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I'm not a conservative, but thought you might be interested in this post:
http://www.investorshub.com/boards/read_msg.asp?message_id=20833536
As you and I both know, these sorts of extemporaneous events with no new news tend to be futile, in part because they're used as shorting opportunities by...people like me. Although obviously I won't be shorting this one.
I'll be interested to see how many sheeple buy tomorrow.
JAV
JAV trying to rescue its stock price from the doldrums. I personally can't figure out what it's doing way down at ~$6.20.
Javelin Pharmaceuticals to Host Conference Call on Recent Major Milestones
BusinessWire - June 27, 2007 3:35 PM ET
Javelin Pharmaceuticals (AMEX: JAV) announced today that Dr. Daniel Carr, CEO and CMO, and members of Javelin's senior management will host a call on three recent milestones as well as progress in the clinical development of PMI-150 (intranasal ketamine). The call will be held tomorrow June 28, 2007 at 8:30 a.m. EDT.
Recent milestones include recently reported top line results for Javelin's Phase 3 pivotal trial of Rylomine (intranasal morphine), the ten year extension of European patent protection for Dyloject (injectable diclofenac) to 2024, and the selection of Javelin Pharmaceuticals by Russell Research for the Russell 2000(R), 3000(R), Micro-cap(TM) and Global Indexes.
The Company invites all interested parties to participate. The call will also be webcast and accessible live through the following URL: http://ir.javelinpharmaceuticals.com/events.cfm The call will be archived on the Company's website www.javelinpharmaceuticals.com.
CONFERENCE CALL ALERT
Javelin Pharmaceuticals, Inc. Conference Call
Date: June 28, 2007
Time: 8:30 a.m. E.D.T.
Please call: 1-800-289-0726 domestic callers OR international participants 1-913-981-5545
Javelin Participants: Daniel B. Carr, CEO and CMO; Fred Mermelstein, President; Steven J. Tulipano, CPA., CFO; David B. Bernstein, General Counsel and Chief IP Counsel; and Curtis Wright, IV, EVP, Risk Management and Regulatory Affairs.
About Javelin Pharmaceuticals, Inc.:
With US corporate headquarters in Cambridge, MA, and a European office in Cambridge, UK, Javelin applies innovative proprietary technologies to develop new drugs and improved formulations of existing drugs to target unmet and underserved medical needs in the pain management market. For additional information, please visit www.javelinpharmaceuticals.com.
JAV
Article in The Street Real Money today that I can't read because I'm not a subscriber. Probably not deep or intelligent analysis.
Aside from Fuerstein, I don't trust anyone else at The Street farther than I can throw 'em.
I guess DSCO.
And NovoNordisk. I think they rank right up there with Novartis.
>Valuation wise which one is cheaper<
XNPT: 1) The RLS market is a bigger opportunity than developing yet another drug for PHN; 2) Remember that they have a baclofen analog in development as well; this is a potential billion-dollar drug.
I own neither, but I did own XNPT.
IDP
I shorted the heck out of IDP this morning. I think it still has another 10% to 20% to fall.
Thus far, there hasn't been a lot of success in the TLR space.
This news makes other TLR companies great shorts.
Pipex
It's really too bad this isn't a urology-focused company.
JAV
Couple of points to raise:
1) Owning JAV isn't like owning DNDN. There's not much risk in any of the drugs in their pipeline, so you're not going to get an overnight 100% pop.
2) Given that analysts (and not just the usual culprits of Punk and R&R) have targets ranging from $12 to $18 on a company that is not in imminent need of their services suggests that the market cap deserves to be substantially higher.
3) Each of the products alone isn't worth much, but at $250M market potential for each, it's not bad and essentially equivalent to sales of, say, bivalirudin (which supports a $1B market cap for The Medicines Company)
4) Not much has been said about this, but JAV represents a tasty takeover target for companies focused on acute care/hospital markets. A company like TMC could more than double their pipeline by buying JAV, and they already have an ideal sales force in place to sell Dyloject and other products.
I don't think $12-$18 is unreasonable considering the low-risk characteristics of JAV's pipeline.
That said, we should have gotten more of a pop today. As I'm writing this, JAV is actually down.
VICL
Thank you. I covered at ~$5.63. I don't think VICL is a bad company, nor do I think it is tremendously overvalued. I just thought it got ahead of itself. In fact, I've added it to my long watch list.
OT: I remember a presentation Leonard Guarente gave at Columbia about 6 or 7 years ago discussing the link between caloric restriction and longevity. I distinctly remember him saying something along the lines of "although it is clear that caloric restriction extends the lives of all animals studied so far, it also kills your sex drive."
Doesn't seem worth it to me. Aside from sacrificing bacon cheeseburgers.
Edit: I just found this in Psychology Today:
The psychological calming that's largely a result of the hormonal changes -- markedly less testosterone -- and some of the neurochemistry changes that occur as a result of CR are really why I'm in it at the moment....I don't miss my libido one bit.
http://psychologytoday.com/articles/pto-3443.html
I occasionally put in a high limit sell, but not for that reason. I do it just in case the PPS jumps dramatically. I actually managed to get $6.50 (the highest price ever) for some of my YMI shares that way.
VICL
Any thoughts on these data? While interesting, I thought a 20% gain for the day was way overblown. I shorted at $6.02.
Vical is touting interim Phase III data from AnGes regarding an experimental therapy to expand blood vessels. AnGes licensed Vical's DNA delivery technology for the development program and reported that 70.4 percent of the patients taking the therapy reported improvements in chest pain, the primary endpoint for the trial. Only 30.8 percent of patients taking a placebo reported an improvement, prompting the data monitoring committee to suggest ending the trial to avoid any ethical issues that would arise. The treatment uses Vical technology to deliver a gene encoding Hepatocyte Growth Factor, a human protein that causes angiogenesis in areas of restricted blood flow. AnGes plans to file for approval in Japan.
"The successful Phase III results from our Japanese licensee position the AnGes product candidate to be the first approved for human use based on our DNA delivery technology and provide proof of concept for DNA delivery in the treatment of disease," said Vijay B. Samant, president and CEO of Vical.
But seriously, I'm retarded. My order was placed at $5.85, not $6.85. I am continuously humbled by my stupidity.
One time I almost placed an order for 12 shares at $10,000 instead of 10,000 shares at $12.00.
JAV
I find it very irritating that I have a 12000-share limit order in for JAV and it's not getting filled while others are getting filled at 5.80 to 5.84. Dew mentioned that E-Trade routes orders to alternative markets--are there any brokerages that don't do this?
I'm afraid I don't understand the logic of your reply.
In any case, I think we can all agree that these results are excellent.
You have cause and effect backwards. The reason women aren't on Lupron long-term is because of all of the bad effects of suppressing estrogen.
In terms of long-term clinical benefit, you have to juxtapose these results against Lupron. Nobody is suggesting that Proellex is going to be marketed for osteoporosis. Instead, the absence of effect on markers of bone turnover makes Proellex a viable long-term treatment for endometriosis and UF, which Lupron can't be for the very reason that it suppresses estrogen, eliciting osteoporosis etc.
RPRX--Dow Jones
Where do they get these idiots?
Repros Therapeutics Inc. (RPRX) said a six-month study of Proellex showed the drug reduced the duration and intensity of pain more effectively than Lucrin when treating endometriosis.
The Woodlands, Texas, pharmaceutical company said it plans to start a Phase II clinical trial of the drug by the end of the year.
Repros's shares closed Monday down 37 cents, or 2.5%, $14.93.
-Andrew Edwards; 201-938-5400; AskNewswires@dowjones.com
Just on principle, I had to sell 200 shares to whomever was bidding $15.80.
RPRX
Here's the press release, for archival purposes
Repros Reports That Proellex Has Demonstrated
Superior Efficacy and Safety in Endometriosis When Compared to Standard of Drug Care
THE WOODLANDS, Texas--(BUSINESS WIRE)--Repros Therapeutics Inc. (NasdaqGM:RPRX) today released top-line findings from its six month study of Proellex™ in the treatment of endometriosis. This study, conducted in Europe, enrolled 39 premenopausal women and has completed six months of dosing. The study included three dose levels of Proellex™ as well as a positive control arm. The positive control was Lucrin®, a GnRH agonist also known as Lupron® or leuprolide acetate, commonly used for the treatment of endometriosis. Proellex was administered in a double blinded fashion as a daily oral dose of either 12.5mg, 25mg, or 50mg capsules. Data from this study demonstrate that treatment with the 50mg Proellex dose reduces both the duration and intensity of pain more effectively than 12.5mg or 25mg and is significantly better (p = 0.0012) than Lucrin in reducing the number of days of pain over the course of the study. Pain reduction also occurred more rapidly than with the active control, Lucrin. Biomarkers of bone loss were unchanged on Proellex therapy but increased on Lucrin.
Pain Results
Pain is the most prevalent and debilitating symptom of endometriosis. The response of pain to treatment in this study was analyzed in 2 ways. Patients in the study maintained daily pain diaries to record the severity and frequency of pain. In addition, at each office visit, patients filled out endometriosis symptom surveys that included a questionnaire that evaluated intensity of pain on a bad day on a scale of 0-10, with 10 being the greatest intensity.
Over the 180 day treatment period, pain diaries indicated that women on the 50mg Proellex dose had 170 or 96% pain free days (standard deviation 8.86 days). This decrease in duration of pain was statistically significantly better (p = 0.0012) than the 117.8 (74%; standard deviation 51.4 days) pain free days achieved with Lucrin. The 50mg dose of Proellex was also statistically superior to both the 25mg and 12.5mg doses with regard to pain free days. Patients on Proellex 12.5mg and 25mg had 115.9 (66%; standard deviation 69.2 days) and 133.6 (75%; standard deviation 27.4 days) pain free days, respectively. These results clearly support a dose response for Proellex. The 25mg and 12.5mg doses of Proellex were not statistically different from Lucrin. At the end of the first month of therapy there was a statistically significant reduction in days of pain in the 50mg Proellex group (p = 0.031) compared with baseline, but not in the three other treatment groups.
The intensity of pain was assessed by the question “On a scale of 1-10, with 0 being no pain and 10 being extreme pain, how intense was your pain on a bad day?” The mean scores for intensity of pain at baseline were 6.3 for the Proellex groups and 6.1 for the Lucrin group. Statistically significant relief from pain was evident by the first month in the 25mg and 50mg Proellex groups. At month three all four active treatment groups had statistically significant reduction in pain compared with baseline, with the following scores: 3.7 (p = 0.03) for 12.5mg, 3.2 (p = 0.03) for 25mg, 1.6 (p = 0.016) for 50mg Proellex and 1.5 (p = 0.016) for Lucrin. These dose related reductions continued until month six when the values for pain intensity were 2.0 (p = 0.008), 2.8 (p = 0.023), 0.6 (p = 0.004) and 0.7 (p = 0.016), respectively. Two months after stopping treatment pain returned and was of similar intensity in all four treatment groups.
Safety Findings
All doses of Proellex maintained estrogen concentrations in the low normal range (mean > 40 pg/ml). Importantly, there were no significant changes in biomarkers of bone resorption in any of the dose arms of Proellex at three and six months of treatment. Women receiving Lucrin in the study, on average, experienced a reduction of estrogen to post-menopausal levels (< 25 pg/ml) by month three and this was maintained through month six of treatment. This outcome was associated with a statistically significant increase (p = 0.023) in biomarkers of bone resorption compared with the baseline values and at month three, and therefore an increased risk of bone loss. At month six as well as at the one month follow up visit, this increase in markers of bone resorption was still present in women treated with Lucrin.
Side effects of Proellex were generally mild with no individual organ system being involved systematically. This is a small study and no definitive conclusions can be made from the safety data but there was no single signal of safety observed.
Safety evaluations also included ultrasound examinations of endometrial thickness. The data from these examinations suggest an inverse dose dependent effect of Proellex on endometrial thickness at three months. After three months on treatment, women receiving 50mg Proellex had a non-significant reduction in the thickness of the endometrium compared to baseline, whereas women receiving 12.5mg and 25mg Proellex had a non-significant thickening of the endometrium. This inverse relationship was still present at six months of treatment although there was some increase in endometrial thickness as compared to baseline for all three doses of Proellex at that time. In two cases where non-menstrual spotting and bleeding was observed in patients with excessive endometrial thickening in the 12.5mg and 25mg groups, a dilation and curettage (D&C) procedure was performed to stop the bleeding. A similar event has not been seen at the 50mg dose during the treatment phase. Greater than normal bleeding occurred in two patients in the 50mg Proellex group after treatment was stopped and a D&C was performed in one and the other successfully managed conservatively.
Dr. Andre van As, Repros’ Chief Medical Officer and Senior VP of Clinical and Regulatory Affairs, noted, “Although these data are from a small group of women with endometriosis, they are reflective of six months of treatment, and we are pleased that the data from the three-month interim analysis have been confirmed. This study has been significant in indicating that there is a relationship between dose, duration of therapy, the risk of endometrial thickening and potential for unusual endometrial bleeding. In studying these relationships Repros has formulated a strategy to successfully manage this by adjusting treatment cycles to four months, and to use a 50mg dose that is associated with a lesser tendency to endometrial thickening with time. Each treatment cycle will be followed by a drug holiday in order to refresh the endometrium. After the occurrence of normal menstruation, a new four-month treatment cycle will be started. In this way the symptoms of endometriosis could be controlled in the long term without the occurrence of unscheduled bleeding. This treatment strategy was discussed with the FDA at our March Pre-IND meeting and all future studies with Proellex will be conducted in this way.”
Joseph Podolski, President and CEO of Repros, added, “The endometriosis market is large and remains under-served and represents a significant unmet need in women’s health. Few drug therapies are viable for long-term use, leaving invasive laparoscopy as the most common treatment. We strongly believe that Proellex, with the efficacy and safety it is demonstrating here, has the potential to become an important medical approach to the long-term treatment of this difficult to manage condition.”
Repros met with the FDA at a Pre-IND meeting in March and will be submitting an IND for the treatment of endometriosis this summer. Repros plans to commence a U.S. Phase 2 clinical trial before year end, pending approval of the IND.
VRUS
Pharmasset Initiated At Buy At UBS
This has to be the greatest number of coverage initiations of a recent biotech IPO in recent memory.
RPRX
52-week high. Finally!
I'll write up the expected news flow for 07-08 later today or tomorrow. Plenty of things coming up.
VRUS
You are right that there are not many near-term value drivers for VRUS.
However, I am not so concerned about VRUS in the short term. Their pipeline is impressive; both clevudine and racivir remain unpartnered, and the company is cheap.
Plus, as noted by Dew, clevudine is a very similar compound, structurally, to Tyzeka/Sebivo from NVS/IDIX, which makes me highly confident that it will succeed in clinical trials. So it does fit my investment profile in that there's less efficacy risk for clevudine because it's a tried and true class of compounds (although again, that fluorine...). Similarly, one can make a rational case that both racivir and R7128 are relatively low-risk, from an efficacy standpoint.
So you've got three drugs, two unpartnered, that have reasonably low efficacy risk. None will be blockbusters-unless R7128 shows spectacular efficacy for Hep C--but all can achieve reasonable market share. Plus we've got a reasonable spread from phase 1 to phase 3.
Perhaps most importantly, though, is that it takes forever for me to accumulate low-volume stocks. I've just started accumulating VRUS, and unless volume picks up so that I can pick up the pace at some point it will take me well over a year to buy enough to make a difference in my portfolio. By that time things will be happening.
ALTU
As I stated previously, I'm expecting the summer slump to take this near or below $10...in short, with biotech seasonality and the other issues ghmm pointed out, no need to rush.
VRUS
Sorry, not really. There are plenty of examples of molecules with identical mechanisms of action, very similar structures, and disparate safety and efficacy results. For example, statins, Cox-2 inhibitors, etc. As I said, adding a fluorine onto anything that size is likely to alter its biochemical properties substantially.
Anyway, it's not that important. What is important is that the company is *very* cheap for the pipeline.
PS: You're disobeying your own rule about including the ticker in each message. I'm the only one who follows the rules around here.
VRUS
I dunno. I actually decided to start accumulating shares at the ridiculously slow rate of 1000/wk. One would think that with their pipeline and all the analyst coverage there would be more interest.
[Edit]
PS: Despite being a published virologist this marks my first entry into a company focusing on antivirals. So I'm fairly impressed.
VRUS
Remarkable: three initiations at buy from major analysts. Volume: 11,000 so far today.
Dew,
As you know, small modifications can markedly alter the therapeutic and toxicity patterns of various chemotherapeutics. Just taking a gander at the structures says little about how similar these two agents are. Particularly because that's a fluorine--the most electronegative element--on clevudine.
Hi ghmm,
I am not in ALTU right now as I sold shortly after I purchased it because I felt that AIS at $1.15 had more near-term upside potential, so I ended up buying a lot more.
I agree that ALTU is a very promising company. It remains a little expensive (market cap $405M), but they do have plenty of cash in the bank and, as you noted, upcoming milestones and a great partner in Genentech.
I would love to see the traditional summer slump knock this down to <$10, then I might reconsider.
I'm relying on JAV, AIS, and RPRX to take me through the summer, but I have been looking at KOOL (they have several major milestones coming up) as a short-term investment and VRUS, although I think there's no harm in waiting until Q4 for this one.
DNDN
Offers $70 million in notes and the thing is up?
>I received a return email questioning the authenticity of the JAV reports because I said they came from an “anonymous” donor.<
A little paranoia is good in investing, but this is taking it a little to far
CRME
Cardiome To Hold Conference Call
http://biz.yahoo.com/prnews/070601/to464.html?.v=21
VANCOUVER, June 1 /PRNewswire-FirstCall/ - Cardiome Pharma Corp. (NASDAQ: CRME / TSX: COM) today announced that a teleconference call and webcast will be held on Monday, June 4, 2007 at 9:00am EDT (6:00am PDT) to discuss results from the ACT 2 Phase 3 study for vernakalant (iv). A press release will be issued prior to the call.
The conference call will be hosted by Bob Rieder, Chief Executive Officer, Doug Janzen, President and Chief Business Officer and Dr. Charles Fisher, Executive Vice President and Chief Medical Officer.
To access the conference call, please dial 416-340-8010 or 866-540-8136. There will be a separate dial-in line for analysts on which we will respond to questions at the end of the call. The webcast can be accessed through Cardiome's website at www.cardiome.com.
Webcast and telephone replays of the conference call will be available approximately two hours after the completion of the call through July 4, 2007. Please dial 416-695-5800 or 800-408-3053 and enter code 3225539 followed by the number sign to access the replay.
About Cardiome Pharma Corp.
Cardiome Pharma Corp. is a product-focused cardiovascular drug development company with two late-stage clinical drug programs focused on atrial arrhythmia (intravenous and oral dosing), a Phase 1 program for GED-aPC, an engineered analog of recombinant human activated Protein C, and a pre-clinical program directed at improving cardiovascular function.
Vernakalant (iv) is the intravenous formulation of an investigational drug being evaluated for the acute conversion of atrial fibrillation (AF). Positive top-line results from two pivotal Phase 3 trials for vernakalant (iv), called ACT 1 and ACT 3, were released in December 2004 and September 2005. An additional Phase 3 study evaluating patients with post-operative atrial arrhythmia, called ACT 2, and an open-label safety study evaluating recent-onset AF patients, called ACT 4, are ongoing. Cardiome's co-development partner Astellas Pharma US, Inc. submitted a New Drug Application for vernakalant (iv) in December 2006.
Vernakalant (oral) is being investigated as a chronic-use oral drug for the maintenance of normal heart rhythm following termination of AF. Cardiome announced positive results from a Phase 2a pilot study for vernakalant (oral) in September 2006. A Phase 2b study for vernakalant (oral) is ongoing.
In April 2007 Cardiome acquired exclusive worldwide rights for GED-aPC for all indications. Cardiome intends to initially develop GED-aPC in cardiogenic shock, a life-threatening form of acute circulatory failure due to cardiac dysfunction, which is a leading cause of death for patients hospitalized following a heart attack.
Cardiome is traded on the Toronto Stock Exchange (COM) and the NASDAQ National Market (CRME).
VRUS
There *is* something wrong with BofA webcasts. The audio for the VRUS webcast cut out intermittently. Also had a problem with another webcast earlier this week. I know little about computers, but somehow they "reset my proxy server." Whatever that means.
CGRB.OB
Interesting company here: CB7630 appears to have significant anti-tumor activity in chemotherapy-naive patients with castration-refractory prostate cancer despite hormonal therapy.
The only thing is that--since Yahoo doesn't provide market caps for bulletin board stocks--I calculated that this thing has a market cap of at least $440 million. Or am I miscalculating? Seems a little rich for a company with one drug in phase II and a couple in phase I.
Whole-person electroporation, of course. Haven't you read the Mars series by Kim Stanley Robinson?
Is that a rhetorical question? I'd imagine that you'd increase the risk of secondary hemorrhagic stroke significantly.
SGMO
Just as a guess--I'm no longer an expert in DNA binding proteins--but most naturally occurring zinc-finger motifs are nonspecific because they have only a limited number of fingers and thus recognize only a limited number of base pairs. I'd assume that SGMO's engineered products will contain more fingers and thus have greater specificity.
Just a half-ass guess.
JAV