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IDEV
Hard to tell honestly why it was down hard earlier. My guess is sell the news. The Sept 7.50 calls (which I am short through covered calls) pricing was was very very firm with modest activity last week - so someone seemed to know news was coming. And when the result was not what was expected (stock-wise), I presume they got selling.
But this approval was critical given the cash infusion it provides for milestones. IDEV needed the money - still have to do a financing soon and with all approval news out for a while it may come sooner than later.
Jon
Just to follow up on PDUFAs and notifications, IDEV got approval a week before the PDUFA for their follow-on overactive bladder drug. First good news in my bio portfolio in a while, although I am short covered calls against entire position.
Jon
with more smog in the Valley than I’ve ever seen anywhere. (I haven’t been to Mexico City or São Paulo.)
Or Hong Kong or Beijing either I assume!
Jon
Missing week for what it was worth was 65 (3.3%) and 180 (2.5%). New drugs usually do worst in holiday weeks and recover more in weeks right after (or before) which it appears was part of the blip on the week of the 13th (some of which was given back during week of 20th).
Jon
Target is $2 cash and $2 rest of pipeline.
Jon
Most planes can stop without using any reverse thruster if need be although this is not done often, and the plane still had one.
Jon
Sorry about that. Try this link for Feuerstein.
http://www.thestreet.com/s/these-10-biotechs-have-drugs-near-finish-line/newsanalysis/biotech/103690...
Jon
Nice move
I can just see the headlines:
And the US federal government today announced sanctions against 2 of its most important states: California and Massachusetts for defying the dictator commander in chief.
Jon
My odds are as follows:
OS is focus of questioning and discussion: 1/2
Let's wait for data: 60%
Not wait: 40%
Not focus: 1/2
PFS compelling: 75%
PFS not compelling: 25%
This gives case odds of: 1a 30% 1b 20% 2a 37.5% 2b 12.5%
Odds of approval are: 1a 20% 1b 70% 2a 80% 2b 5%
Overall odds: 51% (did not game this either)
Jon
SPPI Notice the volumes and OI in the $5 puts for August. Lot of hedging or betting going on. Anyone have thoughts on downside with approvable? Cash is about $2 and they do have other far along candidates and Europe potential for satra.
http://finance.yahoo.com/q/op?s=SPPI&k=5.000000
Jon
Some more Feuerstein work - good table (missing a lot but still informative) on current trials ongoing.
http://www.thestreet.com/p/pf/newsanalysis/biotech/10369012.html
Jon
Apparently the main issue folks are having with GPCB and SPPI here relates to issue with PFS measure and inclusion for first time of initial OS data - and with the P value in the 30% area, some folks are concerned with what it is going to say. The company did have the subset analysis for 12-monthers (supposed to mimic curve better (at 8% for low-powered subset).
Jon
FDA briefing doc - the other was the company's.
http://www.fda.gov/ohrms/dockets/ac/07/briefing/2007-4309b1-03-GPC.pdf
Jon
LOL
Just like I read the wrong briefing doc! At least I knew better than to trade!
Jon
There must be another doc out there.
http://www.reuters.com/article/marketsNews/idUKWAT00790520070720?rpc=44
Jon
There is one reference to survival data being available soon on page 42 (not direct but answerable with a simple question). I also have not seen the proposed questions yet.
Jon
http://www.fda.gov/ohrms/dockets/ac/07/briefing/2007-4309b1-03-GPC.pdf
Have only gone through executive summary but talks about strong STATISTICAL efficacy (I wonder about clinical efficacy however - may be statistical but still not much). Strong statement on safety/side effects. Looks done deal to me from exec summ. Will go read section on efficacy and come back later.
Jon
EDIT PS - Must be something in there not good as SPPI now has massive sell block below last night's close.
Date NRx TRx NRx% TRx%
Jun29 86 214 3.8% 2.8%
Jun22 78 197 3.6% 2.7%
Jun15 91 212 4.0% 2.8%
Jun08 80 191 3.5% 2.5%
Jun01 65 167 3.4% 2.5%
May25 79 169 3.6% 2.3%
May18 80 152 3.7% 2.2%
May11 93 191 4.4% 2.6%
May04 92 188 4.1% 2.5%
Apr27 80 161 3.6% 2.2%
Apr20 76 146 3.6% 2.1%
Apr13 61 135 2.9% 1.9%
Apr06 82 137 3.9% 1.9%
Mar30 87 142 3.9% 2.0%
Mar23 55 90 2.7% 1.3%
Mar16 54 103 2.4% 1.4%
Didn't he just merge all these things together?
Jon
PS Reminds me of Panic.
Updated Tyzeka - weird week as many drugs off modestly sharply. Tyzeka worse than most.
Date NRx TRx NRx% TRx%
Jun22 78 197 3.6% 2.7%
Jun15 91 212 4.0% 2.8%
Jun08 80 191 3.5% 2.5%
Jun01 65 167 3.4% 2.5%
May25 79 169 3.6% 2.3%
May18 80 152 3.7% 2.2%
May11 93 191 4.4% 2.6%
May04 92 188 4.1% 2.5%
Apr27 80 161 3.6% 2.2%
Apr20 76 146 3.6% 2.1%
Apr13 61 135 2.9% 1.9%
Apr06 82 137 3.9% 1.9%
Mar30 87 142 3.9% 2.0%
Mar23 55 90 2.7% 1.3%
Mar16 54 103 2.4% 1.4%
Same issue with Somaxon at some point.
Jon
Sorry about that guys - that one stat is just a pet peeve of mine and I reacted to that and wanted to agree methodologically.
Not living in the US, I have to admit I am not as close to the situation as all of you. What I see from over here though are:
1. Very high costs for regular appointments
2. Very high costs for diagnostics
3. Very high costs for drugs - wish ROW would go up though
4. High but trailing life expectancy - not sure how much of that is first year of life
5. Very, very high medical expenses
Some anecdotes:
1. Regular OBGYN checkup costs $100-125 over here with one of the star doctors in HK
2. Said checkup includes ultrasound
3. 30 days of Crestor 10 mg - $30-35 (Understand the monopolistic pricing curves but I assume pricing will eventually move to one world price or close to it in order to protect US price - will come down some)
5. A trip to an ER here for GI upset (flu, food poisoning) has cost me about $50-75 to a private hospital with drugs. A trip to a US ER to get a piece of dirt out of my wife's eye cost $600.
Conclusions:
1. I do not know what is wrong, just that something is.
2. Covering more people costing them nothing will drive up cost of system, even if certain costs go down (emergency treatments).
3. Soc security cap will be gone soon (to pay for both systems) and Medicare rates will go up
4. French system looked very interesting
5. Drug pricing will come under greater pressure
6. Forced insurance will not work when plans require Cadillac care - states should trim down requirements of base plans
7. Is it last year of life, attorneys/malpractice, too much embedded technology driving costs up?
8. Does France do better in diabetes because they have better eating habits/listen to doctors/have lower incidence of diabetes overall?
Jon
Other nations also frequently abort problem babies earlier in the process whereas American practices may go for it.
Jon
VRTX
Hard downtrend recently, almost as pronounced as some of the more juniors like ARNA and MNTA and IDIX.
Jon
Do you have a raw format file of the data - if so send it to me and I will update directly here each week or two instead of over on SI. No one on SI seems to care.
Jon
Good answer! ELN had 3 different 30% crashes: the first being the financial unwinding worries(ENRON structure), the second being Tysabri Black Monday, and the third being the extra case of PML. It then had gains of 300+% each time, unlike most stocks which were down a year after such a drop. Also most 30+% gainers were down a year later too.
Jon
Bear Stearns has run an analysis of blow-ups in biotech land following their universe. They have concluded that the performance one year after the blow-up (>30% loss on one day) is positive about 15%. BUT if you remove one company from the analysis (and its three collapses), the numbers go negative. QUIZ: Can anyone name this company with 3 collapses and recoveries sinc 2003?
Jon
Point taken and with several different varieties all with similar issues, that almost makes the point for the FDA.
Jon
I think we generally agree, accept with respect to TNFs. I look at the class and see PML, cancers and deaths. Extreme toxicity. What if a small difference exacerbates the effect? And don't forget, for some diseases, these drugs can be taken off and on for life.
Jon
Any idea which will require more detailed clinicals?
Partly depends on ease of copying which I clearly do not understand the nuances of.
But seems to me that EPO could require clinicals given the recent attention/SEs.
TNF, given toxic side effects, probably would too although the number of similar drugs might argue that any slight variances might not be that important.
Insulin is crucial to life but do the many varied types argue for ease of approval? Many effectively branded generics already in main part of market.
Does the number of beta/alpha interferons and lack of super severe effects argue for easier approval?
Jon
JNJ's labs have been very unproductive if you ask me. They seem to have to do major acquisitions to keep the drug division going. Think CNTO (best deal), that company that gave them the failed congestive heart failure drug, AZA, many others.
And I have a feeling that if CNTO had been left alone, they would have been massively profitable by now and some of their deeper pipe would actually be further along independent than as part of JNJ - kind of counter-argumentative as most would have said JNJ had deeper pockets!
Jon
Nowhere do they discuss overall efficacy. I see commments on subgroup. I see 2-3 other PRs about this from earlier in week (including an 8-K filing), none of which I opened. I assume drug failed the IIB but will move into III anyway.
I would also point out overlaying this stock movement over recent ARNA movements probably results in similar picture given many think obesity will be impossible to get improved.
Jon
Probably part of the reason for the large late trade in MNTA.
Jon
I lost my lists and layouts when I switched to the newer version a few weeks back. How do you guys configure yours? Any good tips? Any suggestions for news configurations - I have never been able to get work and so do not use.
TIA and GLTA!
Jon
Russell rebalancing per someone on MNTA SI board. Although a late buy there did drive it sharply higher during the day.
Jon
[On the whole I agree, but it still matters a lot which Big Pharma one buys.]
<<
And which do you like - I know about Novartis, but any others? And yes, Novartis does appear to be the best of the best lately.
Jon
Tyzeka scrips stuff.
http://siliconinvestor.advfn.com/readmsg.aspx?msgid=23641231
Jon
ENCY,
I hope Given is terminated - this is inexcusable IMHO. I will do fine as long as I get an open or quick bounce into 2.50 area. I still think this is doable but not as sure.
Jon
Feuerstein on IDIX and soon apparently VRUS.
Biotech
Feuerstein's Biotech-Stock Mailbag
By Adam Feuerstein
Senior Writer
6/16/2007 1:31 PM EDT
URL: http://www.thestreet.com/p/newsanalysis/biotech/10362909.html
Thanks for stopping by the Biotech Mailbag. I'm keeping my promise of last Saturday to steer clear of cancer talk this week. Well, sort of, as you'll see below. But seriously, I'm moving on to other topics. If you have comments, suggestions or gripes, please email me here.
Bruce H. emailed me last month about Idenix Pharmaceuticals' (IDIX) hepatitis C drug NM283. "What do you see as the likely results of the drug-drug interaction of NM283 and standard of care?" he asked, adding that he thought Idenix was an undervalued stock because NM283 would find a place in future hepatitis C treatment regimens.
NM283, also known as valopicitabine, is a polymerase inhibitor that works against the hepatitis C virus. On Tuesday, Idenix released phase II data showing that NM283 does not interact negatively with ribavirin, one of two drugs (the other one being pegylated interferon) that are currently considered the standard care for hepatitis C.
This is good news for Idenix because there were concerns that NM283 and ribavirin (and PEG-interferon) might not be combinable into a single treatment regimen.
But with that said, the knock on NM283 that it is a relatively impotent hepatitis C drug remains intact. A closer look at the data released Tuesday underscored that point, as I pointed out on RealMoney. So with all respect to Bruce, I have to take issue with his assertion that Idenix is undervalued today based on NM283's potential.
Efficacy data on the drug to date suggest that it's perhaps marginally better than current standard of care. The problem is that other experimental hepatitis C drugs in development look more effective. And there are still worries about side effects and tolerability of NM283 that need to be resolved.
And Tuesday, Idenix indicated that NM283 will need additional phase II work before pivotal phase III studies can begin late next year. That sounded like a delay to the program.
I think Citibank analyst Yaron Werber said it best recently when he wrote that NM283 has the potential to be like the HIV drug AZT -- a pioneering drug (albeit one with flaws) that is quickly surpassed by more effective and better tolerated competitors coming up behind it, fast.
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Joe C. asks about Altus Pharmaceuticals (ALTU) . "Altus announced they reacquired rights to ALTU-135 in Europe. Is that important news for the company? More importantly, Adam, do you still feel the same about Altus? Do you still see the stock as undervalued?"
My Altus call has not worked out at all, even though I see this as more of a long-term story. This stock has taken the express elevator straight down from $18 to $11 since I first wrote about it in January. Needless to say, I'm not happy.
I think I made two big mistakes: First, I overestimated the market's enthusiasm for ALTU-135, a pancreatic enzyme replacement product that I believed would take over the market if, and when, approved. In reality, there are concerns (some well founded) that ALTU-135 will face formidable competition. Furthermore, the pace of the ALTU-135 clinical program has been slower than I expected, while competitors are moving faster.
The partnership signed by Altus with Genentech (DNA) last December to develop a long-acting human growth hormone was a nice validation of Altus' drug-delivery technology. But again, I overreached in my expectations. This program is moving ahead slowly, and the initial focus on adults is a small segment of the overall human growth hormone market. The big prize -- a pediatric product -- has a long way to go.
To answer Joe's specific question: Altus reacquiring European rights to ALTU-135 is probably a good thing because its partner was more of a hindrance than a help. Now, Altus can negotiate a new worldwide partnership, if it so chooses.
With that said, I don't expect the company to get much credit, and in fact I won't be surprised to see many people view this latest development as a negative. The slump in Altus' stock price reflects widespread skepticism in the company's ability to meet expectations -- and a lack of confidence in current management, to boot.
I think it will take clearly positive data from the phase III study of ALTU-135 -- data that shows the product to be superior in some way to its competitors -- for investors to start believing in the Altus story. That won't likely come until the second half of next year.
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A painful lesson learned in Geron (GERN) this week: If investors insist on owning this highly speculative and relatively expensive biotech stock, please buy it after the company disappoints with either lackluster clinical data or some delay/setback in its pipeline.
The thing to remember about Geron is that it is a stock pumper's dream. Some headline about stem cells hits the tape, the CEO makes yet another bullish comment or an article or two is published about the greatness of Geron's science -- the result: Momentum investors and daytraders get to sell overpriced shares to gullible buyers who think this time, finally, is Geron's breakthrough moment.
Except, it's not. This week was so typical. In May, people got all excited about data from the company's telomerase-inhibitor cancer drug, GRN163L. The stock was bid up in anticipation. But when the data were finally presented this week, it disappoints. The stock falls. It's happened before, it will again.
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Raffaele asks: "What do you think about Vasogen (VSGN) and its Celacade technology?"
Let's look at how Celacade works: A small amount of blood is drawn from a patient. The doctor then places the blood inside a machine that exposes it to oxygen and ozone. The blood is then zapped with ultraviolet light and warmed.
This "treated" blood is then injected back into the patient and is supposed to open clogged arteries, prevent heart disease, etc., via some magical anti-inflammatory effect.
Does this sound ridiculous to anyone else? Well, so far, large clinical trials of Celacade have failed. No surprise.
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As I write this column Thursday, Onyx Pharmaceuticals (ONXX) trades near $30. That's essentially where it was before the big ASCO meeting, before the great news about Nexavar's liver-cancer data was delivered. And before we learned that Pfizer's (PFE) drug Sutent doesn't seem like a credible competitor in liver cancer. Strange.
Onyx did have a nice run into ASCO, so some amount of post-meeting selling is expected. Maybe it's the summer doldrums I mentioned. Merrill Lynch analyst Eric Ende emerged from his Florida bungalow this week to whack at Onyx, too, issuing a report suggesting that the liver cancer market is much smaller than most people, including myself, believe it to be.
I still think the stock is worth more. Over the next quarter or two, we'll see how much Nexavar sales pick up due to off-label use in liver cancer.
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As of this writing, the FDA has yet to issue an approval decision on Encysive Pharmaceuticals' (ENCY) drug Thelin. That's supposed to happen Friday night, so perhaps the news is out as you read this.
One theme running through much of the email response to my column Wednesday on the topic is that the FDA is somehow biased against Encysive because drug regulators are in the pocket of rival Gilead Sciences (GILD) . This explains why the FDA has delayed Thelin's approval twice, so Gilead can catch up, or so the theory goes.
It's an interesting theory, but I really don't buy it. And there is absolutely zero evidence to back up the claim. Perhaps the problem with Thelin lies with Encysive itself?
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Now that I'm free from the clutches of the ASCO meeting, I meant what I said about working on new ideas of the non-cancer variety. A few of the stocks on my research radar screen right now are antiviral plays GeneLabs (GNLB) and Pharmasset (VRUS) .
I'm also interested in Amicus Therapeutics (FOLD) , a relatively new IPO that may bring some competitive heat to Genzyme (GENZ) .
I want to dig deeper into Salix Pharmaceuticals (SLXP) , a gastrointestinal specialty pharma company, and Canadian cardiovascular specialists Cardiome (CRME) .
And with Sanofi Aventis' (SNY) weight-loss drug Zimulti apparently kicked to the curb, the obesity drug market is being roiled again. What's out there that looks interesting in that segment of the market?
If anyone has any thoughts on these stocks, or others, feel free to drop me an email .
Please note that due to factors including low market capitalization and/or insufficient public float, we consider Idenix Pharmaceuticals, Altus Pharmaceuticals, Vasogen, Encysive Pharmaceuticals, Genelabs Technologies, Pharmasset and Amicus Therapeutics to be small-cap stocks. You should be aware that such stocks are subject to more risk than stocks of larger companies, including greater volatility, lower liquidity and less publicly available information, and that postings such as this one can have an effect on their stock prices.
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Adam Feuerstein writes regularly for RealMoney.com. In keeping with TSC's editorial policy, he doesn't own or short individual stocks, although he owns stock in TheStreet.com. He also doesn't invest in hedge funds or other private investment partnerships. Feuerstein appreciates your feedback; click here to send him an email.
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Ghmm,
That is my read too. Would account for the new data submission (and its speed), probably with ENCY trying to "save" some patients from the affected center(s) and FDA probably tossed them all. This would also account for the Class II response as FDA wanted time to dig through all the data again.
Jon