Miramar, FLA October 26, 2009 – Toro Research is initiating coverage of Sunwin International Neutraceuticals Inc. (OTCBB: SUWN), a diversified nutraceutical company, with a speculative "Buy" recommendation and a performance rating of 8.5, on a scale of 10.
To view the complete report, please visist:
http://www.tororesearch.com/reports/SUWN/SUWN_102609.pdf
The report states: "The recommendation is based on several considerations, such as the company's past financial performance, which included annual net revenues in upwards of Twenty Million dollars for the fiscal year ended April 30, 2009, as well as a well-established operating history."
"But of particular interest are the recent developments in one of the company's key markets, which included the December 2008 FDA approval of Reb A, an active ingredient found in one of Sunwin International's products, stevia. As an established and leading producer of stevia for years now, Toro Research believes the company is uniquely positioned to meet the surging global demand that is just beginning to scratch the surface of the billion dollar “Artificial Sweetener” industry. Consequently, it is important to note, Sunwin International has recently attained FDA self-affirmed GRAS status, clearing the way for the company’s high grade extracts to be used in food and beverage."
Content Disclaimer:
Readers are urged to carefully read the disclaimer found at the end of the Toro Research report. Toro Research is not a registered securities broker/dealer, investment advisor or financial analyst. The materials contained in the Toro Research report are offered for informational purposes only, and should be viewed as commercial advertisement. The report is not intended to be investment advice. The report may contain inaccuracies and errors. Sunwin International Neutraceuticals does not warrant the accuracy or completeness of the materials or the reliability of any advice, opinion, statement or other information in the Toro Research report. Any reliance on any such opinion, advice, statement, memorandum, or information shall be at your sole risk.
Toro Research has been compensated $3,000 by third party Stock Market Alert LLC., (who is under contract and has been compensated by a third party to perform an investor relations campaign for SUWN) for the creation of this report. All direct and third party compensation received has been disclosed within each individual profile in accordance with section 17(b) of the Securities Act of 1933. Toro research certifies that it currently does not own, nor will it own any securities or securities of the company profiled in this report
This release contains "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E the Securities Exchange Act of 1934, as amended and such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. "Forward-looking statements" describe future expectations, plans, results, or strategies and are generally preceded by words such as "may," "future," "plan" or "planned," "will" or "should," "expected," "anticipates," "draft," "eventually" or "projected." You are cautioned that such statements are subject to a multitude of risks and uncertainties that could cause future circumstances, events, or results to differ materially from those projected in the forward-looking statements, including the risks that actual results may differ materially from those projected in the forward-looking statements as a result of various factors, and other risks identified in a company's annual report on Form 10-K or 10-KSB and other filings made by such company with the Securities and Exchange Commission. You should consider these factors in evaluating the forward-looking statements included herein, and not place undue reliance on such statements. The forward-looking statements in this release are made as of the date hereof and Toro Research undertakes no obligation to update such statements.
Sunday, October 25, 2009
Saturday, October 24, 2009
Orexigen(R) Therapeutics Presents New Data Showing Weight Loss with Contrave Significantly Improves Important Markers of Cardiometabolic Risk
- Up to 48% of Patients Completing One Year of Contrave Therapy Lost at Least 10% of Baseline Body Weight -
- Data Presented at The Obesity Society Annual Scientific Meeting -
SAN DIEGO, Oct. 24 /PRNewswire-FirstCall/ -- Orexigen® ( )Therapeutics, Inc (Nasdaq: OREX) today announced new data from the COR-I, COR-II and COR-Diabetes trials for Contrave® (bupropion SR/ naltrexone SR) to expand on top-line results announced in July. Contrave is the first of the Company's two late stage candidates for the treatment of obesity. These data were presented during a panel discussion at the 27th Annual Scientific Meeting of The Obesity Society.
These new data show that after completing 56 weeks of therapy with Contrave32:
* Approximately 34-48% of patients lost at least 10% of their baseline body weight and approximately 17-23% lost at least 15%;
* Obese patients classified as higher risk for developing cardiovascular disease and diabetes demonstrated significant improvement in markers of cardiometabolic risk such as waist circumference, HDL, and triglycerides;
* Patients with type 2 diabetes taking Contrave who began the trial with a hemoglobin A1c (HbA1c) level greater than 8% saw a mean HbA1c reduction of 1.1%, which was highly statistically significant compared to placebo;
* Patients reported an increased ability to control their eating and resist food cravings; and
* There was no evidence of increased abuse liability.
"These data show that Contrave provides obese patients with meaningful reduction in weight and improvement in important markers of cardiometabolic risk, with even greater improvement seen in patients at higher risk," said Dennis Kim, M.D., Senior Vice President of Medical Affairs. "Results also illustrate the robust glycemic benefit of Contrave in patients who have poorly controlled diabetes, as defined by a hemoglobin A1C level greater than 8.0. These patients experienced a clinically meaningful A1C reduction of 1.1% from baseline."
Additional findings presented today from patients who completed 56-weeks of therapy include:
Efficacy Results
----------------
COR-I COR-II
----- ------
PBO Contrave32 PBO Contrave32
(N=290) (N=296) (N=267) (N=434)
------ ------ ------ ------
Equal or greater
than 5% weight
loss (%) 23.1% 61.8%* 21.7% 75.8%*
Equal or Greater
than 10%
weight loss (%) 10.7% 34.5%* 7.9% 48.2%*
Equal or Greater
than 15%
weight loss (%) 3.1% 17.2%* 3.4% 23.0%*
Markers of Cardiometabolic Risk (mean change)
---------------------------------------------
COR-I COR-II
----- ------
PBO Contrave32 PBO Contrave32
(N=290) (N=296) (N=267) (N=434)
------ ------ ------ ------
Waist
circumference
(cm) -2.7 -6.9* -2.1 -7.1*
Fasting
triglycerides
(mg/dL) -3.8 -19.0* +0.5 -14.8*
Fasting HDL
(mg/dL) -0.1 +3.5* -1.0 +4.2*
Fasting LDL
(mg/dL) -2.8 -4.3 -2.0 -6.3*
hsCRP (mg/L) -0.5 -1.6* 0.0 -0.7*
Markers of Cardiometabolic Risk (mean change among patients with increased
cardiometabolic risk)
--------------------------------------------------------------------------
COR-I COR-II
----- ------
PBO Contrave32 PBO Contrave32
--- ---------- --- ----------
Waist
Circumference -2.8 -7.1* -2.2 -7.3*
(cm) (N=282) (N=279) (N=254) (N=410)
Males >102
cm
Females
>88 cm
Fasting
Triglycerides -32.0 -66.3* -13.9 -51.2*
(mg/dL) (N=82) (N=87) (N=69) (N=135)
>/=150 mg/dL
Fasting HDL +1.3 +5.0* +1.3 +6.2*
(mg/dL) (N=122) (N=121) (N=117) (N=184)
Males <40
Females <50
Fasting LDL
(mg/dL) -22.5 -12.8 -8.0 -27.3
>/=160 mg/dL (N=29) (N=31) (N=26) (N=44)
hsCRP (mg/L) -0.7 -2.9* -1.1 -1.6*
>3 mg/L (N=163) (N=177) (N=144) (N=261)
*p<.05 for difference between Contrave and placebo
"The focus of today's panel discussion on pharmacotherapy among distinguished members of the scientific community serves as further validation that medication may play an important role in the treatment of obesity," said Eduardo Dunayevich, M.D., Chief Medical Officer, Orexigen Therapeutics. "We believe that, if approved, Contrave can benefit a broad range of obese patients. The results of the COR program, coupled with recently disclosed results from our Empatic Phase 2b trial, support our belief that these two product candidates can help fill the current gap in obesity treatment by providing physicians with multiple pharmacologic options to address the varying needs of this diverse patient population."
Contrave Obesity Research (COR) Trial Design and Safety Profile
All Phase 3 trials in the COR program were 56 week, randomized, double-blind, placebo-controlled trials. The co-primary endpoints were the proportion of patients achieving at least 5% weight loss and percent change in body weight compared to placebo. Secondary endpoints included multiple markers of cardiometabolic risk, patient reported food cravings and eating control measures, as well as HbA1c in the COR-Diabetes trial. Patients were randomized to receive either placebo or Contrave, BID, with a four week titration period.
As previously reported, seven serious adverse events were attributed by investigators as possibly related to Contrave treatment across the entire COR program. These include cholecystitis (gallbladder inflammation), seizure, palpitations, paresthesia and vertigo. The most frequently observed treatment-emergent adverse events were nausea, constipation and headache. Nausea was the leading adverse event resulting in discontinuation; however, for the majority of patients experiencing nausea, it was mild to moderate, transient and manageable.
At week 56, mean blood pressure was generally unchanged from baseline for Contrave patients compared to placebo patients, who tended to experience a slight decrease (approximately 2 mm Hg) from baseline. Contrave treatment did not appear to disrupt the normal circadian pattern of blood pressure. There was a slight increase in pulse (approximately 1 beat per minute) in Contrave patients compared to placebo patients, whose pulse was generally unchanged. There were no meaningful treatment effects on ECGs or laboratory measures including liver function tests. Treatment with Contrave was not associated with increases in symptoms of depression or suicidal ideation.
The Company is on track to submit a New Drug Application (NDA) for Contrave with the FDA in the first half of 2010.
Additional Presentations at The Obesity Society
Additional data including Intent-to-Treat (ITT) analyses from COR-I and COR-II will be presented as late-breaker presentations in the Marriott Ballroom Salon 2 on Tuesday, October 27, beginning at 11:00 am EST. In addition, three posters (220-P, 218-P, 216-P) featuring data from the COR-BMOD trial will be presented in the Marriott Exhibit Hall on Sunday, October 25 from 1-2 and 6:30-7:30 pm EST (posters available for viewing from 1-7:30pm).
About Orexigen® Therapeutics
Orexigen Therapeutics, Inc. is a biopharmaceutical company focused on developing therapies that offer multiple approaches to treating obesity. The Company's lead investigational product, Contrave®, has completed the COR clinical development program and is on track for a regulatory submission with the FDA in the first half of 2010. The Company's second obesity drug candidate, Empatic(TM), has completed Phase 2 trials. Each product candidate is designed to act on a specific group of neurons in the central nervous system with the goal of achieving appetite suppression and sustained weight loss, through combination therapeutic approaches. Further information about the Company can be found at http://www.Orexigen.com.
Forward-Looking Statements
Orexigen cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements. Words such as "believes," "anticipates," "plans," "expects," "indicates," "will," "intends," "potential," "suggests," "assuming," "designed" and similar expressions are intended to identify forward-looking statements. These statements are based on the Company's current beliefs and expectations. These forward-looking statements include statements regarding the efficacy and safety of Empatic(TM) and Contrave®, the potential for, and timing of, proceeding to Phase 3 clinical trials for Empatic or filing an NDA for Contrave, the commercial and therapeutic potential of Empatic and Contrave, and the potential to obtain regulatory approval for, and effectively treat obesity with, either product candidate. The inclusion of forward-looking statements should not be regarded as a representation by Orexigen that any of its plans will be achieved. Actual results may differ from those set forth in this release due to the risk and uncertainties inherent in the Orexigen business, including, without limitation: additional analyses of data from the Empatic Phase 2B trial or Contrave Phase 3 trials and any other clinical trials of Empatic or Contrave may produce negative or inconclusive results, or may be inconsistent with previously announced results or previously conducted clinical trials; the FDA may not agree with the Company's interpretation of efficacy and safety results; earlier clinical trials may not be predictive of future results; Empatic or Contrave may not receive regulatory approval on a timely basis or at all, and the FDA may require Orexigen to complete additional clinical, non-clinical or other requirements prior to the submission or the approval of NDAs for either product candidate; the potential for adverse safety findings relating to Empatic or Contrave to delay or prevent regulatory approval or commercialization, or result in product liability claims, including serious adverse events that are not characterized by clinical investigators as possibly related to Empatic or Contrave and adverse events associated with the individual components of these product candidates; the third parties on whom Orexigen relies to assist with the development programs for Empatic or Contrave, including clinical investigators, contract laboratories, clinical research organizations and manufacturing organizations, may not successfully carry out their contractual duties or obligations or meet expected deadlines, and the quality or accuracy of the data or materials generated by such third parties may be of insufficient quality to include in the Company's regulatory submissions; the ability of Orexigen and its licensors to obtain, maintain and successfully enforce adequate patent and other intellectual property protection of its product candidates; and other risks described in the Company's filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Orexigen undertakes no obligation to revise or update this news release to reflect events or circumstances after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement. This caution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995. Information included herein is based on the Company's review and evaluation of the clinical data. All conclusions and determinations contained herein are subject to the Company's further analysis of the clinical data. The ultimate determination of the safety and efficacy of Contrave and Empatic will be made by the FDA and other relevant regulatory authorities.
SOURCE Orexigen Therapeutics, Inc.
- Data Presented at The Obesity Society Annual Scientific Meeting -
SAN DIEGO, Oct. 24 /PRNewswire-FirstCall/ -- Orexigen® ( )Therapeutics, Inc (Nasdaq: OREX) today announced new data from the COR-I, COR-II and COR-Diabetes trials for Contrave® (bupropion SR/ naltrexone SR) to expand on top-line results announced in July. Contrave is the first of the Company's two late stage candidates for the treatment of obesity. These data were presented during a panel discussion at the 27th Annual Scientific Meeting of The Obesity Society.
These new data show that after completing 56 weeks of therapy with Contrave32:
* Approximately 34-48% of patients lost at least 10% of their baseline body weight and approximately 17-23% lost at least 15%;
* Obese patients classified as higher risk for developing cardiovascular disease and diabetes demonstrated significant improvement in markers of cardiometabolic risk such as waist circumference, HDL, and triglycerides;
* Patients with type 2 diabetes taking Contrave who began the trial with a hemoglobin A1c (HbA1c) level greater than 8% saw a mean HbA1c reduction of 1.1%, which was highly statistically significant compared to placebo;
* Patients reported an increased ability to control their eating and resist food cravings; and
* There was no evidence of increased abuse liability.
"These data show that Contrave provides obese patients with meaningful reduction in weight and improvement in important markers of cardiometabolic risk, with even greater improvement seen in patients at higher risk," said Dennis Kim, M.D., Senior Vice President of Medical Affairs. "Results also illustrate the robust glycemic benefit of Contrave in patients who have poorly controlled diabetes, as defined by a hemoglobin A1C level greater than 8.0. These patients experienced a clinically meaningful A1C reduction of 1.1% from baseline."
Additional findings presented today from patients who completed 56-weeks of therapy include:
Efficacy Results
----------------
COR-I COR-II
----- ------
PBO Contrave32 PBO Contrave32
(N=290) (N=296) (N=267) (N=434)
------ ------ ------ ------
Equal or greater
than 5% weight
loss (%) 23.1% 61.8%* 21.7% 75.8%*
Equal or Greater
than 10%
weight loss (%) 10.7% 34.5%* 7.9% 48.2%*
Equal or Greater
than 15%
weight loss (%) 3.1% 17.2%* 3.4% 23.0%*
Markers of Cardiometabolic Risk (mean change)
---------------------------------------------
COR-I COR-II
----- ------
PBO Contrave32 PBO Contrave32
(N=290) (N=296) (N=267) (N=434)
------ ------ ------ ------
Waist
circumference
(cm) -2.7 -6.9* -2.1 -7.1*
Fasting
triglycerides
(mg/dL) -3.8 -19.0* +0.5 -14.8*
Fasting HDL
(mg/dL) -0.1 +3.5* -1.0 +4.2*
Fasting LDL
(mg/dL) -2.8 -4.3 -2.0 -6.3*
hsCRP (mg/L) -0.5 -1.6* 0.0 -0.7*
Markers of Cardiometabolic Risk (mean change among patients with increased
cardiometabolic risk)
--------------------------------------------------------------------------
COR-I COR-II
----- ------
PBO Contrave32 PBO Contrave32
--- ---------- --- ----------
Waist
Circumference -2.8 -7.1* -2.2 -7.3*
(cm) (N=282) (N=279) (N=254) (N=410)
Males >102
cm
Females
>88 cm
Fasting
Triglycerides -32.0 -66.3* -13.9 -51.2*
(mg/dL) (N=82) (N=87) (N=69) (N=135)
>/=150 mg/dL
Fasting HDL +1.3 +5.0* +1.3 +6.2*
(mg/dL) (N=122) (N=121) (N=117) (N=184)
Males <40
Females <50
Fasting LDL
(mg/dL) -22.5 -12.8 -8.0 -27.3
>/=160 mg/dL (N=29) (N=31) (N=26) (N=44)
hsCRP (mg/L) -0.7 -2.9* -1.1 -1.6*
>3 mg/L (N=163) (N=177) (N=144) (N=261)
*p<.05 for difference between Contrave and placebo
"The focus of today's panel discussion on pharmacotherapy among distinguished members of the scientific community serves as further validation that medication may play an important role in the treatment of obesity," said Eduardo Dunayevich, M.D., Chief Medical Officer, Orexigen Therapeutics. "We believe that, if approved, Contrave can benefit a broad range of obese patients. The results of the COR program, coupled with recently disclosed results from our Empatic Phase 2b trial, support our belief that these two product candidates can help fill the current gap in obesity treatment by providing physicians with multiple pharmacologic options to address the varying needs of this diverse patient population."
Contrave Obesity Research (COR) Trial Design and Safety Profile
All Phase 3 trials in the COR program were 56 week, randomized, double-blind, placebo-controlled trials. The co-primary endpoints were the proportion of patients achieving at least 5% weight loss and percent change in body weight compared to placebo. Secondary endpoints included multiple markers of cardiometabolic risk, patient reported food cravings and eating control measures, as well as HbA1c in the COR-Diabetes trial. Patients were randomized to receive either placebo or Contrave, BID, with a four week titration period.
As previously reported, seven serious adverse events were attributed by investigators as possibly related to Contrave treatment across the entire COR program. These include cholecystitis (gallbladder inflammation), seizure, palpitations, paresthesia and vertigo. The most frequently observed treatment-emergent adverse events were nausea, constipation and headache. Nausea was the leading adverse event resulting in discontinuation; however, for the majority of patients experiencing nausea, it was mild to moderate, transient and manageable.
At week 56, mean blood pressure was generally unchanged from baseline for Contrave patients compared to placebo patients, who tended to experience a slight decrease (approximately 2 mm Hg) from baseline. Contrave treatment did not appear to disrupt the normal circadian pattern of blood pressure. There was a slight increase in pulse (approximately 1 beat per minute) in Contrave patients compared to placebo patients, whose pulse was generally unchanged. There were no meaningful treatment effects on ECGs or laboratory measures including liver function tests. Treatment with Contrave was not associated with increases in symptoms of depression or suicidal ideation.
The Company is on track to submit a New Drug Application (NDA) for Contrave with the FDA in the first half of 2010.
Additional Presentations at The Obesity Society
Additional data including Intent-to-Treat (ITT) analyses from COR-I and COR-II will be presented as late-breaker presentations in the Marriott Ballroom Salon 2 on Tuesday, October 27, beginning at 11:00 am EST. In addition, three posters (220-P, 218-P, 216-P) featuring data from the COR-BMOD trial will be presented in the Marriott Exhibit Hall on Sunday, October 25 from 1-2 and 6:30-7:30 pm EST (posters available for viewing from 1-7:30pm).
About Orexigen® Therapeutics
Orexigen Therapeutics, Inc. is a biopharmaceutical company focused on developing therapies that offer multiple approaches to treating obesity. The Company's lead investigational product, Contrave®, has completed the COR clinical development program and is on track for a regulatory submission with the FDA in the first half of 2010. The Company's second obesity drug candidate, Empatic(TM), has completed Phase 2 trials. Each product candidate is designed to act on a specific group of neurons in the central nervous system with the goal of achieving appetite suppression and sustained weight loss, through combination therapeutic approaches. Further information about the Company can be found at http://www.Orexigen.com.
Forward-Looking Statements
Orexigen cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements. Words such as "believes," "anticipates," "plans," "expects," "indicates," "will," "intends," "potential," "suggests," "assuming," "designed" and similar expressions are intended to identify forward-looking statements. These statements are based on the Company's current beliefs and expectations. These forward-looking statements include statements regarding the efficacy and safety of Empatic(TM) and Contrave®, the potential for, and timing of, proceeding to Phase 3 clinical trials for Empatic or filing an NDA for Contrave, the commercial and therapeutic potential of Empatic and Contrave, and the potential to obtain regulatory approval for, and effectively treat obesity with, either product candidate. The inclusion of forward-looking statements should not be regarded as a representation by Orexigen that any of its plans will be achieved. Actual results may differ from those set forth in this release due to the risk and uncertainties inherent in the Orexigen business, including, without limitation: additional analyses of data from the Empatic Phase 2B trial or Contrave Phase 3 trials and any other clinical trials of Empatic or Contrave may produce negative or inconclusive results, or may be inconsistent with previously announced results or previously conducted clinical trials; the FDA may not agree with the Company's interpretation of efficacy and safety results; earlier clinical trials may not be predictive of future results; Empatic or Contrave may not receive regulatory approval on a timely basis or at all, and the FDA may require Orexigen to complete additional clinical, non-clinical or other requirements prior to the submission or the approval of NDAs for either product candidate; the potential for adverse safety findings relating to Empatic or Contrave to delay or prevent regulatory approval or commercialization, or result in product liability claims, including serious adverse events that are not characterized by clinical investigators as possibly related to Empatic or Contrave and adverse events associated with the individual components of these product candidates; the third parties on whom Orexigen relies to assist with the development programs for Empatic or Contrave, including clinical investigators, contract laboratories, clinical research organizations and manufacturing organizations, may not successfully carry out their contractual duties or obligations or meet expected deadlines, and the quality or accuracy of the data or materials generated by such third parties may be of insufficient quality to include in the Company's regulatory submissions; the ability of Orexigen and its licensors to obtain, maintain and successfully enforce adequate patent and other intellectual property protection of its product candidates; and other risks described in the Company's filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Orexigen undertakes no obligation to revise or update this news release to reflect events or circumstances after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement. This caution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995. Information included herein is based on the Company's review and evaluation of the clinical data. All conclusions and determinations contained herein are subject to the Company's further analysis of the clinical data. The ultimate determination of the safety and efficacy of Contrave and Empatic will be made by the FDA and other relevant regulatory authorities.
SOURCE Orexigen Therapeutics, Inc.
Thursday, October 22, 2009
Rodman & Renshaw Provides Clarification Regarding "Shelf" Registration Statement Filed on October 21, 2009
NEW YORK--(BUSINESS WIRE)--Rodman & Renshaw Capital Group, Inc. (NASDAQ: RODM - News) clarified today that the Shelf Registration Statement it filed with the U.S. Securities and Exchange Commission (SEC) yesterday, covering the prospective sale by the Company of up to $75 million of securities, from time to time, and the prospective sale of up to three million shares of common stock by specified selling stockholders, from time to time, does not include any specific information with respect to the price at which any such securities may be sold. The reference to the selling stockholders selling “up to 3 million shares they own at a maximum price of $5.415 a share” in a media story issued earlier today was an erroneous reference to the historical price of the Company’s common stock used only to calculate the registration fee payable to the SEC in compliance with Rule 457(c) under the Securities Act of 1933, and has no direct relationship to the prices at which selling stockholders may sell shares, from time to time, following the Registration Statement being declared effective. Pricing in connection with any sales of securities that may be made pursuant to the Registration Statement, once declared effective, will be set by the Company or the selling stockholders, as the case may be, or negotiated by the Company or the selling stockholders, as the case may be, with underwriters, selling agents, or third party purchasers, if applicable, and, if required, will be included in a prospectus supplement with respect to any such sale.
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