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.
These may be some of those "Dark days of opportunity" that jerrydyan referred to many posts ago.
I am very confused by the references to continuing holds. The progression of events has gone exactly as Cortex outlined in earlier press releases, with the exception of the FDA response taking longer than initially predicted. It is clear that THE hold placed on CX717 was lifted. The interesting part is that the FDA lifted its hold after only a preliminary review of the data provided by Cortex. This means that the submission data is indeed compelling as Cortex has stated. It also means that the hold release needed a formality caveat that some additional requirements may be levied as the full submission is reviewed. Cortex needs to allow for at least some of this review to take place prior to filing any new INDs for the same compound. I'm sure there will be continued discussions between Cortex and the FDA regarding the finding, and I expect Cortex to be fairly confident in the response when the IND is filed. As for upcoming PRs, I expect the next PR to be something like a simple "Cortex has submitted an IND to Psychiatry for a ADHD PII study."
Press Release Source: Cortex Pharmaceuticals, Inc.
Wednesday May 16, 8:31 am ET
Cortex's CEO to Present at the JMP Securities Research Conference and Cortex's COO to Present at the Neurotech Industry Investing & Partnering Conference
IRVINE, Calif.--(BUSINESS WIRE)--Cortex Pharmaceuticals, Inc. (AMEX: COR - News), Chairman, President and CEO, Roger G. Stoll, Ph.D., will speak at the 6th Annual JMP Securities Research Conference to be held at The Ritz-Carlton Hotel located at 600 Stockton Street in San Francisco, California. Dr. Stoll will speak at 3:30 pm PDT on May 21, 2007 in Salon II. The conference will feature over 217 small-cap companies across a broad spectrum of sectors, including technology, healthcare, financial services and consumer products.
Dr. Stoll will provide an update on the Company's progress on its two distinct classes of AMPAKINE® product candidates, termed high and low impact compounds. Cortex's most advanced low impact AMPAKINE product candidate is CX717, a Phase IIa novel treatment for ADHD with proof-of-concept in adult patients. Dr. Stoll will also report animal findings on the ability of selective high AMPAKINE compounds to restore deficits found in brain growth factors associated with a number of neurodegenerative diseases.
Dr. Mark Varney, Ph.D., Cortex's CSO & COO, will participate in the 2nd Annual Neurotech Industry Organization (NIO) Conference to be held at the Westin San Francisco Hotel from May 17-18, 2007. Dr. Varney will participate with three other neuroscience company executives in a panel discussion that will be moderated by Dr. Harry Tracy, Publisher, Neuroinvestment. The topic of discussion will be "Advances in Neuropsychiatry." The session will take place between 10:45 am and 12:00 noon PDT on Thursday, May 17, 2007.
Semi-OT - Some casual observations on Paxil.
The successful uses of Paxil that I have observed have been related to anxiety disorders. In these cases, Paxil has had a dramatic impact. All (n~5) have observed significant mental effects with slight changes in dosage, and the best approach seems to be start at a low dosage (< 5 mg), build slowly up to a sustaining level, then very slowly taper down to find a minimum effective dosage for the individual. My wife is one of these patients, and her current dose at 1 to 2 mg once daily is well below most starting dosages, but still has a very noticeable positive effect at managing her anxiety level. Other patients (including my wife) that have started at higher dosages (10 – 20 mg BID), or who have changed dosage (higher and lower) by similar amounts have experienced mental and physical impairment (disorientation, hallucinations, ‘fogginess’, fatigue). These same folks have benefitted from the higher or lower dosages if they are slowly reached.
The Cortex website News section has the Schering-Plough acquisition of Organon news release with the following preface:
News
Alliance:
Cortex Pharmaceuticals has licensed its AMPAKINE® technology for the treatment of schizophrenia and depression to Organon BioSciences N.V. Organon BioSciences is currently a pharmaceutical business unit of Netherlands-based Akzo Nobel, which recently announced the proposed sale of Organon to Schering-Plough Corporation. Organon BioSciences has two low impact Ampakine compounds (Org.24448 & Org.26576) in clinical trials for the treatment of schizophrenia and depression. In addition, Cortex recently ended a research collaboration with Servier Laboratories. Servier retains the right to select up to three compounds for further development in the areas of neurodegenerative diseases such as AD and Parkinson’s disease. Cortex may receive additional milestones and royalties if either Organon or Servier is successful in the development and commercialization of Ampakine compounds.
Could also be related to Organon. Here is a news release from last week.
AMSTERDAM, March 1 (Reuters) - Dutch chemical group Akzo Nobel NV (AKZO.AS: Quote, Profile , Research)(AKZOY.O: Quote, Profile , Research) said on Thursday it was cutting the size of its board to eight from 10 members as a result of its plans to spin off its Organon pharmaceutical business.
Akzo said in a statement Toon Wilderbeek, board member responsible for pharma, has left to concentrate fully on his role as chief executive of Organon BioSciences, 20-30 percent of which it plans to list before the end of March.
It added that Cees van Lede, Abraham Cohen and Alain Merieux would be leaving the board on May 1, while Peggy Bruzelius, former chief executive of ASEA Brown Boveri, would be appointed to the board for a four-year term.
The annual shareholders meeting on April 25 will be asked to approve the changes.
At a meeting on Wednesday, Akzo said the board also formally decided to divest a minority stake in Organon.
Akzo said earlier this week investor pre-marketing for the Organon listing was planned for the first two weeks of March, with a management roadshow expected to start shortly after that.
Organon and Intervet, the units that will form Organon BioSciences, together realised a fourth-quarter operating profit of 127 million euros.
© Reuters 2007. All Rights Reserved.
neuro, I'm sure that this also revisits old information, but I've been trying to better understand the status of the Cortex licensed compounds at Organon. I believe 3 compounds were included in the agreement, and have followed the recent discussions wrt ORG 24448 (aka farampator), but have heard no discussion related to ORG 26576. ORG 26576 is listed (link below) as an ampakine in Phase I. I assume it is one of the Cortex licensed compounds, but don't even know that is correct. I was surprised to see it listed in Phase 1, since I thought Organon was only advancing one Cortex compound with the others as backups. Has any information been provided for ORG 26576 or the other Organon licensed Cortex compound?
Thanks.
Karl
http://www.organon.com/innovations/pipeline/index.asp
Oldies,
Thanks. I also looked for any publications, and this came up from August 2005. I have not heard anything else about ORG 26576, and was wondering if there was more information available.
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=15993447&...
Regionally selective and dose-dependent effects of the ampakines Org 26576 and Org 24448 on local cerebral glucose utilisation in the mouse as assessed by 14C-2-deoxyglucose autoradiography.Jordan GR, McCulloch J, Shahid M, Hill DR, Henry B, Horsburgh K.
Division of Neuroscience, University of Edinburgh, 1 George Square, Edinburgh EH8 9JZ, UK. g.r.jordan@sms.ed.ac.uk
AMPA receptor potentiating drugs (e.g. ampakines) enhance glutamatergic neurotransmission, and may have potential therapeutic consequences in CNS disorders. The neuroanatomical basis of action for these compounds is at present unclear. This study aimed to identify the effects of two novel ampakines, Org 26576 and Org 24448, on local cerebral glucose use (LCGU) in the mouse. C57BL/6J mice received Org 26576 (0.1, 1, 10 mg/kg i.p.) or Org 24448 (3, 10, 30 mg/kg i.p.) or vehicle and LCGU was assessed using 14C-2-deoxyglucose autoradiography. Both compounds produced dose-dependent increases in LCGU with specific regional activation at low doses. Org 26576 (1 mg/kg) produced significant increases in 9 of the 43 areas examined, including the anteroventral and laterodorsal thalamus, cingulate cortex, dentate gyrus and CA3 subfield of the hippocampus. Org 24448 (3 mg/kg) produced significant increases in LCGU in 4 of the 43 regions examined, including the dorsal raphe nucleus, medial lateral habenula, CA1 subfield of the hippocampus and median forebrain bundle. Furthermore, the increases in LCGU observed with both Org 26576 (10 mg/kg) and Org 24448 (10 mg/kg) were blocked by pre-treatment with the AMPA receptor antagonist NBQX (10 mg/kg). These data demonstrate that both Org 26576 and Org 24448 produce dose-dependent AMPA receptor mediated increases in LCGU and provide an anatomical basis suggestive that these drugs may be of use in the treatment of conditions such as depression or schizophrenia.
PMID: 15993447 [PubMed - indexed for MEDLINE]
Aiming,
I see that Organon lists 2 Ampakines in their pipeline, Farampator in phase II and ORG 26576 in phase I. I believe that Farampator is ORG 24448, and I'm guessing that ORG 26576 is one of the other Cortex compounds. I think there were 3 compounds in the agreement. Do you have any information on the Organon Ampakine status other than what has been recently discussed about ORG 24448?
Thanks.
gfp,
Have you looked at Anadys Pharmaceuticals? They have had trouble over the years - recently with their Hepatitis C treatment and a change in CEO. Yesterday they had higher than expected losses, and PPS is down today. Even though they have gone through several name changes, they seem to be well run and have a variety of compounds they are advancing, and have a seemingly good partnership with Novartis. Situations like this can go either way, but it may mean there is an investment opportunity. Any thoughts?
Thanks.
gfp,
Please correct me if I missed something, but these observed spectrin effects seem inconsistent with Dr. Stoll's CC statement that the effect was not observable soon after discontinuation of administration of the high dosages.
Of course a longer term prediction of stock price performance must take a lot more into account than just looking at the possible outcome of binary events. This means assessing the value of potential revenue streams, the quality of the managers and staff, the potential for growth and expansion, the current value of assests and the change in thier value with time, the impact of competition, costs of growth, and much more. But for small companies like Cortex, just looking at the outcome of likely to occur events over a relatively short period of time may not be too bad of a way to do a risk/reward assessment. After all, it is the outcome of these events that makes the stock jump in ways that create the allure and repulsion of small biotech investing.
Thanks for letting me get in my 2 cents.
Karl
Sorry, I didn't realize all of the spaces would be stripped out of the message, leaving the table unreadable. Here is a second shot.
Thanks.
Event Likelihood Estimated Change in Share Price Weight Expected Outcome
General Market - - 1 -
General Market Up >10% 30% 0.15 - 0.05
General Market Down >10% 70% -0.15 - -0.11
General Market - - - -0.06
CX717 - - 3 -
CX717 Dropped 30% -0.3 - -0.09
CX717 AD only 30% 0.3 - 0.09
CX717 AD &ADHD 30% 2.5 - 0.75
CX717 - - - 0.75
BP Deal - - 2 -
BP ND Deal <$5M 60% 0.5 - 0.30
BP ND Deal $5-10M 30% 1 - 0.30
BP ND Deal >$10M 10% 2 - 0.20
BP Deal - - - 0.80
Financing - - 3 -
no more shares 20% 0 - 0.00
<5M more shares 30% -0.25 - -0.08
5-10M more shares 30% -0.4 - -0.12
>10M more shares 20% -0.5 - -0.10
Financing - - - -0.30
Estimated Change in Value @ End 2007 - - - 0.32
It seems to me that the recent tensions on the board are a result of our general inability to value small biotech stocks that have no reliable revenue stream on which to base a fundamental valuation. Some, like jerrydylan, use a technical evaluation to predict stock price, which may be more reflective of market psychology in the absence of widely disseminated significant information. Many of the folks on this board seem to be pretty analytical, and some likely have some kind of quantitative risk/reward valuation algorithm to help them price small biotech stocks, where the value is in the potential future revenue stream. To have any chance of being reasonably useful, such a valuation algorithm should also take into account the market psychology associated with recent performance of the stock.
There is always some subjectivity, but attempting to quantify outcomes can keep expectations confined at least a little.
Here is a really simple approach. It attempts to estimate the value at the end of a specific period of time as by combining estimates for the impact of the outcome of specific events.
Value(@end of period) =(weight* sumevent( Likelihood * Estimated Change in Share Price))/ sumevent(weight)
So, for 2007 one such estimate might be:
Event Likelihood Est.Change in SP Weight Expected
General Market 1
Market Up >10% 30% 0.15 0.05
Market Down >10% 70% -0.15 -0.11
General Market -0.06
CX717 3
CX717 Dropped 30% -0.30 -0.09
CX717 AD only 30% 0.30 0.09
CX717 AD &ADHD 30% 2.50 0.75
CX717 0.75
BP Deal 2
BP ND Deal <$5M 60% 0.50 0.30
BP ND Deal $5-10M 30% 1.00 0.30
BP ND Deal >$10M 10% 2.00 0.20
BP Deal 0.80
Financing 3
no more shares 20% 0.00 0.00
<5M more shares 30% -0.25 -0.08
5-10M more shares 30% -0.40 -0.12
>10M more shares 20% -0.50 -0.10
Financing -0.30
Estimated Change in Value @ End 2007 0.32
So, in this case, the estimate of the most probable change in share price over the course of the year is $0.32, for a year end share price of about $1.50. But, note the estimate on the extremes - a change of -$0.95 and +$4.65 for resulting year end share prices of $0.20 - $5.80!
This is pretty crude, and I don’t expect anyone to take it too seriously. I’m just trying to get a more analytical discussion started on how to value this stock based on the likelihood of the outcome of expected events, which is the only way I think these kinds of stocks can be valued.
davidal,
If I recall the last couple of CC's correctly, you neglected to mention that the 'lesion' is only static with continued dosing from 2 to 13 weeks, and completely resolves with cessation of dosing. (I do not recall the time for resolution or if it was ever mentioned, but I think it was short.)
jerrydylan,
You seem track the trading much better than I do, but the pattern of trade prices seems a bit odd today. Do you read anything into it?
Thanks.
Sorry. The point I was trying to make is the semi-flat response in share price to what has been interpreted on this board as great news is explainable by:
1. The CC was only (as far as I could find) announced at the end of a PR release with a title (Cortex Completes $5.6 Million Direct Equity Placement) referencing old news, and was likely poorly attended.
2. There was no PR release (again, as far as I could find) that summarized the CC or provided any information other than that about the financing.
3. Fund traders look for things that are already moving, and are much more risk adverse than most of us imagine.
4. The volumes do not indicate supression of a widespread enthusiastic response to great news.
And thinking further, if a fund really was mad at COR, it would not cost them much to put one of their own guys on the BOD.
Combine these with past COR performance, and I think that a muted share response should be expected.
Thanks.
Exploding cigars - another reason to give up smoking! I suspect that the reasons for the price depression is that many sellers just are not paying attention to what is going on with the company. The share volumes are higher, but not huge, and in dollars pretty small, and I've looked, but I cannot find any summary of the conference call or PR release from COR. In fact, the only reference to the CC I've seen is the COR announcement for completing the financing with the upcoming CC notice tucked in at the end. How is a poorly advertised CC alone going to to interpreted by the average shareholder as great news? As for all those fund guys, I don't think they have a memory at all. The only questions they seem to ask is, 'What are you going to do for me today?' and maybe 'What are you going to do for me tomorrow?' If they don't see a sudden rise initiated by others, why should they tie-up their dollars that they could put on something that is already moving?
But, then again, those pirates could have the crew of COR tied to the mast...
Bladerunner,
I don't think I've seen anyone suggest that any in-licensed program would be positive. Most of the in-licensed posts to this board have obviously been negative, but I think that we have just not been creative enough to figure out what types of in-licensing might occur to assess whether all scenarios would have a negative impact. Without being especially knowlegable on the the subject, I think I can imagine some scenarios for in-licensing that would provide a positive impact, even with the limited funds the company currently has available. For example: in-licensing a compound that has already met significant milestones for some indication, but is licensed for an orphan indication in which the compound owner has no interest; in-licensing a compound for a neurological indication that your staff is familiar, and can be managed with less impact than for a completely new indication; in-licensing a compound that has failed to be effacious within some dosing limits, but looks like it could be effacious at much lower doses when combined with an ampakine; arranging a back-end licensing agreement where payments are only due after success. I'm sure there are many possibilities that I can't imagine. I'm also guessing that the Cortex folks are very worried about spending their money wisely, and are only considering options that require low costs - especially if they have evidence that a compound has significant potential and have an opportunity to obtain the rights before someone else does.
Dew,
Thanks, but is that $300K - $600K in addition to the $5.6M or will COR actually receive that much less after paying the fee?
Thanks, again.
Dew,
As jerrydylan pointed out in message #3196, the deal was not assembled for free, so you should also add a fee into your calculations. I don't know what a standard fee would be, but these guys usually make out like bandits. I'd guess 10% - 20% at least. That would put the cost (using your warrent value)near today's share trading price, and be closer to a 20% - 25% discount from the price before the announcement.
...While the pressure mounts to replenish the pipeline...
http://yahoo.reuters.com/news/articlebusiness.aspx?type=health&storyID=nL19865438&WTmodLoc=B...
UPDATE 2-Europe revokes patent on AstraZeneca's Nexium
Tue Dec 19, 2006 7:00am ET
By Ben Hirschler, European Pharmaceuticals Correspondent
LONDON, Dec 19 (Reuters) - The European Patent Office has revoked a key patent on AstraZeneca Plc's (AZN.L: Quote, Profile, Research) top-selling drug Nexium, dealing a fresh blow to the Anglo-Swedish pharmaceuticals group.
"The patent has been revoked," a spokesman for the Munich-based patent office said by telephone. "The reasons and comments (for the ruling) will be published next year."
Shares in the firm fell as much as 5.8 percent to a nine-month low of 27.07 pounds before ending 4.4 percent lower at 27.38.
The news comes at a difficult time for AstraZeneca, which is relying on established medicines like Nexium to drive sales and profits in the mid-term, following several high-profile new product failures, most recently for stroke drug NXY-059.
Nexium is the world's second biggest-selling drug with global sales of $4.6 billion in 2005, of which Europe accounted for $1.1 billion.
The European patent ruling followed an appeal from German generic manufacturer Ratiopharm against Nexium's main substance-of-matter patent, which protects the heartburn and antiulcerant pill from cheap generic copies. Continued...
Wow! This may be another symptom of a dearth of high volume, high $ drugs in development across the industry.
http://yahoo.reuters.com/news/articlebusiness.aspx?type=health&storyID=nL19200238&WTmodLoc=H...
UPDATE 4-Glaxo signs record $2.1 bln deal for Genmab drug
Tue Dec 19, 2006 7:38am ET
By Ben Hirschler, European Pharmaceuticals Correspondent
LONDON, Dec 19 (Reuters) - GlaxoSmithKline Plc (GSK.L: Quote, Profile, Research) has bought global rights to Danish biotech company Genmab's (GEN.CO: Quote, Profile, Research) most promising new drug, a treatment for leukaemia, in a record deal worth up to $2.1 billion, the two firms said on Tuesday.
The agreement is the biggest ever clinched by a biotech company, eclipsing a $2-billion alliance between ImClone Systems Inc. (IMCL.O: Quote, Profile, Research) and Bristol-Myers Squibb Co. (BMY.N: Quote, Profile, Research) that was revised down in 2002 when ImClone's drug Erbitux hit snags.
Genmab shares surged as much as 24 percent to a new all-time high of 424 Danish crowns before ending up 11 percent at 380, valuing the business, which has yet to make a profit, at around $2.7 billion.
The deal is the latest in a string of product acquisitions by large pharmaceutical firms eager to tap biotech know-how to boost their drug pipelines, and the price paid -- higher than analysts had expected -- reflects the fierce competition for late-stage assets.
It covers HuMax-CD20, an experimental human antibody in late-stage development for CD20 positive B-cell chronic lymphocytic leukaemia and follicular non-Hodgkin's lymphoma.
The drug, which is also in Phase II trials for rheumatoid arthritis, is similar to MabThera/Rituxan from Roche Holding AG (ROG.VX: Quote, Profile, Research) and Genentech Inc. (DNA.N: Quote, Profile, Research). Continued...
OT - It looks like one of gfp's binary events that was mentioned in an earlier post may occur today. Northfield Labs (NFLD) has scheduled a trial update call for later today. It looks like many investors are taking gfp's advice and avoiding the event!
Karl
At Nerdseeksblonde's prompting I looked through a few PubMed searches based on some earlier discussions. This paper (found in PubMed search on 'ampa tauopathy') caught my eye because it shows a specific link between tau toxicity and a brain receptor activation. It also seems relevant to current discussions. Since I'm way out of my field, please don't slam me too hard for this post!
http://www.pubmedcentral.nih.gov/articlerender.fcgi?tool=pmcentrez&artid=1413822
Thanks,
Karl
Here is the conference link.
http://www.wsw.com/webcast/rrshq10/cor/
I think this trail is very intriguing. Postulation of these two mechanisms implies that the response curves would likely be species dependent and the effects difficult to untangle with a small sample size. But would they fall into the ‘never-before-seen’ category?
nerdseeksblonde,
Thank you for the response. Histologic, Toxic, Reversable, Asymptomatic, and Never-Before-Seen... I'm not knowledgable enough to judge, but it does seem to be quite the puzzle. The type of tissue where the phenomenom is observed was not disclosed. There was some speculation in earlier postings that it was in brain tissue. I think there was also an assumption that the effect was visually observed in thin sections, though I do not recall anything that specific stated in the CC. I haven't a clue whether there would be any more specific tests of tissue samples, nor if many organs from the courageous volunteers would be sampled. I suppose they might notice the effects of some histologic changes indirectly (e.g. too much intercellular H2O concentrations indicating affected astrocytes), but it is hard for me to believe that there was a visually identified brain cell pathology that was completely asymptomatic.
My initial guess was that they observed some hepatic pathology, but that would not fall into the Never-Before-Seen catagory, especially since it was observed only at extemely high dosages.
I think your suggestions that some change in osmosis or some other uptake mechanism causes a temporary cell size change. During the CC I think there was some discussion of whether multiple cell or tissue types were involved, but I think it was a single tissue type with some evasion on whether multiple cell types were involved. I suppose it is possible to have some cellular hypertrophy in some brain cell type that would be asymptomatic. But, would such a phenomenom be considered toxic?
Your suggestion to imagine storage granules is more interesting. I can easily imagine the accretion of some material (extracellular protien crystals, to the walls of something, ???) in the presence of exceedingly high concentrations of some compound that meets the Never-Before-Seen requirement, but again, would that be considered toxic.
Well, thank you again. All this tells me is that I need to go back to school!!!
wahjjhugo,
I am certainly not qualified answer your question, but I, too, find the description of the observed cellular changes very interesting.
First, during the CC, Dr. Stoll selected his words carefully, and seemed to go out of his way to emphasize that the observed response was toxicological in nature. However, he also pointed out that while the observed impact scaled with dosage, all effects disappeared after a short period of time (2 weeks?). To cellular biologists there may be some implications here that I cannot appreciate, but there are some basic questions that I don't think have been answered - do the affected cells die off but no other cells are affected once CX-717 is discontinued, or is there some cellular change that has been induced that resolves with the discontinuation of CX-717, leaving an apparently healthy cell? The fact the cellular response has never before been observed (tox or recovery?) is also quite interesting, and I'm sure the Cortex researchers are running in overdrive trying to understand what is occurring. Never-before-observed phenomena always have the potential to cause increases in understanding -one way or another.
I don't think these details have been discussed in this forum, but the description caught the attention of several posters who pointed out that the response may not be related to CX-717 (species specific metabolite, impurity, etc.) Perhaps one or more of the regular posters could help enlighten us.
davidal66,
There have been quite a few posts in the last few days that I have not yet been able to read, so I apologize if this subject has been addressed. I have not seen any comments on the remarkably fast recovery of the observed toxicity. I would have expected any histological changes to be very long lasting or permanent. I believe Dr. Stoll reported in the CC that all toxicological effects were completely reversed in only a couple of weeks. If my memory of his comments is correct, and this is in fact the case, then I suspect that this played a big part in the FDA lifting of the hold.
Any comments (perhaps ones I’ve already missed!).
Thanks.
Alertmeipp
I think you answered your own question - to drive down the pps.
gfp927z,
I'll need to review Dr. Stoll's statements also, but I think your assessment is too pessimistic. I thought he implied that for both back-up compounds they did not see a similar cellular toxicity response as with CX-717. I interpret this to mean that they conducted similar dosing level studies (probably in rats)with theses compounds. Perhaps I missed something, and was just looking for something positive...
Aiming4,
If I read between the lines correctly, Dr. Stoll expects that if there are no additional issues found with CX-717, and the toxicology assessments show a suitable safe dosing range, then they would conduct some TBD AD efficacy tests, the results of which would be available mid-year 2007 at the earliest. He also said he does not expect any AD deals to be made in the absence of solid efficacy data.