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Trying to digest the BSX asset purchase agreement. Seems more reactionary/desperate than strategic?
Magnetom 7T (Siemens). MRIC mentions compatibility with both 1.5 and 3T MRI systems. The field is evolving and higher resolution systems are just over the horizon. Does anyone have info regarding the expectation of the company (or scientific justification) that Clear Point can operate within the realm of 7 or 11.75T scanners?
Thanks.
Thanks. I believe there is a real need for this technology. Hopefully the business team can successfully bring it to the market. Thinking of investing soon...
Price drop. Can anyone comment on material events behind the significant drop in MRIC stock price this month? Hi, I'm new to the board.
"Why would such a technical matter as the accounting treatment of an asset sale have to delay a quarterly CC?"
You got me. Something seems to have happened at the last minute. There was elevator music playing on and on for hours (maybe still going?) in lieu of the conference call, and then the delayed "preliminary" 1Q12 earnings report PR. Very odd.
Re: FWIW (ART bioresorbable DES)
ABT's ABSORB BVS has anecdotal reports of cracking. Perhaps there is a demand for ART's technology if indeed this is a problem and they have solved it. Fully absorbable stents are likely less deliverable due to necessarily thicker struts, however. Probably best suited for disease that is not complex.
Micell's MiStent DES (bioabsorbable polymer over Co/Cr platform) appears to have a high probablilty of clinical success and sizable market penetration, IMHO. It may have some important advantages over JNJ’s Nevo and BSX’s Synergy -such as more rapid biodegradation- decreasing the length of required DAPT.
In any event, the case for biodegradable polymer coatings is bearing out some truth:
http://www.medicalnewstoday.com/releases/226624.php
re: accounting
True, the quarterly profits were meager to none and the business model is floundering.
The good news is they certainly seem to have become proactive in facing their troubles. Gary was a breath of fresh air.
Safety concerns for DES appear to be evaporating?
Drug-coated stents safe for large heart arteries
By Debra Sherman and Ransdell Pierson
CHICAGO, Nov 16 (Reuters) - Drug-coated heart stents are as safe as the old bare metal variety for patients with narrowed large coronary arteries, a large European study showed, alleviating concerns about their long-term use.
There was no increase in the number of deaths or heart attacks two years after the drug-coated stent was implanted, according to data presented at the scientific sessions of the American Heart Association in Chicago.
The clinical trial, conducted and paid for by the University Hospital in Basel, Switzerland, is important because there had been significant concern that drug-coated stents caused blood clots to form, resulting in death or heart attack, long after implantation.
Stents are tiny wire mesh tubular devices that prop open diseased arteries. The drugs on the stent keep the vessel from reclogging, reducing the need for repeat procedures. They are implanted using a catheter that is threaded through a vessel, usually in the groin, up to the heart.
Dr. Christoph Kaiser, co-author of the study and head of interventional cardiology at the University Hospital, said drug-coated stents are generally preferred over the older bare metal stents for smaller vessels.
In addition to an improved safety profile, patients treated with drug-coated, also known as drug-eluting, stents had fewer repeat procedures.
"Now that drug-eluting stents show no late harm in large vessels, I think doctors will change," he said.
"The fear of using drug-eluting stents in large vessels is no longer justified," he added.
The study of 2,314 patients in Switzerland, Denmark, Austria and Italy were divided into three groups: one group got Johnson & Johnson's (JNJ.N: Quote, Profile, Research, Stock Buzz) Cypher-Select sirolimus-eluting stent, another got Abbott Laboratories' (ABT.N: Quote, Profile, Research, Stock Buzz) Xience everolimus-eluting stent, and the other got Abbott's Vision bare metal stent.
The patients were enrolled from March 2007 to May 2008 and after two years, the rate of cardiac death or heart attack was 2.7 percent for the sirolimus stents, 3.3 percent for the everolimus stents and 4.8 percent for the bare metal stents.
Kaiser said he was surprised by the positive results.
"We can only speculate, but it is probably due to the fact that stents are getting better over the years and so are doctors and implantation techniques," he said.
Medtronic Inc (MDT.N: Quote, Profile, Research, Stock Buzz) and Boston Scientific Corp (BSX.N: Quote, Profile, Research, Stock Buzz) also manufacture stents. (Reporting by Debra Sherman and Susan Kelly; Editing by Dave Zimmerman)
http://finance.yahoo.com/news/Drug-coated-stents-safe-large-rc-4289511732.html?x=0&.v=139
Edge Therapeutics License Agreement
Regarding the recent license agreement between Surmodics and Edge Therapeutics, Edge is a VC-backed startup with an interesting business model. By focusing on local delivery of established, off-patent drugs to treat various brain bleeding disorders (chronic subdural hematoma, intracerebral hemorrhage, and subarachnoid hemorrhage -- all with significant unmet clinical needs), the regulatory pathway should be accelerated. The delivery system is apparantly an injectable biodegradable polymer carrier. The name "Nimogel" implies that the formulated product is to be in gel form. The carrier is composed of GRAS materials. Overall this approach could be slightly risky but seems highly logical, and with the possibility of high rewards in a relatively short period of time. I'll post more if I can learn more.
http://edgetherapeutics.com/what-we-do/pipeline/nimogel/
A key interest for Surmodics investors is, of course, is what IP Surmodics is contributing to the product development.
Re: R&D revenue
I don't know, SRDX certainly has had Q2Q flux in it's R&D revenue. Could be a bad sign but not necessarily. For example, if DNA is busy running preclinical tests, there might not be much work for SRDX. DNA probably wants to keep as much work as possible in-house.
I haven't followed Lucentis closely lately, is Avastin still cutting into market share?
Re: GTCB finally canned CEO Geoff Cox
In addition to worst CEO, I wonder if GTCB is setting records in dilution-based financing?
Re: Barclay 's Departure. Democritus, I agree with your speculation. I would add that the departure of Bruce might be the culmination of the shakeout announced nearly 3 months ago, which suggested a predilection towards Surmodics Pharma.
Re: Pharmodics
Dew, no doubt surface modification is and will remain an important component of Surmodic's business for some time. My suggested name change was intended tongue-in-cheek. However, the shuffling of management (and the build up and consolidation in Birmingham) does seem to reflect an increased emphasis on the Surmodics Pharmaceuticals (Brookwood) group and a decreased emphasis on some of the legacy expertise. My guess is that SRDX sees sustained drug/peptide/biologics delivery (both local and systemic) as the primary growth driver for the future. Their abilities in drug-device combos, microparticles, and long-duration drug delivery may give them an advantage in this space.
http://www.surmodicspharma.com/brookwood-science.html
http://www.surmodicspharma.com/partners.html
http://www.d4pd.com/news.html
Genzyme Pharmaceuticals and SurModics Pharmaceuticals Enter Broad Collaboration in Drug Delivery with an Initial Focus on Peptide Delivery
CAMBRIDGE, Mass. and BIRMINGHAM, Ala. – Genzyme Pharmaceuticals, a business unit of Genzyme Corporation, and SurModics Pharmaceuticals, a SurModics company, announced a broad collaboration to develop novel drug delivery solutions, with an initial focus on peptide delivery. The partnership offers customized solutions for parenteral formulations by combining expertise in design for peptide delivery, peptide synthesis, and drug delivery technologies.
The ‘Design for Peptide Delivery’ approach optimizes peptide physical and chemical properties early on in drug development, so as to match a peptide with the properties of microparticles, implants and other drug delivery formulations required for optimal drug delivery. Combining the capabilities and knowledge of Genzyme and SurModics Pharmaceuticals in parallel design of peptide and delivery systems will result in clients developing sophisticated pharmaceutical products that will benefit the patient.
"SurModics Pharmaceuticals’ scientific team has industry-leading experience in a wide range of drug delivery systems, with particular depth in long-acting parenterals such as microparticles and solid implants", said Dan Hayden, Senior Vice President and General Manager of Genzyme Pharmaceuticals. "Combining SurModics Pharmaceuticals’ strengths with Genzyme’s expertise in custom GMP peptide development and manufacturing provides a powerful service to peptide drug delivery customers." In the longer term many new and important drug delivery technologies can be developed from the portfolio of novel materials and technologies owned by Genzyme and SurModics Pharmaceuticals.
"By working with an industry leader like Genzyme, we envision this collaboration to generate plenty of energy, creativity, and new drug delivery solutions and products, from which our clients will greatly benefit," said Arthur Tipton, Ph.D., President and CEO of SurModics Pharmaceuticals. "From our experience in peptide delivery, we have learned that focusing on peptide modification and peptide properties can greatly aid in the stability and performance of a peptide drug delivery product."
Rather than promoting a specific technology, the Genzyme-SurModics Pharmaceuticals collaboration will offer customers a solution-oriented approach through synergistic capabilities and technologies, depending on the peptide and the customer's target drug profile. Customers will also benefit from enhanced capabilities and services such as research-scale peptide synthesis for backbone and side chain modifications, evaluation of available drug delivery technologies, large-scale peptide drug substance production, formulation feasibility studies and development of micro-encapsulation processes, drug excipients manufacturing (phospholipids and polymers), drug product formulation, and manufacturing of clinical supplies and final drug delivery product.
About SurModics Pharmaceuticals
SurModics Pharmaceuticals, a SurModics company, is a drug delivery company based in Birmingham, Alabama with formulation and scale up laboratories, clean rooms and a quality system that supports the manufacture of biomaterials and drug delivery dosage forms for clinical trials and the market. The company formulates long-acting products for its clients' active pharmaceutical ingredients. These active pharmaceutical ingredients include peptides, proteins, small molecules, nucleic acids, and other biological macromolecules. In addition to microsphere and implants, SurModics Pharmaceuticals provides drug delivery technology with solid-lipid nanoparticles, liposomes, and hydrophobic drug salts. SurModics Pharmaceuticals holds 19 patents in drug delivery and is adding new process and formulation patents to its proprietary technology portfolio. For further information, see www.surmodicspharma.com
About Genzyme Pharmaceuticals
Genzyme Pharmaceuticals works with pharmaceutical and biotechnology companies in the development and manufacture of specialty pharmaceutical materials and drug delivery technologies. Its technologies, products and services are focused primarily in the peptide, amino acid derivative, lipid and drug delivery markets. Genzyme Pharmaceuticals offers two novel drug delivery technologies. LipoBridge® is an innovative technology specifically designed to facilitate transport of drug compounds across the blood brain barrier (BBB) and into the Central Nervous System (CNS). LipoMask® is designed to increase the circulation half life of drug substances in blood. For further information, see www.genzymepharmaceuticals.com
About Genzyme
One of the world's leading biotechnology companies, Genzyme is dedicated to making a major positive impact on the lives of people with serious diseases. This year marks the 25th anniversary of Genzyme's founding. Since 1981, the company has grown from a small start-up to a diversified enterprise with more than 8,000 employees in locations spanning the globe and 2005 revenues of $2.7 billion. Genzyme has been selected by FORTUNE as one of the "100 Best Companies to Work For" in the United States.
With many established products and services helping patients in more than 80 countries, Genzyme is a leader in the effort to develop and apply the most advanced technologies in the life sciences. The company's products and services are focused on rare inherited disorders, kidney disease, orthopedics, cancer, transplant and immune diseases, and diagnostic testing. Genzyme's commitment to innovation continues today with a substantial development program focused on these fields, as well as heart disease and other areas of unmet medical need. For further information see www.genzyme.com
This press release contains forward-looking statements, including without limitation statements about the anticipated results of the SurModics Pharmaceuticals - Genzyme Pharmaceuticals collaboration; the potential development of new technologies and products; and the potential benefits to customers. These statements are subject to risks and uncertainties that could cause actual results to differ materially from those projected in these forward-looking statements. These risks and uncertainties include, among others: Genzyme's ability to develop drug delivery solutions and combine its materials and technologies with SurModics Pharmaceuticals' materials and technologies; Genzyme's ability to market and sell its technologies and products to customers; the actual results of the development work performed during the collaboration and the analysis of such data; and the risks and uncertainties described in reports filed by Genzyme with the Securities and Exchange Commission under the Securities Exchange Act of 1934, as amended, including without limitation the information under the heading "Factors Affecting Future Operating Results" in the Management's Discussion and Analysis of Financial Condition and Results of Operations section of the Genzyme Annual Report on Form 10-K for the period ended December 31, 2005. Genzyme cautions investors not to place undue reliance on the forward-looking statements contained in this press release. These statements speak only as of the date of this press release, and Genzyme undertakes no obligation to update or revise these statements.
Genzyme Pharmaceuticals' press releases and other company information are available at www.genzymepharmaceuticals.com.
SurModics Announces Organizational and Leadership Changes
http://finance.yahoo.com/news/SurModics-Announces-bw-1811495300.html?x=0&.v=1
Come to think of it, I'm not sure the name Surmodics still fits well. Pharmodics?
Re: ultraweb
Corning issue a memo on their website on this subject a few months ago. In the memo they stated that the reason for discontinuing the product was a lack of supplier for the electrospun nanofibers. Thus, it looks like Donaldson backed out. I don't get the sense that these products were yet generating much revenue. I wonder what plans SRDX might have for their IP in this area.
Did everyone notice that Xience V has been approved in Japan? Japan is the world's second largest DES market. I don't know of any other explanation for the accelerated drop in SRDX's valuation the past week. Any other ideas?
http://finance.yahoo.com/news/New-Market-for-Abbotts-XIENCE-zacks-2261172979.html?x=0&.v=1
Hi Bridge, my take on SRDX is that it is currently a good value if you have a long-term investment horizon and a measure of risk tolerance. The rapid return to the low 20's could be due to a combination of frustrated long-term shareholders and a lack of near-term revenue growth drivers, but one never knows for sure. I did notice that the shorts shorted the heck out of the stock following the Roche announcement, and short interest has now returned to pre-announcement levels (~3M shares).
I sold some shares at a bit over $30 following the announcement and repurchased some of them at $24-25. The long-term outlook certainly looks better now than it did a three months ago, and the stock price is essentially the same. Efficient market?
I was surprised by the Orbus announcement, because it utilizes SRDX biodegradable drug delivery technology (licensed from OctoPlus) on a stent that may compete with SRDX's prohealing technology if they both make it to the market on DESs (the Orbus combo stent does not utilize SRDX's pro-healing technology). I suppose an unfavorable royalty rate or licensing fees with OrbusNeich could make this an unwise opportunity. However, all things being equal, Orbus's antibody-mediated EPC capture may be at a disadvantage since antibodies can be somewhat toxic towards their targets (SRDX's/Stuart Williams' Finale prohealing coating utilizes an ECM protein-based coating to promote endothelialization -- perhaps an advantage). I'm tempted to speculate that this might be why the Genous R Stent has lack-luster performance, and why Orbus is now pursuing a combo stent. I will be interesting to see how Protex performs.
I'm intrigued by your cash positioning, what makes you to anticipate another severe market correction?
Re: rapamycin on Sparrow
I assume as much, since Cardiomind reported doing pre-clinical work with Rapamycin and Symbiosys. This was reported in 2007 through EuroPCR online. This information can be found in the first link in my previous email, under technical specifications. You may have to cut and paste the link into your browser window to view the pdf document. IMHO this is pretty cool stuff, since it is precisely in the smaller vessels where DES becomes more essential, compared to BMS (as you know, equivalent degrees of late loss make less of a clinical impact in large vessels, and thus the perceived threat of late thrombosis due to DES may outweigh the perceived benefit of a DES, in large vessels).
I agree completely with you about the benefit of thin struts. Bulk effect and trauma are minimized with the Sparrow. Closed-cell formats are also nice in terms of distributing pressure evenly on vessel walls, further minimizing trauma. And then there is the aspect of self expansion...maybe a little risky/bold, but seemingly essential for in-the-guidewire delivery. I think they put a lot of thought into the design of the Sparrow. Let's just hope Cardiomind doesn't get acquired by BSX ;)
P.S. I think this would be a great format for SRDX's Finale coating.
FP and Dew, the Sparrow DES is a delicate (minimally damaging), thin-strut closed-cell self-expanding nitinol platform loaded with Rapamycin using Surmodics Synbiosys biodegradable polymer (although other drugs could be used). Due to it's very low crossing profile (it actually fits inside the guidewire lumen), such a stent could be well utilized in diabetics, as well as being potentially suitable for the neurovascular and the peripherial vasculature. Current sizes range from 2-3.5mm o.d., expanded.
www.europcronline.com/eurointervention/download_pdf.php?issue=9th&article=25
http://www.azom.com/news.asp?newsID=5004
www.touchbriefings.com/pdf/1133/Innocore_tech.pdf
Re: Keough Resignation
"Steven J. Keough joined SurModics as its Senior Vice President and Chief Intellectual Property Counsel in January 2004 and added the duties of Vice President and General Manager of the SurModics New Ventures business unit in April of that year which then became the Orthopedics Business Unit in August of 2005. Before joining SurModics, Keough practiced law at Minneapolis-based Fredrikson & Byron, P.A., where he was a senior member and past chairman of the intellectual property department. He previously served as president and co-founder of the intellectual property law firm Patterson & Keough. He also was manager of Asia-Pacific matters at the Minneapolis law firm of Merchant & Gould. Keough has 16 years of extensive business and legal experience involving medical technologies, technology transfer, strategic planning, licensing and high technology business management. Additionally, Keough is registered to practice before the United States Patent and Trademark Office and has been admitted to practice law in Minnesota's Federal District Courts and before the Court of Appeals for the Federal Circuit. Keough earned his law degree from Boston College, his master's degree in Congressional studies from the Catholic University of America and his bachelor's degree from the United States Naval Academy . "
http://www.surmodics.com/pageDetail.aspx?pageId=50&menuId=56#Keough
He has a good resume. However, it might just be time to replace him as head of Orthopedics. The business unit he joined, 4 years ago, has since changed significantly. This was the "New Ventures" business unit, for those of you who may not remember, and technically it no longer exsists. I was impressed that they had such a business unit, BTW.
Furthermore, Ortho has seemed to progress more slowly than SRDX's other endeavors, being just over the horizon for a few years now. Perhaps it would be better to have someone with more of an Orthopedics-specific (or chemistry/biology) background in charge of that business unit. Nevertheless, the question on my mind at this point is, what will happen next? Will Ortho be dissolved or will it get a new GM?
This is good news, as expected. Congrats longs! The next hurdle for this trial is immunogenicity. I don't expect any significant problems there, but it is a bigger hurdle than efficacy, IMHO (only bad luck or inadequate trial design could have interfered with reaching the primary endpoint). GTCB has moved a step closer to profitability, which is fundamentally important since cash has long been their biggest concern.
Cheers.
Democritus,
I agree with you that R&D revenue is a very important leading indicator long-term. My hunch is that SRDX and Brookwood saw potential synergies that will ultimately be consistent with SRDX's business model of high margin royalties and licensing fees, leading to the merger. This supposition is consistent with, but not necessarily implied by, the recent increase in R&D revenue.
The most speculative investment I have made so far is BLSI (ALSE). It has been a poor long-term investment, to say the least, but it is long-shot and fortunately I invested only a small allocation accordingly (~1% at the time). My investment premise was based on their imaging agents. I think the science is there but the company obviously lacks follow-through. It will be interesting, at least, to see what happens.
This indicator of DES sentiment is obviously good news for the DES market.
U.K. to Keep Reimbursement
For Coated Heart Stents
By KEITH J. WINSTEIN
January 25, 2008 5:14 p.m.
The United Kingdom's National Institute for Health and Clinical Excellence, or NICE, will keep its existing recommendations on the cost-effectiveness of drug-coated stents, according to people familiar with the matter.
Stents are tiny scaffolds that prop open clogged arteries. Last year, the agency opined in draft recommendations that the fanciest stents -- those coated with drugs to keep arteries from reclogging -- weren't worth the extra cost.
The reversal is good news for coated-stent manufacturers, including Boston Scientific Corp., Johnson & Johnson, Abbott Laboratories, and Medtronic Inc. Had the agency adopted its draft as a final recommendation, the National Health Service would likely have reduced its coverage of the coated stents.
A bare stent costs about $800, compared with roughly $2,000 for a coated stent. But arteries opened with bare stents clog up and require a repeat procedure about 8% of the time, compared with roughly 4% for coated stents.
The agency presented the decision under an embargo to British doctors Friday. News of the decision, set to be announced next week, was first reported by the Web site www.theheart.org.
Write to Keith J. Winstein at keith.winstein@wsj.com
http://online.wsj.com/article/SB120129812237617907.html?mod=yahoo_hs&ru=yahoo
I'm here, just listening. I don't have much of anything useful to say about SRDX's accounting methods, or accounting in general for that matter. For simplicity, I tend to focus on revenue (absent any material change in the business model).
FWIW, I don't think SRDX would intentionally use accounting to artificially lower share price in support of a buy-back. But I suppose they might preauthorize a buy-back if they thought acting in the long-term interests of the company would produce a good buying opportunity.
BTW, has anyone thought much about potential synergies between Brookwood and MRK?
Re: Xience
I think the shortcoming of DES is the focus on suppression of scarring without due consideration of normal healing. The advance of Xience over existing DES technology so far looks small and incremental. I see no suggestion that it will perform any better than Cypher or Taxus on late thrombosis (which was foreshadowed by Dr. Virmani's data, revealing that while Xience -- and Endeavor for that matter -- had more rapid endothelization than Cypher and Taxus, the neointima showed biochemical and cellular irregularities).
Thus, in the big picture, Xience so far does not look like the paradigm-shifting technology that interventional cardiology needs. Rather, I view it as further evidence that late thrombosis is not commonly a polymer-specific issue (likely a combination of drug-induced neointimal irregularities and changes in stent usage/patient selection in the DES era), and also continue to doubt that degradable polymers will solve the problem. SRDX's Finale and/or similar pro-healing technologies continue to hold promise, IMHO. Another possibility might be drugs or drug combinations that better support healing.
Re: another round of share repurchases
It worked out very well the first time. I was hoping this might happen again and see it as a positive indicator of insider sentiment. Last time, however, if I remember correctly, management did not control the timing of share repurchases. They will this round.
The setting of a mandatory age for retirement from the BOD is arbitrary, generally unnecessary and unfair, IMHO. I'm not surprised that Dale is retiring (willingly or otherwise), but I am surprised to see such a blanket policy, and moreover, an immediate exception to this policy as it concerns Dr. Keller. It seems perhaps a bit political, and gives the impression that Dale is being pressured off the board.
Could this impression be intentional, perhaps? Voluntary retirement by Olseth might worry some investors. As Democritus recently reminded us, Dale owns a considerable slice of SRDX and I assume that the Emeritus Chairman title is not an insider designation according to the SEC, so his future transactions will not be public (if anyone knows otherwise, please correct me).
But, in any case, thanks to Olseth for his years of hard work!
"anything approvable via a 510(k) is by definition not a cutting-edge innovation."
It is possible there could be exceptions to this statement. Some polymers used in drug delivery, for example PBMA which is a component of the Cyhper drug-eluting stent, have long been used in the orthopedic arena for other purposes (in this case as a cement). Thus, if SRDX is using a polymer that has well-established safety in orthopedics to deliver a drug, then perhaps that device might slide in under the 510(k)?
Hi and thanks.
I've been very busy lately with no let up in sight. I'm sure I speak for many lurkers when saying I appreciate all the posts. I'll post with greater depth and frequency when time allows. As far as this run-up goes, its about time. With so many good prospects for SRDX I'm holding on, waiting to see what's around the corner...
ABT CC: excerpts re Xience from transcript
In late May, we submitted our final PMA module for FDA approval of XIENCE V, our drug-eluting stent. Our PMA submission includes safety and efficacy data from the XIENCE SPIRIT family of clinical trials, which not only met their primary end points, but demonstrated superiority of XIENCE over Taxus. This is the first ever FDA submission to include clinical trial data that demonstrates the superiority of one drug-eluting stent over another.
We anticipate launching XIENCE in the first half of next year. The international launch of XIENCE continues to proceed well. Interventional cardiologists are impressed with the clinical data as well as the deliverability of the XIENCE platform.
We are capturing new accounts as they become available through the hospital tender process. Since our launch in the fourth quarter of last year, we are gaining on average 4 share points per quarter. In many of the early launch countries, we have exceeded 20% market share.
XIENCE is performing exceptionally well in the Asia Pacific region. In India, for example, when looking across the major competitors, XIENCE has already surpassed 30% market share. So we remain on track to exit 2007 with overall market share in the mid to high 20% range.[note, BSX refuses to break out Promus market share numbers, so they are probably well south of here]
Our global DES franchise sales, which as a reminder, includes XIENCE, as well as other DES product revenues that we receive, were approximately $60 million. This included a 40% increase in XIENCE sales on a sequential quarterly basis, offset by lower sequential third party related DES revenues.
We are also encouraged by the upward trend we've seen for May XIENCE sales, which grew nearly 40% from April monthly sales. In addition, sales of XIENCE in June were the highest monthly sales since the launch at the end of last year. As a reminder, June sales are not reported here in the second quarter, given that we report international sales on a one-month lag.
In May at the EuroPCR meeting, results from our SPIRIT first trial demonstrated no thrombosis and a very low MACE rate out to three years. At the same meeting, data from a 1,300 patient meta-analysis of SPIRIT II and SPIRIT III reaffirm the superiority of XIENCE compared to Taxus. These results add to the growing body of evidence supporting XIENCE as a best-in-class next generation DES technology.
And as you know, Abbott is in a unique position to participate in both the drug-eluting and the bare metal stent markets. Physicians appreciate the excellent deliverability and acute performance of our VISION bare metal stent, which remains the global market leader.
So total coronary stent sales, which again include bare metal and drug-eluting stents, were $166 million in the quarter, up sequentially from the first quarter. In our DES pipeline, we're advancing a number of next generation stent technologies behind XIENCE.
Our goal is to release new technology at regular intervals over the next several years. This includes a more deliverable workhorse stent, a bifurcation stent design, as well as our bioabsorbable drug-eluting stent. [more deliverable --Lubricity is a likely bet, IMHO]
...
DES penetration, our information shows that it's in the mid to upper 60% range, which I think is fairly consistent with what we've heard from our competitors. And it looks like it's stabilizing in the U.S. X-U.S., it's actually ticking up a little bit depending on the market, Europe and Japan.
And the forecast is that that will continue to tick upward. So we're pleased with that. And of course, having the latest new technology in the marketplace with XIENCE will hopefully help with that when we get the product launch in the U.S. to launch into an accelerating, reaccelerating marketplace.
PCI volume based on the data that we have, which is pretty good, that we triangulate on in terms of catheter sales and so forth, our PCI volume looks to be down in the high single-digit range.
http://seekingalpha.com/article/49487-abbott-laboratories-q2-2007-earnings-call-transcript?source=ya....
Genentech to Curb Avastin's Use
In Treating Eye Degeneration
This is not a very friendly (nor likely effective) way to manage the issue of Lucentis sales lost to off-label Avastin use in AMD.
By JACOB GOLDSTEIN
October 11, 2007 4:25 p.m.
Genentech Inc. said it will no longer make its cancer drug Avastin available to so-called compounding pharmacies in a bid to curb its widespread use in treating a degenerative eye disease -- which has cut into sales of the company's high-priced eye drug.
Although regulators haven't authorized Avastin's use against eye disease, it is chemically very similar to Genentech's Lucentis, which was approved last year to treat wet macular degeneration, a condition caused by an overgrowth of vessels in the retina that leak and damage vision. Compounding pharmacies re-package vials of Avastin into syringes that contain a once-monthly dose of the drug for use in the eye and cost about $40. A once-monthly dose of Lucentis costs about $2,000.
In the first six months of this year, U.S. sales of Avastin were $1.1 billion, and Lucentis sales were $420 million.
In a letter explaining the decision, Genentech pointed out that Lucentis was developed expressly for use in the eyes, and said the Food and Drug Administration has expressed safety concerns about the repackaging of Avastin for that use.
Avastin, which is sold through wholesalers, will continue to be available to hospital pharmacies and directly to doctors. But it won't be available to compounding pharmacies as of Nov. 30.
Anne Fung, a San Francisco ophthalmologist, said she worries that some doctors may try to do the repackaging work themselves without the proper safety equipment. "This move is taking it out of a regulated environment into an unregulated environment," she said. That could increase the risk of contamination and serious eye infections.
Dr. Fung, who said Avastin and Lucentis are split roughly 50-50 among macular-degeneration patients, said she would likely try to get Avastin from a hospital pharmacy for her patients. That could increase the cost of treating her patients.
Genentech spokeswoman Dawn Kalmar said most macular-degeneration patients are covered by Medicare, and said the company helps connect patients who can't cover their copayment -- which can be $400 a month for Lucentis -- with charities that help with payment.
Write to Jacob Goldstein at Jacob.Goldstein@wsj.com
Re: Endeavor
I don't know what the royalty rate to SRDX for lubricity on the delivery system is. Thus, I also have no idea whether entry into the US market will help boost overall royalty income for SRDX.
Endeavor will take market share from both Cypher and Taxus: if for example, Endeavor takes 10% of the market from Cypher and 10% from Taxus, and SRDX earns half the royalty rate on Endeavor as it does from Cypher, the overall royalty stream to SRDX will be unaffected (excluding reagent sales). Thus, if SRDX earns substantially more than 0.5% royalty, they stand to benefit.
Democritus, that is interesting. Thanks.
re: QLTI acquisition of ForSight Newco
ForSight Labs has Eugene de Juan (formerly of InnoRx) as a founder. ForSight Newco II, inc. is a spinoff of ForSight Labs. For drugs that are effective in eye-drop form, this plug sounds like a good alternative (at least in theory), which could enhance convinence, efficacy, and patient compliance.
Good point.
Re: Trap
Since FDA approval is likely, lets put that issue aside. Don't you think docs will tell their patients that "both drugs showed 6 (or whatever) letters of improvement on average" and leave it at that? This is probably a naive question, but how does the FDA criterion factor into marketing? Are you talking about the ability of the companies to make claims in direct to patient advertisements? In this scenario, the FDA has created (inadvertently or not) a huge first to market advantage. If REGN/Bayer were to use a placebo control arm in their 1200 patient trial, they would probably be able to demonstrate improved vision.
Beyond approval, do FDA semantics really make a big impact on drug usage? When I hear PFE, for example, claim that zyrtec is the only antihistamine approved for "indoor allergies", I laugh. What a joke! I assume doctors can see through this smoke as well.
Re: VEGF Trap-eye trial design
Dew, I don't yet see eye to eye with you on this one. Sure, from a marketing perspective it would be better to claim that Trap shows non-inferiority to Lucentis in terms of improved vision, but in some ways, I think this is just a sound bite.
For Lucentis Phase III, although the results were remarkable, as you know really a minority of patients improved (33% gained 3+ lines in Marina). This could be close to the ceiling for anti-VEGF drug monotherapy in diverse patient populations. Trap would probably come in equivalent on this metric, given enough patients, but have little chance of superiority IMHO. Thus, I can see some logic in simply comparing directly the visual acuity changes of the overall patient populations, and getting the drug approved. They'll have a better chance of performing better than Lucentis on this measure (if they get lucky), and in any case get enough sales to make funding the trials profitable. (and they'll have an approved drug they can load on an implant ;))
A related issue that we haven't broached in this discussion, which I think we can agree on, is of course the role of Avastin in influencing the tide of the AMD market. Thus, why fund a massive trial (the existing Phase III Trap trial is already larger than Marina) with an equivalent product? Patient recruiting might be slow to boot. Surely everyone must be concerned with the low cost of Avastin (even if Avastin turns out not to be quite as good as Lucentis), and the 12 week dosing for Trap in Phase II didn't look much better than the Lucentis quarterly dosing, if I remember correctly. If pharma/biotech wants to make further substantial improvements to AMD patient lives (and substantiate blockbuster profits), they need to either improve dosing or go after more efficacious targets (IMHO).
Re: VEGF trap-eye
The Phase II data were pretty decent, I think (average of 5-6 letters improvement for trap-Eye, compared to 7 letters in the Phase III Marina trial with Lucentis or 5 letters in Phase II Focus study). Phase III for trap-Eye will compare trap-Eye with Lucentis. Dew, do you know whether the study is powered adequately to test for superiority vs. Lucentis?
If powering a study to show equivalency (or superiority) to Lucentis requires fewer patients than a study powered to meet the FDA's current definition of improved vision, this might be the better route to take from a business perspective, No?
If a second essentially equivalent, injectible drug for wet AMD comes to the market, this will be a good scenario for occular sustained drug-delivery technology holders.
P.S. I don't know enough about viral techniques for cloning animals to comment meaningfully on your recent query regarding GTCB.
Study finds drug-coated stents safe for high-risk patients
Here is yet another study to add fuel to the debate.
By Val Brickates Kennedy, MarketWatch
Last Update: 6:17 PM ET Oct 3, 2007
BOSTON (MarketWatch) -- A study published Wednesday in a leading medical journal has found that the use of drug-coated rather than bare-metal stents resulted in the need for fewer repeat procedures and did not significantly raise the risk of heart attack in certain high-risk patients.
Drug-coated stent recipients who were at higher risk of developing a condition called restenosis did not need to have the surgical procedure repeated as often as those who received bare-metal stents, according to a Canadian study published in the New England Journal of Medicine.
Stents are tiny mesh devices that are inserted into arteries after they are cleared of blockages through such procedures as angioplasty. The stents are often coated with a drug that prevents the build up of scar tissue, or restenosis, which can re-block the artery. The condition often results in surgeons having to repeat the procedure in order to keep the artery clear.
However, the wide use of drug-coated stents has been called into question recently by a group of studies that found some recipients had a slightly elevated risk of developing blood clots in the months following the procedure. Blood clots are a leading cause of heart attack and stroke.
The publicly funded Canadian study also found that those at higher risk for restenosis who received drug-coated stents did not have an appreciably higher rate of heart attack or death. Significant risk factors in developing restenosis include having diabetes or small blood vessels.
The study noted, however, that those who were not at higher risk for developing restenosis did not appear to benefit any more from drug-coated stents than from bare-metal stents.
"In conclusion, the experience in Ontario, Canada, is that drug-eluting stents are more effective than bare-metal stents in reducing the need for target-vessel revascularization in patients at highest risk for restenosis after PCI but offer minimal benefit to patients at lower risk," wrote the researchers. PCI is a technical term for angioplasty.
"The small absolute difference in mortality in favor of [emphasis added] drug-eluting stents in our study warrants further investigation and should be confirmed or refuted through large, randomized clinical trials with long-term follow-up," the researchers added.
http://www.marketwatch.com/news/story/study-finds-drug-coated-stents-safe/story.aspx?guid=%7B32FF3B5...
Regeneron Shares Rise on VEGF Data
Note, I've always liked the idea of "Trap" technology. It essentially works like an antibody, but uses a soluble, recombinant derivative of the engodenous VEGF receptor...which of course binds VEGF. In theory this could have advantages over Lucentis, but so far I am not aware of any data to validate this.
Monday October 1, 11:10 am ET
Regeneron Pharmaceuticals Shares Rise on Positive Midstage Data From VEGF Trap-Eye Study
NEW YORK (AP) -- Shares of Regeneron Pharmaceuticals Inc. rose Monday after the company said it saw positive results in a midstage study of its treatment candidate for age-related macular degeneration.
The stock rose 53 cents, or 3 percent, to $18.33 in morning trading. Shares have traded between $13.55 and $28.74 over the last 52 weeks.
The condition is the most common cause of vision loss in the United States for those aged 50 years or older. Central vision deteriorates because of a hardening of the arteries that feed the retina.
In the Phase II clinical trial, the drug candidate met its primary goal of reducing retinal thickness after 12 weeks of treatment. The drug candidate also reduced the number of patients with vision of 20/200 or worse, which is a generally accepted definition for legal blindness, the companies said.
The drug candidate, VEGF Trap-Eye, is being codeveloped with Bayer HealthCare AG.
The study involved 157 patients, divided into five groups and treated with VEGF Trap-Eye in one eye. Two groups received monthly doses and three groups received quarterly doses ranging from a half-milligram to 4 milligrams.
The company has already decided to study both the half-milligram and 2-milligram doses in a Phase III, or late-stage, clinical trial, which will involve more patients.
Biotechnology company Genentech Inc. received approval for its age-related macular degeneration treatment last June and saw sales of $209 million from the drug during the second quarter of 2007.
Meanwhile, potential competitor Alcon Inc. is facing problems with its proposed treatment after the Food and Drug Administration asked for an additional study on its drug candidate Retaane.
The company said it had no plans to conduct a new study because of the difficulties in recruiting patients, but will continue with a study aimed at reducing the risk of age-related macular degeneration to progress from the dry form to the wet form.
Shares of Genentech fell 68 cents to $77.34 and shares of Alcon rose 99 cents to $144.91 in morning trading.
http://biz.yahoo.com/ap/071001/regeneron_pharmaceuticals_mover.html?.v=1