Salix Pharmaceuticals (Nasdaq: SLXP) $24.25. Today announced that the Gastrointestinal Drugs Advisory Committee of the FDA has recommended by a vote of 14 to 4 in favor of the approval of XIFAXAN® (rifaximin) Tablets, 550 mg for the maintenance of remission of hepatic encephalopathy (HE).
“We are very pleased with the advisory committee’s support for the approval of XIFAXAN 550 mg tablets. If approved, XIFAXAN 550 mg will be the first new option for the management of hepatic encephalopathy in over 30 years,” stated Bill Forbes, Pharm.D., Senior Vice President Research and Development and Chief Development Officer, Salix. “We believe the availability of XIFAXAN 550 mg has the potential to change the treatment paradigm for HE. Today’s independent recommendation from the outside experts comprising the advisory committee reinforces the Company’s confidence in the potential for XIFAXAN 550 mg to provide a solution for patients suffering from this serious condition.”
The committee reviewed data from the Company’s 299-subject, double-blind, placebo-controlled, multinational, Phase 3 study. This study demonstrated a statistically significant and clinically meaningful reduction in the risk of recurrent overt HE.1 The primary endpoint – the risk of experiencing a breakthrough overt HE episode – was reduced by 58 percent in XIFAXAN 550 mg-treated subjects compared with placebo (p<0.0001). The key secondary endpoint – risk of experiencing HE-related hospitalization – was reduced by 50 percent in XIFAXAN 550 mg-treated subjects compared with placebo (p=0.0129). The committee also reviewed supporting evidence from the Company’s long-term, open-label, Phase 3 study, as well as evidence derived from clinical studies in acute HE, three-month and six-month studies from the published literature and meta-analyses.
What They Do: Salix Pharmaceuticals, Ltd., headquartered in Raleigh, NC, develops and markets prescription pharmaceutical products for the treatment of gastrointestinal diseases. Salix’s strategy is to in-license late-stage or marketed proprietary therapeutic drugs, complete with any required development and regulatory submission of these products, and market them through the Company’s gastroenterology specialty sales and marketing team.
SRS Labs (Nasdaq: SRSL) $7.66 Today announced financial results for the fourth quarter and fiscal year ended December 31, 2009. Revenues in the fourth quarter 2009 increased 43% to $7.0 million from $4.9 million in the same period a year ago. For the full year 2009, revenues increased 36% to a record $25.0 million from $18.3 million in 2008. The increase was primarily attributable to increased revenues in the home entertainment, personal telecommunications and personal computer markets.
Net income in the fourth quarter increased 244% to $473,000 or $0.03 per diluted share, an improvement from a net income of $137,000 or $0.01 per diluted share in the fourth quarter of 2008. For the full year 2009, net income increased 688% to $2.1 million or $0.14 per diluted share, from $271,000 or $0.02 per diluted share in 2008.
What They Do: Founded in 1993, SRS Labs is the industry leader in audio signal processing for consumer electronics. Beginning with the audio technologies originally developed at Hughes Aircraft, SRS Labs holds over 150 worldwide patents and is recognized by the industry as the foremost authority in research and application of audio post processing technologies based on the human auditory principles.
Ultratech, Inc. (Nasdaq: UTEK) $12.98. Today announced that it has received an order from Taiwan's largest light-emitting diode (LED) chip manufacturer for an LED lithography system, which is specifically designed and optimized for high-brightness LED (HBLED) manufacturing. In addition, this customer has provided a conditional commitment to purchase several additional Sapphire 100 systems to meet its ramp requirements over the next few quarters. The Sapphire 100 tool is scheduled to be available for volume shipments in the second half of 2010.
According to a representative of the Taiwan-based company, the Sapphire 100 lithography system provides the high-economic value and advanced technology required for HBLED manufacturing. Upon the successful integration of the first Sapphire 100 into its manufacturing line, the additional systems will be used to support the company's HBLED capacity expansion plans.
What They Do: Ultratech designs, manufactures and markets photolithography and laser processing equipment.
About SmallCapReview
Copyright SmallCapReview. SmallCapReview.com is a leading site for news on small-caps, penny stocks and microcaps. SmallCapReview has built a loyal opt-in following for their investor products by providing a newsletter at no cost, sent to subscribers, highlighting select stocks in play, to register visit http://www.smallcapreview.com/. To follow us on Twitter visit http://twitter.com/SmallCapReview.
