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OT: BioLineRx
Blade:
Their best known program, from CNS 2011:
<<BiolineRx’s BL-1020, (formerly partnered with Cypress Bioscience) combines Trilafon/perphenazine, a first-generation D2 antagonist, with GABA. GABA ordinarily does not have BBB access, but the conjugation with perphenazine is believed to promote such access--although it must be wondered just how nonselective that GABAergic activity could be. A 363 pt Phase IIb study comparing BL-1020 with both placebo and Risperdal was reported as indicating BL-1020 had a better impact upon cognition than Risperdal; a lower discontinuation rate; and no impact on weight/metabolic measures, though its eps impact was similar to Risperdal. Curiously omitted from the report was any mention of how BL-1020 compared to Risperdal on the PANSS symptom measures, only its benefit compared to placebo was discussed. Given the detail allotted to the other comparisons, the inevitable inference would be that it had less impact on those symptoms than did Risperdal. It turned out that was the case, in terms of numeric trends, but that may have been an artifact of dosing, with Risperdal titrated up to a relatively high dose. Thus the potential trade-off may not be in terms of positive symptom efficacy, though this needs to be confirmed, but perhaps on the eps side, where first-generation drugs do have a legacy. There is some evidence supporting the need for GABAergic activity in schizophrenia, providing a counterbalance for glutamatergic activation, particularly in the frontal cortex. Whether this is the optimal route to such remains to be seen, but BioLineRx decided that Cypress’ new management was not the steward they wanted for their prize project, and they took back the rights, paying $10 million to do so. They will look for another partner. >>
I'm going to be out of touch for two weeks.
NeuroInvestment
It's the same situation as before the Biovail deal: There is nothing that can be said when corporate activity is --due to fiscal constraints--solely limited to licensing/M&A. 'We continue to explore a variety of strategic paths forwards for Cortex.' They can't, and should not, discuss where they stand with any of it. And it's July, where the pace of anything that was in process will be slow to zero until September. We know they added some runway (my guess, three months) with the Servier option. And the fact that Servier could exercise that option during the later months of this year means that other potential partners/buyers cannot assume that the clock is ticking to zero even then, eliminating some of their ability to squeeze Cortex on terms.
We will know whether anything worthwhile is en route--after they get there.
NeuroInvestment
If someone walks into an ER spouting nonsense as out of touch with reality as this is, they will almost always leave the ER heavily medicated.
NeuroInvestment
OT: Just to close the circle, Fibiger was Amgen's Neuroscience head when that GDNF work was being done. He never lost his interest in it.
NeuroInvestment
Unfortunately, this is another example of someone building a fantasy and then moving in. CX-1632 is a Phase I compound. It has not yet even started testing for efficacy in any disorder. Given the tiny survival rate of programs that have not even finished Phase I, postulating this as potentially "making billions" is....premature. And if this compound does eventually show that kind of success, other companies will want their own, and the only likely source of competing compounds would be.....Cortex. But only if they still exist.
No one on this board was jumping up and down with excitement about CX-1632 a week ago, talking about its "billion-dollar" potential for Cortex. You can't have it both ways, casting it as irrelevant when in Cortex's hands, and the treasure-that-was-given-away for a pittance once they sell the option.
NeuroInvestment
He's consulting for the time being, with a particular interest in the MedGenesis Therapeutix program delivering neurotrophic factors under pressure.
NeuroInvestment
Yes--the dosing is a lot higher; I suspect that they figure in an aggressive, advanced Alzheimer's patient, since antipsychotics are used even though associated with higher death rate, thus the tolerance of side effects would be higher.
But I do not get the impression from Lilly that this is seen as a priority program, nor do they appear to have much interest in AMPA-modulators at present.If that trial produces OK data, maybe that would change, but I have the sense that this is vestigial rather than prospective.
NeuroInvestment
Everything disclosed (and anything else would have been material) refers to this as a CX-1632, molecule-specific agreement. Servier can (if they exercise the option) market it anywhere, for anything. Cortex can do the same with any of its inhouse Ampakines.
My guess is that Servier is waiting for the end of their Phase I and all subsequent analyses: Safety has always been the Achilles Heel for the high-impact Ampakines, and they (remember, they were the company behind dexfenfluramine/Redux, so they have become very cautious about anything that could eventually reach the US market) will want to be very sure they aren't caught by surprise by some rare or slow-to-develop adverse event. If all looks OK in October, they'll likely exercise the option. What would be interesting is if they see the results as promising but problematic due to some kind of tolerability or pk issue--would they then be interested in the rest of the Cortex high-impact collection?
NeuroInvestment
I'm happy to see this agreement. It beats the alternatives, like a bottom-feeder financing (e.g. fourteen million shares at 7 cents). This probably extends the timeframe for a sale/deal by about three months, and it also means that another party cannot assume that they can play the string out and starve Cortex into a lower price, since if Servier exercises the option, that would be yet another six months or so.
If CX1632 is developed over the long run, we could rue its sale for $3 million. But Cortex doesn't have the luxury of planning for the longterm, and if CX1632 ends up looking good, I think that Cortex's inhouse high-impacts will end up looking better.
NeuroInvestment
The take home point is that none of us know what the exact options available at any given time were for Cortex: And thus determining whether they underperformed or overperformed is, to some degree, a question of interpretation---Not, as claimed by those who replied so acerbically to your post, some objectively defined reality. My own personal opinion is closer to your hypothesis, but that's all it is--my opinion.
NeuroInvestment
In fact, doing a financing at that time, before the news, is exactly what we have been citing as something Cortex should have done more often--hedging against the risks by raising money pre-emptively.
NeuroInvestment
Is Gfp the only member of this board who has not forgotten that you shouldn't eat wild mushrooms that you can't identify? Some viewpoints are the usual vacuous projections rushing to fill the silence for lack of anything better to do, some come from people who used to know better. But there are a couple things worth remembering:
1) The last time that I recall the price closing at .07 was shortly before the Samyang financing. Which itself came a couple months before the Biovail deal.
2) Which only shows that we have no idea what is really going on. It is not an efficient market, the share price for a stock this thinly traded says more about the ebb-and-flow of emotion than anything else. History does show that Cortex management does not leak news, good or bad.
3) The absence of news does not mean that a deal or financing or buyout is going to happen; it also does not mean they won't happen. Anyone who claims they know how this is going to play out is just making it up, out of ignorance or hubris. I don't know how it will end, and neither does anyone else on this board.
4) Gfp had posted some back-of-the-envelope calculations on how long the money would last, and extrapolating from last time, Cortex has the ability to exist on fumes for even longer. So any guesses that the lights will simply go out at the end of June are not taking into account even the meager information available.
5) Anything else, in terms what may be under discussion in terms of selling the company, a program, or raising money at would be awful terms, isn't something Cortex, or any other company in this position, can discuss. So at the moment, it's just a giant Rorschach test, on to which everyone can project their own assumptions about human nature. They have nothing to do with what is going on behind the scenes.
NeuroInvestment
Gfp:
I think--I have not discussed this with Cortex--that they will do whatever they have to do to stretch the window to get something done. Including salary cuts. And in anticipation of the usual carping about Varney/Stoll/Coleman being in place: My opinion is that the workload associated with tapping every possible licensing/merger/financing possibility (repeatedly, because timing is everything), and utilizing whatever relationships each has developed--warrants having the three being in place and active. Another place they'd be careful is in cutting a couple of important people, and I refer to Les Street and perhaps Steve Johnson. Between their AMPA chemistry and preclinical AMPA expertise, they could be seen as adding value in a sale of the company, depending on who the potential acquirer is.
NeuroInvestment
Not worth the time. If anyone who has not fallen in love with their own fantasies of how the CNS bioworld works has an idea, or question--post it, or email it. There are reasonable discussions to be had on what the tactical possibilities going forward are, and where mistakes were and were not made getting to this point.
But for the blowhards bravely issuing verdicts from behind the walls of Internet anonymity--you're boring. I have other things to do.
NeuroInvestment
Your perseverative theme of 'broads and booze' stopped being amusing after one repetition--not that you noticed. Between you and Haysaw, there's enough self-congratulatory delusion to populate a small asylum.
NeuroInvestment
Just because you know how to operate a mouse doesn't mean you have anything of value to say--you do not. As complete a repertoire of idiocy as I have seen since Crease on Yahoo.
NeuroInvestment
Gfp: Not for the first time, your posts thankfully retain both sanity and humor in the midst of what has otherwise become a sludge pool of baseless character assassination, and repetitive caterwauling.
One note on the timeframe--if you think back to the last time, Cortex was able to stretch out their dwindling resources longer than expected. In other words, I wouldnt use the 1Q burn as a definitive marker of how long they have to get something done.
Secondly--it takes longer to complete a sale of the company than to partner an asset: More money, more DD, more lawyers.
NeuroInvestment
Cortex has the license from UC, and has to pay small royalties on any eventual commercialization. UC has a couple of times had to decide whether to renew that license, and on each occasion, decided they were best off staying with Cortex.
NeuroInvestment
<< no kick-it-down-the-road financing, no licensing or partnership deal or sale of certain assets>>
None of us know whether or not this will turn out to be the case ( I don't think it will, but I don't know that). The fact that nothing has publicly materialized as of May 19 does not in itself define what may or may not materialize over the next days, weeks, months.
NeuroInvestment
My point is that in such a situation, companies get pennies on the dollar for their assets.
NeuroInvestment
I'm puzzled too. The number of shares is so idiosyncratic that I'd wonder if this is a purely internal Samyang machination--some realignment of the percentage of their fund allocated to biotech, CNS, companies in SoCal, I don't know.
What I don't think it is would be the 'warning shot' scenario--if they wanted to do that, they could pick a round number--and secondly, this is based on the presumption that Cortex management is trying to drag out the process however fruitlessly, and that they have to be forced into finding a resolution. It's not so, and just because somebody built a house with paranoid framing doesn't mean everybody else has to move in.
The time is running down, I think Cortex is simultaneously looking at both outright sales and licensing, and will take the best deal that ends up available. Financing is a bridge to either of those, should more time be needed. And keep in mind that without at least the appearance of being able to raise money, offers tend to be reduced as the cash balance approaches empty.
Finally: this fantasy of the 'forced sale.' As if there is some orderly auction process, a Biotech CarMax, where reasonable value can be produced. That does not exist. Closing down and dispersing assets does not obtain value. If you doubt this, look at Dov Pharma, which at one time had a market cap over $300 million (if I recall correctly). The assets were finally sold for $2 million to Euthymic Bioscience. Epix Pharma suffered the same fate. Now, I believe that Cortex's assets have more value than either of those two companies, and that it will not come to that. But be careful of what you wish for.
NeuroInvestment
DavidAl--Come on, your memory is getting fuzzy.Watching paint dry for three years? I wouldn't mind watching more paint dry, if it involved a licensing like Biovail's, which was made possible by that Samyang financing. I don't think they will do a financing as a bridge to nowhere--either it gets them to completion of a sale or licensing, or there's no point to it. They can't raise enough money per se to go it alone on any clinical development--and I don't think there is any desire within the Company to limp interminably.
NeuroInvestment
All of the acquisitions you list are of companies with products on the market, where the buyer can claim that the acquisition will soon be accretive to earnings--largely by lopping off employees. The environment for small/microcap companies is completely detached from this, since there is no nearterm commercial payoff--and that is what drives most M&A these days.
NeuroInvestment
Speaking of changing operational conditions. Three 'fun facts' that illustrate something of the fluidity and complexity of the CNS business environment:
1) I am completing an annual publication which, among other things, includes evaluations of all Big Pharma licensing agendas--I have spoken with heads of BusDev at virtually every Big Pharma, some midsize. The number of wishlists that even mention ADHD is: Zero
That does not mean that it would be completely impossible--some talk about being open to opportunism, projects that don't fit the priority but have enough human data to make it worthwhile.
2) I was puzzled by the slow pace of orders for this same annual publication, but when I looked at the pharma BusDev people who ordered it last year, I understood the reason. 40% of them are unemployed or have been forced to go elsewhere to start again. Which means that old relationships and strategies (see #1) no longer apply.
3) The head of CNS BusDev for Merck told me that they were presented 5000 licensing opportunities last year.
Figure 250 work days, that is 20 projects per day, every day. In an eight hour day, that's one every 22 minutes or so. It's a challenge to get visibility in this kind of rapidfire flow.
NeuroInvestment
I look at this comment, and the post it allegedly is in response to, and I'll be damned if I can see the reasoning. So I have to ask myself--Why do I bother?
At the moment, no good answer is apparent.
It seems to me that there is a disconnect between these two statements:
<<I have direct experience of a lengthy e-mail correspondence with Stoll and Varney>>
AND
<<they could have been more forthcoming and amicable than they have been>>
On the other topic:
The conversation regarding the prospects for Cortex is similar to that of Jan-Feb 2010, prior to the Biovail deal.
I don't see a pure financing that would fund program development--not at this valuation. There could be a small bridge financing that allows them to complete a deal, not finance clinical development.
There are two ways this is most likely to play out:
1) A specialty pharma licenses/buys either the small molecule pipeline for (mainly) psychiatry or the neurorespiratory programs. Similar to the Biovail deal. The high impacts would not give them enough cash to develop either of the other two components.
2) A specialty or large pharma buys the entire company. Cortex's dwindling cash position again reduces their leverage. Your range of .25-.50 per share for a buyout as cash declines is as good a guesstimate as any I can come up with.
NeuroInvestment
No, I don't think so. This will never be resolved. The divergence of opinion involves not only the journey, or the destination, but also the motivation of those carrying it out. I have no idea what the destination will end up being, and it could be the result of strategic execution or serendipity, for better or for worse. The journey, the route taken, can be debated reasonably--for example, Enemem raising valid questions about the pursuit of sleep apnea.
But there is also a bifurcation of opinions expressed about management's motivation: Those who see them as attempting to act in a productive and ethical fashion on behalf of the Company, versus those who paint them as exploitatively self-serving and/or irredeemably incompetent. Far more than anyone else contributing to this Board, I have direct experience of their approach and motivation; it is not the latter. I think that those who dismiss this information as sycophancy reveal far more about their own character than about anything else.
It's like the birthers who are unwilling to accept any evidence that their engrained belief system is off-the-mark. They are more wedded to their personal view than to anything approximating objective truth, and that says a lot about who they are.
NeuroInvestment
Thank you for the sane post. Those three asset groups and/or the whole company are the four alternatives. Starting from scratch, it would be difficult but not impossible to effect a sale of the company, but that presumes they are starting now, which overlooks the fact they've been beating the bushes for some time.
An interim financing just to have enough time to get a deal done might not have to be this large.
A high impact deal would not yield enough to advance any of the other programs, and would be insufficient. The others might.
Stoll and Varney were both in San Francisco at a partnering meeting this past week--I saw them in passing. Those who sarcastically depict them as carousing or focused purely on their own aggrandizement say far more about themselves with that projection than about Stoll/Varney.
When there is something to announce, they'll announce it. They cannot say anything about possibilities that may or may not come to fruition. There is no point to issuing a PR that says nothing. There would be no point to an ASM where there is no news.
NeuroInvestment
OT: TRGT
Right. Given that they already pay for a chunk of the TC-5214 Phase III program, they can't take this on alone. Along with the package GSK returned, they need a new partner for both.
NeuroInvestment
OT: TRGT
Blade:
This is what NI published in February on the sz trial results. I had expected AZ would probably exercise the option, but recently Targacept had made comments indicating that this was not at all certain, and now we know why:
<< Targacept's PhIIb trial of TC-5619 in schizophrenia hit its primary endpoint, a computerized measure of frontal-lobe mediated problem solving/executive function (Groton Mazes). Perhaps more importantly in the long run, it also produced positive signals on global functioning and negative symptoms, as assessed both by a clinician and by patients themselves. It did not produce a signal on the overall cognition battery used (CogState), and Targacept has not yet completed a full analysis of the other six cognitive subdomains tested to see if changes occurred there (parenthetically, it is unlikely that the higher-order thinking required in mazes could improve if there were no changes whatsoever in lower-order domains like attention, memory, and/or processing speed, to name but three). It will be reassuring if positive trends are found in some other CogState subtests.
The initial data summary raised a number of intriguing subplots and questions:
1) The first question emerged from the use of the pre-specified hurdle as bettering p=.10 in a one-tailed test, which is more easily reached than the typical two-tail, p=.05 criterion. This is a benchmark used by some pharma companies internally in making go/no-go decisions on furthering development of a program, and the fact is that the Mazes score came very close to p=.05 here.
2) The greatest divergence between drug/placebo came at the four week mark, when the lowest dose (1mg) had been utilized. This begs the question of whether, when it comes to dosing the nicotinic alpha 7 receptor, 'less is more.' Given that these were not independent groups, but rather, the same patients gradually escalating in dosing from 1 to 5 to 25mg (and thus perhaps experiencing some changes in receptor density or sensitization), that question is not definitively answered. Targacept believes that they are in the right dosing 'ballpark;' our suspicion is that ultimately, optimal dosing will be towards the lower end of the range--and the FDA may want them to prove they have identified the minimum effective dose.
3) The most counterintuitive finding was that non-smokers did not show benefit from TC-5619, only the 46% of patients who were smokers improved with the drug. Many observers had expected the opposite, thinking that smoking might obscure drug effects, perhaps due to nicotine saturation of receptor sites. Instead, the results leave open the question of whether smoking sensitizes receptors and allows greater response to alpha 7 binding, or if receptor density is different between the two populations. Targacept worked at having a schizophrenia trial with just 46% smokers (likely by including an Indian patient subgroup more likely to be nonsmokers) and in retrospect, this made achieving an overall positive signal all the more impressive, in that half the patient population consisted of a group that turned out to be nonresponders at this dose-range. With 75-80% of schizophrenics being smokers, this puts the vast majority of schizophrenics into the potential responder population, and powering the next trial will be made somewhat easier, simply by virtue of the proportion of smokers in the general schizophrenia population (offset by the need to hit a more exacting statistical hurdle).
The bottom line is that this TC-5619 trial provided something between hint of concept and proof of concept. There are some questions about breadth of cognitive effect and optimal dosing, but the drug appears to be very safe and well-tolerated. It is possible that the next trial could be powered to be a potentially pivotal Phase IIb/III, even with a dose-ranging component. The next step is for AstraZeneca to decide--they have through 1H:11--if they will pay the required $30 million and exercise their option on TC-5619. If they are at all serious about staying in psychiatric drug development, they will. Perhaps AZ will be influenced by the results--early 2Q-- from EnVivo Pharmaceuticals' Phase IIb schizophrenia trial of EVP-6124. Replicating success and safety there might provide enough additional validation of the mechanism's promise to seal the decision for AZ. Targacept has the resources and motivation to take the program ahead if need be, but we do not expect this will be necessary.
The nicotinic alpha 7 story, from Targacept and perhaps from EnVivo as well, has the potential to be one of the most important CNS therapeutics stories of the year, perhaps shifting the psychology away from what has become an atmosphere of learned helplessness.>>
I had spoken to one of AZ's licensing heads last week (not about this specifically) and he had noted that AZ had terminated all inhouse psychiatry R&D, but was still open to licensing in sz and depression. I suspect that they felt that for TC-5619 to have fallen short of POC in a large Phase IIb, with substantial questions about dosing, means that the program will take more work to advance than they are willing to allocate. It is going to be difficult, if not impossible, to find psychiatry programs with that level of maturation and certainty.
NeuroInvestment
There has not been anything worthwhile discussed on the Board of late. If and when there is, I'll be happy to participate.
NeuroInvestment
Athero:
If you were to try to have a rational conversation with Glenn Beck about his underinformed and half-baked ideas, this only would add to his conviction that he has something of value to say, and that he should stand his ground, because otherwise, why would you be engaging him on the topic?
Same principle applies here.
NeuroInvestment
deleted--not worth the fleeting satisfaction
NeuroInvestment
The other plus for ADHD--besides the fact that you can use endpoints that get measured a month in, instead of having to wait six months to a year (e.g. Alzheimer's) is that it taps into the same drug abuse issue. The psychostimulants are generally very effective, but they are amphetamines, they are commonly sold amongst students, and there are a lot of kids that go untreated because the parents are afraid of those drugs--and nontreatment is not innocuous. The approved nonstimulants--Strattera, Intuniv--are pretty mediocre. The FDA is well aware of the abuse issues, which is why this is not a pointless strategy.
NeuroInvestment
It should, it has, but I know (not from Cortex) of one pain company that decided it was too much work, and unclear reward. Developing a coformulation of an opioid and Ampakine is complicated in itself--plenty of preclinical and Phase I testing to evaluate the correct proportion of each; the pk characteristics of various combinations; and any safety/tolerability issues that come up along the way, with any particular dose and proportion. As Gfp has noted, the clinical trial process isn't clearcut either. Cortex took on the most controllable context, perisurgical anesthesia, and we saw how challenging that could be. To go after the chronic analgesia market means figuring out a way to show that an Ampakine adjunct or combo decreases the risk of RD. How to do that? I don't know how many of those 11,000 opioid overdoses were based on licit vs. illicit use, but one isn't going to be able to track the latter. So you have a relatively rare phenomenon (a few thousand deaths annually out of the--3% of American adults--5-6 million--estimated to be on chronic opioid therapy): Tracking the effect of Ampakine supplementation on the incidence of a rare event is not going to be easy, it will take either a huge number of patients or a long time to establish a statistically significant divergence.
Funding, because of the 'War on Drugs', has been largely for developing abuse-resistant formulations. Opioid-associated RD should be attractive, and if the product were developed, it could be widely used, because of the decreased risk. But getting to that point is a long journey.
NeuroInvestment
The level of insight displayed on this Board (there are a couple of exceptions, you know who you are) over the weekend really speaks for itself. Any comment on my part would be superfluous.
NeuroInvestment
In Boston's Fenway Park, where the Red Sox play, there is an area in the right field bleachers, the (relatively) cheap seats, that extends up to the back wall. Those seats are 450 feet or more from the plate. That's where you'll often find a middle-aged guy who peers in without benefit of binoculars, bleary-eyed from four or five beers, convinced that he can call balls and strikes better than the umpires, and could utilize the roster better than the manager. On a night that the Sox are losing, he starts to yell insults and obscenities at the field, and the people around him shrink away from the spittle and the risk that the beer may make a sudden return. He doesn't care: He paid his money, he bought his ticket, and he is 100% certain that he knows the game better than those overpaid clowns on the field and in the dugout.
You're that guy.
NeuroInvestment
OT: Prana
I know Rudy Tanzi, who along with Ashley Bush, developed the whole metal-binding/amyloid model for AD--that turned into Prana:
<<Rudy Tanzi and Ashley Bush, the founders of Prana Biotechnology, took this a step further, arguing that beta-amyloid is a natural antioxidant molecule, akin to superoxide dismutase, another reason that eliminating beta-amyloid entirely would entail risk. It has been suggested that beta-amyloid binds to copper and thereby begins to aggregate into more toxic forms. In addition to other toxic effects, this model states that aggregates create hydrogen peroxide, a potent oxidant. Prana initially used an old antibiotic (clioquinol) as a metal binding substrate, and a 32 pt Phase II trial showed trends towards cognitive improvement. However, clioquinol itself was not viable due to manufacturing impurity and IP issues. Prana eventually developed a followup molecule, PBT-2, for which Prana claims inhibition of AB oligomers, reduced tau, and enhanced cognition. A Phase IIa trial reported a dose-related effect upon patient performance on two measures associated with executive functions, and a 12.8% decrease in beta-amyloid in the CSF. No effect on the ADAS-cog was seen, nor were there any trends on the more sensitive memory testing of the NTB. Since only 29 patients received the highest dose, this is tentative. Prana suggested that the ability to plan may be more important than the ability to remember, but we would note that if a patient forgets a task, it does not matter if they could have planned its execution more effectively had they remembered it. The import of reduced AB levels in the CSF is something that is not established, indeed many expect successful treatment to increase CSF AB, as it is cleared from the brain. They have reported further animal data supporting the protectant effects of PBT-2 in restoring synaptic spine density, and an independent UC Irvine study has provided an explanation for how beta-amyloid and zinc may interact to produce toxic aggregation.
In April 2010, Prana released a re-analysis of their Phase II Alzheimer’s trial, initially reported in the July 2008 issue of Lancet. The re-analysis sought to correct for the practice effect that has received increased attention in the literature as a source of distortion in cognitive testing trials. 81% of patients receiving PBT-2 performed better on the Executive Function component of the NTB than the best performing subject receiving placebo; 41% performed better on the overall NTB than the best-performing placebo subject. >>
So: More than three years after the Phase IIa data came out, they have been unable to partner it. Being an Australian company, they have been able to leverage government assistance and some Australo-centric sentiment on the part of their investor community. Unlike the US, which gave out a billion dollars last year to anyone who asked for it (not wanting to look like they were playing favorites) turning it into (primarily) $733K grants that are nearly useless--the Australian government put in $15 million.
Perhaps they are hoping that if they finally start a Phase IIb, a partner will be stirred to join them. Maybe they can afford some kind of risk-sharing arrangement. Australian clinical trials can be done more cheaply--I know one Australian company running a post-stroke apathy trial for-- $900K.
NeuroInvestment
Big Pharma is not a unitary construct. You have companies like GSK, Sanofi-Aventis, and AstraZeneca who have almost completely left psychiatry, and whose leadership is ambivalent at best about neurology. As I have mentioned before, on the other hand, you have Roche putting its credibility on the line for CNS--while taking drugs into Phase III for Fragile X and CIAS (cognitive impairment associated with schizophrenia). You also have AZ and Targacept in Phase III with TC-5214 as a treatment adjunct for depression (seemingly contradicting AZ's exit from psychiatry, but they are keeping a couple chips in the game). These, and a few other programs, are the linchpin upon which the momentum out of the CNS sector will turn (hopefully).
The truly pathetic and appalling thing is that there is no shortage of cash--BPs are literally swimming in an ocean of cash-on-hand. Yet they are insisting on nickel-and-dime risk-sharing arrangements with VCs, who themselves cannot raise money sans an exit strategy, and academia, as if the universities have resources to spare. Lundbeck is fully committed to CNS, but they don't have much cash; their reliance upon academic/governmental grant funding is much more understandable.
Having said that, when I presented to a drug development conference two weeks ago, I was asked to not be as depressing as I usually am, and was able to come up with 'Ten Positive Signs for CNS Drug Development' (actually there were just eight, but I cheated). It will only take one positive event to reverse sentiment--Roche, AZ/Targacept, Naurex? Could be one of those, or something unexpected.
NeuroInvestment