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JAV
Yes, you're right.
I'm not in yet, just waiting to see if the downtrend is broken. You'll know it when I buy
JAV
Almost time to be getting back in, for me. It's pretty clear that the intranasal ketamine will be effective for breakthrough pain. Note that cancer breakthrough pain will be a label extension. It is already known that only PK/PD studies will be required for initial approval. These quick studies should be initiating shortly.
Also note that the next PR should be for Dyloject approval in the UK, followed shortly thereafter by approval in Germany through the mutual recognition process.
Javelin Pharmaceuticals Initiates Phase 3 Breakthrough Cancer Pain Trial for Intranasal Ketamine
CAMBRIDGE, Mass., Jul 31, 2007 (BUSINESS WIRE) --
Javelin Pharmaceuticals (AMEX: JAV) today announced dosing of the first patient in a Phase 3 clinical study of PMI-150 (intranasal ketamine) at the Beth Israel Deaconess Medical Center (BIDMC), a teaching hospital of Harvard Medical School. The Principal Investigator is Dr. Zahid Bajwa, Director, Education and clinical pain research, of the BIDMC Comprehensive Cancer Pain Service. The trial is expected to enroll up to 90 patients and is designed to extend published observations by Javelin in a pilot study of PMI-150 in treating breakthrough pain.
"We are excited to dose the first patient in this Phase 3 study evaluating intranasal ketamine for the treatment of breakthrough cancer pain, a widespread problem for which innovative, nonopioid therapies are needed" stated Dr. Bajwa.
The Company has begun to assemble its New Drug Application (NDA) for this same product candidate for an initial indication as an emergency analgesic for military and civilian use, and plans to submit it to the US FDA in 2008. Clinical efficacy trials to support this initial NDA have been completed. A later, supplemental NDA is planned for the indication of breakthrough cancer pain.
About Breakthrough Cancer Pain
According to a leading business intelligence firm, the global breakthrough cancer pain market was valued at $1.2 billion in 2005 and forecast to reach $2.5 billion by 2016. The notable projected increase is attributable to, among other things, unmet clinical need, expanding patient populations and introduction of new products. The Company estimates that about two-thirds of patients with cancer pain experience transient flare-ups of pain - "breakthrough pain" -- characterized by episodes of acute, moderate-to-severe pain that suddenly flare up and overcome a standing, by-the-clock pain management regimen with morphine or other opioids.
About the Trial
Up to 90 patients with breakthrough cancer pain from the United States are planned to be randomized in this multicenter, double-blind, crossover, placebo-controlled study. Cancer patients with daily breakthrough pain episodes are eligible for treatment. The primary measure of efficacy is the sum of the differences from initial pain intensity as measured on a 0-10 scale during the first 60 minutes after dosing, In this blinded randomized, cross-over manner study, patients will receive, 7 active and 3 placebo treatments whose identity will not be known to either them or the investigator.
About Ketamine
Ketamine, a non-opiate, is an N-methyl-D-aspartate (NMDA) receptor antagonist that has been in clinical use for over 30 years. Since its approval by the FDA, ketamine has been safely used as an anesthetic in tens of thousands of patients. NMDA receptors are located in the central nervous system and play a role in the perception of acute and chronic pain. Ketamine, at lower doses than those approved for anesthetic use, has been reported in the medical literature to be an effective analgesic for post operative settings, nerve injury pain, and pain during medical procedures, such as burn dressing changes.
About PMI-150 (Intranasal Ketamine)
The Company is developing PMI-150, a proprietary nasal formulation of ketamine, for several intended indications. One indication, for which clinical efficacy trials have been completed, is as an emergency analgesic intended for military and civilian use. The Company anticipates undertaking additional clinical studies aimed at broadening PMI-150's potential indications. Javelin believes that PMI-150 is optimized for use as a pain medication and may offer a safe, non-opioid alternative for the treatment of moderate-to-severe pain.
Prior randomized, double-blinded, placebo-controlled phase II clinical studies of PMI-150 have demonstrated rapid, statistically significant relief of moderate to severe postoperative and breakthrough pain. Prior study results have been presented at the American Society for Clinical Pharmacology and Therapeutics (Atlanta, 2002), the American Society of Clinical Oncology (Orlando, 2002), and in a plenary session of the Advanced Technology Application for Combat Casualty Care (ATACCC, Orlando, 2003). Following this last presentation, the U.S. Department of Defense awarded the Company approximately $4.3 million in funding extensions to develop PMI-150. This award reflected the need for a fast-acting, noninvasive, and nonsedating alternative to the intravenous and oral medications commonly used for treatment of combat-related injuries.
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-G
>The Talecris sellers are not stupid.<
Agree completely. The sellers aren't stupid--anyone who buys into the IPO is and should have their license to buy stocks revoked by a responsible family member or friend.
Talecris
I wonder who is going to be dumb enough to take this off of Cerberus and Ampersand's hands? This has got to be the world's worst investment.
Talecris backers design a $1 billion IPO
Two big private equity firms appear to be behind the decision to push a $1 billion IPO for Talecris Biotherapeutics. Talecris uses plasma to make new therapies for chronic illness. Cerberus Capital Management and Ampersand Ventures, which arranged the buyout of Talecris from Bayer, seem to be betting on cashing out of the debt-heavy company before the stock market weakens too much.
It remains to be seen if investors are still willing to buy into a company that has been pushed hard by equity groups. Talecris has more than doubled its payroll in the past two years, significantly raising expenses. If the IPO is successful, it would also mark a major coup for the industry, which has seen a string of biotech IPOs pulled recently.
Nerf,
I think all you have to do is provide detailed reasons why you think RPRX is undervalued.
And if you want to get RPRX some more attention, the best thing you could do is update the RMF. I don't have time to do it, but if you do it everyone will have a basis for discussion. I'd be happy to edit it after you're done, if you want.
Dew,
I think you should delete this guy's messages and ban him. He spends all his time spamming Yahoo boards with this crap. He's already done it on Cortex and Dendreon boards here at I-Hub.
No need to let him do it here as well.
The management inspires significant doubt among many investors. For good reason, although I view it as ancient history.
Agree. Objective evidence suggests that *much* more attention is given to so-called women's diseases than men's diseases. Part of this is just a swing of the pendulum: for many years, women's diseases were neglected; now there are numerous (and very noisy) foundations and interest groups to represent women's health, but not very many addressing men's health.
Presumably, the pendulum will swing back at some point and eventually achieve some sort of balance. The current overemphasis on women's health is in many ways justified because of so many years of neglect.
While I think it is incorrect to draw parallels between stocks, I have to say (again) that I've never seen anything like this in any of the stocks I've owned. Five percent declines per day--without any change in the fundamentals, and day after day--argues for something a little strange going on.
It's clear that the decline is primarily the result of shorts piling on to this stock, given the huge increases in the short positions. DrBio suggests that the participants in the offering are shorting and will cover with registered stocks. In any case, it's pretty clear to me that there's a concerted effort on someone's part to drive JAV down the toilet.
Yes. The fact that there were no hyperplasias, EIN, or carcinomas far outweighs novel the novel cytopathology.
Proellex is a drug that affects the endometrium, of course it's going to have a structural effect. The fact that they're seeing poor secretory activity and apoptotic cells argues that this is a phenomenon associated with aging of a tissue that is normally turned over rapidly. I'd suspect that intermittent shedding with a pulsed dose will eliminate this issue.
RPRX
I can't emphasize how huge this is, and as you know I'm not given to exaggeration. At least I hope I'm not
In my opinion, this is all that's needed for RPRX to get bought.
Improves my day after JAV.
Repros Reports That Patients Exposed to Proellex For Up To Six Months Demonstrated A Benign Endometrium Based On Biopsy
THE WOODLANDS, Texas--(BUSINESS WIRE)--Repros Therapeutics Inc. (NasdaqGM:RPRX) today released the endometrial biopsy findings from its three and six month studies of Proellex™ in the treatment of uterine fibroids and endometriosis respectively. The clinical study results of efficacy and top-line safety were reported in April and June 2007 and in both instances unequivocal efficacy was demonstrated in the treatment of both conditions with reduction of pain associated with endometriosis and reduction of bleeding in uterine fibroids.
Endometrial biopsies were done at baseline before treatment and after treatment in two different studies: in 26 women (67% of study participants) with endometriosis exposed to 12.5, 25, or 50 mg Proellex for six months and: in 39 women (31% of the study participants) with uterine fibroids exposed to placebo, 25, or 50 mg Proellex for three months.
Repros had reached agreement with the FDA that the primary endpoint of the endometrial pathology interpretation would utilize the WHO1 endometrial hyperplasia classification with a progressive scale of diagnoses from benign and disordered proliferative endometrium, through four types of endometrial hyperplasia, to carcinoma. A secondary end point was the identification of presence or absence of an endometrial polyp. A prospective protocol was also submitted to the FDA whereby the tissues would be read in parallel with an additional diagnostic schema, the Endometrial Intraepithelial Neoplasia (EIN)2 classification.
A panel of three leading gynecological pathologists was retained to read all of the tissues utilizing both diagnostic schemas. After the blinded pathology reads were completed the panel met to discuss their impressions of the process and any potential administrative, logistic or quality of materials issues. In addition they each gave their overall impressions of the histology before being unblinded. A consensus primary end point result was determined for each specimen by majority (two or more of three pathologists agree), or in the event of all pathologists disagreeing the "worst" diagnosis of the three was assigned. Analysis of the data was performed to show the predominant primary diagnosis. A correlation of the WHO and EIN consensus results was performed.
Histology Results
Prior to unblinding at the pathology panel debriefing meeting on July 21, 2007, blinded data listings were reviewed to decide if there was a need to re-examine any of the materials. This was judged not to be necessary and unblinding proceeded.
The results from both the WHO and EIN interpretations showed a consensus primary diagnosis in all Proellex treated subjects of benign endometrium, without any hyperplasias, EIN, or carcinomas. The correlation of the primary diagnosis of the EIN with the WHO reads at baseline was 1.00 (p < .0001) and at the end of treatment was 0.911 (p < .0001) indicating near perfect agreement of the two instruments. The results were in general no different between the subjects with endometriosis or uterine fibroids or the subjects exposed for three or six months or to different doses.
There was also consensus among the pathology panel on the absence of endometrial polyps in all of the specimens read by the WHO classification.
Additional secondary findings within the “benign” category were noted by the pathologists. Most prominent were the presence of non-uniform cystic dilatation of glands similar to the histological pattern recently described for women treated with other Progesterone Receptor Modulators (PRMs) such as asoprisnil, mifepristone and CBD 2914 (VA2914)3,4,5. The glandular epithelium within these cysts varied in appearance, but contained non-physiologic combinations of poorly developed secretory activity, dying cells (apoptotic bodies) and rare mitoses. Other cystic glands were lined by inactive epithelium. The pathologists described this constellation of cysts and epithelial findings as “novel,” noting that they are sufficiently different from what has been seen in clinical practice that their long term behavior cannot be precisely predicted without performing serial biopsies in future extended studies.
Dr. Andre van As, Chief Medical Officer of Repros commented that “Although these histology results are from a limited group of women with endometriosis and uterine fibroids, they are reflective of up to six months of treatment over a range of three doses. With the end of treatment diagnoses being that of benign endometrium in all of the women biopsied, we feel confident that our recently described treatment paradigm of sequential four month treatment cycles each followed by a drug holiday, in order to refresh the endometrium, may further enhance the safety of Proellex in the long term.”
Joseph Podolski, President and CEO of Repros, added, “Both endometriosis and uterine fibroids represent an un-served need in the arena of woman’s health and these supplementary safety data are very encouraging. No approved drug therapies in this class of compounds (PRMs) are available for these indications, and we strongly believe that Proellex, with the efficacy and safety we reported earlier, together with the results reported here, represents a significant advance to the medical approach of the long-term treatment and management of these difficult to treat conditions.”
Repros intends to continue to perform endometrial biopsies in all of their future studies with Proellex to further extend the understanding and significance of the histological changes observed in longer term exposure to this compound.
I hope you're right. This decline is not justified at all by the fundamentals. JAV should be 7+ right now and 10+ post-approval. Nevertheless, I obey my rules, even when it hurts.
JAV
I think it's a great company with a lot of promise, in the near term. Unfortunately, it hit my (mental) stop-loss today, so I'm out. I always obey my rules. Planning to get back in at some point.
PS: There is no fundamental reason why JAV has declined so far. Shorts have piled into this stock--in fact, the short position has increased over 6-fold over the past month to a little <10% of the float. I wouldn't be surprised to see 20% or more when short positions are next reported.
I have never seen any company--small cap biotech or otherwise--take this much of a hit for absolutely no reason.
It would help if management would put their money where their mouth is and buy more stock.
OT--don't I know it. I own like 10 days volume. Took me forever to accumulate.
Take a look at the change in short position from last month to this month.
I added more today. JAV is only 0.25 cents above where I started buying last fall. Waste of 8 months, unfortunately. Can't win 'em all, at least not immediately.
VRUS has made up for my JAV position, though. NOT that I'm recommending buying it...volume is pathetic and the spread is huge.
Is Oliver Twist an employee of Urchin Capital?
JAV
10 out of 10 investment banks agree: JAV is a buy.
Fortis just initiated coverage with a target of $11. Targets for JAV current range from $11 (Fortis) to $18 (Punk).
Fortis must have a big client that wants out
Correct. Lyrica was in development before the takeover.
What about Chantix?
Could you stop arguing about this? Our friend Jellybean--the same one who argued with me about DNA repair because he went to a lecture once--is sadly mistaken. Can we stop now?
It's not a conspiracy, and it's perfectly legal and fine if you hide size.
Level 2 means nothing any more.
>That is why I wear a lead apron and the patient does not.<
Plus a lead apron on the patient probably wouldn't do much to protect them from radiation, given that they're the ones receiving treatment.
It always makes me laugh how paranoid people are about radiation. The precautions we had to take in my lab for tiny little vials of P-32 and S-35 were amazing compared to the complete lack of precautions mandated for chemical mutagens. Plus all that polio, Coxsackie virus, various pathogenic bacteria and fungi, and other nasty stuff in the unlocked freezers in the hallway. Guarded only by a semi-literate, very sleepy security guard.
Not to mention an occasional unbalanced ultracentrifuge. Now *that* can ruin your day.
But there were no precautions taken, nor was any of this stuff monitored.
There are some serious sharks in JAV. There are tens of thousands of hidden shares for sale just below the bid. In other words the bid/ask means nothing for this stock.
Yes. I now have a lot of shares, at an APP of $5.20.
Very nice post.
This is making me seasick. I was rather hoping for price to remain depressed for a while so I could accumulate more.
Former Bush Surgeon General Says He Was Muzzled
By REUTERS
Filed at 4:25 p.m. ET
WASHINGTON (Reuters) - The first U.S. surgeon general appointed by President George W. Bush accused the administration on Tuesday of political interference and muzzling him on key issues like embryonic stem cell research.
"Anything that doesn't fit into the political appointees' ideological, theological or political agenda is ignored, marginalized or simply buried," Dr. Richard Carmona, who served as the nation's top doctor from 2002 until 2006, told a House of Representatives committee.
"The problem with this approach is that in public health, as in a democracy, there is nothing worse than ignoring science, or marginalizing the voice of science for reasons driven by changing political winds. The job of surgeon general is to be the doctor of the nation, not the doctor of a political party," Carmona added.
Carmona said Bush administration political appointees censored his speeches and kept him from talking out publicly about certain issues, including the science on embryonic stem cell research, contraceptives and his misgivings about the administration's embrace of "abstinence-only" sex education.
Carmona's comments came two days before a Senate committee is due to hold a hearing on Bush's nomination of Dr. James Holsinger as his successor. The administration allowed Carmona to finish his term as surgeon general last year without a replacement in place.
Gay rights activists and several leading Democrats have criticized Holsinger for what they see as "anti-gay" writings, but the White House has defended him as well qualified.
U.S. surgeons general in the past have issued influential reports on subjects including smoking, AIDS and mental health.
"Political interference with the work of the surgeon general appears to have reached a new level in this administration," said Rep. Henry Waxman, a California Democrat who chairs the House Oversight and Government Reform Committee to which Carmona testified.
"The public expects that a surgeon general will be immune from political pressure and be allowed to express his or her professional views based on the best available science," he said.
Carmona said he was politically naive when he took the job, but became astounded at the partisanship and manipulation he witnessed as administration political appointees hemmed him in.
Bush in 2001 allowed federal funding for human embryonic stem cell research, but only with heavy restrictions that many scientists condemn as stifling.
Carmona said the administration prevented him from voicing views on stem cell research. Many scientists see it as a promising avenue for curing many diseases. But because it involves destroying human embryos, opponents call it immoral.
Carmona said he was prevented from talking publicly even about the science underpinning the research to enable the U.S. public to have a better understanding of a complicated issue. He said most of the public debate over the matter has been driven by political, ideological or theological motivations.
"I was blocked at every turn. I was told the decision had already been made -- stand down, don't talk about it," he said.
Carmona testified with two predecessors, Dr. C. Everett Koop, who served under President Ronald Reagan, and Dr. David Satcher, named by Clinton but whose term ended under Bush.
Carmona said some of his predecessors told him, "We have never seen it as partisan, as malicious, as vindictive, as mean-spirited as it is today, and you clearly have worse than anyone's had."
JAV
Yeah, me too, same answer. By the way, you get very prompt responses from RP if you copy the President and VP...otherwise not so quick
I'm still confident this is a $12+ stock, but hate sitting through this crap. Last time I did was for RPRX, which went from $7 to $5.50 before it took off.
JAV
Provided that all of the information about the company is in the public domain this selloff is not rational. I bought more.
These two statements should tell you all you need to know about this company:
>CVBT co-founder Dr. Thomas Stegmann knew he was on the right track when, in 2006, he celebrated a 10-year reunion with patients from his first trial in Germany.<
>They have one Phase I clinical trial.<
JAV
I had a hard time believing my eyes today. Unless material information was released to a major shareholder that I am not aware of, a drop of this magnitude is completely unwarranted. I bought more today, and will continue buying. This company is worth twice what it's going for.
If one of your criteria is wealth generation, working for a single company isn't the way to do it. I guess my question is, why would you want to go back to full-time with a company?
I don't think this is the appropriate place to discuss this; feel free to e-mail me. I do something similar, but on the E Coast.
Yes, I understand Proellex also cures urinary incontinence and genital warts.
MDCO
This could represent a great opportunity. Both cleviprex and cangrelor are in the pipeline and represent relatively low-risk opportunities.
The issue in Europe, as I understand it, isn't the premium price, it's the crappy job Nicomed has done promoting the drug. Given MDCO's expertise in marketing, I'm sure they'll be able to ramp up Angiomax sales in Europe.
Population sizes are mostly driven by the anticipated effect size of the intervention on an outcome. In other words, if an intervention is expected to produce a large effect, the population can be small. Conversely, if the intervention is expected to produce a small effect, the population must be large.
Other factors can also drive enrollment size, for example, cost of the trial, potential incremental revenue derived from positive results, the need for an adequate number of patients for a safety database, and the total size of the population affected with the condition under study (which drives trial size both in terms of the amount of money that will be devoted to the trial and the ease and speed at which patients can be enrolled).
What kind of question is this? There is a big difference between a chronic medication (such as Advil) and an injectable used for the transient management of post-operative pain.
Old but grammatically funny
Why does this guy waste his time? More importantly, why does he waste mine?
http://biohealthinvestor.com/2007/06/sanofi-should-blame-itself-for-fda.html
Rimonabant/Acomplia by Sanofi-Aventis (SNY) was touted as a blockbuster drug in the obviously lucrative market sector of obesity. Diet and exercise have generally been shown to fail and dieting may actually make obesity more difficult to reverse. While bariatric (obesity) surgeries are the fastest growing operations in America, they have generally been reserved for the most overweight, the morbidly obese or those likely to die of obesity. Somewhere in the neighborhood of 30% of the U.S. population could qualify for a long-term pharmacological treatment.
The recent history of pharmacological treatments have not gone well. The pharmaceutical treatments do cause significant weight gain but side effects have been the rule rather than the exception. First there was Phen-Fen. While effective cardiologists at Mayo clinic observed and reported that it caused heart valve changes . This report ultimately led to Fen's (fenfluarmine; dexfenfluramine—Wyeth) withdrawal from the market and ensuing litigation. Xenical (Orlistat; Roche) came next and was touted by the Company as a $>1b blockbuster. The company, apparently unhappy with the pace of sales to patients being seen by obesity experts, went directly to the patient with ads. Unfortunately for them, the side effects were branded in the American publics consciousness and prescription rates were disappointing. As a pancreatic lipase inhibitor, it blocks the absorption of dietary fat in the gut. Simply stated, the pizza you ate for lunch goes in the mouth and out of the body as a fatty stool or diarrhea. Gas and stool leakage strategies exist but most patients are immediately disinterested when such a discussion starts with their physician. If overeating of good or great food is an addiction then addiction-like treatments may be the wave of the future.
Acomplia is a novel treatment that blocks the brain's marijuana or THC receptors. It blocks the MJ munchies and slowly appears to interfere with some of the hedonic or rewarding aspects of eating. Unfortunately, the brain's own marijuana system is extensive and important. All of its functions are not known but it appears important to memory formation, mood, eating, pain to name a few obvious candidates. So, it is was not surprising for researchers to discover that a number of patients treated for obesity developed depression out of the blue.
THe FDA's open hearings yesteday on this drug demonstrated a number of things. First, Sanofi-Aventis had done a very poor job in managing the clinical trials of this blockbuster drug. Sanofi did a fine job at promoting the discovery and getting enough market cap to buy Aventis. With the study details, data and the FDA they were a complete bust. They attempted to use the metabolic effects of the medication in reversing diabetes – like blood markers and risks and avoid the psychiatric effects. However, the metabolic experts on the FDA panel were not impressed with the typical weight loss and predicted that millions of patients would be stuck on the medication for years. They feared suicides and depressions without a major weight loss benefit. Second, Sanofi-Aventis did a very poor job at mobilizing the advocacy community and had few speakers in their corner. Last, when they suggested that they could reduce the psychiatric risks with a plan that they described, it appeared that it was way too little too late. The FDA usually follows the Advisory Panel and no one gave them any reason to do anything but Just Say No. So, this will become another example of a medication approved in Europe and Mexico, but not America. This drug may have a use in some patients with tobacco or marijuana or other addictions but you have to wonder who is managing this group and potential $1b drug market for Sanofi? This Big Pharma has lost its way and lucky to have taken over Aventis scientists, Psychiatrists, and pipeline.
The day after the announcement of the unanimously negative vote of the advisory panel for approval of its weight-loss drug Acomplia, Sanofi-Aventis (SNY) was trading down nearly 8% and downgraded to neutral at both Merrill Lynch and J.P. Morgan.
I would characterize myself as a fiscal conservative and a social liberal. In short, no good party for me, since neither is fiscally conservative and only democrats are socially liberal. Hoping for Bloomberg.
JAV
I haven't seen studies for interactions among intranasal drugs; however, if you look at the Exubera label you'll see that they did extensive studies to examine not only interactions between inhaled drugs, but also the effect of intercurrent respiratory illnesses.
It only makes sense that drugs that affect the nasal mucosa, such as topical nasal decongestants, would affect the absorption of an intranasal drug. And speaking as someone who is getting over a cold, I'd expect that the abundant mucus I produced would also interfere with absorption.
These are relatively minor issues, though.
JAV
I obviously agree since I'm still invested in the stock. There is no reason whatsoever that JAV should be sitting at 6 and change right now.
Although things can still go wrong, the interesting thing about JAV is that in the intranasal ketamine they already have a product that is--for all intents and purposes--approved. At least if you take Carr's statement at face value that the PK studies are just for labeling. What I don't understand is why they can't accelerate the schedule for the PK studies and the eventual filing. It's not like they need to enroll a thousand patients--50 volunteers are all that's necessary.
Dyloject alone is enough to support a market cap 2-3 times current value. Plus I think it will have no problem being approved in the Europe or the US, because 1) ketorolac is black-boxed because of GI bleeding issues; 2) the European competitor is infused; 3) In the US, at least, management should have tremendous pull with the FDA.
Not sure what to say about Rylomine yet. I think it has potential but a more complicated path to market than either Dyloject or IN ketamine.
Not that I'm unhappy with JAV's performance since I bought it...but it remains tremendously undervalued.