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JAV
The FDA won't be approving Dyloject any time soon. I think you are thinking of European approval, which should be coming any time now.
JAV
Javelin Pharmaceuticals Initiated At Overweight At JP Morgan
JAV and RPRX
You guys are pounding the table for my two favorite stocks, which is nice, but just as a suggestion instead of saying "a ton of news coming out soon" you might consider listing the information or writing an RMF.
A few months ago I started writing an RMF for JAV. Here's what I had at the time, feel free to cut and paste and then add to it. I don't have time to write a full RMF right now.
JAV RMF
Company
JAV is a specialty pharmaceutical company that applies technologies to develop new drugs and improved formulations of existing drugs that target medical need in the pain management market. By developing new formulations of existing pain drugs, JAV owns a portfolio of improved, late-stage, and low-risk acute pain medications.
The Company's product candidates are focused on treating a variety of pain disorders ranging from acute and episodic moderate-to-severe pain associated with cancer pain, post-operative pain, post-trauma pain, such as orthopedic injury pain, procedural pain and burn pain.
Javelin has three late stage product candidates in clinical development:
*Dyloject (diclofenac sodium injectable)
*Rylomine (intranasal morphine)
*PMI-150 (intranasal ketamine).
From a brokerage report:
In our view, Javelin has a number of characteristics making it an attractive, low-risk investment proposition including: 1) three products in late-stage clinical development that address major existing medical needs in the management of pain, 2) products that are differentiating, new formulations of well-known chemical entities with very well established efficacy and safety profiles, 3) available positive Phase II safety and efficacy data already available for all three products currently in development, 4) pivotal trials in acute pain indications that are easy to test, thereby lowering development risk, and 5) an impressive management team led by Dr. Carr, the Company’s Chief Executive and Chief Medical Officer, a thought leader in pain and analgesia.
Near-term catalysts
Products
Dyloject (diclofenac sodium injectable)
Ryloject (intranasal morphine)
PMI-150 (intranasal ketamine)
JAV
Nothing particularly new. A couple of key points:
1) Expecting to get approval for Dyloject in Europe "this summer."
2) Expect sales in Europe for Dyloject to be approximately $75 million at 1 year
3) Re-emphasized fact that the ketamine product will not require phase III studies for approval, only a few phase I PK studies
4) Timelines for all products remain on track (except for the ketamine product, which will be coming *much* sooner than originally anticipated.
5) Outlined plans for expanding the labels for the ketamine and morphine products
6) Did some bragging about their staff, which is really quite good. Their executive VP for "risk management" was the head of the FDA division through which all of JAV's products will be approved.
7) In the absence of revenue, they have enough cash for the next 14 to 18 months.
8) Noted that all products remained unpartnered, which sort of sounded like a plea for partners, but my understanding has always been that they're going to go it alone, because selling these products requires only a tiny sales force and not much marketing dollar.
JAV
If anyone wants to listen
Javelin Pharmaceuticals to Present at the Citigroup 2007 Healthcare Conference
BusinessWire - May 24, 2007 8:45 AM ET
Javelin Pharmaceuticals, Inc. (AMEX: JAV), a leading developer of novel products for pain control, today announced that Daniel B. Carr, MD, CEO & CMO and Stephen J. Tulipano, CPA, CFO , will make an investor presentation at the 2007 Citigroup Healthcare Conference. Their presentation will take place on Thursday, May 24, 2007 at 11:00am in the Regent Parlor at the Hilton New York -- 1335 Avenue of the Americas, New York, NY.
The presentation will be webcast live. The replay will become available one hour after the conclusion of the live event. Both the live webcast and the replay can be accessed by pasting the following link into your web browser: http://www.veracast.com/webcasts/citigroup/healthcare07/43307424.cfm . The event will be archived and remain available for replay for 30 days.
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 the website at www.javelinpharmaceuticals.com.
ADLS
Dew,
I agree with the FDA's stance on antibiotic trials. However, it wasn't clear when ADLS's trials were initiated and now they're going to be penalized for it.
I think he means that Novo Nordisk was spreading disinformation on the Byetta LAR horse needle.
Eats shoots, and leaves.
ADLS
I don't know what the market size is, but I am guessing that cethromycin will not be approved. Not because it's a bad drug, but because they conducted non-inferiority trials and the FDA has since changed its mind about the value of these types of trials.
Not fair, I know, but I'm staying away.
PS: Anthrax tests are generally conducted on Republican volunteers.
I don't consider yet another testosterone gel to be a competitive threat. What's their marketing spin? "Shrinks testicles even faster?"
Seriously, though, the ease with which Testim could achieve hyperphysiologic testosterone levels is *not* a good thing. All of the problems associated with testosterone gels are exacerbated by a more effective product.
The key--at least from my perspective--is to achieve physiologic concentrations similar to that in a normal male, without the risks to both the patient and partners that are associated with a topical agent.
The N value is the number of patients enrolled in a trial. Capital "N" generally refers to the total number of patients in the trial, lowercase "n" refers to patients in a particular group.
For example, a trial may enroll a total of 1000 patients (N=1000); if patients are randomized in a 50:50 ratio to, say, sertraline or citalopram, the n values would be n=500 for each group.
P values indicate the level of statistical significance. The smaller the value of P, the less likely it is that the results are a matter of chance, and the greater the level of significance. A P value of .05 (that is, 1 in 20) or smaller is widely accepted as an indication that the results are statistically significant. If the P value is .01 or .001, the results are considered even more significant because there is even less likelihodd that the results are attributable to chance.
Okay?
>With almost any type of partnership deal, the stock should move higher than the current $7.00.<
Oh yes, big pharma is going to pay up for a drug that may or may not ever reach market--and even if it does, it's years in the future and has only marginal efficacy. Plus selling Provenge would require a huge investment in infrastructure and training with no clear benefit.
Anyone who thinks DNDN is getting a partner any time soon is crazy. There are dozens of better opportunities out there. Of course, big pharma has been known to do some really stupid things.
JAV
I've been on vacation, so I missed this until today. For the record. Not that anyone cares except me
Pacific Growth Equities also just initiated coverage on JAV with a buy. No idea regarding the target--can anyone help?
Javelin Is Right on Target
http://www.fool.com/investing/high-growth/2007/05/17/javelin-is-right-on-target.aspx
Mike Havrilla
May 17, 2007
With shares of Javelin Pharmaceuticals (AMEX: JAV) trading at their highest since the IPO in 2005, and a plethora of key events coming up, its recent stock offering of 7.1 million shares at $6 apiece seems to be very timely.
The company expects to receive approval to market Dyloject, an injectable form of diclofenac for pain and inflammation, in Europe soon. It has completed enrollment for the first of two planned pivotal phase 3 clinical trials in the U.S. for Rylomine, an intranasal form of morphine for pain, and the company expects to announce preliminary results by the end of June. It's enrolling patients for the first of two phase 3 trials of Dyloject in the U.S., with preliminary results expected during the third quarter. It will start the second trial in the second half of the year.
Dyloject should not have any problems making it to the market in both Europe and the U.S. because it's a reformulation of a drug that can be injected either into the veins or the muscles. Clinical trial results back this, as the drug has proven to be both effective and safe and works quickly.
Rylomine provides an alternative way to administer morphine that starts to work quicker than when it's taken orally and has effects similar to when it's given intravenously -- without the hassle of needles.
Javelin is also developing an intranasal formulation of ketamine (PMI-150) that's designed to provide fast-acting, non-invasive, and non-sedating pain relief. Company officials had a successful meeting with the FDA in January, four additional trials are planned, and a New Drug Application will be submitted next year.
As Javelin get closer to the likely commercialization of Dyloject in Europe later this year, it's right on target for bringing its other two candidates to the market. As the company, which reported a loss of $5.9 million, no revenue, and $15.3 million in cash and investments for the first quarter, looks to become profitable, its low-risk approach of reformulating existing drugs to fill unmet medical needs makes the stock worthy of consideration.
DNDN
Quiz: Does anyone know what piano piece is playing right now? (4:43).
DNDN
This is the longest I've ever waited to get on a call.
>Let's see here, Solvay owns a small testosterone topical drug called androgel and they leave behind an endometriosis drug before seeing results of the trials. Does anyone else know a company with a testosterone drug (in PII) and an endomtriosis drug (in PII)??. Maybe Solvay has just become the number one suitor for little old Repros therapeutics!!!<
This is extremely logical. LHRH's are dead for endometriosis and uterine fibroids if Proellex makes it to market. And Androgel is dead if Androxal makes it to market.
DNDN
>As a matter of disclosure, I now own some DNDN puts as of yesterday.<
Me too. Aug $5.00.
I find it difficult to believe that DNDN has any support at all down to $3-$4. Who are the ijits buying right now?
Very nice post.
RPRX
Although I haven't had enough time to say anything intelligent recently and haven't succumbed to the temptation to post no-value-added comments, I have to say I agree with Spartex completely. I have some cash free and have been hunting for new prospects, but--at least in my opinion--there is no better value than RPRX anywhere in the sector.
>I am more confident that Proellex is worth big bucks.<
Agree. I don't even think about Androxal when valuing the company. I consider it a bonus.
If anyone has any questions about the value of various Wall Street firm's opinions, this link at Motley Fool compares their calls with "CAPS" player calls.
Interesting that the Punk and R&R rate in the bottom 20% of "players."
http://caps.fool.com/Stats.aspx?sortcol=5&sortdir=0&filter=27<=player
Take that post with a grain of salt...as far as I know, this guy is an AVNR cultist.
Truth be told, 1) AVNR's management, past and present, is incompetent (first-hand experience); 2) AVNR also has pretensions of becoming an integrated biopharmaceutical company, so there's little if any chance it will be sold (nor would any big pharma want them or their pipeline); 3) AVNR's products are extremely high-risk and I find it highly unlikely that Zenvia is going anywhere.
AVNR has a *long* history of mismanagement and outright failure.
Also the fact that he says "RPRX came into existence in May '06" indicates that he has no clue whatsoever.
Constructive criticism is great...but this poster's comments are completely useless.
YMI
Surprised nobody posted this yet.
YM BioSciences Reports AeroLEF(TM) Randomized Phase IIb Trial Meets Primary Endpoint in Patients with Post-Surgical Pain
Wednesday May 2, 6:24 pm ET
MISSISSAUGA, ON, May 2 /PRNewswire-FirstCall/ - YM BioSciences Inc. (AMEX:YMI, TSX:YM, AIM:YMBA), an oncology company that identifies, develops and commercializes differentiated products for patients worldwide, today announced top-line results from its randomized, placebo-controlled Phase IIb trial of AeroLEF(TM) in opioid naive patients with post-operative pain following orthopedic surgery. AeroLEF(TM) met the primary endpoint of the study, showing a statistically significant difference in SPRID4 from placebo (p=0.0194).
AeroLEF(TM) is a unique, inhaled-delivery composition of free and liposome-encapsulated fentanyl in development for the treatment of moderate to severe pain, including cancer pain. Unlike fixed dose approaches to opioid delivery, where a significant titration period is often required to determine the suitable dose for the patient, AeroLEF(TM) is being developed as a non-invasive patient self-titrated delivery system designed to enable patients to identify and select a personalized dose for each pain episode, achieving both rapid onset and extended duration of analgesia.
The trial evaluated the SPRID4 for AeroLEF(TM) compared with placebo for the treatment of the first pain episode. SPRID4 is a summary of the combined changes in pain relief and in pain intensity that patients report over the first 4 hours following initiation of dosing. The trial also examined a number of secondary endpoints including various measurements of pain relief, pain intensity, as well as onset and duration of analgesia, that are commonly used as indicators of efficacy for acute pain products. Various safety measurements were also examined.
"These results continue to demonstrate the unique potential for AeroLEF(TM) to be further developed into a valuable product for pain management across a broad range of indications, which could include post-operative pain, medical emergency pain and breakthrough pain," said David Allan, Chairman and CEO of YM BioSciences. "We look forward to completing a detailed analysis of the numerous secondary endpoints and safety data from this study to extend the information we will make available. These results will also be used to enhance the design of the additional Phase II trial that we are planning for the U.S. as well as the eventual Phase III trial."
Clinical Trial Design
The Phase IIb clinical study (DLXLEF-AP4) was a 2-part, multi-center study to evaluate the efficacy, safety and tolerability of repeated, self-titrated inhalation of AeroLEF(TM) for the treatment of acute post-operative pain following orthopedic surgery. Part 1 of the study was a 21 patient open-label, lead-in study to ensure consistency of AeroLEF(TM) administration across study sites. Results of Part I of the Phase IIb study were presented at the 2006 American Society of Anesthesiologists (ASA) Annual Meeting in Chicago, IL.
Part 2 was a 99 patient randomized, placebo-controlled study. The treatment phase of the study began in the post-anesthetic care unit (PACU) after completion of surgery when the patient reported a pain intensity score (PI) of at least 2 (moderate pain) on a 4-point verbal rating scale (0 (none) to 3 (severe pain)). The clinical trial study period was up to 12 hours and patients were allowed to self-administer AeroLEF(TM) to treat up to two additional pain episodes during the study period.
About YM BioSciences
YM BioSciences Inc. is an oncology company that identifies, develops and commercializes differentiated products for patients worldwide. The Company has two late-stage products: nimotuzumab, a humanized monoclonal antibody that targets the epidermal growth factor receptor (EGFR) and is approved in several countries for treatment of various types of head and neck cancer; and AeroLEF(TM), a unique, inhaled-delivery composition of free and liposome-encapsulated fentanyl in development for the treatment of moderate to severe pain, including cancer pain.
This press release may contain forward-looking statements, which reflect the Company's current expectation regarding future events. These forward-looking statements involve risks and uncertainties that may cause actual results, events or developments to be materially different from any future results, events or developments expressed or implied by such forward-looking statements. Such factors include, but are not limited to, changing market conditions, the successful and timely completion of clinical studies, the establishment of corporate alliances, the impact of competitive products and pricing, new product development, uncertainties related to the regulatory approval process and other risks detailed from time to time in the Company's ongoing quarterly and annual reporting. Certain of the assumptions made in preparing forward-looking statements include but are not limited to the following: that nimotuzumab will continue to demonstrate a competitive safety profile in ongoing and future clinical trials; and that YM and its various partners will complete their respective clinical trials within the timelines communicated in this release. We undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
>Minimally cross-linked<
That's putting lipstick on a pig. Uncrosslinked HA is rapidly absorbed by the body.
Denosumab
Reclast is a bisphosphonate, and as such it is associated with the limitations of these agents. Most prominently, bisphosphonates have an incredibly long residence time in bone, even after discontinuation of therapy.
While this might seem like an advantage, a problem has cropped up with osteonecrosis of the jaw (ONJ). While not a huge problem from an epidemiogic standpoint, people are (rightly) very afraid of it.
Don't know if you've been to the dentist recently (if not, you should go) but most pretreatment forms contain a check box asking whether the patient has taken/is taking a bisphosphonate. Extractions are often delayed because of bisphosphonate use.
Denosumab, on the other hand, doesn't have this problem. As long as it provides at least equivalent efficacy, it will have a huge advantage over bisphosphonates in osteoporosis.
JAV
Up 13% after announcing offering. This should be the last time the company needs to raise cash.
CAMBRIDGE, Mass. (AP) -- Drug developer Javelin Pharmaceuticals Inc. on Wednesday said it plans a public offering of 7.1 million shares of common stock.
The company also gave underwriters an option to buy about 1 million additional shares.
Shares fell 26 cents, or 4.3 percent, to $5.80 in morning trading on the American Stock Exchange.
I think the total market for Proellex, provided all goes well, will be $750 M to $1B. Which of course makes this company an extremely attractive takeover target once the safety results are in.
DM has suggested that the value of RPRX (presumably *right now* is $40). For his reasoning, you'll have to see his update. Personally, I think RPRX is worth $20+ right now. Depending on when RPRX is sold, it could fetch anywhere from $500M to $1.2B. Probably closer to the latter.
Just a guess.
You don't want to be adopted by me...although I have a good job, and a decent-sized portfolio I still live like a grad student.
I added too. I'm up to 50,000 shares. This is so ridiculous: while I think DM's suggestion that RPRX is worth many multiples of what it's trading at right now is a little ridiculous, it should certainly be trading in the $20+ range.
RPRX
Yes, I am. When I want to build a decent-sized position, I tend to accumulate mechanically. In this case, I've been buying 1000-2000 shares/day for a while now.
My average purchase price this time around is about $10.50 (it would be higher, but I still have some of the shares purchased in the sixes from the first round trip).
I'm not done yet. Unless something significant occurs, I'm planning to hold these shares until sale of the company.
I'm still accumulating.
BCRX
I think this represents an interesting opportunity again (I owned it from $6 to $18 during the bird flu scare). Stock price has plummeted because of formulation issues with IV fodosine--apparently the stopper was releasing particulate matter into the vial. Anyone know of any other negatives?
Yes and if you say so.
XNPT
Unfortunately, I only had a few shares left (which were all sold today).
The rise in XNPT may not have been as dramatic as that of DNDN, but it's up from about $14 since I first wrote about it.
DNDN
Just *one* simple request. Could everyone include tickers in their posts? Makes it easier to find later, plus it makes it easier to skip posts about things I really don't care about.
Although I don't care about DNDN at all, this discussion is really quite interesting aside from the sniping.
DORB
I joined the DORB club today after re-reading the most recent publication. I believe the evidence is compelling enough for approval.
>The Dendreon Effect<
I've woken up every morning for years to Bloomberg radio. Today was the first time I heard them giving updates on mid- and small-cap biotech stocks.
>You’re playing word games—such a combination includes a drug whose only purpose is to thwart the side effect of another drug.<
Actually, I'm not. There's a huge difference between 1) administering an NSAID until GI lesions develop and then allowing the lesions to heal through use of a PPI and 2) Coadministering an NSAID and a PPI so that lesions never develop in the first place.
Roger Clemens could have done equally well on a traditional NSAID, provided he didn't start barfin' blood. There's no evidence whatsoever to support improved pain relief with COX-2 selective agents over nonselective agents. The one and only reason to use a COX-2 over plain old ibuprofen is to minimize GI toxicity.
RPRX
Thomas, why don't you update the RPRX RMF? I don't feel proprietary about it at all.
>It’s better to avert a side effect than to treat it.<
Huh?
Coadministration of an NSAID and a PPI from the start should prevent development of GI lesions. It should be standard practice...it's cheap and there are few implications from a side effect standpoint.
Again, a combo PPI and NSAID makes a lot of sense.
CDC says gonorrhea is drug-resistant
Anyone know if any companies are running trials specifically in gonorrhea?
I think it might be time to find that special someone and get married
By DANIEL YEE, Associated Press Writer1 hour, 16 minutes ago
The sexually transmitted disease gonorrhea is now among the "superbugs" resistant to common antibiotics, leading U.S. health officials to recommend wider use of a different class of drugs to avert a public health crisis.
The resistant form accounts for more than one in every four gonorrhea cases among heterosexual men in Philadelphia and nearly that many in San Francisco, according to a survey that led to Thursday's recommendation by the Centers for Disease Control and Prevention.
Gonorrhea, which is believed to infect more than 700,000 people in the United States each year, can leave both men and women infertile and puts people at higher risk of getting the AIDS virus.
Since the early 1990s, a class of drugs known as fluoroquinolones has provided a relatively easy cure. These antibiotics, taken as tablets, include the drug Cipro.
But a growing number of gonorrhea cases is resistant to those drugs, and officials at the CDC for the first time are urging doctors to stop using fluoroquinolones and switch to cephalosporins, a different class of antibiotics, to treat everyone.
Those drugs — which include the generic ceftriaxone or brand name Rocephin, made by Swiss drug maker Roche Holding AG — must be given as a shot and aren't as readily stocked as Cipro on most doctor's shelves.
"Gonorrhea has now joined the list of other superbugs for which treatment options have become dangerously few," said Dr. Henry Masur, president of the Infectious Disease Society of America. "To make a bad problem even worse, we're also seeing a decline in the development of new antibiotics to treat these infections."
The CDC made the new recommendation after discovering that nearly 7 percent of gonorrhea cases among heterosexual men in a survey of 26 U.S. cities last year were drug-resistant. In 2001, only about 0.6 percent of gonorrhea cases among heterosexual men were drug-resistant.
"That leaves us with a single class of highly effective antibiotics," said Dr. John Douglas Jr., director of the CDC's division of STD prevention. Other experts called the situation perilous.
"We are running out of options to treat this disease," added Douglas, who said there are "no new drugs for gonorrhea in the drug development pipeline."
Previously, CDC recommended against fluoroquinolones to treat drug-resistant gonorrhea among men who have sex with men and in certain states, including California and Hawaii where most of these cases were turning up.
Described by Douglas as a "very wily" disease, gonorrhea has worked its way through decades of other treatment regimens, from sulfa drugs used in the 1930s and 1940s, to penicillin, which was used from the 1940s until the mid-1980s.
Gonorrhea, spread through sexual contact, is the second most commonly reported infectious disease in the United States, trailing only chlamydia, which the CDC says affects more than 2.1 million people yearly in the U.S.
The highest rates of infection are among sexually active teens, young adults and African-Americans. Because many people don't have obvious symptoms, they can unknowingly spread it to others. And having it makes people more susceptible to HIV. Gonorrhea's spread is preventable through consistent and proper use of condoms, experts said.
In women, the infection can cause pelvic inflammatory disease. In men, it can cause epididymitis, a painful condition of the testicles that can lead to infertility if untreated, the CDC said.
In the survey of gonorrhea cases among heterosexual men in 26 cities last year, Philadelphia had the highest percentage of drug-resistant cases with almost 27 percent, a dramatic increase from only 1.2 percent in 2004.
San Francisco's drug-resistant cases more than doubled between 2004 and 2006, from 10.3 percent to 22.5 percent. During the same period, Miami's cases spiked from 2.1 percent to 15.3 percent and Atlanta's climbed from 1 percent to 5.7 percent.
____
On the Net:
CDC info: http://www.cdc.gov/mmwr