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OT - Cubist - Not sure if anyone else here follows Cubist, but the stock has been in a topping formation all year and is currently rolling over. They actually have several outright Sell ratings (Piper Jaffray and Lazard) which is very unusual on Wall St. Outright "Sells" are usually reserved for when a Wall Street firm has been continually excluded from a company's financings/underwritings, or when there's some other ax to grind, they're short, etc.
Cubist doesn't have a very broad pipeline, but their antibiotic for resistant Staph infections, Cubicin, has been rapidly ramping up sales. Last year, Cubicin's label was expanded to include endocarditis and bacteremia, though it had already been used for these indications to some extent off label. I still like the stock for the longer haul, though would like to see them use their growing revenues to start expanding their pipeline. Current efforts are mainly to create a version of Cubicin that will be effective in the lungs, a weak area for Cubicin.
OT - Biomarin update - just in case anyone else is interested in this stock -
>>> BioMarin Initiates Phase 2 Clinical Study of 6R-BH4 in Peripheral Arterial Disease
Thursday January 4, 6:30 pm ET
NOVATO, Calif., Jan. 4 /PRNewswire-FirstCall/ -- BioMarin Pharmaceutical Inc. (Nasdaq and SWX: BMRN - News News) today announced that the first patient has initiated treatment in the Phase 2 clinical study of 6R-BH4 for the treatment of symptomatic peripheral arterial disease. The company expects to announce data from this study in the first half of fiscal year 2008.
"Peripheral arterial disease results from endothelial dysfunction and affects approximately eight million Americans, many of whom also suffer from intermittent claudication," stated Emil Kakkis, M.D. Ph.D., Chief Medical Officer of BioMarin. "This study is the second company-sponsored Phase 2 trial and part of a broader program to evaluate the role of 6R-BH4 in the treatment of different types of cardiovascular diseases. 6R-BH4, commonly known as tetrahydrobiopterin, is an essential enzyme cofactor that is involved in the production of nitric oxide, a molecule that has been shown in clinical studies to play a key role throughout the cardiovascular system, including regulation of endothelial function."
The Phase 2, multicenter, multinational, randomized, double-blind, placebo-controlled study is designed to compare oral 6R-BH4 to placebo in subjects with intermittent claudication (IC) caused by peripheral arterial disease. The study will be conducted at approximately 35 multinational sites and will enroll approximately 210 subjects. Among other eligibility criteria, to participate in the study, patients must have a 6-month or longer history of walking limitation due to IC, the severity of which has not changed in the past three months. Study patients will receive oral doses of 800 mg/day of 6R-BH4 or a placebo, divided into two doses for a 24-week period. The primary endpoint analysis will compare the change from baseline to Week 24 in peak walking time between the 6R-BH4 and placebo groups.
About 6R-BH4
6R-BH4, commonly known as BH4 or tetrahydrobiopterin, is a naturally occurring enzyme cofactor that is required for numerous biochemical and physiologic processes, including the synthesis of nitric oxide (NO). NO has been shown to play a key protective role throughout the cardiovascular system and produces multiple positive effects, such as relaxing smooth muscle, reducing blood pressure, controlling inflammation and reducing platelet aggregation. Researchers have demonstrated that a deficiency of BH4 can disrupt NO synthesis, resulting in a loss of normal endothelial NO production. This loss of endothelial NO production, commonly referred to as endothelial dysfunction, has been associated with many cardiovascular diseases, including hypertension, diabetic vascular disease, peripheral arterial disease, coronary arterial disease and pulmonary hypertension, and has been shown to be a strong predictor of cardiovascular adverse events in a number of clinical studies.
6R-BH4 is the same enzyme cofactor currently being evaluated in BioMarin's Phenoptin(TM) (sapropterin dihydrochloride) for phenylketonuria (PKU). In March 2006, BioMarin and Serono, BioMarin's corporate partner for the Phenoptin and 6R-BH4 programs, announced positive results from the Phase 3 clinical study of Phenoptin for PKU. All primary and secondary endpoints of the study were met. The type and incidence of adverse events was similar in the Phenoptin and placebo groups. Phenoptin was well tolerated and investigators reported that no serious adverse event occurred.
About BioMarin
BioMarin develops and commercializes innovative biopharmaceuticals for serious diseases and medical conditions. The company's product portfolio is comprised of two approved products and multiple clinical and preclinical product candidates. Approved products include Naglazyme® (galsulfase) for mucopolysaccharidosis VI (MPS VI), a product wholly developed and commercialized by BioMarin, and Aldurazyme® (laronidase) for mucopolysaccharidosis I (MPS I), a product which BioMarin developed through a 50/50 joint venture with Genzyme Corporation. Investigational product candidates include Phenoptin(TM) (sapropterin dihydrochloride), a Phase 3 product candidate for the treatment of phenylketonuria (PKU), and 6R-BH4 for cardiovascular indications, which is currently in Phase 2 clinical development for the treatment of poorly controlled hypertension. For additional information, please visit www.BMRN.com. Information on BioMarin's website is not incorporated by reference into this press release.<<<
Jerry, I havn't followed Memory Pharma for quite a while, so I don't know what's going on there. I remember their PDE-4 program bombed, and all they had left was a nicotinic receptor program. Neuro would know what's going on with them.
BTW, if you were a Grateful Dead fan, you might want to check out the Disco Biscuits, a local Phila band. They've taken the Grateful Dead / Phish thing into sort of a space rock/funk/jazz area they call "trance-fusion". I know I shouldn't be listening to this stuff at my age, but these guys are good. I'm also a musician of sorts (guitar/keyboards). Bela Fleck/Flecktones is another favorite. I was never a huge Dead fan, though Jerry Garcia was truly amazing. I actually went out to visit Haight Ashbury one Summer in the 1970's, but the scene there was pretty much over. I did bring back around 150 albums though from some of the record shops there.
Ombow, Here's a likely timetable. Most of these are based on Dr. Stoll's comments at the recent Montreal Conf presentation, with my guesses in (parentheses) -
1) Early '07 - Will need to raise some money (likely in the $10-12 mil range via a shelf offering).
2) End of Feb/early March - the go/no go decision on CX-717, based on the new tox study results which Cortex should be getting and analyzing over the next month or so.
3) Q1-07 - The first non-Ampakine in-license.
4) Early Q2 - Cortex gets the draft report for the CX-701 tox studies.
5) Mid Q2 - (FDA decision on dose liberalization, if Cortex decides to seek one).
6) 2007 - Global Neurodegenerative/High Impacts BP deal (I'm figuring by Summer, though could possibly be sooner).
7) Early Q3-07 - CX-701 enters human Phase 1.
8) Q3-07 - AD PET scan with CX-717 completed.
9) End of 2007 - Lead high impact should go into toxicology.
10) Early 2008 - Can initiate Phase 2 trials with CX-701.
Also, sometime in 2007 the Org-24448 Schizo monotherapy results could be published.
Bladerunner, >> We've heard these exact same arguments since the Sixties. <<
Yes, and the dollar has lost approx 90% of its purchasing power since the 1960's.
Jerry, Yes, there is still a lot of potential here with Cortex. My only point was to not put your last available dollar into it. BTW, here's a really intriguing non-bio stock, courtesy of Dew -
>>> Elbit Systems, Ltd. (ESLT) and its subsidiaries engage in the development, manufacture, and integration of defense electronic systems and electro-optic systems worldwide. It focuses on designing, developing, manufacturing, and integrating command, control, communication, computer, intelligence, surveillance, and reconnaissance (C4ISR) network centric systems for defense and homeland security applications. The company also performs contracts in the areas of upgrading programs for airborne, land, and naval defense platforms. In addition, it develops and manufactures avionic products for the commercial aviation market, as well as provides a range of support services. The company operates in the areas of military aircraft and helicopter systems and upgrades; helmet mounted systems; unmanned air vehicle systems; electronic warfare and signal intelligence systems; commercial aviation products; land vehicle systems and upgrades; C4I and government information systems; military communications systems and equipment; electro-optic, and countermeasures systems and products; homeland security systems; and naval systems. Elbit Systems was founded in 1966 and is headquartered in Haifa, Israel. <<<
Daviddal, This could make for an interesting confluence of events, making the complete reassembling of all Ampakine rights by a BP more feasible, since an outfit like KKR might not be averse to quickly selling off some of Organon's peripheral programs. This, timed with the availability of the recently reassembled Cortex/Servier properties, could be attractive to a BP interested in the AMPA platform -- suddenly the global Ampakine rights for all the major indications could be available. Well, maybe..
Dew, Concerning Maxygen, I was wondering if your interest in them is primarily for their Hep C program, or perhaps more for the entire pipeline? Their programs do look interesting but all look to be very early stage. I thought their G34 neutropenia program looked particularly interesting. I also wonder if in doing the various spinoffs over the years they have perhaps given away too much? The spinoffs did eliminate the need to raise money and dilute the stock, which was admirable. Thanks for any insights.
OT - MF comment concerning recent Telik implosion -
>>> Teddy Roosevelt said of the man who strives for great things that "if he fails, at least he fails while daring greatly." This may be cold comfort, though, for investors that now are 70% poorer than they were before this unfortunate announcement. <<<
OT - More consolidation coming in the generics sector. This is one of the more attractive pharma sub-sectors, as many huge blockbusters go off patent and the world's healthcare systems grapple with controlling costs. Demographics also favor the sector, as does the Democrat takeover of the US Congress. Plus there's a strong trend toward consolidation. The generics industry is also far less risky than regular drug development. While small molecule drugs have been the mainstay of the generics industry, a huge potential emerging area is generic biologics -- generic versions of therapeutic proteins, antibodies, MABS, etc. Teva is the obvious pick in the sector, but with takeovers continuing, owning the entire sector makes a lot of sense -
>>> Merck KGaA reportedly mulls sale of generics unit
By Steve Goldstein, MarketWatch
Last Update: 3:32 AM ET Jan 4, 2007
LONDON (MarketWatch) -- Merck KGaA is considering selling its generic-drug division, a deal that could bring the German firm more than $5 billion, according to a published report Thursday.
Merck (DE:659990: news, chart, profile) may sell its generic unit for more than 4 billion euros ($5.3 billion), the Handelsblatt newspaper reported. The sale could help it focus on innovative drugs and also slash its debt burden after buying biotech Serono, the report said.
Merck's generic unit had 2005 operating profit of 238 million euros on sales of 1.8 billion euros and is the leading supplier in Australia, France and Scandinavia. Its top products were DuoNeb, an inhaler used in treating asthma and chronic bronchitis, and EpiPen, an injector for use in allergic reactions.
A spokeswoman for the company declined to comment, calling the story a "rumor." Shares in Merck, which isn't related to the American drugmaker of the same name, rose 3.8% in early Frankfurt trading.
According to the report, private-equity buyers may be interested, noting their involvement in Nycomed's recent acquisition of Altana's pharmaceutical unit. Israel's Teva Pharmaceutical (TEVA) and the Sandoz unit of Novartis (NVS) also may have interest, though they would face antitrust concerns if they were to buy Merck's generics unit.
Generic-drug-making businesses have been bought around the globe, as governments try to cut health-care costs by promoting copycats rather than brand-name drugs.
Recent deals include Barr Laboratories (BRL) agreed deal to buy Croatia's Pliva and Sandoz's acquisition of Germany's Hexal.
It's "somewhat surprising that Merck's management is thinking about the sale of one of the former core businesses," said Martin Posseinke, an analyst at German broker Equinet. "On the other hand, the current price level for generic assets is quite tempting." <<<
Alertmeipp, No problem. I just see others making the exact same mistakes I did, using the same self-delusional thought processes. But I guess like alcoholics, compulsive gamblers have to hit bottom before they can change.
I actually enjoy following these stocks a lot more now that I don't have that gnawing fear of losing money all the time. The Cortex saga has been interesting to follow over the years, but once the remaining rights/indications are licensed out and the non-Ampakine programs are in place, the stock won't be nearly as interesting to follow, so I'll probably gravitate to some other stocks or to some non-bio hobbies. But where else can you find such cool science, colorful characters, dramatic moon shots and spectacular implosions? Biotech definitely has a lot of entertainment value :o)
Daviddal, Yes, but ending up broke is a distinct possibility when wagering on long shots. I knew a broker who lost everything - his job, house, and wife, all because of a massive biotech bet. I could see myself going down the same path, and had to take extraordinary measures before it was too late. I don't like CD's either, but I figure it's better than watching it all go down the biotech drain, which is what would have happened sooner or later.
I remember a discussion on that subject several years ago, but the complexity and time involved in setting up such a financing arrangement with shareholders was apparently a major drawback from the company's perspective. I seem to remember Dr. Stoll discussing the concept once, though it might have been in response to an email question he received from Ombow.
Daviddal, If you already have a monster stake in this extremely risky company, why add still more? One can easily find several dozen stocks with better prospects than Cortex. That you've never sold a share is amazing, but it may indicate that you've made the mistake of "falling in love with a stock", which is something investment experts often warn about. My problem was always the opposite - I could never hold a big position in anything for long, and would always take profits as soon as they materialized. I was using a lot of borrowed money though, which encouraged a very nervous/jumpy approach.
Owning CDs is the only way I've found to avoid continual, futile bio stock speculating, since the money is all tied up for years and unavailable.
Daviddal, Just curious if you've ever sold any Cortex over the years, or has it been a steady, gradual accumulation?
OT - Exchange traded funds. 2006 saw the introduction of an Israeli stock index fund (HAISM), which was long overdue, although not a true ETF. I'm still waiting for an ETF covering the entire generics pharma industry. ETFs provide a good alternative to individual stocks for aggressive investors. The biotech ETFs didn't have a good year. I follow the BBH and IBB, one which includes Genentech and the other doesn't. In the managed mutual fund area, bio funds specializing in mid and small caps seem to be lacking in the marketplace (Franklin Bio Discovery has some mid/small caps but carries a sales load). It would be fun to run such a fund, and I already have around 25 stocks in my virtual list. Anyone want to pay me 1.50% per year to lose their money? I didn't think so. Losing it on your own is so much more fun, lol :o) -
>>> A Big Year for ETFs
http://www.fool.com/investing/etf/2007/01/03/a-big-year-for-etfs.aspx
Zoe Van Schyndel, CFA
January 3, 2007
Not only did 2006 bring us new ETFs springing up like jack-in-the-boxes to cover various market niches, but it was also the year in which this investment product showed how powerful it can be for individual investors. You didn't need to stray any further than your computer or phone to invest in many profitable corners of the globe. ETFs made it easy and relatively inexpensive to get exposure to far-flung reaches of the planet, and if you picked the right country, the returns were eye-popping. Looking ahead, we may find some lessons from the ETFs that shone over the past year.
Go global
The top five ETFs in 2006 were, with one exception, a non-U.S. story. These strong returns follow a somewhat similar pattern as that of 2005, when non-U.S. energy- and natural resource-based funds outperformed the rest of the market. In '06, China moved to the fore with two impressive funds -- the iShares FTSE/Xinhua China 25 Index (NYSE: FXI), which had an 84% return, and the PowerShares Golden Dragon Halter USX China (AMEX: PGJ), which came in with a 55% return. Single-country funds from opposite sides of the globe also made it into the top five funds: The iShares MSCI Spain Index was up strongly with a 49% return, while the iShares MSCI Singapore Index came through with a 45% return. Ironically, the Internet Infrastructure HOLDRs,which were at the bottom of the ETF pile in 2005, rebounded with a 43% return in 2006 to secure a slot in the top five ETFs.
Performance continuation?
Dig a little deeper, into the top 10 ETFs of 2006, and the only other exception to the non-U.S. funds dominance is a surprising one -- the First Trust Value Line Dividend Index fund (AMEX: FVD). Tax-law changes and the recent emphasis on dividends have helped make this fund a top performer.
Global markets have been hot, and that trend could continue. The big question is whether countries that outperformed this year will continue their run, or whether a new region or country might shine in 2007. My bet would be on the latter option. In 2005, the iShares funds for both Latin American and South Korea were top performers, with respective returns of 55% and 54%. Neither of these funds made the top 10 ETF list in 2006.
Reversal of fortune
Internet-related funds dominated the list of worst-performing ETFs in 2005. And once again in 2006, some of the worst-performing funds were Internet and technology-related. The Internet HOLDRs (AMEX: HHH) were down 20%, and the Biotech HOLDRs (AMEX: BBH) fell 9%.
In a 180-degree turnaround, several of the top losers in 2005 surprised investors with outstanding returns in 2006. Pick the right fund from these bottom-feeders, and one year later, you could have done quite well. The Internet Infrastructure HOLDRs, as previously mentioned, was the best ETF turnaround. The Telecom HOLDRS (AMEX: TTH) went from a nearly 10% decline in 2005 to a roughly 32% positive return in 2006.
Of course, some ETFs at the bottom in 2005 continued their negative performance. There was a stark difference in returns if you selected the wrong fund. The B2B Internet HOLDRS (AMEX: BHH), for example, lost nearly 11% in 2005 and continued that trajectory in 2006 with a 16% decline.
If the change in fortune for some of the laggards of 2005 is any guide, there may be a few diamonds among the detritus of 2006. Even with hindsight, it's hard to say why some losers in 2005 were the lucky ones in 2006, but if you can distinguish the good from the bad, it is well worth the effort.
Trends to ponder
The economic fundamentals still seem to be well positioned for the coming year. Of course, there is no telling what unforeseen event may shock the markets and change the picture. Several big uncertainties already on most investors' radar screens are Iraq, Iran, and North Korea.
The United States has been the world's economic powerhouse for a number of years, with consumers soaking up supply from all corners of the planet. Now that Europe and Asia are ascendant and playing bigger roles in the global economy, the U.S. may not be the place to bet on, at least for extraordinary returns.
The residential real estate market is experiencing a sharp rise in inventory, which is good news for shoppers who will have more choices. Housing prices rose so long and so far that their decline, historically sticky, probably has a way to go and has not yet reached bottom. Overall, this seems like an area to stay away from unless select opportunities arise.
Energy seems to have found a new price level, which turns both the traditional suppliers and alternatives into interesting places to hunt. Alternative energy and clean tech have lots of promise, and if energy prices stay at these levels, companies in these areas may benefit.
With new and innovative ETFs sprouting like mushrooms after a rain, there will no doubt be many additional choices for investors in the coming year. The new crop of ETFs should be carefully culled before being added to your portfolio. Some of these funds are gold nuggets, and others are fools' gold. It is foolish not to figure out which of these you are buying before investing. <<<
OT - Boy, the overall market turned on a dime today, after being up huge in the morning. A couple of things that keep gnawing at me are -
1) Dollar Crisis - The possibility that a steadily weakening dollar may eventually prompt Fed tightening to prop up the currency, regardless of the state of the economy. US budget and trade deficits have been massive year after year, steadily weakening the dollar. Higher interest rates could eventually be the only way to prevent foreign holders of US stocks and bonds from bailing out and heading to Euro based investments. But interest rates high enough to prop up the dollar would also put the US economy into recession. There also seems to be a growing consensus on Wall Street that Fed chairman "Helicoptor" Ben Bernanke may not be tough enough on inflation, and hasn't tightened credit enough. Critics also say Bernanke is an academic with little real world experience.
2) Real Estate Reversal - Fallout from the bursting of the real estate bubble could help take down the US economy. Residential real estate activity was one of the primary drivers of the recovery from the last recession, not only on the construction end, but also by giving homeowners more cash to spend. That's been thrown into reverse.
3) US Stock Market - The US market has been up for 4 years in a row.
4) Iran - The Bush administration now faces the decision on whether to - 1) bomb Iranian nuclear sites now, 2) let the next administration do it, or 3) possibly let Israel do it. If Bush wants to do it now, he'll likely have to do it in H1-07, since 2008 is an election year and the primary season starts in earnest by early '08. The US is currently moving a second carrier force into the Persian Gulf.
Anyway, I guess there's always something to worry about. But I figure that investing for the longer haul with a monthly dollar cost averaging approach will help smooth out the inevitable bumps in the road. FWIW, I also figure a 20% allocation into international markets is prudent, not only as a dollar hedge but also for the added investment opportunities.
MarketFest, I no longer have the exact figures on the put levels, but even if the open interest got that high (5000), one would have expected it just based on the number of remaining hedge funds sitting with big blocks of Cortex prior to the long awaited and highly publicized Sept/Oct tox data announcement. Anyone with a big block of stock would have been pretty foolish not to have been at least partially hedged heading into that event. So that would be the obvious source of most of the increased put activity. There were probably also some speculators buying naked puts, and perhaps even some insider activity going on, who knows, but the bulk of it was probably the hedge funds doing their thing -- hedging.
Looking back to the early 2006 period, while the participants of earlier PIPES held a lot of unexcercised freebie warrants, some still had long positions which could previously only be hedged by having a concurrent short position. Once options began trading on Cortex (around early '06), they could then hedge with put options, as could ordinary investors. Where hedge funds got screwed was in the way events unfolded in Q1/Q2 of 2006. The first event due was the ADHD results, of which there was considerable skepticism. Next due were the DARPA results, which most figured would be positive. Once the ADHD results came out, the stock spiked strongly to $5-6, but most of the hedge funds didn't sell their shares or excercise their warrants as they normally would have done, because they figured the upside would continue (with not only good DARPA results in the offing, but also a great BP deal coming soon). So everyone sat tight, riding the tiger, with some buying protective puts during the spike just in case. But as we know, the stock then got slammed by the unexpected clinical hold, getting cut in half overnight.
Over the Summer period there was still an opportunity for hedge funds to unload shares and excercise warrants at around breakeven or a small profit, but most just held on. Of course anyone who bought during the Spring spike got royally screwed, unless they had the prudence to hedge with puts concurrently. Then when the new tox data was due to come out in Sept/Oct, there was additional new hedging by longs via buying puts.
Anyway, this explanation of the put activity seems to make the most sense, and it would have been very odd to not see increased put activity precisely when it happened. While any bio event can have some insider activity, the put buying was most likely due to the above explanation. Either that or Daviddal, Jim Haynes, and Neuro were the ones hedging their large positions with puts, since together they could probably account for 500,000 shares :o)
Jerry, Yes, that will be a nice event, if it happens. But if it doesn't happen, or the stock gets cut in half again, in a highly concentrated portfolio, then what? That's the problem with extreme concentration, you only get one chance. It's just like a huge binary bet in Vegas, with the exception that in Vegas you can get close to 50/50 odds, where with Cortex currently it's probably 25/75 in the nearterm, though perhaps 50/50 by Summer. I'll stick to diversification, which is more fun anyway.
OT - Bio-Imaging, Exelixis, and Pharmion all up around 5% today. Ah, the joys of diversification (even if it's only in my "virtual" portfolio) :o)
MarketFest, As I recall, the 5000 figure was the trading volume, not the number of puts outstanding. If I remember correctly, that outstanding put position was a relatively large 1500 puts back in the Spring, which appeared during/after the stock runup to $5-6, and this position continued through Summer and into Fall. Options hadn't been available on Cortex prior to that, as I recall they started trading in early 2006. A big put position taken after/during the big spike in the Spring wouldn't be unexpected.
As I recall, there was some additional put activity in the Fall right before the tox results were due to come out, as evidenced by the 5000 volume in that period, but that would also be expected since the timing of that binary event was widely known. There were still many holders of large blocks of stock around - the hedge fund participants from the earlier PIPES for example, who would have wanted to hedge their long positions. So I don't see that increased put activity as being especially suspicious. If anything, I thought there might be more put activity since the many hedge funds stuck with long positions would likely want to be hedged going into the risky binary event.
That brings up a related subject. With the participants of the last PIPE getting so severely burned, "bagholders" as it were, I wonder how much more difficult it's now going to be to do the financing Cortex so desperately needs? As Neuro suggested, attached warrants are pretty much a given again. The current share price could make this the least favorable of all the PIPES that Dr. Stoll has done, the previous being at $1.50 (2003), $2.75 (early 2004), and $2.66 (late 2004).
Alertmeipp, Yes, if the fundamentals are good, then the share price should take care of itself. But Cortex's fundamentals are not particularly good. Oh well, I don't own any anyway, so for me it's just an alternative to watching TV :o)
Aiming, Yes, buying at $1.25 seems like a reasonable bet, all things considered. At the very least a Neurodegenerative BP deal is almost certainly going to happen sometime in 2007. The only thing that could mess that up would be if it's with a no-name marginal pharma partner, in which case the positive effect on share price probably wouldn't materialize. More likely though, there should be some decent interest by a well known BP.
While unexpected curveballs are common in this sector, the most likely timeline scenario as I see it is as follows - 1) a shelf financing in January, 2) a CX-717 decision by Stoll in late Feb/early March that is a no-go for ADHD, but which keeps alive the possibilities for AD. 3) Also in Q1 will be the first of the non-Ampakine in-licenses. Then 4) the Neurodegenerative/high impacts BP deal by Summer.
Share price-wise the above scenarios might translate into - a) initially a modest January effect bounce to $1.50 or so in the next week or two, followed by b) some price swings around the time of the shelf financing which bring the price back down to current levels, then c) a modest relief bounce after the financing is over, followed by d) some weakness leading up to the late Feb/early March go/no go decision period, after which e) the price movement will depend on the actual decision. Somewhere along the way will be f) the non-Ampakine in-license announcement. Of course with so many variables, anything can happen. If you get in cheap enough though, like $1.25, then just sitting tight until Summer might be the best strategy. One thing with this stock though, if by some miracle we get a big move up again, then take at least something off the table.
Misc late night ramblings --
If we assume that CX-717's dosing restrictions eliminate ADHD as an indication, that will probably mean that CX-717 will end up as an added element to the Neurodegenerative BP deal. It would make sense for the BP to want a low impact as part of the Neuro/high impact deal, especially considering the low impact/Aricept synergy for AD. The issue then becomes, with CX-717's somewhat tainted safety profile, the BP will probably also want a backup, and Cortex has both CX-701 and CX-1501 available. One of those could be kept by Cortex with the other going to the BP.
I'm starting to come around to the idea that even with puny upfronts, the Neurodegenerative deal could still be a major catalyst for Cortex's stock price, especially if the BP partner is a high profile household name. The usual suspects come to mind - Lilly, Glaxo, Sanofi-Aventis, Merck, Pfizer, Amgen, any of these would do nicely.
Assuming this Neurodegenerative BP deal doesn't happen until later in 2007, then we first need to get through a very unfavorable shelf financing and then a likely bad go/no go CX-717 announcement in late Feb/early March. The wildcard would be if Stoll can somehow pull off the Neuro BP deal in January - not completely impossible but definitely not something to count on. Of course the even bigger wildcard invloves the outside chance of much better than expected tox data on CX-717 (Feb/March), and a much better than expected dose liberalization decision by the FDA (May). I'm not expecting either of those CX-717 developments to happen however. So realistically, our chief upside hopes for 2007 rest on the Neuro BP deal with a big name partner.
So my prediction is that we continue wallowing in the muck for a number of months, until the BP deal is announced (perhaps mid-year). The stock is currently so cheap though, that we could see a modest January effect rebound, and/or a relief bounce after the financing. All eyes are on the new tox data however (late Feb/early March), so the sword of Damocles will still be hanging over the stock. Bottom line - we need to get some of the current myriad of uncertainties resolved.
Here's that paper on Org-24448 and Org-26576. Though we don't know for sure if Org-26576 was originally from Cortex's labs or Organon's, I remember Neuro saying he was fairly sure it is covered under the existing partnership deal between Cortex and Organon (unlike the situation with Servier and S-18986) -
>>> Neuropharmacology. 2005 Aug;49(2):254-64.
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] <<<
Bladerunner, Concerning Org-24448, in the Montreal Conf presentation Dr. Stoll said that it's in Phase 2b in Schizo and Phase 2a in Depression (the monotherapy Schizo Phase 2 was completed around a year ago, with the results apparently to be published fairly soon). The other compound, Org-26576, I think might be in Phase 1, though we don't know the origin of that compound for sure, whether it was Cortex-developed or from Organon's own labs. Based on a published preclinical paper, Org-26576 looked to be somewhat more potent than Org-24448 (based on the doses used).
I'm not expecting great things from the Org-24448 Schizo mono trial, but some cognitive improvement was probably observed. Ampakines likely have a better chance as a combo treatment for Schizo, and it appears that the TURNS/NIMH combo program is back on track, though results probably won't be for several years.
Org-24448 is less potent overall than CX-717, though it's possible that its activity in animal models of Schizo might have been particularly favorable, so we can't assume that it would necessarily be less potent than CX-717 for Schizo. It does have a shorter halflife though (approx 6.5 hours vrs 9-10 hours for CX-717).
Some good Schizo monotherapy results would certainly be a shot in the arm for Cortex right about now. Organon was supposed to be partially spun off from parent Akzo, and the publishing of good Schizo results for Org-24448 might have provided some added publicity prior to the IPO. But with Asenapine in limbo, the Organon IPO might also be in limbo. Still, it will be interesting to see the monotherapy results. One would think that they wouldn't bother publishing bad results, so with luck the results might surprise on the upside.
One trial with the potential to create a real buzz would be combining a low impact with Aricept for AD, since there appears to be a strong synergistic effect between the two. That type trial will probably be up to the Neurodegenerative BP partner to do. The synergism between Ampakines and the ACHase inhibitors is a good selling point for getting the BP deal. It's become increasingly clear that the huge resources of a bonafide BP partner is going to be the key to finally getting things moving for this technology. We need a motivated big name BP partner. That would also get the stock moving.
Daviddal, Another factor to consider is that there probably won't be much/any patent life left when/if an Ampakine finally reaches market. Due to chronic underfunding, slow poke partners, and compound problems, we've dawdled away much of the technology's patent life. I figure at best it will probably take at least another 7-8 more years to get anything to market.
Being a neurologist and still fairly young, you can probably afford to roll the dice big on Cortex and still prosper if the investment goes to zero. But there are so many other promising bio companies out there to choose from that aren't in the dire straights faced by Cortex. I guess the type of company Cortex is morphing into (non-Ampakine orphan indications) just isn't very interesting. Cortex without Ampakines just doesn't do it for me.
I still think Stoll has done a fine job overall. He didn't have much choice but to roll the dice on CX-717, but it looks like the compound's luck just ran out. Of course, there could still be a positive surprise on that front, but it's not very likely. I'd still like to see Cortex go after ADHD with CX-701. That's one program with a high probability of success, and it would be provide a nice pharma deal after the Phase 2. The high impacts remain the big potential monster story, but I suppose it will take a BP's resources to bring that to reality.
Daviddal, I'm not sure that anyone with a huge position in a stock can ever be considered "objective". They may want to be, but their judgement is always altered by having their financial butts hanging out, waiting to get shot off.
Concerning the histo problem, and what Cortex knew and when, it would be an interesting courtroom excercise. Just for fun, the courtroom arguments could go something like this -
Defense - "Yes, Cortex did see something histologically in one primate, but figured it was some kind of artifact, not a problem with the drug."
Prosecution - "Yes, but wasn't it around this same time that Dr. Stoll suddenly started discussing the non-Ampakine in-licensing strategy, seemingly out of the blue?"
Defense - "Yes, but this new strategy was not due to a perceived problem with CX-717 or the platform, but to the growing realization that once CX-717 was successfully outlicensed, there would be a 2 year gap in Cortex's pipeline to fill."
Then suddenly Jim Haynes bursts into the courtroom, accompanied by Ampakineman. After pistol whipping the guard, they begin opening fire with an Uzi. "Give those options back!" they demand, as the bullets fly. Stoll, Coleman, and Varney hit the deck, then scramble for the door. However, Neuro and Daviddal block their path, shouting "face the music you bums!", and GFP lectures them on the dangers of hubris and the need for diversification, then tries to sell them all life insurance.
Aiming, Not exactly jumping in, more like dribbling in gradually since I still don't have much available to invest. I'm "aiming for" an eventual 50/50 allocation between fixed income/CDs and equities, which I figure is appropriate for my age (51). I have the CD part in place but not the equity portion, so will use dollar cost averaging as funds become available.
BTW, in addition to Durect, you might want to check out an interesting microcap called Bio-Imaging Technologies (BITI), which even after its recent run still has a market cap under $100 mil. They're the world's largest independent, dedicated provider of medical image management/analysis for clinical trials. The trend is for the FDA to no longer accept image analysis by cooperatives (groups of academic experts), but only by commercial core providers, and Bio-Imaging is the leader. They also have a personal health record software business. Covance has a 20% stake in the company. BTW, Covance is another great company. Unlike CRO competitors who do primarily Phase 2 and 3 clinical trials, two thirds of Covance's revenues are laboratory based - they do the tox/preclinical trials. These CRO "picks and shovels" type companies make money regardless of whether the drugs ultimately succeed or fail, and are much safer than regular bio companies.
2007 New Year's resolutions -
Though resolutions are often broken, here are some general investment strategies/guidelines I'm going to try to follow in 2007 -
1) Diversification - the bulk of equity investments spread widely across the US and global stock markets, with some modest real estate, natural resource, and gold related exposure included for diversity. Biotech is limited to 10% of the total portfolio, and then diversified among numerous small/mid/large cap names. No bio company is to represent more than 2.5% of the entire investment portfolio. If a position grows to more than 2.5%, it is trimmed back by taking profits.
2) Dollar Cost Averaging - automatic monthly or bi-monthly investments into each investment category.
3) Long Term Buy and Hold Strategy - avoid short term trading.
4) No Leverage - no margin or borrowing allowed.
5) No Shorting allowed.
6) No Naked Options. Some covered options on individual stocks allowed, like covered call writing, or hedging of a long position with puts.
Most folks on this board have probably had a bad 2006 due to an overweighting in Cortex. or some other bio long shot. I know the feeling, and had my disasters in previous years. The key though is to learn from these mistakes and not make them over and over again. I only wish I had followed something resembling the above rules 10 years ago.
Dew has said that the efficient market hypothesis is BS. True, there is a big pricing delay/inefficiency in this sector, due to the huge amount of uncertainty surrounding drug development. The outcome is extremely uncertain, so the market can't accurately assign a price to most bio stocks at any given time. The bigger BS however, and the dangerous part, is the notion that an investor can consistently know more than the market does. To be right once doesn't mean anything, unless you walk away from the casino altogether and never return. For success, one needs to beat the system *consistently* over a considerable period. The odds simply won't allow this to happen in biotech, even for the brainiest bio-sleuth. Of course everyone thinks they'll be in the skillful/lucky 1%, but that is laughable. What happens is that greed and hubris get us into trouble, and then we try to make back what we lost, but only dig our hole deeper.
I guess everyone ultimately has to learn for themselves the hard way. But if your massive bet on Cortex does somehow manage to work out, save yourself a lot of grief and just leave the casino. Don't think you can do it again by ploughing the winnings back into another foolish speculation. It just doesn't work that way for us mere mortals. End of sermon :o)
Some food for thought from the Dewmeister :o) -
>>> Risk Factors in Clinical/Regulatory Outcomes
Not only is your observation regarding a partnership (or lack thereof) relevant vis-à-vis clinical trials, it is relevant for regulatory submissions too. However, the lack of a partnership is pretty far down on my list of risk elements. Before worrying about that, investors ought to mull some even greater risks.
For simplicity, I’m omitting such obvious risks as a clearly undersized trial or a regulatory submission based on pivotal trials that missed their goals. I.e., we are talking about the most important risks for a bona fide phase-3 trial or NDA/BLA.
The major risks in descending order of importance (IMO) are as follows:
1. Large insider selling around the time when data mature (e.g. PARS).
2. Poorly-understood disease, especially when there is no animal model. This includes such conditions as CFIDS, fibromyalgia, interstitial cystitis, irritable bowel syndrome, and the like.
3. Novel mechanism of action.
4. Non-disclosure of key details of the trial design and statistical-analysis plan. (This reared its head in NUVO’s recent failure in catheter occlusion.)
5. A high proportion of trial sites in third-world countries.
6. Failure to obtain a Special Protocol Assessment (FDA) or formal protocol guidance (EMEA).
7. Unduly complex trial design, which increases the likelihood of protocol violations.
8. Unusual primary endpoint (if there is no SPA).
9. Unusual scheduling of data reporting to investors (e.g. TELK).
10. Lack of a partner.
Feedback is welcome on any of the above! <<<
Don't let microcap myopia keep you from seeing the bigger picture going on in the sector -
There's No Doubt About Biotech Buyouts
By Marc Lichtenfeld
Senior Columnist
12/31/2006 9:09 AM EST
Anyone who's interested in trying his hand at risk arbitrage should get plenty of practice if he focuses on the biotech sector in 2007.
With a profusion of companies of all sizes and at varying stages of product development occupying the landscape, the sector is ripe for significant mergers and acquisitions activity, many industry observers believe.
In particular, Big Pharma names, especially those with weak pipelines, will likely move to snap up smaller firms whose drugs are already approved, thereby quickly gaining a new revenue stream.
Michael Weiss, the CEO of Keryx Biopharmaceuticals (KERX) , says the large drug companies will go after small outfits "and pay a pretty good premium, almost what you'd expect to pay for a nearly perfect sales strategy."
He calls this kind of deal "relatively low risk because Big Pharma puts it into their portfolio, and they know they probably won't have a major product failure."
Jeff Matthews of RAM Partners agrees. He believes companies with approved products, especially in the fields of cancer and diabetes, will prove the most attractive to potential buyers.
Companies that fit the bill include Amylin Pharmaceuticals (AMLN) , Millennium Pharmaceuticals (MLNM) , and some of the larger companies. Smaller players could include names such as Bioenvision (BIVN) .
While I've been a proponent of investing in the large-cap, profitable companies, I'll acknowledge that some investors want the thrill and upside potential of the next great cure for cancer or any number of debilitating diseases. Those investors usually focus on the small-caps.
Weiss believes there will also be M&A activity in very early stage companies. Tiny Memory Pharmaceuticals (MEMY) , which has a partnership with Roche, and Incyte (INCY) , which is collaborating with Pfizer (PFE) , fit that description.
Partnerships of this sort may suggest that the large drugmakers are taking the small-cap biotechs for a test drive, says Bob Wasserman, director of research for Jesup & Lamont, a New York-based brokerage and investment-banking firm.
"We'll see consolidation in terms of buying partners like Eli Lilly (LLY) and Icos (ICOS) ," he says, referring to a $2.3 billion deal in which Lilly plans to take over its much smaller marketing partner for the impotence drug Cialis.
Other conceivable buyout targets are Intermune (ITMN) , which is partnered with Roche in studying a hepatitis C drug, and BioMarin (BMRN) , which is being acquired by its partner Genzyme (GENZ) .
(To see why I'm bullish on BioMarin, click here.)
However, before you charge in to the small-cap arena, be sure to do your homework and know what you're up against. That's the advice of Gabe Hoffman of Accipiter Capital Management, whose Accipiter Life Sciences Fund is up 43% through October, according to HedgeFund.net.
"Don't think about small-cap biotech as a sector, but try to analyze individual companies," he advises.
Steven Burrill, CEO of Burrill & Co., a San Francisco-based life sciences venture capital and merchant banking firm, predicts 30 IPOs in the biotech sector in 2007, a 50% increase over this year. But Hoffman warns, "The more deals you see, the closer you are to seeing the whole sector roll over."
Keryx's Weiss believes that because of some blowups this year, such as Nuvelo (NUVO) and NeoPharm (NEOL) , there's a smaller amount of supply.
"Theoretically, you should have increased demand for those names, especially going into binary events," he states. He suggests that because large-cap biotech had a solid year, "people might be looking to see where other opportunities may lie."
Indeed, the Amex Biotech Index, which is made up of larger-cap stocks, gained 10.8% through mid-December, while the Nasdaq Biotechnology Index advanced only 2.8%.
Burrill believes biotech's "elite companies" will outperform the Dow Jones Industrial Average and the Nasdaq Composite in the coming year.
Names that can be found in this group include Genentech (DNA) , Amgen (AMGN) , Gilead Sciences (GILD) , Genzyme, Biogen Idec (BIIB) and Vertex Pharmaceuticals (VRTX) .
He also expects significant M&A activity, a more proactive stance toward drug safety by regulators and increased funding for stem-cell research.
Important Upcoming Events
Perhaps no other sector is more affected by binary events than biotech. Below is a calendar that lists a few important items to keep on your radar screen during the year.
Company Drug Indication Data Date
Gilead Sciences Aztreonam lysine Cystic Fibrosis Phase III Q1
New River Pharmaceuticals NRP-104 ADHD Phase III Q1
Millennium Pharmaceuticals MLN1202 Relapsing remitting MS Phase III Q1
BioMarin Phenoptin PKU NDA filing Q2
Adolor Entereg OBD NDA H1
Biogen/Genentech Rituxan Relapsing remitting MS Proof of concept H1
Genzyme Tolevamer CDAD Phase III/NDA H1/YE
Genzyme Mozobil Multiple meyeloma/NHL Phase III H1
OSI Pharmaceuticals. PSN357 Diabetes Phase IIa H1
Protein Design Labs M200 Renal/pancreatic cancer/melanoma Phase II Mid-year
Gilead Sciences Viread Hepatitis B Phase III Q4
Myriad Genetics Flurizan Alzheimer's Interim Phase III Q4
Keryx KRX-101 Diabetic neuropathy Phase III YE
Source: Merrill Lynch
Daviddal, OT - Concerning a libido booster for women, scientists should do a complete analysis of a girl I knew back in high school. She was a complete nympho, totally insatiable. All I can say is that she wore me out, and I was actually glad to leave for college just to get some rest. I only knew one other girl like that, and always wondered what it was physiologically that made them that way. Both were brunettes. Blondes I've gone out with have seemed to be on the cold/passive side. There must be more to it though, something involving brain chemistry.
Dave, Your "bet the farm" strategy simply won't work over the long haul. Half the battle in bio investing is managing risk and living to fight another day. With your approach, one mistake and the game is over.
"I also don't diversify much at all ... Those rules are for others". Just curious how long you've been in the bio sector?
OT - 10% rule -
>>> Love it or hate it, the 10% rule for selling stocks works
Updated 12/27/2006 5:10 AM ET
Q: You mentioned the "10% rule." Who came up with that and does it actually work?
A:The "10% rule" is pretty controversial among Ask Matt readers. Some love the idea, some violently disagree.
Essentially, the rule tells you to consider selling a stock if it falls 10% below the price you paid for it.
Doing this prevents you from suffering a devastating loss that will be difficult to recover from. The rule was created and described by famed investor Gerald M. Loeb in his book, The Battle for Investment Survival. In Section 22, called "Gaining profits by taking losses," Loeb describes how investors commonly hang onto their losers too long.
"It is a great mistake to think that what goes down must come back up," he writes. By hanging on to losing stocks, investors miss out on better opportunities elsewhere.
So, Loeb suggests as a rule of thumb that investors consider selling a stock if it falls 10% below the price paid. He clearly says it's not a hard and fast rule, rather it's a guideline. "I'm inclined to say that when a new investment has shrunk by 10%, it is time to stop, look and listen. I think it usually ought to be sold out and the loss taken," he writes.
The key point Loeb makes is that a good defense is often the best offense with investing. By avoiding a catastrophic loss, you can increase your overall performance. And yes, sometimes you'll sell a stock, only to watch it recover. But think of the 10% rule as insurance. The protection from disaster is worth the cost.
Some Ask Matt readers hate this idea. They say they're long-term holders of stocks and think short-term swings are meaningless. Others say a 10% drop is too small and will create needless trading. I would agree with those investors if they own a diversified basket of stocks through mutual funds or exchange-traded funds (ETFs). In that case, short-term swings are meaningless because you've eliminated a lot of risk by diversification.
But if you're buying individual stocks, it's a different story. You need to protect yourself from a catastrophic loss. It's not hard to think of examples. My favorite is Lucent (LU). This blue-chip stock was a favorite among "buy and hold" investors. After all, how could a giant, successful firm like Lucent not be a profitable stock?
Investors who bought the stock when it was $70 or higher kept hanging on when it fell to $60 (a 14% drop). "It will come back," they said. Then it fell to $50 and $40 (a 43% drop). "I'm a long-term investor," they said and held on. Many held on as the stock sank to $30, $20, $10 and now less than $3, losing nearly their entire investment in the stock.
If they'd followed Loeb's advice, their loss would have been $7, not $67.
Owning individual stocks without some bail-out strategy is the stock market equivalent of owning a home with no fire insurance. <<<
OT - Hedge funds can lose too -
>>> I Hope They're Hedged Award: The implosion of biotech firm Telik Inc. (Nasdaq: TELK - News) was a rude, unwanted, late Christmas gift for many investors, but none more so than Eastbourne Capital Management, which owns about 13 million shares of the stock, or an almost 25% stake in the company. From February 24th to December 22nd, Eastbourne, through its Black Bear Offshore Master Fund LP, bought approximately 3.7 million shares of Telik at an average price of $16.90, or an investment of about $65 million. Eastbourne is down more than -72% on that position alone, and based on the firm's historic holdings of Telik and Telik's historic stock price, the firm looks to be anywhere from $150 million to $200 million in the red on the position.<<<
Here's a recent study showing that decreased expression of the various glutamate receptor subunits is seen in schizophrenia, depression, and bipolar disorder. These subunits are the targets for Ampakines -
>>> Beneyto M, Meador-Woodruff JH
Lamina-specific abnormalities of AMPA receptor trafficking and signaling molecule transcripts in the prefrontal cortex in schizophrenia.
Synapse. 2006 Dec 15;60(8):585-98.
Ampakines, positive AMPA receptor modulators, can improve cognitive function in schizophrenia, and enhancement of AMPA receptor-mediated currents by them potentiates the activity of antipsychotics. In vitro studies have revealed that trafficking of AMPA receptors is mediated by specific interactions of a complex network of proteins that also target and anchor them at the postsynaptic density (PSD). The aim of this study was to determine whether there are abnormalities of the molecules associated with trafficking and localization of AMPA receptors at the PSD in the dorsolateral prefrontal cortex (DLPFC) in schizophrenia. We analyzed AMPA receptor expression in DLPFC in schizophrenia, major depression, bipolar disorder, and a control group, by examining transcript levels of all four AMPA receptor subunits by in situ hybridization. We found decreased GluR2 subunit expression in all three illnesses, decreased GluR3 in major depression, and decreased GluR4 in schizophrenia. However, autoradiography experiments showed no changes in AMPA receptor binding; thus, we hypothesized that these changes in receptor subunit stoichiometry do not alter binding to the assembled receptor, but rather intracellular processing. In situ hybridization for AMPA-trafficking molecules showed decreased expression of PICK1 and increased expression of stargazin in DLPFC in schizophrenia, both restricted to large cells of cortical layer III. These data suggest that AMPA-mediated glutamatergic neurotransmission is compromised in schizophrenia, particularly at the level of AMPA-related PSD proteins that mediate AMPA receptor trafficking, synaptic surface expression, and intracellular signaling. [Abstract] <<<
Here's that abstract on Farampator (Org-24448). It was posted previously but is worth another look. In this study, the drug improved short term memory but appeared to impair episodic memory, perhaps due to side effects -
>>> Wezenberg E, Jan Verkes R, Ruigt GS, Hulstijn W, Sabbe BG
Acute Effects of the Ampakine Farampator on Memory and Information Processing in Healthy Elderly Volunteers.
Neuropsychopharmacology. 2006 Nov 22;
Ampakines act as positive allosteric modulators of AMPA-type glutamate receptors and facilitate hippocampal long-term potentiation (LTP), a mechanism associated with memory storage and consolidation. The present study investigated the acute effects of farampator, 1-(benzofurazan-5-ylcarbonyl) piperidine, on memory and information processes in healthy elderly volunteers. A double-blind, placebo-controlled, randomized, cross-over study was performed in 16 healthy, elderly volunteers (eight male, eight female; mean age 66.1, SD 4.5 years). All subjects received farampator (500 mg) and placebo. Testing took place 1 h after drug intake, which was around T(max) for farampator. Subjects performed tasks assessing episodic memory (wordlist learning and picture memory), working and short-term memory (N-back, symbol recall) and motor learning (maze task, pursuit rotor). Information processing was assessed with a tangled lines task, the symbol digit substitution test (SDST) and the continuous trail making test (CTMT). Farampator (500 mg) unequivocally improved short-term memory but appeared to impair episodic memory. Furthermore, it tended to decrease the number of switching errors in the CTMT. Drug-induced side effects (SEs) included headache, somnolence and nausea. Subjects with SEs had significantly higher plasma levels of farampator than subjects without SEs. Additional analyses revealed that in the farampator condition the group without SEs showed a significantly superior memory performance relative to the group with SEs. The positive results on short-term memory and the favorable trends in the trail making test (CTMT) are interesting in view of the development of ampakines in the treatment of Alzheimer's disease and schizophrenia.Neuropsychopharmacology advance online publication, 22 November 2006; doi:10.1038/sj.npp.1301257. [Abstract] <<<
OT - For the sake of accuracy, the partnered program (with Endo Pharma) I mentioned in the previous post is in acute back pain, not chronic back pain, fwiw..