Javelin Pharmaceuticals (AMEX: JAV) is all about controlling pain. The company now has three products it is planning to introduce in upcoming quarters, and approvals would not only ease patient suffering but give investors relief as well.
 
Based in Cambridge, Mass., Javelin is an emerging specialty pharmaceutical company that searches out unmet and underserved needs in pain management. Incorporated in 2005, Javelin’s three product candidates are designed to better relieve pain with fewer adverse side effects and faster results than other treatments. The company has successfully retained intellectual property rights on these products, extending the term of commercial exclusivity.

Rylomine, or intranasal morphine, is one product in Javelin’s pipeline. It is in Phase III development in the United States for acute moderate-to-severe pain and in Phase II studies in Europe. Rylomine works faster than oral morphine and does not require professional medical assistance, as injected morphine usually does. A second product is PM-150, or intranasal ketamine. A formulation of ketamine, a non-opiate, the product is in Phase III trials in both the United States and Europe.

It’s the third offering—Dyloject—that’s of the moment. Dyloject is a formula for injectable diclofenac and is in a Phase III trial in the United States and awaiting approval in the U.K. Diclofenac, an NSAID, is widely prescribed for post-operative pain. Dyloject is in development in the United States for post-surgical pain; in the U.K., it additionally targets acute pain.

The wait for regulatory approval of the U.K. plant for Dyloject has put investors on edge. Originally hoped for by the end of summer, it is still expected soon: in late September at the UBS Global Life Sciences Conference, Fred Mermelstein, founder and president, said the company expects approval in the near term and plans for a U.K. commercial launch in the fourth quarter. Javelin has been hiring sales people for the rollout, which is expected to extend into the EU in 2008.

Just this month, Patricia Bank, analyst at Pacific Growth Equities, said in a research note that she fully expects the Dyloject manufacturing plant to be approved. “However, after speaking with industry consultants, we are resigned to the possibility that the agency may request additional minor corrective actions,” she said, adding that this would be routine practice.

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