April 17, 2008
Knobias Clip Report (04-16-2008)
By admin
Submitted By Knobias ClipReport
POZN: Shares Spike on FDA Approval of Treximet
Wednesday’s session saw green spread across the board as upbeat results from Intec Corp, J.P. Morgan Chase, and Coca Cola helped lift sentiment. IBM and eBay reported after the bell which also weren’t as bad as expected. eBay saw a slowdown in its core business but benefited from the weakened dollar, which also put in a record low on Wednesday. The gains may be short-lived if earnings on Thursday do not continue the streak.
Causing more trepidation was economic data in the form of the Beige Book but the market showed little reaction to the release of the data which found the economy weakened further since mid-March. The CPI was even at .3%, matching estimates while Oil also topped $115 a barrel. Even with the downbeat market data, earnings surprises lifted the Dow over 256 points.
Some larger cap names that are expected to report on Thursday include which are of interest include: TD Ameritrade, E Trade, Harley Davidson, Pfizer, and Advanced Micro Devices.
In the small cap space, one name saw an increased amount of attention following some positive news. GlaxoSmithKline (GSK) and POZEN Inc. (POZN) announced that the FDA has approved Treximet(TM) for the acute treatment of migraine attacks with or without aura in adults. Treximet is the first and only migraine product designed to target multiple mechanisms of migraine by combining a triptan, a class of migraine-specific medicines pioneered by GSK, and an anti-inflammatory pain reliever in a single tablet.
Treximet contains 85 mg sumatriptan, formulated with RT Technology(TM), and 500 mg naproxen sodium. Sumatriptan is the active ingredient in Imitrex(R) Tablets, available in 25 mg, 50 mg and 100 mg strengths. In clinical trials, Treximet provided a significantly greater percentage of patients migraine pain relief at two hours compared to sumatriptan 85 mg or naproxen sodium 500 mg alone. In addition, Treximet provided more patients sustained migraine pain relief from two to 24 hours compared to the individual components.
Treximet is well studied, with more than 3,700 migraine sufferers treating nearly 30,000 migraine attacks in clinical studies. The product is expected to be available in U.S. pharmacies by mid-May. The approval of Treximet was based on data from two identical double-blind, randomized, placebo-controlled, parallel-group, multicenter studies of more than 2,900 migraine sufferers.
Findings from these pivotal studies demonstrated that Treximet provided more patients migraine pain relief at two and four hours compared to sumatriptan 85 mg, naproxen sodium 500 mg or placebo alone. Importantly, in these studies Treximet was effective at relieving the pain of a migraine attack and maintaining that relief from two to 24 hours. In addition, Treximet effectively relieved migraine associated symptoms — nausea and sensitivity to light and sound — compared to placebo.
Following the news, shares jumped some 28% on almost 13 million shares traded. With any follow through pending a favorable overall market, the name could be one to watch.
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