Tag - Endp

Small-cap stocks pulled higher this morning and remained in positive ground after a mixed batch of economic reports buffeted the market. A firm tone in energy stocks, momentum from overseas gains and optimism about upcoming stimulus plans provided a lift. At 10:04 a.m. ET, the Russell 2000 (NYSE:IWM) was up 8.51, or 1.68% at 513.54.

The ISM Non-Manufacturing Survey came in at 40.6, which was better than the forecast of 37.0 and a nice bounce off record lows from the previous reading. Still, this number is low historically and consistent with recession. Although the ISM reading was positive relative to expectations, the same can’t be said for factory orders, which tumbled 4.6%, much worse than the projection for a decline of 2.5%. Completing the early data trifecta, pending home sales were also sour, sinking 4.0% versus the consensus for a decline of 1.0%. Now that this rush of economic data is out of the way, the market should be free to focus on other factors before this afternoon’s 2:00 p.m. ET release of FOMC minutes.

Crude oil prices pulled back above $50 dollars a barrel for the first time in some ...

Hooked on oxycodone, morphine, codeine or tramadol? Acura Pharmaceuticals (Nasdaq:ACUR) is on the way, intent on saving the world from addiction while defeating acute pain.

Acura wants to be the Superman of pain relief, but for now it’s just a Mighty Mouse in the making. As a development stage company, Palatine, Ill.-based Acura addresses what it terms the growing societal problem of prescription drug abuse. Its job is to make products that deter misuse but still ease discomfort. It has no revenue to date — only payments from a license agreement with King Pharmaceuticals (NYSE:KG), which agreed in October 2007 to market certain Acura products should they be approved for sale. 

Acura, actually, is just getting off the ground. Its shares moved onto Nasdaq in February after a reverse stock split, having traded previously on the OTC Bulletin Board. The company hoped to attract analyst coverage after its move to Nasdaq, but no analyst yet follows Acura. There also haven’t been presentations at investor conferences, so visibility into the company is limited.

But one thing is clear: becoming profitable depends on payments from King, and on the successful commercialization by King of future licensees of products using Acura’s Aversion Technology platform. The platform is key: Acura believes it has the power to develop a range of abuse-deterrent pain drugs. King expanded its arrangement in May, paying Acura $3 million for a license on a third Acura drug.

Acura’s agreement with King includes milestone payments for meeting goals of a late stage study on Acurox tablets — the company’s lead drug. An application for Acurox is expected to be submitted to the Food and Drug Administration for approval by the end of 2008. The most recent Acurox payment was $5 million in June.

Acurox is an immediate-release opioid analgesic that discourages misuse, including intravenous injection of dissolved tablets or capsules, nasal snorting of crushed tablets and swallowing pills in excessive numbers.

Mash a tablet and snort the powder, and your nose will burn. Try to separate . . .

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.