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Something worthwhile fromt the Yahoo Wasteland
http://messages.finance.yahoo.com/Stocks_%28A_to_Z%29/Stocks_I/threadview?m=tm&bn=22883&tid=...
NVS and TEVA Square off today
Anyone care to hadicap it.
http://israelnewsletter.com/2007/05/25/teva-tuesday-is-d-day/
Please excuse my lacking French language skills. But I may disagree with the following statement
>In other words, I’m saying that a meaningful antagonistic interaction can only be bad, not good.<
I realize that on the whole a antagonistic drug reaction is likely to be a negative. But if the 10% of the population cannot tolerate the treatment (which I beleive is the case for a vrtx 950 combo with RIBA) does it matter that it is more effective?
I think you are comparing NM283 to the current benchmark comparisons to SOC. I agree that the NM283 combo would have to prove more effective than SOC alone (i.e., cannot be antagonistic in this sense). But assuming that a protease combo and a polymerase combo were approved at some point in the future wouldn't tolerability become an issue?
It really becomes a question of efficacy. A slight reduction in efficacy (relative to a protease combination) might be tolerable if the side effects are are more manageable for the population that can't handle the rash issue side effects.
It's probably best not to think that far ahead but I think it could highlight what IDIX has said about NMP 283 being likely to have a role in future HBV treatment whether it is in the triple combo or as a part of another combination.
Thanks to the active posters on this board for continuing to educate.
FL
Synergistic v. antagonistic interaction?
There has been much discussion on this board on the potential interaction with Ribavarin. It is interesting to note that the protease inhibitor VRTX 950 is considered to work synergistically with RIBA but had a 10% drop out rate due to rash side effects often associated with RIBA. The NM283 combination with RIBA does not appear to have many discontinuations due to side effects associated with RIBA (I believe JP attributed 2 of the 3 discontinuations to interferon SE's) and the other to pneumonia.
Is it possible or likely that that a continuoum of interaction effects exists. If a drug works too synergistically it magnifies the side effects of RIBA (i.e., Rash). The antagonistic interaction mitigates some of these side effects. So the big question becomes to what extent the efficacy is also reduced.
However, if the efficacy is within the margin suggested by this board 10% above SOC, is it likely that a market would still exist for patients who are RIBA sensitive (i.e, will the combination with NM283 ameliorate side effects but still maintain sufficient efficacy to maintain a market as part of a triple therapy combination?). As such could a potential nitch market exist as part of triple therapy for those who cannot tolerate a Protease-RIBA combination.
Do others see this as a question of the size of the market. 10% improvement in efficacy still preserves enough of an improvement to go after (especially in the segment of the population who is sensitive to Riba).
Good Luck FL
Go Seek
I appreciate your efforts to keep the readers of this board informed.
I can think of a lot of reasons to close out short positions. IDIX is being valued as if NM283 has no future application. The June top line data could show potential as part of a triple therapy or a testing program with a protease inhibitor combination could be announced. Another milestone payment from NVS would further enhance the valuation. Finally, Sebivo has started launching in markets in Europe and Asia and upside traction could jump start IDIX. I realize NVS will benifit from many of the new market launches but milestone payments and royalties will become significant. It will also help to draw attention to the need for more testing of the immigrant population in the US.
As painful as it is to add to my worst holding, I've done so in the last couple days. I think the worse case is a test of $6 but the upside could be easily take it into the low teens in less than a year. Valuation on the forward earnings potential of Tazeka/Sebivo alone is sufficient to justify the current share price. However, it will likely be several more quarters before this becomes evident. The expansion of the HBV market will also be more apparent in the comming quarters.
Once again, I feel like I'm way to early into IDIX but the long term prospects have not diminished to the extent that it has been discounted by Wall Street. A catalyst is really necessary to jump start things.
As I've indicated before, I worry a little about the idea of running tests to produce head to head tests v. Barraclude. It seems that being one of the best products in an expanding market is an ok position. I'm not sure if the head to head is worth the risk. I'm interested in your opinion on this point.
Thanks Again
FL
Good Luck
Biotech revs
The Annual Report did not seam to break it out by sector. They break out trading vs. investment banking etc. Not Healthcare vs. telecom or alt. energy vs telecom. I'll keep looking. The 10K indicated that 35% of the research staff is focused on healthcare.
Here is a summary of the investment banking health care activities over the past couple years.
http://cowen.com/InvestmentBanking_833.asp
I'll listen to the 1st qtr call on Tuesday and let you know what I learn.
FL
I agree about the cyclic nature of IB in this sector. However, how strong a run do you think biotech has been on? It has been spotty at best. Great if your big biotech (DNA, GILD etc.) but hit or miss outside of these high profile firms. I'd put us in the middle innings rather than late in the game. My thinking is that big pharma is the money driving bio appreciation and the pipelines of these firms still need juice to make up for what they are not doing with their internal R&D. This should provide for more years.
Secondly, the as aging baby boomers in management positions
of private biotech firms look to cash their shares out they will need to find equity either by going public or private equity. This should create opportunities in IB.
Finally, the valuations are very mixed in IB. If you look at the big powerhouses GS, MER, etc. they have had a big run up but the boutique shops have been hit or miss. They may be over valued if inflated earnings contract. COWN is interesting since it is reasonably valued with a specialty in healthcare which may have more room to run. I've been tepid in my buying because I'm worried about the ability to go up against the powerhouses. I need to see if last quarters good earnings can be sustained. Insider buying helps but it is a sector I'm not really up to speed on.
The other negatives include a fair amount of litigation and options to be excercised but I think there may be good potential even given these concerns.
Thanks for the input DEW.
FL
Biotech values/investment banking angle
After several years of biotech investing, I've been burned by numerous secondary offerings, Pipes, convertibles .... I started thinking that investment bankers catering to the biotech industry may be an interesting play, especially if healthcare turns around in a strong way. I'm looking at COWN and have started establishing a small position based on attractive valuation (PE=5) and their strength in healthcare.
http://www.cowen.com/InvestmentBanking_439.asp
The price has not moved much above their 2006 IPO price, but I believe that could change if healthcare gets hot. Pharma's recent show of strength and mergers suggests things may be heating up. If so, additional IPO's might hit the market and add to their investment banking income. They anounce earnings on Monday. Any opinions on Cowens strength in biotech investment banking.
Good Luck
FL
Rumor on NVS Board
Has NVS buying DOR:BB. At first I blew it off as a pump and dump attempt but thought I'd see what you guys thought.
Any chance that this firms lead product under FDA review might have any utility in treating gastrointestinal side effects of NMP 283 at 800 mg. It looks like a steroid aimed at inflamation. Was NM283 SE nausea and inflamation?
Just curious whether it is a possible fitfor the innovative solution we have heard about.
Good Luck FL
Lucentis in Europe
I thought part of the reason for the engineering of Lucentis was to improve uptake relative to Avastin. I heard some speculation that Avastin could have a worse stroke profile than Lucentis. Probably won't know until the results of the studies are in.
Would you expect the formulation of Lucentis vs. avastin to be more prone to strokes.
Good Luck FL
That's becaus NVS has been in the proverbial wood shed all week. Tekturna unlocked the door.
Do you see Lucentis following a similar trajectory in the EU as DNA has seen in the US? The recent concerns and notification of strokes may slow it some but I think it will still do well. It is a tough choice - slight risk of stroke vs. eventual blindness. Can Dr's medicate to reduce the risk of stroke where feasible?
Thanks
FL
Given the complementary cross-resistance profiles alluded to below, what are the most likely protease agents to team Valopicitabine with?
I know there has been considerable discussion on this topic on this board. I believe JP indicated that collaborative agreements to evaluate combinations were likely before the end of the year. What possible combinations does the board see as most likely?
VALOPICITABINE (NM283) IS FULLY ACTIVE AGAINST KNOWN HCV PROTEASE RESISTANCE MUTATIONS IN VITRO
V. Bichko 1, L. Lallos 1, M. Soubasakos 1, M. LaColla 1, M.M. Tausek 1, J. Gillum 1, D.N. Standring 1
1 Idenix Pharmaceuticals, Cambridge, MA, USA
Background and aims: Valopicitabine (NM283), an inhibitor of the HCV NS5B polymerase, is an orally bioavailable prodrug of NM107 (2’-C-methylcytidine), and is in phase II clinical development for the treatment of chronic hepatitis C. Agents that target the NS3 serine protease are also in development for HCV. A number of NS3 mutations that confer resistance to protease inhibitors have been identified in vitro and have emerged rapidly in clinical trials. This suggests that development of resistance to these agents may limit clinical efficacy, and combinations of HCV antivirals with different resistance profiles may maintain viral suppression more consistently. To evaluate the potential for development of such combinations, the present study assesses the antiviral activity of NM107 against major mutations that confer resistance to protease inhibitors.
Methods: Protease inhibitor resistance mutations, including R155Q, A156T, D168A, D168V, and D168Y, were introduced into the HCV replicon cDNA by site-directed mutagenesis. Following RNA electroporation and G418 selection, stable Huh7 cell lines harboring mutant replicons were generated. Alternatively, mutant HCV replicons were transiently transfected into Huh7 cells (that had been cured of the replicon) for drug susceptibility studies. Inhibition of viral replication was measured by quantitative real-time RT-PCR as well as western blot analyses for NS5A protein. To identify NM283/NM107 resistance mutations, a Huh7 cell line harboring NM107-resistant HCV subgenomic replicon was selected by passaging with increasing amounts of NM107.
Results: All tested protease inhibitor resistance mutations were fully sensitive to NM107, with EC50 values similar to that of the wild type replicon. In separate experiments, sequencing of NM107-resistant HCV replicons identified a single mutation (S282T), in the highly conserved B domain of NS5B, that conferred a moderate degree of resistance to NM107 (<20-fold change in EC50 values).
Conclusions: These initial results suggest that valopicitabine and HCV protease inhibitors have complementary cross-resistance profiles, thus combination therapies with these agents could be an advantageous strategy to suppress the emergence of resistance and maintain effective viral suppression. Additional in vitro drug combination studies are underway.
Bloomberg Analyst interview this morning
I was on my way out this morning but caught part of a analyst interview. He said that big Pharma in the US had to buy promising pipelines since they are not making up for there patent expirations organically, through R&D.
He thought antiviral biotech firms were likely to be one of the top targets over the next couple years. Unfortunately, I did not get his name.
Good Luck FL
I" saw my shares go green yesterday. I think NVS is generally an astute buyer so based on their basis being closer to $20 I intend to hold for a while.
I think the Hepsera sales data as a basis of comparison suggests IDIX could justify a low teens valuation on Tezeka/Sebio alone in a couple years.
FL
Waxman had a busy couple of days. First he denounced NVS for trying to enforce its patents against Indian generic Gleevec competition. Now he introduces legislation for generic biopharma drugs. Looks like he comes down squarely on the side of cheaper drugs regardless of whether it violates intellectual property rights or not.
Anyone know the specifics on how the legislation proposes bioequivalency should be demonstrated?
Good Luck
FL
$5B unrealized gain.
Dew
I do not see NVS realizing that gain anytime soon. If Roche will not merge with NVS, I think NVS does not want Roche going to anyone else. They may maintain this investment until the entire generation of Roche shareholders who have rejected the previous NVS offers are out of the picture.
On another note, were you surprised by yesterdays reaction to the earnings falling a few cents short despite higher than expected sales? To me I've seen NVS refuse to minipulate the bottom line or play the game the way wall street likes that it was no surprise. So many investors are so conditioned to pull the trigger as soon as they see a miss (regardless of the reason) that they don't see the overall progress.
I can't believe NVS still puts out the very low projections that are obviously understated based on growth of existing products not to mention the launch of several major new ones.
Thanks
FL
Hi Dew
It was Diovan vs. Norvasc in June of 2004. It came up being essentially equal for its chief end point (cardiac arrest events I believe). I saw a post on the NVS board and remember it but did not find the article to post.
In any event Diovan went on to be the best selling drug in that space and NVS' best selling drug so the results of the study were not detrimental. At the time it seemed like more of a positive for Norvasc.
You're right, there have not been many things that NVS has botched.
Good Luck FL
Dewophile I appreciate your effort as well as Dews to clarify the timeline issues. I think Dews response addresses the differences in the NVS slides. My reference to Doug D. slide corresponds to Dews slide 25 of 103. It includes a couple inferences that might have been too large of a leap.
1st I assumed that the stage 4 2009-2010 time frame was for approval (not filing) which I believe the NVS slides address.
I also assumed that NM283 was the furthest along of the nucleoside polymerase inhibitors and therefore was most likely to be the first to be used in the Stage 4 combination identified by the plan (2009-2010 time frame).
Based on these two leaps, my take away was that Doug D. thought NM283 would be on the market in either 2009 or 2010 whereas NVS is now indicating late 2010 or 2011 (based on a 2010 filing).
Is my thinking messed up on this or am I reading too much into Doug D's slides?
In any case I don't want to come off, negative since I'm long both IDIX and NVS.
Thanks for calling attention out on the head to head vs. Barraclude on the HBV front that really caught my attention. I used to think that pharma only ran those tests if they had a pretty good idea of the outcome. One of the few major NVS misteps I can remember was this type of a test a few years ago ( I beleive it was a hypertension product). Man it's embarrasing when you come up on the short side of your own head to head test data. Lets hope it goes better this time around.
Good Luck
Thanks
PS Sorry about the delay getting back to the board.
The NVS Investor pipeline update in Nov suggests that NM283 would not be filed until 2010 or later.
http://www.novartis.com/downloads_new/investors/pipeline/Planned_filling_2007_to_2010.ppt#1
This seems to have been at least a year later than the timeframe alluded to by Doug Dietrich at the investor lunch (Slide 13). What changed in the month following the investor lunch to push back the anticipated filing date. During the NVS pipeline conference I believe albuferon was described as the company's stongest treatment candidate (not an exact quote). Is it likely that NM283 is being considered primarily for use in combination with protese inhibitors or albuferon, thus the change in the anticipated filing dates?
I know you guys are pretty sharp on this subject, so please excuse me if these questions are way off base or easily explained.
Also, does anyone have more information on the senior VP who exited Idenix today?
Thanks
FL
Anyone have a link to todays Idenix presentation. I connected to Idenix's home page which routed me to JPMorgan on demand service which provided the Vertex's presentation but not the Idenix's presentation.
It figures that I had to take a call during JP's presentation.
FL
I was long NVS long before IDIX, which is a good thing given the valuation hair cut IDIX has taken relative to when NVS bought in. NVS and Roche are the cream of BP in my opinion. Although, the disparity in the pipelines that was so evident over the past few years is not as obvious this year.
I frequently wonder whether Vasella intends to make good on his promise to step down and retire in a couple years. NVS appears to have irons in the fire for several potential high growth areas. I'd like to see Dan stick around long enough to see things through.
Thanks for your work to in developing these informative boards.
Have a Happy Holidays.
FL
Thanks
Sorry about butchering the meaning of your previous post.
FL
Riba interaction
I read on this board (I believe) that the VX 950 9% discontinuation rate was largely associated with a skin rash SE. Dew (I believe) speculated that this SE might be the result of the VX950 enhancing the action of Riba, since skin rash is a known SE of Riba (in sensitative populations, I guess).
Is this likely to be easily addressed through Riba dosage modulation or are the studies conducted at a minimal dosage that should not be varied? Or is it likely to be a manner of additional trials (time) to determine optimal dosing?
Is it likely that there is a continuum of synergistic vs. antagonistic interaction with the best dosing/interaction performance occurring somewhere in the middle of the spectrum rather than at either of the extremes?
This is probably something that can only be determined with additional testing but I'd be interested in this boards thoughts.
Thanks
FL
I did not mean to convey the impression that LFB would not pull their weight in the relationship. Rather, I would liked to have seen a deal structured with some milestone payments to help with GTC's future cash burn. I guess that would reflect a licensing agreement rather than a 50-50 partnership. Since GTC has not yet tested any product in the area, a partnership is more appropriate.
Are you aware of LFB entering into similar collaborative partnerships? What is the track record for LFB in collaborative agreements?
GTC will tie up some resources and will probably increase the cash burn, but the market for FVIIa should be lucrative for a low cost producer bringing a product to market. The question is to what extent will ATryn and revenue from other licensing agreements be able to sustain GTC in the future. What is your best guess as to when financing will be come an issue again (18 months or longer?).
Thanks for your thoughts. This is the type of vote that only time can provide answers to. I'm not terribly swayed by the BOD recommendation since collectively they hold relatively few shares and most of their percentage ownership is in the form of options. But I do believe management sees enough upside to warrant the risks inherent in the partnership.
I realize each of us need to reach our own conclusions and vote our shares accordingly.
Thanks for your thoughts
FL
Dew
I still have not voted and have not really been too excited about the LFB deal. There are so many intangibles that it is hard to determine whether it is worth the cost of the dilution.
Your musings in post 1164 suggest that the you would not expect any factor VIIa product to reach market before 2013. Is this based on the development time frame for Atryn? Does your estimate factor in any net acceleration due to the technical collaborative benefits and expertise of LFB. Realistically, I know the time for pre-clinical and clinical work would make it difficult to launch in anything less than 6-7 yrs.
It is apparent that LFB is a strong partner for the development and marketing of plasma proteins but the proxy materials do not allow an investor to quantify the net benefit. It seems that the attitude of the Board is that the relationship will allow more rapid diversification of plasma protein portfolio of products (which is good) but I can't quantify whether it is worth the dilution or the potential impediment this could cause to a potential future buy out of GTCB.
My inclination is to vote no based on the information provided in the proxy. Perhaps LFB will sweeten the deal at some point. GTCB is positioned to be a low cost producer of these plasma products it seems that LFB ought to pay up more fore the partnership. Perhaps some milestone payments etc. If the deal does not go through, I know offering/additional dilution will probably occur anyway. So is this really as good a deal as GTCB could expect?
I have been called 3 times in the past 10 days by representatives offering to take my vote. I just don't feel like a very compelling case has been made yet. It sounds more like "trust us the collaberation will be good" type of thing. Any additional last minute thoughts.
FL
Dew
The Galvus extension has me dumfounded. The NVS Gallient and Glorius trials provided data for over 8000 patients, supposedly with no skin related issues. Since when does minor side effects during preclinical testing on animals warrant such caution compared to 8000 humans. The Merk Januvia trial appears to have been based on just over 2700 patients (see passage below). It would seem that preclinical animal testing concerns have been way overblown. NVS excercised caution going forward with Galvus and allowed Merk to beat them to the US market. Now it appears that FDA is looking to add to Merks cushion by allow Merk a few more months to launch ahead of Galvus. I don't like to be a conspiracy theorist but this seems suspicious.
Galvus appears to have efficacy advantage in terms of the level of blood sugar reduction. I don't know that NVS focused on the weight loss aspect whereas Merk may have to put a good spin on Januvia. The additional 3 months is a frustration but it will not be enough to trump efficacy advantages.
I realize the the link indicates that Galvus was used in combination with pioglitazone (reduces insulin resistance). Is pioglitazone likely to have improved the efficacy of Galvus?
What is your take on the delay and the potential efficacy question?
FL
http://www.statesman.com/health/content/shared-auto/healthnews/dia2/535575.html
"Januvia was studied in 2,719 patients with type 2 diabetes, with follow-ups of 12 weeks to more than a year. It lowered blood sugar levels by 0.67 percent for participants in a yearlong trial, or just as much as another, older drug, glipizide. Novartis' pill, Galvus (vildagliptin), reduced blood sugar levels by 1.9 percent when used with another older drug, pioglitazone, which reduces insulin resistance "
Gleevec use for autoimmune diseases
Saw this article on Bloomberg. The link did not seem to work. Search NVS News.
Evidently the Stanford research is supposed to be released this month. Has anyone seen it?
Autoimmune diseases constitute a huge market. However, the potential side effect profile and costs are likely to be issues limiting Gleevec use for these diseases.
FL
Cancer Drug May Be Remedy for Rheumatoid Arthritis, Stanford
Study Finds
STANFORD, Calif.--(BUSINESS WIRE)--
The potent cancer drug Gleevec, used to combat leukemia and some gastrointestinal cancers, may be useful in treating rheumatoid arthritis, according to a team of researchers at the Stanford University School of Medicine. Their findings will be published in the October issue of the Journal of Clinical Investigation.
¶ Although the study shows that Gleevec worked well in mice, the researchers cautioned against doctors using Gleevec for treating rheumatoid arthritis until clinical trials are completed demonstrating its effectiveness and safety for people with the disease.
¶ Rheumatoid arthritis is a painful, chronic autoimmune disorder, characterized by inflammation of the lining of the joints. It affects more than 2 million Americans; up to half of those with the disease are disabled after 15 years due to disfigured joints. Standard therapy for rheumatoid arthritis now includes agents that suppress the immune system, but many patients do not benefit from such treatments. They do not get adequate reduction in the symptoms and signs of disease; they may also continue to have damage to their joints or develop side effects that make continued use of such therapies impossible. Thus, new approaches are needed.
¶ Bill Robinson, MD, PhD, assistant professor of medicine and the study's senior author, led a team that set out to find drugs that might provide additional benefit to rheumatoid arthritis patients. They screened a range of drugs in mice that have a condition similar to human rheumatoid arthritis.
¶ Ricardo Paniagua, an MD/PhD student and the study's first author, explained that they looked at every drug approved by the U.S. Food and Drug Administration, considering which ones might modulate the immune system and thus be effective in combating an autoimmune condition, regardless of the drug's FDA-approved use. Paniagua chose several drugs to test, including an antihistamine, a platelet modulator and other approved drugs with known effects on cells of the immune system.
¶ "It was the combination of rational selection and serendipity that we found that Gleevec worked better than anything else," said Paniagua, who works in Robinson's laboratory at the Geriatric Research, Education and Clinical Center of the Palo Alto Veterans Affairs Health Care System.
¶ In their study, Gleevec almost completely prevented the development of the rheumatoid arthritis-like disease in the mice. The drug also halted the progression of established disease, significantly reducing the amount of inflammation and bone destruction around the joints. The researchers also tested Gleevec on the cells of human rheumatoid arthritis patients and found that it reduced the processes associated with inflammation and abnormal growth in the joints.
¶ Gleevec is the brand name of imatinib, a drug produced by the pharmaceutical company Novartis AG. It is part of a class of drugs called kinase inhibitors, which act by blocking communication signals between cells. These signals, when they go awry, are often at the root of diseases such as cancer and autoimmune conditions.
¶ Gleevec targets kinase gene mutations seen in chronic myelogenous leukemia or CML (a bone marrow cancer) as well as certain types of stomach cancers. The same kinases turn out to play a critical role in rheumatoid arthritis.
¶ Robinson said that the field of autoimmune disease research has been trying to develop kinase inhibitors for more than a decade. "We were very surprised that Gleevec worked as well as it did," said Robinson. "It just seemed too simple." The results are especially encouraging since the drug is already FDA-approved, and has relatively few side effects. None of the authors in the study has any affiliation with Novartis.
¶ "We have taken a very potent kinase inhibitor and discovered that it works very well for an autoimmune disease," said Robinson. "The significance is twofold. First, it might provide insights into the mechanisms underlying rheumatoid arthritis by figuring out what Gleevec inhibits." Second, he added, it might represent a new therapeutic approach to rheumatoid arthritis and other autoimmune diseases. The kinases the drug inhibits likely play a role in other autoimmune diseases, such as scleroderma, psoriasis and inflammatory bowel disease.
¶ Gleevec's potential in humans is buoyed by two published case studies of rheumatoid arthritis patients with CML; both experienced significant improvements in their arthritis symptoms after taking Gleevec to treat their cancer. In addition, there has been a published case study of Gleevec alleviating psoriasis in a cancer patient. Robinson said he hopes that in the near future, clinical trials will be conducted that look at the drug's effectiveness for a range of autoimmune diseases.
¶ Others who contributed to the study are associate professors of medicine Mark Genovese, MD, and Paul Utz, MD; professor of orthopedic surgery Stuart Goodman, MD; assistant professor of pathology John Higgins, MD; professor of neurology and neurological sciences and of pediatrics Lawrence Steinman, MD; research associate Peggy Ho, PhD; research assistants Orr Sharpe, MS, and Beren Tomooka, MS; MD/PhD student Steven Chan; medical fellow Jason Song, MD; Stanford undergraduate Anna Chang, and visiting undergraduate Fiona Thomas.
¶ Stanford University Medical Center integrates research, medical education and patient care at its three institutions -- Stanford University School of Medicine, Stanford Hospital & Clinics and Lucile Packard Children's Hospital at Stanford. For more information, please visit the Web site of the medical center's Office of Communication & Public Affairs at http://mednews.stanford.edu .
¶ NOTE: Reporters may download a copy of the paper, which has been posted in advance of publication, by visiting http://www.jci.org and searching the site using the term "imatinib mesylate."
CONTACT: Stanford University Medical Center Mitzi Baker, 650-725-2106 (Print Media) mabaker@stanford.edu M.A. Malone, 650-723-6912 (Broadcast Media) mamalone@stanford.edu
Last Updated: September 28, 2006 12:29 EDT
Thanks
I'm not an MD nor do I have any specifics on the source of the blood clot that nearly took Rusch life. I'd might try to email a link to the GTCB site for him and his physician to evaluate. If the indications are consistent with antithrombin, I assume he could access ATryn either in Europe, potentially through US trials or from GTCB on a compasionate use basis.
Then he could go on to be a 20 game winner and the Cubs could win the world series on the 100th anniversary of their last win. Oh yeah and GTCB goes to $100. What a great story from an obviously delusional, long suffering fan.
Have a good weekend.
FL
Could GTCB save Rusch's career? Based on the attached article it appears that he suffers from hereditary antithrombin deficiency which is currently being treated by blood thinners. The article suggests that fear of injury while on blood thiners may cut his career short.
http://www.chicagotribune.com/sports/baseball/cubs/chi-0609270243sep27,1,6937622.story
FL
--------------------------------------------------------------------------------
CUBS
Retiring an option for ailing Rusch
Fighting blood clot in lung with thinners, out at least part of '07
By Paul Sullivan
Tribune staff reporter
Published September 27, 2006
Cubs pitcher Glendon Rusch said Tuesday he would remain on blood thinners for six to 12 months and would miss part of the 2007 season, if he returns at all.
The 31-year-old left-hander, who was hospitalized with a blood clot in his lung two weeks ago, isn't sure if his condition will force him to retire.
"I haven't gotten that far yet," Rusch said.
"I would hate to make any decisions until I know what [my condition is] going to be in the future.
"I really wouldn't like [to retire]. I'd love to play longer. But we'll see what happens."
Rusch will see hematologists in Los Angeles when he returns home next week for the off-season. The danger in continuing to play would be if he develops another clot, which would mean that he must remain on blood thinners the rest of his life.
"You don't know if that's a risk you want to take," he said.
A pitcher would be particularly vulnerable on line drives. If he were to get hit, it could lead to clotting.
"You can't risk yourself getting hit," Rusch said. "It could be fatal. That part is tough. I just have to see if it's going to be longer than six months."
Rusch also might have to take shots before flying, an occupational hazard he won't be able to get around if he continues to play.
Doctors never were able to discover where the clotting began before it went to his lungs, but further blood tests on Rusch and his parents showed the condition was genetic.
Rusch first felt chest pains Sept. 13 while running on a treadmill in the Cubs' weight room.
He eventually was diagnosed with a pulmonary embolism after team physician Stephen Adams ordered Rusch to get a CT scan.
Adams' persistence may have saved Rusch's life.
"The pain was really bad that night, but fortunately they found it, because it could've been a lot worse as the night went on," Rusch said.
Rusch credited his teammates with helping him get through a scary time in his life. Rusch's condition, along with the recent news that Derrek Lee's daughter Jada is suffering vision problems, have made it a difficult time for the entire team.
"You see teams that have bad luck, a couple guys hurt their arm or a position player breaks his leg," Rusch said. "But with us, the health problems are completely not tied to baseball. It's pretty tough."
Dew
Thought the same thing about Soros being a little too coincidental. He got in just in time for the GS downgrade. Perhaps a chance to add some more.
I agree that the next GTCB agreement will be more lucrative. Having the European approval takes this technology out of the realm of pure speculation into that of having a legit platform. As you suggested, this should equate to more lucrative future agreements.
Not trying to turn this to a political forum, but I also think GTCB position could be strengthened by the fall election. I've added some more on dips.
Not trying to push you into any statements on NVS. It's a totally different type of investment compared to the more speculative issues generally discussed here. I just find it interesting that Wall Street shows such apathy toward NVS and Roche.
FL
Thanks Dew.
The intellectual property rights are huge in this arena. Thanks for pointing that out. I'm surprised that there have been so many opportunities to purchase GTCB after the technology has been validated by the EMEA approval. The biggest drawback is obviously the cash position is constraining the development of additional proteins and approvals for new indications.
This should improve in the future with milestone and royalty payments. Interesting to see Soros establishing a position.
Did you ever pull the trigger on NVS?
Good Luck
FL
Dew
The Chicago Science and Industry Museum had a small exhibit dealing with the production of transgenic proteins. They highlighted the use of transgenic pigs to treat hemophelia. I think I saw a reference to the research being conducted at Iowa State University but don't think it was aligned with a comercial venture as far as I can tell.
Outside of Pharming and GTBC are you aware of any other transgenic biotherapeutic protein products for human use in late stage testing or at the application stage?
Thanks flatlander
I saw the article in the Chi Tribune this morning. Evidently this could be huge for 3rd world countries where it claims several million lives a year.
FL
It looks like the attorneys have had a difficult time finding a lead plaintiff. I keep seeing the notices.
I agree with your take.
FL
I would agree that NFLD is producing polyheme in Mt. Prospect. The discussion about availability of reagents seems to confirm this. Furthermore, this is the only product NFLD has so I think they always intended to take it thru the entire cycle.
This post indicates that the production agreement would not risk serious expenditures for construction until phase III data reviews are completed. The newspaper article emphasized construction without it being contingent on the approvals.
http://phx.corporate-ir.net/phoenix.zhtml?c=91374&p=irol-newsArticle&ID=873246&highlight...
FL
Thanks for the update Dew.
The Chicago Tribune reported about 6 weeks ago that Nfld had contracted with Jacobs Engineering to build a Polyheme production facility in Mt. Prospect IL. Seems like puting the cart ahead of the horse if the Phase 3 data is under evaluation.
FL
Hi Dew
I did not see any mention of the Telbivudine filing in the pipeline and regulatory update section (or mention if IDNX for that matter). Did I miss it somewhere else? If not, what do you make of this omission?
FL
Beachgal
It's easy to be biased against a drug which is the active ingredient in rat poison. However, Coumadin has been effective blood thinner. My mother has been on it for a couple of years. I looked up the original Univ. of Wisc. patent and was shocked at the uses.
Best wishes to you and your Father.
FL
What now?
Those of us who are unfortunate enough to work in a heavily regulated environment could have predicted yesterdays decision. That is why I suggested a week ago that trading around a core position would help reduce the potential downside.
Regulating Agencies have an apprehension to approving anything new, innovative and different. They would rather see the precident set by others (I'm speaking to the human nature part of the equation not the science). This often occurs even though an applicant tries to solicit input at an early stage. In my industry draft permit denials are issued until the issues are ironed out and a final approval is issued at some point in the future. I think of this decision as a draft or temporary denial.
I firmly believe that the basic premise remains in tact. So GTCB should do exactly what they are proposing to do. Appeal the decision and collect additional data which can be used to support the application and address the perceived deficiencies. My experience says persistence eventually pays off. However, it is somewhat different in a publically traded firm with few cash flow streams. Leo's support is critical, however even with this support some cost cuting and/or other actions mat be necessary at some point.
Just my 2 cents worth.
Good Luck
FL
Thanks however the following paragraph from the 11/05 Scientific American suggests that there may be some "residual protein" issues in the PPL study that extend beyond just the how clean the process is. This may be more specific to an inhaled biotherapuetic product or the specific immune system response of the subjects enrolled in the study but it does relate to the type of concerns I think exist in the approval of transgenic products.
I note that the paragraph specifically indicates that these problems have not been encountered in the GTC study but I it does indicate the critical role that purification plays in this process.
As for the political issues, I hope I'm wrong and that GTC laying the groundwork with the FDA reduces the potential for these types of issues.
I'll be frank, I still need to read more of the background info, so I'll tone down my questions while I come up to speed.
Good Luck
FL
From 11/05 Scientific American Article
"If GTC survives, it could become the leader in transgenics. The impetus for starting the company still appears justified. The capital costs for a drug production facility using hamster cells can amount to $400 million to $500 million, Cox says, whereas a herd of goats can produce the comparable amount of drug for $50 million. “There’s still a need for alternative production methodologies,” says Philip Nadeau, who tracks GTC as an analyst with S. G. Cowen. “There are still proteins that are difficult to produce using traditional methods, and therefore a company like GTC should certainly have a niche.” ATryn’s uses could be broadened to encompass an array of treatments—for coronary bypass, burn or sepsis patients— that might, in total, bring in as much as $700 million annually, Cox estimates. The drug appears to have surmounted an important technical hurdle: so far it has not created any adverse immune response in patients. But such events will always remain a worry. Researchers administering inhaled transgenic alpha-1 antitrypsin from sheep bred by PPL discovered that some patients suffered pulmonary symptoms that caused them to leave the trial—a possible immune reaction to residual proteins from the animal that remained after purification of the drug. The PPL drug, given on a longer-term basis than ATryn is, needed to be better purified, notes Meade, GTC’s chief scientific officer."