Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Best of Dendreon Anthology---foolish,shrewd,wealthy,wise,
If anyone is sick of DNDN posts, then skip this.
After subjecting myself to the painful and illuminating task of reading more than a month of posts from this board I was struck by a few comments that are worth repeating. Although I hope these comments are construed as constructive, I realize some may take offense at having their postings unearthed and scrutinized thru the retrospectoscope.
Here are examples of comments that I think represent financial shrewdness, healthy skepticism, foolishness, and wisdom worth repeating.
Shrewd:
http://www.investorshub.com/boards/read_msg.asp?message_id=18585819
sold half my holdings here in the low 21's. Doesn't make sense to be pig with all the mo-mo pushing the stock up. May add back to my holdings after the dust settles.
Foolish:
http://www.investorshub.com/boards/read_msg.asp?message_id=18708156
If approved, the drug has potential sales of $1 billion, and perhaps double that. If DNDN is valued at 6 times sales of $1 billion, you have a stock that is tremendously undervalued. Walldiver is on record with 90% odds of approval (or approvable with very minor issues). I personally see almost a zero chance of major delays for Provenge.
So, is DNDN still a biotech value? I think so.
My favorite for the healthy skepticism category:
http://www.investorshub.com/boards/read_msg.asp?message_id=18789614
I would argue, the panel's votes nothwithstanding, that the panel really didn't vote for "approval" but rather for "approvable." This requires a "reading" of the minutes of the meeting. But no one here seems to agree with me, so maybe you and David et. al. are right. (But, I think, all of you would have to admit that Goodman's actions in the middle of the panel vote is unprecedented and, thus, we are a bit in unchartered waters here.)
Finally, kudos to Masterlongevity for this piece of dispassionate wisdom:
http://www.investorshub.com/boards/read_msg.asp?message_id=19435941
I'm all for approval and I hope it happens. i just can't see how analysts can call it a sure thing. I have been in the drug development business for a long time and on this board for a few years, so am not going away. There would have to be a paradigm shift in the way the FDA's approval criteria work in order to approve this drug as is. granted i understand people stance on why it should be approved, they are not in the business of aprpoving drugs that miss their primary endpoints in pivotal trials. They know they will be flooded with applications once this happens.
I think it will receive an approvable letter to wait for more data.
Thanks to all on this board for the perspective and knowledge.
Urche
Paion CC-post-mortem
utter denial by management. Nothing wrong with the drug—the only problem was that those placebos were too darn effective.
To add a little color to DEW's impression, one of the speakers on the Paion CC today said, Desmetoplase did not fail....but placebo by chance had a very good outcome".
I sympathize with the company in that I don't know what they could have done differently. The study was reportedly powered with enough patients, assuming 20 % placebo efficacy. Then, the data reportedly showed a 50% placebo response rate. Who's to blame for that? Keep in mind also that this was before the Cerovive failure---in that study placebo also did better than expected with about 35% efficacy.
So, even though desmetoplase is probably a better drug than TPA, we are left with TPA, the "standard of care", which only 1-2% of stroke patients receive---for very good reasons having to do with a very narrow therapeutic time window and a highly questionable risk/benefit equation even under ideal circumstances.
Fortunately, no position in FRX or Paion.
Urche
Any idea what's up?
RPBIF is up 10% today. Some of the recent strength is attribuable to the loonie /US$ exchange rate, but Response is my only green ticker today. Any idea what's going on?
TPA and desmetoplase
That article on TPA segues nicely into the interim phase II results on desmetoplase which I have heard will be released at a meeting around June 1. TPA for stroke is just never going to reach much more than the 3-4% of stroke victims cited in the article. I think most doctors, myself included, just don't find the therapeutic window is wide enough to use the drug more often.
Urche (who is still back in early May trying to catch on more that 1000 BTV posts)
ot-CAMH
Urche, have your feelings changed towards CAMH any since we last "spoke"? It continues to be my largest holding.
I admit that one of the most recent PR's did make me wonder about my skepticism. My gut still says stay away from technology that claims to be smart enough to predict in a useful way who the grim reaper will claim.
But the idea is appealing and I'm keeping my mind more open than I may have sounded in the past.
I don't follow the company closely. Any binary events looming?
urche
So you're not really talking about screening.
If a 30 year old , who comes in roughly once a year, came into the office complaining of diarrhea and running a fever would you prescribe a $20 flu test to rule out the lower probability, higher consequence diseases?
There is no chance I would think of a flu test for this scenario unless the patient requested it.
But, if you change it to an 80 yr old in December with the same symptoms and his spouse was just hospitalized with probable influenza, then I would do the flu testing in hopes of catching it in the early stages when treatment might make a difference. A lot depends on the pre-test probability of a positive test.
urche
A general question about RBM Flu A/B test.
That's a slew of good questions. I'll answer from my own perspective as a practicing general internist. The public health or academic viewpoints would be somewhat different.
Do you or would you prescribe antivirals after a positive flu test?
I wouldn't for the average patient, but nationwide I think most practicioners would. The issue is cost (of the medication) vs benefit (around a day of quicker recovery according to a lot of studies). OTOH, the very young, elderly, or infirm, in short the ones most likely to die from influenza do usually get treated with antiviral drugs. Some of the therapeutic nihilism about treatment is due to the fact that diagnosis and therefore treatment is often delayed until several days into the illness by which point the benefit is lessened. Theoretically during a pandemic and with availability of rapid testing, diagnosis and treatment could occur earlier and more frequently
Is there a great deal of pressure to limit antiviral use because of resistant viral flu strains?
No. It's a reasonable concern, but practically speaking other factors (as noted above)limit use of antiviral drugs more than fear of resistance.
Would the test be used in conjunction with other tests to rule out Flu A/B?
Maybe a chest xray to rule out pneumonia, but a positive test for flu in the right setting should clinch the diagnosis.
What do you think the general utility of such a test rather than a screening during a pandemic and how large a market could it garner?
I don't know how screening (testing people without symptoms) would be useful. Either people with suspicious, early symptoms get tested or in a high risk setting (such as a nursing home exposure) you treat a lot of asymptomatic people prophylactically. So, I don't see pandemic screening as useful. It would have to be repeated every day, practically.
Hope that helps. BTW, I consider flu season over now that black flies and mosquitoes are out.
To tell the truth I think that BNP testing and maybe the other bacterial tests with 3M are more likely to make Response a success than influenza testing.
Regards,
urche
Thanks for sharing the report.
It has a lot of good solid info about the company as well as the usual analyst WAGs and assumptions. The section on potential for acquisition was realistic and thoughtful, IMO.
Any worries about how long it has taken for the FDA to make a decision on approving NT pro-BNP test? I was expecting a decision by now, though the report indicated hearing news this year was expected.
Urche
Whither Cobalis update
If I forgot anyone, please update again:
LongMike 10
Seschm 4.2
RandyChub 3.40
Onco 3.25 (edited from something like "north of 3.25")
Urche 2.75
Beachgal 2.25
Whither Cobalis?
With reasonable predictions that the company will announce pivotal results within a few (LM says 5) days, it's time to list the responses/guesses so far. Until the PR is released, there is time to submit other entries.
Assuming results from the Cobalis phase III studies are favorable enough to make FDA approval likely, predict the closing price 5 trading days after the PR is released. I picked 5 days to allow some time for the wild buying and selling to settle down and also for the word to get out about this under the radar company.
Entries so far:
LongMike 10
RandyChub 3.40
Onco 3.25 (edited from something like "north of 3.25")
Urche 2.75
combining data bases
I don't think we can read much into the PR. Initially I thought this must be a Dendreon like ploy to do some data mining after one of the trials failed to reach significance. But, the PR clearly states that the data has not been unblinded yet. So, if we take it at face value, the company knows no results yet and we have no more reason to worry than we did last week.
This is the first I have heard of combining the data bases. I thought that each phase III was powered and designed to stand on its own in terms of reporting. The third data base must be the older phase 3 study, which had some arms similar enough to perhaps add to the statistical power. But, I dunno.
urche
News is out---Go back to bed
The PR is out, a few hours ahead of schedule.
Cobalis Expects to Report Phase III Top-Line Results in May
Monday April 30, 6:36 am ET
IRVINE, Calif.--(BUSINESS WIRE)--Cobalis Corp. (OTC BB: CLSC - News), a pharmaceutical development company specializing in anti-allergy medications, today announced it has been informed by its independent contract research organization that it would need more time to combine Cobalis' three locked data bases into a single database before un-blinding and conducting the statistical analysis required to generate top-line results for Cobalis' twin pivotal Phase III Clinical Trials of PreHistin(TM) in seasonal allergic rhinitis. The Company anticipates reporting its top-line results later in May.
Yawn.
another stupid question
what is the difference, if any between prehistin and other sublingual B12 pills?
Dunno, I dunno, and it's a very good question. I suspect that Prehistin's "superiority" will only be on the basis of its claim that it has/will have proven efficacy for allergic rhinitis and FDA approval. Other products may have similar bioavailability and even if they have the studies to prove it, won't be able to make the claim of efficacy for a specific indication.
urche
GSK nasal spray
Does the recent FDA approval on the new GSK nasal steroid spray affect anything here?
I don't think it will have any effect on Prehistin. The GSK product is yet another steroid inhaler---perhaps with a few small advantages over existing drugs. But Prehistin would be in a different market niche as a non-prescription, non-steroidal alternative.
urche
Whither Cobalis?
I really like simple little, easy to understand companies. But, even Cobalis facing it's binary, "fly or die" results from its 2 phase III trials is hard for me to fathom. We have to consider factors such as:
1) So called "toxic financing";
2) Legal counsel and officers have been paid with stock and may want to lock in gains;
3) There are no known partners or deals if Prehistin "succeeds" in the trials;
4) Cobalis has essentially no pipeline other than Prehistin for allergic rhinitis;
5) The "market" for Prehistin could be in the billions of dollars, Euros, yen, and about every other currency in the world.
6) Even if Prehistin is only marginally effective, it could be so safe and inexpensive that it could still be a blockbuster if approved.
7) By any measure, this is a very thinly traded stock and not of much interest to retail shorting and speculative investors---this will change after positive news, of course.
Taking these factors into account, we are in for a wild ride..
For anyone willing to risk an educated guess before the PR:
Assuming results from the Cobalis phase III studies are favorable enough to make FDA approval likely, predict the closing price 5 trading days after the PR is released.. I picked 5 days to allow some time for the wild buying and selling to settle down and also for the word to get out about this under the radar company.
Urche
FWIW, my own prediction is $2.75
NO such thing as a (sincere) stupid question
If Prehistin is, in essence, a synthetic fom of B12, then why can't people just take B12?
I'll take a stab at your very good question.
First of all, Prehistin is not synthetic B12--it's the real thing. B12 is not made in the human body, so Prehistin is the same stuff you get from food, a B12 shot, or a B12 pill.
So, what's wrong with taking a pill? Nothing if it does what you want it to do. If the goal is to increase the B12 level enough to treat deficiency, then everyone except those less than 1% of people with pernicious anemia (people who can not absorb B12) will be treated effectively by a pill and even that is unnecessary if they eat even a few servings of fresh foods and dairy products per year.
But let us digress to the hokier realm of belief, rather than accepted science. There is a ton of anecdotal belief and some research that B12 in megadoses works wonders on the immune system, the psyche, and a myriad of other organ systems. Many patients and their medical providers attest to the benefits from megadoses of B12. But the medicine is usually administered by injection because of the belief that oral doses can not produce the effect seen with megadose parenteral doses. In other words, the drug seems to act differently in huge doses directly into the bloodstream than just exposing the gut to a huge dose. In fact, our kidneys just piss away any B12 that our body does not "need". But, the critical and mysterious notion that keeps B12 so popular is that it seems to do wonderful things to the body when delivered systemically in megadoses.
So, my short answer to your question is that Prehistin provides patients a way to get megadoses of B12 without an injection. That's all.
As an interesting corollary, it follows from the above that Monday's (or whenever it happens) results won't necessarily be a binary event. Even if Prehistin fails for allergic rhinitis, I feel there will be plenty of interest in trying it for any number of other ailments, even for pernicious anemia. We'll all be paupers by then, but I am confident that Pre-histin in some form will be on the market in the near future.
Now, since most of believe Cobalis will announce positive results next week, let's have a little fun. See my next post.
Urche
The problem of identifying staph carriers may prove to be more important than one might think.
Especially, the high negative predictive value provides a screening tool to rapidly and accurately identify patients who are at low risk of developing a S. aureus infection after surgery, thus allowing for more targeted use of antibiotics and other infection control measures.
Most tests can't provide both high sensitivity and specificity. In the case of screening for staph, the high negative predictive value is the more important parameter. This is because institutions increasingly want to know if their patients need to be placed on contact precautions (at considerable expense and inconvenience) or need antibiotics to eradicate staph carrier state.
My feeling is that a test that can quickly identify patients negative for staph would fill a valuable niche. The current routine in the hospitals where I work is to send cultures from 3-4 sites, including a nasal swab. The results come back about 3 days later at a cost of several hundred dollars. A quicker, dependable result would be a tremendous boon to institutions caring for these patients.
Unfortunately, as far as i can tell the Response/3M test is not specific for MRSA, the multiply resistant form of staph which is much more important information that whether staph is present or not. So, the rapid test won't replace cultures altogether.
Urche
OK, thanks for putting me straight.
B12 absorption
Here is a patent from AMGN that I though was interesting-->conjugate vitamin B12 to the peptide/protein and it will bind to intrinsic factor and be absorbed. This sounds like a great idea. Will it work in the real world?
Sounds likely to work. But a lousy idea in terms of marketing. Cobalis has already solved the problem of getting B12 absorbed in amounts plenty good enough to treat B12 deficiency even though it's not on the market yet. The Cobalis lozenge is palatable, safe, and effective in terms of measurable B12 levels. It isn't marketed yet, awaiting results from ph III studies for the indication of hayfever. I don't know why they didn't go for seemingly easier indication in B12 deficiency first. But that's a discussion for the Cobalis board.
Is this RAMP technology?
I can't tell from the PR whether the 3M culture based test has anything to do with the RAMP technology or any connection to Response. Does anyone know?
urche
RVX-Apo-A1 and D-4F again
A PR released by Resverlogix today has no news worth reprinting it here.
http://biz.yahoo.com/iw/070402/0233834.html
It is simply an unabashed attempt to show how the mostly negative news from ACC convention does underscore the potential value of the Resverlogix approach to augment natural apo-A1.
The PR mentions an interview from Medscape with Dr. Hollis Brewer. That contains a detailed post-mortem on the torcetrapib failure and is objective and well done, IMO. Most of the article is about the Pfizer study. But this snip about other drugs and approaches in development is worth plagiarizing here (no link because Medscape requires registration):
Medscape: Meanwhile, are there any other ways of raising HDL that are in development that you think are particularly promising?
Dr. Brewer: In one sense, what is most discouraging, and why there were so many hopes for the CETP inhibitor, is that we did not have another group of drugs nearly as effective in raising HDL as the CETP inhibitors. Niacin is currently available, but it is not nearly as potent an HDL cholesterol-raising drug as a CETP inhibitor. In addition, it has been limited in use because of the flushing side effect. The reason for the flushing has now been identified, and a prostaglandin D2 receptor 1 (DP1) antagonist (MK-0524) has been developed that will dramatically decrease this side effect.[15] The HPS2-THRIVE (Heart Protection Study 2 -- Treatment of HDL to Reduce the Incidence of Vascular Events) trial is evaluating the efficacy and safety of MK-0524A, an investigational compound combining extended-release niacin with MK-0524. This combination is expected to have fewer side effects and therefore greater patient acceptability.
Another approach is to increase the level of expression of the apoA-I gene, which we know from animal models raises HDL cholesterol and decreases atherosclerosis. On the basis of those studies, we anticipate that this would be a very effective -- and potentially the most effective -- approach to increasing HDL cholesterol and decreasing vascular disease. Many pharmaceutical and biotech companies are currently trying to identify a therapeutic approach that will turn on the apoA-I gene and increase HDL cholesterol.
In addition to chronic oral therapy for raising HDL cholesterol, there has been considerable interest in acute HDL therapy with the infusion approach in acute coronary syndrome (ACS) patients. Acute HDL therapy was initiated by the apoA-I Milano study,[15] which changed our concept of being able to reverse atherosclerosis in the coronary artery and specifically raised our hopes about the potential to decrease the vulnerable plaque. Infusion of the apoA-I protein in the form of apoA-I Milano, which has a single amino acid substitution, was able to achieve significant regression with only 5 infusions. This suggested that we could significantly change atherosclerosis, not in months to years, but in weeks. A commercial program is under way at Pfizer to develop a commercially viable form of apoA-I Milano for ACS patients (candidate ETC-216 in phase 2).[16,17]
There has also been development of apoA-I mimetic peptides on the basis of the apoA-I sequence as a potential approach to HDL infusion therapy in the ACS patient. Both Lipid Sciences (Pleasanton, California) and Pfizer are developing apoA-I mimetic peptides. In addition, Lipid Sciences is also developing a method to selectively remove the cholesterol from the HDL particle, thus regenerating the pre-beta, or lipid-poor, HDL that can bind to the ABCA1 transporter. The delipidated HDL, containing increased levels of pre-beta HDL, are then infused back into the ACS patient.[18] The Plasma Delipidation System-2 (PDS-2) system, which selectively delipidates plasma, is being studied in a clinical trial in ACS patients to determine whether this easy and relatively inexpensive approach to HDL infusion therapy will be associated with decreased atherosclerosis, as quantitated by the IVUS technique.
Reconstituted HDL (rHDL) infusion is another approach initiated by CSL Behring in Switzerland and being developed by CSL (Melbourne, Australia) as a therapy for the prevention of secondary events in "at-risk" patients suffering from ACS. The phase 2 trial with rHDL, ERASE (Effect of rHDL on Atherosclerosis -- Safety and Efficacy), will compare the effects of rHDL and placebo on atherosclerosis progression and regression as assessed by IVUS in ACS patients, and the results will be presented at ACC.07.[19]
It is important to remember that in normal plasma only approximately 5% of the HDL are in the form of pre-beta HDL, the ligand for ABCA1. With infusion of apoA-I phospholipids in the form of apoA-I Milano, a phospholipid peptide complex, selectively delipidated HDL, or rHDL, we expand the pool size of the ligand for ABCA1, which is one reason why we may get such a dramatic effect of HDL infusion therapy on atherosclerosis quantitated by IVUS. Once these ACS patients have had their infusions, it was anticipated that they would receive chronic oral HDL therapy, with a CETP inhibitor or niacin.
Medscape: Orally administered drugs are also in development for raising HDL cholesterol. Which do you think is most promising?
Dr. Brewer: The major one is the apoA-I mimetic, D4-F, developed initially by Alan M. Fogelman, MD, and colleagues at UCLA with Bruin (Los Angeles) and now in development with Novartis (Basel) as APP018. It is a D-amino acid peptide that cannot be metabolized and therefore can be administered orally without being degraded by intestinal enzymes.[20] It has been unclear on the basis of animal models, however, how it decreases atherosclerosis, because the concentration in plasma is extremely low,[21,22] Dr. Fogelman and his colleagues have suggested, on the basis of their in vitro studies, that it changes proinflammatory HDL to an anti-inflammatory or an antiatherogenic HDL. It is a very interesting and, hopefully, fruitful approach to modulate atherosclerosis.
P3---time to do the right thing
p.s. I am waiting for my DNDN win then I may consider to obtain an IHUB account to try out the additional features.
;O)
Resverlogix
Were you able to ascertain why the stock dropped so much in one day recently? Was it merely because AGIX missed its primary endpoint?
According to IR, the AGIX news was a big part of the drop. However, IR, like myself, was surprised because we would have expected the failure of yet another potential competitor in the HDL therapeutic space to make the Resverlogix approach all the more attractive relatively. As far as I know, Resverlogix still has no competition in the APO-A1 space and there is nothing very promising left in the HDL space. In retrospect, I think the excessive drop in RVX was collateral damage and a buying opportunity.
IR also believes that Resverlogix has developed short sellers taking interest in the stock. They don't know who they are but assume it/they are in US because it coincides with a big increase in trading from the US.
novartis-D-4F
Thanks, Dew, for digging up that update on the D-4F drug. The lack of data is striking in comparison to the detailed PR's put out by ISIS this week. My take is that another drug that targets vascular inflammatory process shows some promise---hard to get excited. It seems odd that this drug which supposedly is a copy of part of the HDL molecule doesn't even seem to raise HDL in a meaningful way. Sounds like they have a long way to go to find measurable, beneficial effects for their drug.
Until then, IMO, Resverlogix gets more and more interesting.
Urche
lava flowing which way?
I was on edge this morning wondering how the Biosite acquisition by Becton would affect Response.
Most of my gut says that the high (if not exorbitant) price tag that Biosite received should enhance the value of Response, which makes, arguably, the most likely competitor for Biosite, at least in the US market.
On the other hand, there is the nagging question of why they chose to acquire Biosite and not Response.
Should response feel spurned and hurt or emboldened and validated? Evidently, the market can't decide either, judging by the modest uptick in Response share price today.
DrBio, how do you feel about the deal?
urche
ISIS on thin ICE
Much as I am smitten with the ISIS story, this PR today makes me glad I've not fallen in love.
The ALT elevations with the 400 mg weekly dose drastically limit the drug's chances, IMO. That would be a very narrow therapeutic window for safety, if the 200 and 300 mg doses are chosen.
This sentence has me wondering about its validity:
The mild increases in ALT at the 400 mg/week dose likely reflect extreme lipid-lowering activity, not toxicity, and are consistent with perturbations in liver chemistries seen with statins.
Does anyone know of the scientific basis for this claim? The implication that the liver enzyme elevations occasionally seen with statins are related to the drugs working so well on lipid lowering seems far fetched to me.
Also, it's worth pointing out that ISIS 301012 is being developed so far as a once weekly SUBCUTANEOUS INJECTION. This snip made me smirk because I can't imagine that weekly injections (for life) to treat a lipid disorder has much chance of commercial success:
The drug's pronounced activity, its predictability, its reduction of all atherogenic lipids and triglycerides, as well as the opportunity for assured patient compliance with infrequent subcutaneous dosing are all attractive attributes.
Urche
What does the BEC\BSTE deal mean for Response?
It's not just Dendreon waiting nervously for a decision from the FDA. Response has, among other products, a BNP test that will compete with the established Biosite assay. The response test, NT-pro BNP, has some differing attributes that may make it better or no different clinically.
I am wondering how the Beckman /Biosite deal will affect Response this week. On the one hand, the hefty price tag may validate the commercial potential for the test and give Response a boost as a potential competitor with a very viable sounding product.
OTOH, obviously Beckman chose Biosite, not Response. Should Response feel spurned or validated? DrBio, what do you think?
For anyone interested, here is a snip from the Dec. 14 PR announcing the Response filing. I've heard that such filings usually get a response within 90 days which is why Response shareholders, myself included are waiting nervously.
VANCOUVER, Dec. 14 /CNW/ - Response Biomedical Corporation (TSX-V: RBM,
OTCBB: RPBIF) announced today that it has filed a US Food and Drug
Administration (FDA) 510(k) submission seeking clearance to market its RAMP(R)
NT-proBNP Test for the diagnosis of congestive heart failure. The Company has
also completed a European CE Declaration to market the product in Europe....
urche
Thanks for the pithy info, Dr. Bill.
I note that the response is USUALLY within 90 days, but no deadline is mentionned. Assuming the filing was made on or before Dec. 14, then the 90day mark is upon us now. Seems likely that explains the recent run up in price and volume over the last month:
http://finance.yahoo.com/q/bc?s=RBM.V&t=3m&l=on&z=m&q=l&c=
urche
CRYOCATH
Those indeed appear to be good results from the ongoing pivotal trial using cryoablation in Atrial Fib. I'll be following this company.
Fid---are you an investor?
Does the company have a US ticker?
My biggest question, other than how the pivotal trials will turn out, is how tight are its pending patents? I'd hate to invest in another good device company only to find there was no barrier to entry after approval and the therapy becomes accepted.
Urche
I haven't used Astelazine, but would place it alongside several other "new" or "nonsedating" antihistamines, which are also, of course the considerably more expensive ones.
Here's a snip from a University website:
http://www.umc-cares.org/health_info/article.asp?ArticleID=118&Category=Seasonal
Newer, second-generation antihistamines such as fexofenadine (Allegra), loratadine (Claritin), and cetirizine (Zyrtec) and the intranasal antihistamine, astelazine (Astelin), have a significantly lower risk of side effects, and usually should be prescribed in place of the older medications for allergic rhinitis. Rhinitis is a general term to describe conditions that cause upper respiratory inflammation and symptoms such as nasal congestion, sneezing and runny nose. Allergic rhinitis (hay fever) is the most common form, affecting from 20 million to 40 million Americans, including from 10 percent to 30 percent of adults and up to 40 percent of children. It is estimated to cost the U.S. nearly $3 billion annually.
I think the main distinguishing trait of Astelazine is its mode of administration.
I agree that it could find a place to control symptoms in conjunction with Prehistin. But, I question your assertions that it is like Singular (it ain't) or that it could be used with Claritin, which is a similar antihistamine.
Keep digging and rooting for Cobalis!
Urche
ASPV:
"It's a compelling value, but I believe the analysts and larger institutions are playing the wait to see game about whether or not mgmt can competently in-license another product to help off-set the upcoming revenue hit from the patent expiration."
If true that would put a damper on stock movement because institutional holdings are huge --- like 75%--- and insider control is listed at 25%.
ASPV
"Have they looked at use as an antiviral ? "
That's an interesting connnection. I'm surprised to hear about the drug having a potential role in HIV, a disease in which the immune system is generally rendered ineffective. Seems counter-intuitive to me.
From reading the last 10-Q, I saw no mention of future development plans for mycophenolic acid (Cell -Cept) other than auto-immune diseases.
urche
Aspreva
Help me figure out what is wrong with Aspreva? From the digging I’ve done this week it looks like a compelling value.
For those not familiar with it, ASPV is a small (approx $US 735 Million market cap) Canadian company with one source of revenue, royalties from Cell-Cept, a drug commonly used worldwide for transplant (kidney, liver, heart) rejection. However, the company estimates that 11% of its revenue derives from off label use in other auto-immune conditions, notably lupus nephritis. Roche actually markets and produces the drug worldwide, except Japan where negotiations are underway with another company.
The royalty revenue is rolling in. At end of 2006 ASPV had $260 M in cash, with guidance for 2007 royalties to exceed $245M! Based on 35 million shares outstanding at end of 2006 (although the effective float is reportedly more like 23M), earning should exceed $3.50 per share, the figure for 2006.
Looking at enterprise value, I figure it is about $475M ($735M-$260M cash), or $13.60 per share. Current share price is about $21. So, the ratio of EV to net income is under 4!
That seems like an unvelievable value to me, and tells me that deeper digging is needed.
The main risks I can find are:
1) This is a one trick pony;
2) Composition of matter patents will start to expire in May 2009 in US and several years later in Europe.
3) There is some competition, the most noteworthy I can find being a Novartis product called Myofortic for prevention of transplant rejection. Undoubtedly other competition exists.
On the other hand, attractive attributes (to me) and potential ways for the company to increase its value in the next few years include:
1) Currency play----a large part of the expenses and revenues are transacted in Swiss francs, Canadian dollars, and Euros;
2) International diversification. Not only is the company Canadian, but about half of current revenues come from outside the US, a portion that seems likely to increase based on patent expiration and likelihood of a Japan deal.
3) Expansion of indications for Cell-Cept. Other auto-immune diseases are reasonable potential markets for Cell-Cept and the main focus of the current business strategy. Phase III study of the drug in lupus nephritis is enrolled, data due to be locked in May 2007. If positive, additional regulatory filing in US is expected late this year. Pemphigus vulgaris is also being studied. Recently ASPV terminated development of Cell-Cept for myasthenia gravis after a study showed it didn’t work.
4) The company is structured in a way (the Roche partnership and a Swiss subsidiary) that its effective tax rate is under 10%, far less than the typical 34% Canadian rate. Who knows if this is sustainable or open to challenge, but it sure looks sweet on the balance sheet now.
So, what am I missing here? Is this a compelling value or am I missing something?
MEDX
I have been accumulating MEDX shares for ~10 years,
LTBH, and now have a substantial profit on those shares.
IMO, the MEDX story may now just be beginning.
Congrats. You have seen some wild gyrations on your ride to profits. I also was a LT holder, but sold late last year. My reasoning was mostly related to the increasing complexity of the company, beyond my comfort zone in terms of understanding the company. I continue to like a lot of the prospects and deals individually. But collectively, I just don't know how to value a company with so many deals with so many companies on multiple continents.
I also am scared by the toxicity data on MDX-010, perhaps the most promising drug in its pipeline. I'm betting there will be a better time to buy back into MEDX when this issue is resolved. I agree with you that the 19% ownership of GENMAB is a very attractive both in terms of valuation and diversification.
Keep us posted on MEDX news.
Urche
All right---- then 63 avg posts/day in 2007
SGP Schering-Plough to sell Danish anti-allergy drug
Seems to me that the marketing for this product is hoping to bend the data supporting the vaccine to encourage use beyond its approved indication.
From the links in Thomas' post it appears to me that all of the studies on the vaccine were on patients with the diagnosis of grass mediated allergic rhinitis. Yet, there seems to be hope that it can be used less specifically in allergic rhinitis. It might be a sound leap, since allergic rhinitis is often multifactorial, with multiple environmental allergens. But, I expect the vaccine will prove to be less effective when given indiscriminately to patients with allergic rhinitis, compared to patients selected by an allergist with specific grass allergy diagnosis. Here is a snip that implies hope that the vaccine will work generally to desensitize the immune system.
ALK-Abelló, is a biological grass allergen
immunotherapy administered sublingually in the form of a once-daily fast dissolving tablet.
The aim of immunotherapy is to desensitise the immune system so that it does not respond
when challenged with environmental allergens.
It will be interesting to follow the efficacy of this vaccine after it is put into clinical use.
I'm embarrased that the only trick was in my own eyes.
OK, my guess for avg posts in 2007 is 62, about 15% higher.
I think that growth beyond that is unlikely because so many posters here like to review substantially all the posts and it becomes too time consuming to read more than that for most people. With less thorough reading, there will be less discussion, and less posting in a negative feedback loop.
Congratulations, Daved on outstanding return for 2006.
I hope you are sufficiently diversified to keep those gains in 2007.
Is this a trick question?
average number of posts per day on this board during 2007
Now that the year is over, my 6th grade math skills figure the average to be: 51.4.
Now, if you are really wanting to know the true number without including the deleted posts, that's a piece of trivia for someone else to figure.
Another imponderable quiz question would be how many additional posts would there have been in 2006 if io io, terry hallinan, and nerdseeksredhead still posted here? Two of them were banned in 2006, BTW.
Urche
Year End Stuff
I wish I had PGS' skills at avoiding the big losses.
My portfolio overall returned about 15%, which is only impressive in that several relatively large positions had stunning losses.
Some of the highlights:
GTCB, IDIX and AOLS are each down 30-40% for me.
I think the story for GTCB is better than it's ever been, so I recently bought a little more.
I bought AOLS based on trust in management more than believing in the story, so I deserve what I got and the best or worst is yet to come.
On the positive side, Conceptus steadily climbed to more than 120% gain overall, where I sold about half, so it is no longer my largest holding.
Resverlogix was my star---more like a meteor, actually--- essentially doubling in the past two months. It has been correcting recently, and will probably fall further. However, I'll be holding this one nervously and excitedly as my largest position going into 2007.
Response has also done well for me this year.
My only short of the year, Quidel, netted more than 10% return in a week.
Like PGS, I am finding it increasingly hard and unfruitful to follow more than a few companies. I am in awe of the diverse holdings and knowledge expressed on this board. Knowing my limitations, I am increasingly invested in foreign mutual funds, which have handsomely outperformed my biotech holdings over the past two years. Also, I am very appreciative of the contribution that HQH and HQL make to my portfolio---a steady decent "dividend", exposure to private companies, and I sleep better at night.
On to 2007...
Urche