[stockgirl88]

3 pipeline drugs all in Phase 3 of development, one of which rivals morphine (so far shown to be safer and higher efficacy (in smaller doses))! Only thing that may put investors off is it is a nasal spray (which SOME other companies who have developed nasal spray drugs have had caused loss of sense of smell etc).

Amazing pipeline with high safety profile if you guys have a chance to research or read through.

Currently having cash issues but I believe they are well financed through 2009/Q1 2010, in which time they will be expecting news on their drugs or filing for FDA approval before the end of this year.

One drug; Ereska will soon report Phase 3 results (they say mid-2009 but its already way passed that).

It has gone higher on bigger volume the last week or so but I think it is just rising in anticipation of the above mentioned news.

More Info can be found here:
Javelin Pharmaceuticals

[FavStocks]

here is a chart

[chitonic]

Of recent, the only company that I can think of, that is receiving consumer complaints about its nasal spray is MTXX, maker of Zicam. The nasal spray contains zinc, which may cause loss of smell, thus the FDA order to pull the drug. There are many blockbuster nasal sprays on the market, for example Flonase and Nasonex. I don't necessarily foresee a Zicam-like issue plaguing JAV's drug as long as it doesn't contain zinc or any other agent proven to ruin one's sense of smell. If JAV can prove the efficacy of its nasal spray, I doubt the FDA will reject it. Just my $0.02.

[stockgirl88]

The only thing I can't fully understand is the lack of volume.

JAV are a specialty pharmaceutical company that addresses acute moderate-to-severe pain medication market segment.

Javelin has three late stage product candidates in development: Dyloject (injectable diclofenac), Ereska (intranasal ketamine) and Rylomine (intranasal morphine) with two possible NDA filings by the end of this year.

1) Ereska is a non-opiate pain drug being developed by JAV for the acute treatment of moderate to severe pain in military, trauma, post-operative, and emergency room settings with the potential for treating breakthrough pain from cancer as well.

The US Department of Defense has contributed $4MM to the development of Ereska because they have a need for a fast acting non-sedative remedy for combat related injuries. Because Ereska is non-sedating, a wounded soldier could alleviate the pain of a combat related injury and still be able to fly a helicopter or operate a weapon. Hope to release primary endpoint data from the Ereska Phase 3 pivotal trial in mid-2009 (late July- early August). NDA filing for Ereska is possible by late 2009.

2) Dyloject: (for post-operative pain) an injectable form of Dyclofenac which is a non steroidal anti inflammatory drug (NSAID) . Dyclofenac is often given in a pill form and commonly in Europe post operatively as an IV infusion, marketed as Voltaren. Dyloject has a substantial cost advantage to Voltaren in that it is given as an injection rather than an IV drip.

In 2007, JAV received marketing authorization approval in the U.K. for Dyloject. Product revenues related to sales of Dyloject in the U.K. were recorded in 2008 before they licensed their U.K. and EU rights to Therabel. The agreement with Therabel provided for $7.0 million in an upfront payment, which they received in February 2009, plus royalties on future sales and the potential for up to $59.5 million in potential future sales and regulatory milestone payments.

In December 2008, JAV released top-line results from its second of two Dyloject pivotal Phase 3 clinical trials, which demonstrated effectiveness across all five primary study endpoints. They hope to file a NDA for FDA approval in the fall of 2009.

3) Rylomine (intranasal morphine). Phase 3 trials – One completed with a second pivotal Phase 3 clinical trial remaining although progress has stalled due to cost restraints.

Potential revenue streams for Dyloject and Ereska ia $800MM in sales potential which could reasonably be achieved in 3 years following US approval of both drugs according to Highland Portfolio Management.

BUT they have enough cash to see it through to only the end of the year. JAV will need additional financing to support their operating plan thereafter or we will need to modify thier operating plans accordingly. There are rumours of a potential buyout.

I’m in with an initial 1000@ 1.25 but am looking at adding to my position once I can free up some funds. Currently trading at 1.27. I’m holding looking for potential spikes following Ereska Phase 3 results coming up this month and the run-up to two possible NDA filings this year.

Fair Value - $3.29 (ValuEngine Research Report)

[ctmoney]

Great info stockgirl! It's been raising gradually in July. Any reason you think why now without current news?

[flagsaxman]

Anyone here in JAV? They should be hearing soon about Ereska's top line results. I think this one should be really good and move the stock at least $1.50 or so.

>>
"The company’s first compound is called Dyloject, an injectable form of Dyclofenac which is a non steroidal anti inflammatory drug (NSAID) , that has shown spectacular results in 2 phase 3 trials and recently demonstrated excellent results in an open label safety study that the company intends to file in support of their NDA. Dyclofenac as anyone with a back problem might know, is often given in a pill form and commonly in Europe post operatively as an IV infusion, marketed as Voltaren. Dyloject has recently been approved for post operative use in the UK for moderate to severe pain and is now a competitive alternative to Voltaren. Dyloject has a substantial cost advantage to Voltaren in that it is given as an injection rather than an IV drip. It is estimated to cost about $150 per patient to treat post operative pain with IV administration. This more than makes up for the cost of the Dyloject and doesn’t even consider complications relating to hospital borne IV infections. Javelin will file the US Dyloject NDA by the end of the year.


The second compound that will be reporting top line phase 3 data very shortly (within a week or so) is called Ereska, an intranasal formulation of Ketamine. Ketamine is officially classified as an NMDA receptor agonist. NMDA receptors are found in the central nervous system and are involved in the perception of pain. Blocking these receptors creates an analgesic effect. The drug has been used for over 30 years (in human and veterinary medicine) as an anesthetic in higher doses which can create a dissociative anesthetic effect. At higher doses it can also cause hallucinations, which makes it a favorite of street vendors where it is known as Special K. Javelin’s intranasal formulation of Ereska makes it difficult, if not impossible to abuse because the mucosal membrane can only absorb a limited amount of the drug and not enough to give it much if any street value.
"

[omarmithu]

Anybody has any idea why JAV is price is falling and when the phase 3 result is coming?

[aandrewcc]

i believe that it will go to $3-4 in a week or so easily.

Pain for Pleasure - Javelin Pharmaceuticals (AMEX:JAV) |

[stockgirl88]

hi guys!
not sure why the stock is falling, but it has risen quite a bit in the last week or two, so this just may be a correction.

Please take this information with a grain of salt, but looking at the daily and due to the OBV, this stock looks to hold well at the 1.70-1.75 mark. personally since I am holding long buying anywhere in the 1.70-1.85 range feels very safe to me (assuming there is no terrible news). I'm not sure why it is they are taking so long with the Phase 3 news on ereska. The delay is a little concerning but it may just be paperwork errors and not fatal results in the trials. We'll see I guess!
Good luck all!

Disclosure: bought at 1.60, added at 1.70, sold all at 2.12 and rebought recently at 1.85 (missed the 1.70 mark unfortunately)

[Stox Face]

Thanks stockgirl