has some form of "influence" only on 20% of BIG shares via WeiGao and Dr Jack Wang. If MDT has already signed some agreement to buy over the Chinamen's 20% shares, i think BIG will know about it also. Under the JWMS deal, one of the terms is that the Chinamen cannot sell / pledge their shares within 12 months from completion date. So if they had already secretly sold their BIG shares to MDT, thats a breach of JWMS agreement term. This 20% BIG shares are multi-hundreds of millions investment and MDT need to perform legal, financial, IP, patent and clinical trial due-diligence and all these due diligence work require BIG's co-operation. There could be a "gentlemen" agreement between the Chinamen and MDT over the 20% BIG shares the Chinamen are holding. But Chinamen are still Chinamen and they can change their agreement if someone else come out with a better offer. The Chinamen will still eventually sell to the party that can give them the highest offer. So what if there was a Chinamen's "gentlemen" agreement to sell to MDT at $2? If JNJ can offer $3, the Chinamen will go back and ask MDT: Can you come out with a higher offer than $3? MDT may be interested in buying over BIG but they are not as desperate as JNJ. When it comes to bidding for BIG, i don't think MDT can come out with an offer higher than JNJ. Since most people can conclude that JNJ is going to be a desperate buyer, JNJ need to talk something about Conor Sirolimus NEVO DES as a smoke screen to appear as if they have other pipelines and not really bothered about temporary loss of market share. Even if JNJ know that NEVO DES will eventually fail, they still have to proceed ahead with NEVO's clinical trials. As long as JNJ takeover BIG before any NEVO's clinical results are out (at least 12 months later), JNJ will use NEVO DES to play a poker game bluff for the next 12 months duration. |
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allright
Senior |
29-May-2008 15:16
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Stupidbear
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29-May-2008 13:03
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I see a squeeze coming up =) | ||||||||
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AK_Francis
Supreme |
29-May-2008 09:47
Yells: "Happy go lucky, cheers." |
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tks for all postings, this burger got bright future, loong leow. | ||||||||
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allright
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29-May-2008 09:43
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Thanks PAE. I like your highlighted RED portions ....There is HOPE for biosensors yet!!!!!! | ||||||||
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PensionAlterEgo
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29-May-2008 09:01
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J&J Hangs On With Older Stent As Fresh Competition Hits US May 28, 2008: 03:46 PM EST As the U.S. market for drug-coated stents becomes more crowded, J&J and How far the company's share declines in a complex market remains to be seen. Stanford Group analyst That would mean U.S. sales of J&J seems like "the odd-man out" in the changing domestic market, Wald said. " I think the biggest loser in all of this is probably J&J will review its medical-devices product pipeline during a conference next week, although there are no known near-term coated-stent developments aimed at the U.S. market. The company, which has seen its new stent efforts hurt by missed acquisition opportunities, seems poised to lean on its cache of Cypher- supporting data while it tries to keep doctors interested. This strategy may help fight erosion, and Cypher may win points for familiarity and its track record, said Citigroup analyst While market-crimping concerns seem to be dissipating now amid new data and new devices, J&J may miss out on a market rebound. "I see them just fighting the rear-guard action this whole time," said Cypher represents a small portion of J&J sales, which were Pointing To Data Coronary stents are tiny devices used to prop open heart arteries, and coated stents such as Cypher use medication to combat renarrowing. The Food and Drug Administration approved use of Cypher in early 2003, and approved Cypher uses a drug licensed from Campbell Rogers, chief technology officer at Doctors will try new products, Rogers said. But Cypher's track record of safety and efficacy "will continue to drive them to use the product," he said. Taxus and Cypher were the only coated stents in the U.S. for nearly four years, until the FDA approved That stent appears off to a faster start than Wall Street expected, and partially at Cypher's expense. Citing outside market research, JPMorgan analyst Abbott's Xience stent, which the company expects will win FDA approval in the current quarter, could bring stiffer competition. Xience has generated high expectations by outperforming That could be detrimental to Taxus market share, but Tim Fischell, a stent-implanting doctor and director of cardiovascular research at the Borgess Heart Institute in "Xience/Promus is going to take over the drug-eluting stent market," said Fischell, who serves on advisory boards for J&J Nearly Had Xience Missed acquisition opportunities have contributed to J&J's bystander status as new coated stents reach the U.S. A long-standing FDA warning letter related to Cypher manufacturing, which was lifted last year, also played a role. J&J lost Guidant to But Guidant was also developing Xience and that prize ultimately went to Abbott, after Abbott stepped in to help Later on, in early 2007, J&J bought a small stent developer called Conor MedSystems for But J&J pulled a Conor stent with this technology, and the same drug J&J has said it was more interested in the Conor platform than this initial device, although the trial failure did pull a near-term, next-generation entry from J&J's stent holster. Conor and "J&J is just going to hunker down and wait for the next-generation" device, Citigroup's Dodds said. As a huge company, of course, J&J also has the option to seek to buy another stent developer. History suggests Cypher can recover from initial market-share losses, to an extent. When "Where physicians moved away, they are now returning to Cypher," |
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bengster68
Master |
28-May-2008 23:01
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Boston Scientific Corp. will pay $250 million to Medtronic Inc., a Texas jury ruled Tuesday. The Natick, Mass.-based medical device maker Boston Scientific (NYSE: BSX) was found to be infringing patents on catheters used to install stents and break up blockages. A release from Fridley-based Medtronic (NYSE: MDT) detailed that the company sued Boston Scientific in 2006, alleging that Boston Scientific's Taxus Express2, Express2, Liberte, Maverick, Maverick2, and Quantum Maverick products infringed on patents owned by Medtronic. The trial, which lasted a week, concluded that the infringement was intentional, and the judge may decide to increase the award by up to $750 million. In a response, Boston Scientific said it still has hope that some of its defenses not heard by the jury will be considered at a subsequent court hearing, and may seek to overturn the verdict in post-trial motions or file an appeal. *** Don't play play about other people's patents..... Multi-million settlement |
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cashiertan
Elite |
28-May-2008 20:17
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to a certain degree yesh i agree with zhuge liang. for some, it represent a good chance to buy on discount of the intrinsic value. however years of trading has taught me singapore is singapore. what applied oversea usually dun apply as well in singapore. just be careful and dun be overconfident of any stock. sell when u have to |
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bengster68
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28-May-2008 15:47
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If at 6 months LEADERS results are good, the 9 months results should not be far off also. At 6 months if Biomatrix is really performing better than Cypher, we should be able to see this truth manifesting via positive data from the LEADERS 6 months reports. This is the beauty of RCTs. One-To-One Boxing Fight. After the first couple of rounds can see which boxer is probably the better fighter liao. No need to wait until the knock out. I have seen some RCTs at 6 months (cannot remember which ones) and can see which one is the better performing DES liao. I think a critical period after stent implant is within one month. The wounds are still raw and if healing is bad, complications may arise and may need re-stenting over at the original area overlapping the old one. This is re-stenting quite dangerous. So far Biomatrix has over 4 years of clinical trial to show that there is no late-thrombosis cases. But i think not many quantity of patients are actually at over 4 years after implant. Perhaps most of these patients are at 2 to 3 years after implant. The good thing is Biomatrix also shows very very low early thrombosis rates at below 6 months. Zero cases for both NOBORI trials while Taxus already has a few percentages cropping out at below 6 months in NOBORI trials. And in Endeavor IV RCT, Endeavor has even more early thrombosis cases compared to Taxus at below 6 months. We can also look at clinical trial results of Xtent and Devax for a better gauge on effectiveness of BIG's DES technology. I posted an EuroPCR08 article on Xtent's CUSTOM's 6 months results and MACE rate is single digit. Most other super long lesion DES already in 20% region MACE rate for that duration. To really go in-depth on whether BIG's PLA biodegradable polymer technology really can significantly reduce early or late thrombosis rates, future clinical trials need to be redesigned for that specific purpose of late-thromnosis end-point measurement. This may happen after Biomatrix has secured a firm foothold in the DES market as BIG don't have so much cash to burn to prove this selling point to extend Biomatrix's product life cycle. Designing such clinical trials need large scale patients (a few thousands) and monitoring for at least 10 years (since stents after implants typically stay in the patient's body for an average duration of at least 10 years). Thats a huge R&D cost that BIG can ill-afford now. However, BIG can extend the old large scale clinical trial like LEADERS for up to 10 years instead of 5 years cut-off to shed more evidence of this PLA biodegradable polymer potential for late-thrombosis solution. If BIG is bought over by JNJ, large scale clinical trials can be initiated for 10 years and beyond to prove the claim and a main selling point that PLA biodegradable polymer is the right answer and holy grail to DES industry for late-thrombosis problems. This is the advantage of MNCs, they have the cash to burn for clinical trials as they already have very stable cash flow from their many other businesses and on a global basis. What BIG has achieved clinically for their technology considering the amount of cash BIG has burnt for their clinical trials is already a very stunning good value-for-money performance results and probably the highest R&D returns this industry has ever seen for cash burn rate VS DES performance. So many other DES rivals each plouging hundreds of millions into R&D (billions of R&D already spent on DES) and they still cannot come out with something more outstanding than what BIG has. BIG's first class DES technology comparing to their R&D cost is really "bang for a buck" man! M&A chances of BIG is always a real possibility. MNCs grow by strategic acquisition of smaller companies to dominate their industry. I heard from someone in the DES industry that JNJ approached BIG somewhere late 2006 and BIG rejected JNJ's offer. It was rumoured that the offer price was twice the traded price at that time. JNJ then went on to acquire Conor. So actually, Conor was the second takeover choice of JNJ, BIG was their first choice. Conor is using Paclitaxel drug and is of totally different "school of thought" from JNJ's Limus drug "school". Plus, JNJ already knew Conor is infringing Angiotech's patent and facing worldwide sales injunction for their Costar DES. The key event in looking at takeover reality is on LEADERS trial. If good results, very very possible. But how long later? Depends on M&A negotiations. Another key event to look out for is whether has BIG licensed out their Biomatrix technology in USA territory? If BIG has not licensed out yet, there is still a chance for M&A. If BIG licensed out their USA territorial rights to say St Judes Medical, i think the M&A chances will be diminshed greatly and most likely "Hung Kan" liao. It will be a long road to achieve BIG's ultimate goal as a truly global DES powerhouse (at least 3 to 4 more years and better pray to Tee Kong nothing bad happen along the way). I think BIG is fully aware of that too and will only do a USA licensing deal when takeover offer is not good enough and its better off to remain independent and go for the long road path. I think an offer of between $2.70 to $3 still got chance. Any offer below $2.50, BIG will definitely choose to remain independent. BIG also not stupid and know their own market worth. How much did JNJ paid for Conor and how much ABT paid for Xience? Let me just put it this way, any Biomatrix USA licensing deal is very bad news for BIG's M&A chances but very good news fundamentally for BIG as an independent DES player. |
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allright
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28-May-2008 15:41
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Business Times 28th may 2008 Biosensors an exciting firm to watch: new CEO Goals include being the No 1 player in Asia, grabbing 10% of Europe market - By CHEN HUIFEN HAVING spent the past three months understanding Biosensors International and the stent market, Biosensors' new chief executive and president Michael Kleine is ready to embark on plans to restructure the group and accelerate growth.
He has spelt out four goals for the next few years - making Biosensors the No 1 player in Asia, winning a 10 per cent market share in Europe, having four new products in the R&D pipeline and making clinical programmes more efficient. The key to the company's Asian ambitions is China, where it is eyeing a 30 per cent market share in three years. Biosensors is in the process of gaining full control of Chinese stent maker JW Medical Systems (JWMS), which markets one of the top-selling drug-eluting stents (DES) in China. Biosensors is also aiming for registration of its flagship Biomatrix DES in China within 12-18 months. In Europe, where it recently obtained the CE mark for BioMatrix, Mr Kleine sees a need for more aggressive sales and marketing. In the past three months, the firm has hired about 20 new sales people in Europe, and will make further investments in direct sales infrastructure over the next two years. 'These people all have key physician relationships that allow us to get in the door, show our clinical data, show our product, and then hopefully grow the business that way,' said Mr Kleine. Sales will be centred on BioMatrix, as Biosensors phases out the Axxion stent. In the meantime, the company is looking at developing next-generation products and a polymer-free DES using different variations of drugs and polymer types. 'All the other competitors continually move quickly, so we have to have a very strong R&D pipeline,' said Mr Kleine. 'Biosensors was very focused on project research. From now on, R&D for Biosensors will be focused on product development and be very market driven.' The market-centric approach will apply to clinical programmes as well. Mr Kleine said that they need to be better designed, with a view to producing results that will drive business in target markets. While he was not able to pinpoint any specific weakness in existing programmes, he feels that the company 'could have done a bit better' with the speed at which it obtained the CE mark for BioMatrix. 'I think the foundation has been laid for a very successful FY09,' he said. 'I think the reason the (financial) numbers are lower than what people would like is because of the delay in the CE mark. But now that we have that taken care of, I think this will be a very exciting company to watch.' Consolidation of global operations is under way. Pilot manufacturing at Biosensors' Newport Beach facility will be moved to Singapore, where the bulk of commercial production is carried out, said Mr Kleine. R&D activity will be consolidated at just two sites - Singapore and La Jolla, California. About 50 staff have been laid off from Newport Beach, which will book a restructuring charge of US$3-4 million in the quarter ending June. Biosensors also plans to divest or discontinue a manufacturing facility in the Netherlands by September. All such restructuring efforts could cut operating expenses by US$7-9 million a year. In a move signalling his focus, Mr Kleine will relocate to Singapore. The former CEO of medical devices firm Microvention Inc expects to spend up to 70 per cent of his time here while making frequent trips to China, India, Europe and the US. The CEO position, formerly held by founder and chairman Lu Yoh-Chie, has been traditionally based in the US, where most of the company's board members sit. 'I'm a big believer that physicians like to meet and understand the company the best they can,' said Mr Kleine. 'And I'd like to, every chance I get, go to the hospitals. Biosensors is in a stage right now where we need to be very strong in sales and marketing. And for me to be a strong contributor to that, then I need to be in Singapore.' |
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altius
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28-May-2008 13:11
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Wow, Bengster and P-A-E, you are both a wealth of information. Thanks again for sharing with us all. If it is 6 month data released this August, probably at ESC, I doubt we will see superiority of Biomatrix's primary endpoints over Cypher. As you said, Sirolimus is a potent drug and probably better than Paclitaxel which is why ABT chose to compare Xience to Taxus. MDT learned the hard lesson when they put Endeavor up against Cypher. I do agree that Biomatrix should be able to establish non-inferiority. Unfortunately, we will have to wait a few years to see the true value of the PLA polymer. I like the direction the company is taking; focus on strong Asian growth, the cost cutting measures, setting up a crack sales force in Europe and more R&D. This should make the company viable and strong in the long run. However, what do you think the chances are now of a takeover by a MNC. The reason I was interested in this company was for the relatively quick, large gain that would occur when the large MNCs such as JNJ, ABT, MDT etc would be competing with each other to acquire the company. Do you think this will still happen? Any ideas as to when this might occur? Who do you think the players will be? I am less interested in the long, slow rise of an independent. What are your thoughts? |
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bengster68
Master |
28-May-2008 12:26
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Even stronger lobbying powers for JNJ in FDA stent approval (interventional cadiovascular)? David Kandzari leaves Cordis for FDA, then Scripps 
Rockville, MD - Dr David Kandzari, who left Duke University in 2006 to become the chief medical officer for Johnson & Johnson's Cordis Cardiology unit, is heading back to the cath lab—this time out West. August 1, Kandzari will begin his appointment as director of interventional cardiology research at the Scripps Clinic in La Jolla, CA.
In the interim, Kandzari, who worked his last day at Cordis May 2, is working as a medical officer in the FDA's Center for Devices and Radiological Health, reporting to Drs Bram Zuckerman and Ashley Boam. He told heartwire he is hoping to continue working with the FDA in some capacity after he starts up at Scripps. The decision to leave Cordis was his own, he clarified. "Everyone is telling me that I've gone in the opposite direction," he jokes. "But for me, I spent many years of my career in clinical research as a clinician and as an investigator and now, more recently, as an industry representative. It was important to me to get the full perspective by also learning more about the regulatory perspective. As idealistic as it may seem, I think if we're going to advance healthcare we need more people who can better understand how to reconcile the needs of academicians and of industry sponsorship and at the same time meet the needs of the regulatory requirements of the FDA for device and drug approval." Kandzari says the impetus behind his return to clinical practice and research was patient care. When he first joined Cordis it had been with the understanding that he would continue to log some hours in the cath lab—this didn't pan out, he says. "Because of the demands and responsibilities of the job, it just logistically wasn't feasible. So direct patient care is something I've really missed and something I'm really looking forward to getting back to, and also being directly being involved in clinical trials as well." He acknowledges that it is somewhat rare for physicians to return to clinical medicine after working in industry, but calls it the right move at the right time and insists he has no regrets about his detour into the commercial side of medicine. "It was an extremely positive and learning experience. I'll miss working with honestly dedicated, wonderful people and learning the commercial side of things, being part of an organization where I had visibility into the commercial, the regulatory, and the marketing aspects that I just did not have exposure to as a clinician." That said, Kandzari says he is excited to be working with renowned Scripps cardiologists Drs Eric Topol and Paul Teirstein in a high-volume practice with dedicated time for research. "I'm really looking forward to taking care of patients and working on a more daily basis with colleagues who are physicians. And I'm extremely excited about working with the physicians at Scripps because I think they really have a good program that's really on the rise."
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bengster68
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28-May-2008 12:01
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Hi Altius, i think PAE is right on the webcast info. BIG did say that 6 months should be ready in Aug (don't know if it implies that BIG will announce 6 months results in any conferences in Aug 08). Full 9 months will definitely be presented in Oct TCT2008. This CEO is a professional manager and i think he can manage BIG's operations better. He was suppose to be based in New Port but after studying the cost structure, he decide to cut down on USA and Netherlands headcount (even the CEO has to shift office). He knows how to cut "unnecessary costs", and spend money based on the potential revenue. One clear strategy is to rope in 25 experienced and well connected direct sales people to tackle europe market. I think he is prepared to hire more well connected sales force. The whole marketing plan is based on Biomatrix's clinical trials (based on solid clinical evidence of product superiority) Spend money on those really necessary clinical trials and will cut the trial halfway if it doesn't show results so as not to further bleed the cash flow. I think BIG has already capture about 15% of China market share (with EXCEL DES) at this present moment and China market is poised to be even larger than Japan market by end 2009. BIG also aim to capture 20% of India market with 3 years and India market growing at least 45% compoundingly yearly. BIG wants to pluck the low hanging fruits (esp in Asia) and dont want to burn more cash for FDA thing. Most likely they will seek a licensee for USA market when FDA IDE is approved. I feel the upfront fee for such a USA licensing deal may be quite huge because Biomatrix would have gotten their IDE and Biomatrix is already a proven DES (if good LEADERS results and confirm good results of NOBORI trials). When Terumo, Xtent and Devax signed licensing with BIG, they didn't have the benefit of knowing exactly how well BiolimusA9 and PLA biodegradable polymer will perform. Now that this technology is already tested and proven, it clears a lot of uncertainty for the future USA licensee. It becomes a question of price. How much licensing upfront fees, what percentage of royalty from sales (to be paid to BIG) VS how much market share can the licensee capture in USA (potential sales), costs of clincal trials to get FDA approval (expenses). It will be a more clear cut business decision with lesser product risk involved. The biggest risk for any licensee is that the technology doesn't work and everything invested in upfront fee and clinical trial is down the drain. I still feel St Judes will be a better licensing target than existing DES players in BIG. There are always internal company politics problem with the existing DES players. Eg: to do a licensing deal, Medtronic will get their Chief Stent Technology scientist to study Biomatrix and its technological advancement. Biomatrix will be difficult to cross this internal political hurdle because Medtronic has already spent hundreds of millions on their Endeavor DES programme, on their durable polymer technology and Zotarolimus drug experiments (which run into tens of millions a year). How can the Chief Scientist suddenly make a U-turn statement after years of investing in the DES own technology he has been advocating to his company and suddenly say: "I think BiolimusA9 and Biodegradable polymer is the best. Better than what we in Medtronic has been doing". The Medtronic directors will ask: "Then W.T.F have you been doing / researching all these years Mr Endeavor Chief Technology Officer???". These are very real politics problems. Abbott's R&D department may think that BIG is the real grandmaster in DES and even their very own Xience DES was a transfer technology from BIG to Guidant. However, Abbott Cardiovascular Marketing and sales may think that "Hey, i've already got the future market leader in hand and its time to make some serious money and corner the USA market. Dual stent program Biomatrix/Xience will affect my overall marketing startegy and its better for Biomatrix to get out of my way." For RCTs, 9 months is a short time but it should be sufficient to see a stent's short-term efficacy to prevent restenosis. In many 9 months results, we can even see evidence of strong superiority statistically in some RCTs. SPIRIT III whereby Xience VS Taxus Express and NOBORI 1 phase 2 whereby Biomatrix VS Taxus Liberte clearly shows superiority Xience and Biomatrix even at just 9 months in many end-points. However in ENDEAVOR IV, Endeavor did not show any clear superiority against Taxus but it just shows non-inferiority. In fact, i think in terms of TLR, late-loss and early blood-clots, Taxus seems to perform even better than Endeavor. Some people classify "late stent thrombosis" as blood clots beyond one month after implant, some classify "very late stent thrombosis" as above 6 months. Strictly speaking, the deadly blood-clots affecting the industry sales of DES are the blood-clots after 6 months. It is considered "more acceptable" to have blood clots within 6 months (even in BMS) as compared to after 6 months. But of course lesser blood clot incidents will be better rated. Perhaps the frequency of short term blood clots could be a sign of what will happen in the long term also (but nothing is certain right)? Sometimes RCTs also depend on element of "luck" like which stent get more sickly patients, skill of doctors (under inflating the balloon?), and plain heaven's fate. Eg: Most clinicians said that in Endeavor IV RCT, Taxus seems to perform a bit better than normal. Cypher is using Sirolimus and it is a very potent drug as well. I personally rank the drug performance in order of Biomlimus, Everolimus and Sirolimus respectively. Because Sirolimus is a better drug than Paclitaxel, Biomatrix will be facing a better stent in the LEADERS trial as compared to NOBORI trials. The superiority of Biomatrix may not be as evident as in LEADERS compared to NOBORI. However, i personally think Biomatrix will definitely be to show "non-inferiority" against Cypher. I think Biomatrix should be able to show some form of superiority in some end-points but the magnitude of superiority will depend on statistical calculation. All the end-point measurements of LEADERS trial can be found here: http://clinicaltrials.gov/ct2/show/NCT00389220 |
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PensionAlterEgo
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28-May-2008 10:29
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Agree with alright that BIG is heading in the right direction. After reviewing the 26th May briefing again.. I see some good signs and decision making. Some positive include.. - Having upto 4 products in the near future.. - Staying ahead of the competition. Technology wise, BIG looks superior with Biomatrix but cannot compete with the sales and marketing force of the big boys. Since FDA has blocked them with the new IDE restrictions, the wise decision is to stay away from US first and make a name in - Ability to attract good talents (hopefully in the sales force ...thats where BIG needs it the most now) |
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