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I bought MCU this morning, drbio,dunno and crs
The P3 trial for MC1 will be very short compared to most and it looks like an 85%+ probability. The P2 trial was big and nothing changes for the P3.
I like the fact that the recent dilution was oversold.
I expect Merck to pick up the option to market the Aggrostat/MC1 combo but it's not neccessary.
The diabetes indication addresses a large market.
I get ongoing revenue, 45 mil in cash and lots of irons in the fire for my fully diluted (at 1.7/sh) 158 mil cap.
Dave
74 ppd. Sad about your loss, Dew.
Dave
Webcast Calendar
[Please see updating procedure at the end of this post. Events listed here are regular quarterly conference calls unless indicated otherwise. All times are U.S. ET. unless indicated otherwise.]
NOTE: ANYONE MAY UPDATE THIS FILE
Edits: Added RPRX, ONXX and SGMO
--
1/04 EST 12:30 RPRX R&D day http://www.reprosrx.com/
1/08 PST 1:30 SGMO JP Morgan Healthcare http://www.sangamo.com/
1/08 PST 8:00 ONXX JP Morgan Healthcare http://www.onyx-pharm.com/
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I will call GTCB. Baseless? Hmmm.
Dave
Thanks much rfj and dewophile. You've been patient with my unfounded concerns. RPRX can proceed apace with little competition.
I was ignorant of RU 486's caste. Maybe whoever buys RPRX cna buy RU 486 low dose rights at some later date.
Aside to rfj. 21 is better than none but irrelevant now that I know the scoop on RU 486.
Dave
With all Dew respect you left GTCB/LEO update unchanged despite recent 10Qs.
Do you feel comfortable about that?
Dave
dewophile re RPRX prospects
How big the drug might be and the likelihood of severe competition makes a lot of difference to thinking investors. If it's an absolute no brainer why don't you have 100% of your money in it? Your attitude bespeaks an investment of less than 1 % of your portfolio.
There are many tradeoffs and comparisons to be made with our other investments. Humor me.
I appreciate your input and help.
Thanks,
re RU 486 I found this (12 month results for 21 patients).
These data look very good. What makes you and RFJ so sure these results won't translate quickly into FDA approved indications prior to RPRX approval? It's been in phase III for quite a while now.
"Twelve-month safety and efficacy of low-dose mifepristone for uterine myomas.Eisinger SH, Bonfiglio T, Fiscella K, Meldrum S, Guzick DS.
Department of Family Medicine, University of Rochester School of Medicine and Dentistry, Rochester, New York 14620, USA. eisinger@rochester.rr.com
STUDY OBJECTIVES: The primary aim was to assess long-term effects of low-dose mifepristone on myoma regression, symptoms, and endometrial pathology. The secondary aim was to assess regrowth of myomas after cessation of mifepristone. DESIGN: Prospective, open-label, randomized, controlled trial of 5 mg versus 10 mg mifepristone daily for 1 year, in women with large, symptomatic myomas, with variable follow-up among a subset of subjects (Canadian Task Force classification II-2). SETTING: University research group set in a community hospital. PATIENTS: Forty premenopausal women with large, symptomatic myomas. INTERVENTION: Oral mifepristone 5 or 10 mg daily for 1 year. MEASUREMENTS AND MAIN RESULTS: Mean uterine volumes decreased in both groups by 48% after 6 months of mifepristone and by 52% to 53 % in both groups after 12 months. Amenorrhea occurred in 61% to 65% at 6 months, and 40% to 70 % at 12 months. Eighty endometrial biopsies were performed. Simple hyperplasia was seen in 5 (13.9 %) of 36 subjects at 6 months and 1 (4.8 %) of 21 at 12 months. All cases of hyperplasia occurred in the 10 mg group. No endometrial sample showed cytologic atypia. Nine women were followed posttreatment for an average of 5.7 months. Uterine volumes increased among most of these subjects, although they remained on average 42% less than baseline. CONCLUSIONS: Long-term administration of low-dose mifepristone results in myoma shrinkage and amelioration of symptoms; modest rates of low-grade endometrial hyperplasia, but no evidence of premalignant potential, also occur. Regrowth occurs slowly following cessation of the drug.
PMID: 15922980 [PubMed - indexed for MEDLINE]"
Re RPRX I agree each drug has different characteristics. I'm happy that asoprisnil, which was further along, is no longer a threat. That it got well into P3 b4 serious problems became apparent gives me pause. Ergo my interest in more recent RU 486 data.
Hopefully it won't work for reasons that won't affect proellex. Does anyone know how big a problem the 8% incidence of elevated levels of hepatic enzymes might have on the RU 486 safety profile vis a vis Proellex?
I asked for the royalty and penetration assumptions by Think Equity because it would help evaluate the value of proellex to another company. In earlier models they showed only a 2.8 % market penetration. The home run results and lack of competition from Asoprisnil seem to augur well for Proellex becoming the standard of care, if approved, for 2 indications. Asoprisnil was forecasted to be a $700 mil drug. I'm thinking Proellex could be a billion due to excellent safety (so far) and very robust responses.
Dave
Re other pipeline RPRX competitors
I'm trying to get the latest on the other SPRM trials to see if they ran into longer term problems that might signal caution to us as investors in RPRX.
I can find nothing later than this on the phase III mifepristone leiomyoma trial.
http://clinicaltrials.gov/ct/show/NCT00133705
Here is a clip that effectively ended the asprisnil P3 trial by Schering/TAP.
"Schering AG and TAP announce extension studies with investigational compound asoprisnil will be amended
Schering
October 12, 2005
Berlin, October 12, 2005
Schering AG, Germany (FSE: SCH, NYSE: SHR) and TAP Pharmaceutical Products Inc. announced today that extension studies performed with asoprisnil, an investigational compound for the management of symptomatic uterine fibroids, will be amended. Asoprisnil is being investigated for its ability to reduce uterine bleeding, shrink the fibroids, as well as reduce pressure symptoms.
Following Phase III controlled trials, patients were able to elect to participate in extension studies which would have extended their total therapy duration for up to four years. During the clinical study program, some patients experienced endometrial changes, which were reversible in most patients after stopping therapy and resulted in additional invasive procedures. In view of these findings, the extension studies will be amended and dosing will be discontinued. Investigators will continue to follow-up with patients as part of the ongoing extension studies.
"Based on Phase II and Phase III data, we believe that asoprisnil may be a promising therapy for the millions of women who suffer from uterine fibroids whose current options remain invasive procedures," said Phil Smits, M.D., Head of Global Business Unit Gynecology&Andrology, Schering AG.
Both companies will continue to discuss submission plans with the U.S. and European regulatory authorities.
RPRX competitor re fibroids in OBYGYN magazine
I can't access the full article
--------------------------------------------------------------------------------
ORIGINAL RESEARCH
Effect of Mifepristone for Symptomatic Leiomyomata on Quality of Life and Uterine Size
A Randomized Controlled Trial
Kevin Fiscella, MD, MPH1,4, Steven H. Eisinger, MD1,2, Sean Meldrum, MS1, Changyong Feng, PhD3, Susan G. Fisher, PhD4 and David S. Guzick, MD, PhD5,2
From the Departments of 1Family Medicine, 2Obstetrics and Gynecology, 3Biostatistics, and 4Community & Preventive Medicine, 5School of Medicine and Dentistry, University of Rochester, Rochester, New York.
OBJECTIVE: To assess the effect of low-dose mifepristone on quality of life, pain, bleeding, and uterine size among women with symptomatic leiomyomata.
METHODS: Forty-two women with symptomatic uterine leiomyomata and uterine volume of 160 mL or more were randomized to mifepristone, 5 mg daily, or placebo for 26 weeks. Quality of life (Uterine Fibroid Symptoms Quality of Life Questionnaire and Medical Outcomes Study 36-Item Short Form survey) and uterine and leiomyoma size (ultrasonography) were assessed at baseline, and at 1 month, 3 months, and 6 months of treatment. Bleeding (daily logs and pictorial charts) and pain (McGill Pain Questionnaire) were assessed monthly. Endometrial pathology was assessed at baseline and 6 months.
RESULTS: Forty-two women were randomized; 37 women completed all 6 months. Women randomized to mifepristone showed an improvement in leiomyoma-specific quality of life. Forty-one percent became amenorrheic, rates of anemia improved, and adjusted uterine size was reduced by 47%. Compared with the placebo group, improvements in these outcomes in the treatment group were significantly greater (P<.05 to .001). There were no significant differences in adverse effects between the groups. No endometrial hyperplasia was noted in any participant.
CONCLUSION: Low-dose mifepristone improves leiomyoma-specific quality of life and reduces leiomyoma size among women with symptomatic leio-myomata.
CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov www.clinicaltrials.gov NCT00133705
LEVEL OF EVIDENCE: I
Pfizer's HIV CCR5 antagonist seems to be progressing quickly.
"Pfizer Announces Plans To Establish Expanded Access Program For Maraviroc, Investigational HIV CCR5 Antagonist
Main Category: HIV / AIDS News
Article Date: 02 Dec 2006 - 0:00 PST
| email this article | printer friendly | view or write opinions | Article Also Appears In
Clinical Trials / Drug Trials
Pfizer announced today that it plans to establish a multi-national Expanded Access Program (EAP) to make the investigational CCR5 antagonist maraviroc, currently in ongoing phase 3 clinical trials, available to HIV/AIDS patients with CCR5-tropic HIV-1 who have limited or no approved treatment options due to resistance or intolerance. Pending regulatory review and approvals of the EAP study protocol, the program will begin enrolling patients in the next few months, with a target to enroll patients from over 30 countries.
Maraviroc is in a new class of investigational HIV drugs known as CCR5 antagonists, designed to work differently from currently available HIV/AIDS antiretroviral medicines. Rather than fighting HIV inside white blood cells, CCR5 antagonists prevent the virus from entering cells by blocking its predominant entry route, the CCR5 co-receptor.
The EAP is designed to provide access to maraviroc for patients who, in the opinion of the program investigators, need it to create a viable regimen. "People living with HIV whose virus is resistant to available therapies have an urgent need for novel medicines," said John LaMattina, president, Pfizer Global Research and Development. "It is our hope that maraviroc, now in final stages of clinical development, may help those patients who have exhausted treatment options and are not already participating in our clinical studies."
Pfizer confirmed plans to submit applications for marketing approval in both the U.S. and EU following review of the data from the two Phase 3 maraviroc registrational trials. These are 24-week studies of Optimized Background Therapy (OBT), with or without maraviroc, in highly treatment experienced patients with CCR5-tropic HIV-1. Pfizer will submit these results expeditiously for presentation at an upcoming HIV conference.
To broaden the program's reach, Pfizer is recruiting many investigators with previous EAP experience as well as HIV clinical experts at centers which have not previously engaged in expanded access initiatives. Study patients will receive open-label maraviroc twice daily in addition to OBT. In some circumstances, the study allows the use of OBT that may contain other investigational antiretroviral agents in Phase 3 clinical development.
Health care professionals interested in enrollment should contact their local Pfizer office.
Maraviroc Expanded Access Study Design
Investigators will follow patients in the EAP according to their local standard of care. The study will continue in each country until marketing approval and reimbursement is obtained in that country and the patient can obtain drug through local commercial distribution channels.
Pending regulatory review, preliminary program eligibility criteria include patients who are, clinically stable with documented CCR5- tropic HIV-1 infection; at least 16 years of age (or minimum adult age as determined by local regulatory authorities or as legal requirements dictate); have limited or no treatment options available to them due to resistance or treatment intolerance; and they must be failing to achieve adequate virologic suppression on their current regimen. The study cannot include patients who have failed prior treatment with any CCR5 antagonist in a clinical trial; have evidence of dual/mixed-tropic or X4-tropic HIV; require any medications prohibited by the EAP protocol; have a condition which the study investigator deems will interfere with the patient's adherence and safety; or who are pregnant or lactating. Investigators will select the OBT based on the patient's prior treatment history and antiretroviral resistance testing conducted according to local practice. Pfizer will not provide OBT. Pfizer will monitor safety and tolerability of maraviroc throughout the course of the study.
Pfizer
http://www.pfizer.com "
SGMO's CCR5 antagonist doesn't start P1 until late 2007.
Dave
rfj re RPRX Some questions.
Think Equity went from a $31 May price target to $18 and dropped Androxal from the future valuation model. I think I know why. It had heretofor been the larger part of the future revenue model. Do you have access to their report in making that move?
What penetration level and % does their royalty revenue from Proellex presume?
Does Think Equity seem to be aware that the Schering Plough P3 trial for Asoprisnil is not on Schering's planning horizon due to long term effects that showed up only in longer term trials?
Do you know when the adverse side effects of RU 486 became apparent in their fibroid testing?
Thanks in advance and thanks for the great reports.
Dave
Personal recap for 2006.
After timing debacles in 2005 on unprotected leaps and then calls based on binary events that happened I retreated to concentrating on my favorite long term biotech. Still risky. but the Roth was up 46%, the 401K 77% and the trading account 105%.
Overall + 77%.
The big pops for SGMO were based on awareness not huge news. That allowed me to time some minor and major exits and lower rebuys. It was up 66%.
Dave
Re willingness to partner on the first drug. I totally agree.
Dave
Predicting Success: A Pipeline Report
Doing some DD on RPRX I googled asoprisnil and hit on this report. It contains a wealth of info worth delving into. Link:
http://www.adisinsight.com/Articles/PE1-08-04e.pdf
Dave
Many RPRX profit takers may wait till 2007 to show their profits. I expect a buying opp Wednesday PM.
Dave
Webcast Calendar
[Please see updating procedure at the end of this post. Events listed here are regular quarterly conference calls unless indicated otherwise. All times are U.S. ET. unless indicated otherwise.]
NOTE: ANYONE MAY UPDATE THIS FILE
Edits: Added RPRX INGN
--
12/28 4:30 EST P3 clinical update INGN http://www.introgen.com/
1/04 12:30 RPRX R&D day http://www.reprosrx.com/ presentations
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When adding or modifying entries, please follow these steps:
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Market CAMH device with ECG/EKG monitors?
Here is a photo and article re the CAMH HearTwave II.
http://www.cadth.ca/index.php/en/hta/reports-publications/health-technology-update/issue3/heartwave
Gee. It looks like a typical stress test set-up. It seems to me that Cambridge has to move toward combining the tests. Make the Heartwave II EKG capable or sell the technology to someone who sells ECG monitoring equipment. Doctors don't want to allocate a scarce room to an extra device if they look the same to the patient. Combine the technologies.
JMHO,
Dave
Re mathematics Dew.
Rats. Does that mean there is no Santa Claus and I can't beat the casino at craps?
Sigh. It looked cute. I'll play with it on a few other high beta stocks before I'll concede to the inevitable.
RPRX Hmmm.
Dave
gfp reply Since early 2004. 80+% of my holdings have been in SGMO since mid 2005 Exception: cash or toys briefly after big run-ups.
To paraphrase Buffet. Investing is like a baseball game with an unlimited number of balls. I wait and wait and then wait some more. When I see the juciest pitch I've ever seen I swing for the fences.
Dave
Loeb's 10% rule biotech corollary. Dew
Let's say you love the fundamentals like I do SGMO and you do GTCB.
If it falls 10% after a high subsequent to your buy sell it.
But, buy it back when it goes up 10% from the next low.
Sell it again 10% below the next high. Rinse, repeat.
i.e. You buy 1000 GTCB. at 1.64 on 1/2/2006. It hits 1.95 on 1/9/2006. You sell it that day for 1.75 leaving you $1740 after a $10 vig. Buy at 1.77 (10% above the low of 1.61 on 1/9/06. etc. etc.
Let's also assume you missed a buy on 2/8 when it briefly hit 1.1 and you had to buy that day at 1.83 and on 2/23 you couldn't sell till it hit 1.18. I calculated that you still would have had a year end profit despite the shares ending down 32.4%. It would have taken 24 trades.
Let's walk through the same sequence on the SGMO chart. 17 trades starting with 1000 shares @$4.02 on 1/2/2006. I ignored the $10 commissions.
Chart:
http://finance.yahoo.com/charts#chart1:symbol=sgmo;range=1y;indicator=sma(200,50)+volume;charttype=l...
cost $4020
sell 1000 @6.02 =$6020
Buy 1088 @5.53
Sell 1088 @5.12 =$5570
Buy 1136 @4.9
Sell 1136 @7.45 =$8463
Buy 1672 @5.06
Sell 1672 @4.77 =$7975
Buy 1700 @4.69
Sell 1700 @5.13 =$8721
Buy 1720 @ 5.07
sell 1720 @ 5.2 =$8944
Buy 1706 @5.24
Sell 1706 @5.5 =$9383
Buy 1807 @5.19
Sell 1807 @ 7.25=$13,100
Buy 2047 @ 6.4 (It touched 5.82 on 12/22/2006)
It closed today at 6.68 =$13,673
240% gain vs buy and hold of 66%
Re 10% exit. rfj has discipline. I still don't. As we speak I'm catching the falling knife that is CAMH.
I also don't diversify much at all. I suspect many of us feel as I do. Those rules are for others.
Bio, the 40% drops you suggest are frequent usually follow binary events. BSR David had some relevant advice on those times.
Regards,
Dave
Congrats for the CNBC appearance, David.
Dave
Exit strategy for other people. Loeb's 10% rule...
Link for entire article:
http://www.usatoday.com/money/perfi/columnist/krantz/2006-12-27-10percent-rule_x.htm
"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."
I wish I had had an exit strategy in 2001.
Dave
SGMO's 6 analysts 1yr consensus =2.31xprice
217mm cap 6.45 sp. consensus 1 yr is 15. Low is 12.5
Analysts named:
http://www.nasdaq.com/earnings/analyst_recommendations.asp?symbol=SGMO&selected=SGMO
That's a bunch of analysts for a tiny company. Check it out.
Dave
Oh, I'm totally relaxed regarding RPRX's trendline. I won't feel stuck in a long position and will not short it. Just playing the volatility.
Dave
Back in rprx. I'll stop posting these. Boring.
Dave
GNVC's 1.5 bil adenovirus competition crosslicenses with Merck.
Merck & Co., Inc. and Crucell Sign Cross-licensing Agreement on Vaccine Production Technology
Wednesday December 27, 5:00 am ET
LEIDEN, NETHERLANDS--(MARKET WIRE)--Dec 27, 2006 -- Dutch biotechnology company Crucell N.V. (Euronext, NASDAQ: CRXL; Swiss Exchange: CRX) announced today that it has signed a cross-licensing agreement with Merck & Co., Inc. In addition to previously licensed rights to PER.C6, the agreement opens the way for Merck to use Crucell technology on an exclusive basis in additional undisclosed vaccine fields. In return, Crucell receives access to Merck's large scale manufacturing technology for its AdVac®-based vaccines.
"This agreement will make it possible to speed up the delivery of our malaria and TB vaccines to the people in need, and makes it realistic to do so on the mass scale required," said Jaap Goudsmit, Chief Scientific Officer at Crucell. "It also opens the way for Crucell to speed up the Ebola program with the VRC, which has recently entered a phase I clinical trial. But most importantly, it brings the reality of vaccines such as these significantly closer."
Crucell's malaria vaccine program is supported by the National Institute of Allergy and Infectious Diseases (NIAID) of the U.S. National Institutes of Health (NIH). The TB vaccine program is a collaboration with the Aeras Global TB Vaccine Foundation. Both programs are based on Crucell's adenovirus vector technology, AdVac®, and are currently in Phase 1 clinical trials.
Back out of RPRX temporarilly. Lately I'm cashing in on substantive short term moves. Ergo I missed the big move in RPRX in favor of 2 little moves. Hoping for technical downspurt. I want to be long but am being penny wise. Dumb and dumber so far.
Dave
Webcast Calendar
[Please see updating procedure at the end of this post. Events listed here are regular quarterly conference calls unless indicated otherwise. All times are U.S. ET. unless indicated otherwise.]
NOTE: ANYONE MAY UPDATE THIS FILE
Edits: Added RPRX
--
1/04 RPRX R & D day http://www.reprosrx.com/ presentations
--
Procedure For Updating Calendar
When adding or modifying entries, please follow these steps:
1. Copy the complete text from the old list. You can find a pointer to this list in the iBox at the top of the main message-board screen.
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Got back in RPRX based on my concurring with the thought that Proellex now looks like a billion dollar drug with an 80% chance of making it.
Dave
Re GTCB LEO losses Sorry urche didn't read your post. Are you clear on those losses now?
Dave
Good call dewophile re rprx. Right on.
Dave
RPRX good rec rfj My compliments. Agree that proellex is 80% + to make it through the FDA jungle and hit the market. We eagerly await your revised take on valuation and timing guesses. It's a very good 6 person company.
Dave
Dew Thanks right back at you. This is a great board.
Merry christmas to all.
Dave
Thanks,
I should have checked the recent price.
Dave
Burned on naked calls. One reason to avoid timeline options is hedge fund activity. I had a massive naked July call position around 20 on a company with 2 drugs that looked like they would be approved in April 2005. The shares were selling in the 14's. Voila! Both were approved. The share price held fast until late summer. I lost it all. It's now in the high 40's. Byetta and Symlyn.
Dave
Re recurrent glioblastoma bad for Lilly good for SGMO.
link:
http://biz.yahoo.com/prnews/061212/sftu060.html?.v=78
Quote:
Sangamo has entered into an exclusive, worldwide license agreement with COH for intellectual property related to a chimeric immunoreceptor useful in treating human cancers. Sangamo and COH have also entered into a research collaboration to develop a novel cell therapy combining this technology with Sangamo's proprietary zinc finger DNA-binding protein nuclease (ZFN(TM)) technology for treatment of glioblastoma multiforme (GM), a progressive and usually fatal brain cancer.
Sangamo scientists are collaborating with Michael C.V. Jensen, M.D., Associate Chair, Division of Cancer Immunotherapeutics and Tumor Immunology, City of Hope, who has developed novel chimeric immunoreceptors called zetakines that can be engineered into human immune cells to generate a population of cells that can specifically recognize and destroy cancer cells. Dr. Jensen is already using these engineered cells in clinical trials for malignant gliomas and lymphoma. The aim of the current collaboration is to use Sangamo's ZFN gene modification technology to enable deletion of the glucocorticoid receptor (GR), a gene that limits the benefit of this novel therapy. Glucocorticoids are steroids that are widely used in glioma patients. The specific deletion of GR in the zetakine, anti-glioma T-cells will allow this novel immune therapy to be used in the presence of glucocorticoids.
Dave
rprx's Proellex was projected to be a 600 mil drug. Does excellent efficacy raise that number?
Dave