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.
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Fool contributor Mike Havrilla, R.Ph., B.S., Pharm.D., is a Rite Aid pharmacist who lives, writes, works, and enjoys running on the streets and trails in the small Pennsylvania town of Portage. He invites your comments and feedback. Mike does not have a position in any company mentioned in this article. The Fool has a disclosure policy.