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新闻
Acura Pharmaceuticals, Inc. secures financing to fund pivotal Phase III clinical trial for lead Aversion® technology product candidate
Palatine, IL, August 20 2007 - Acura Pharmaceuticals, Inc.
(OTC.BB-ACUR) (the "Company") today announced it has entered into a
Securities Purchase Agreement (the “Agreement”), with an investor group
comprised of Vivo Ventures Fund VI L.P., Vivo Ventures Fund VI
Affiliates Fund, L.P., GCE Holdings LLC and certain individual investors
(the “Investors”). Pursuant to the Agreement, the Investors
purchased 23,605,551 Units (“Units”) at a price of $1.08 per Unit with
each Unit consisting of four shares of the Company's common stock, $0.01
par value, and a warrant to purchase one share of common stock.
13,842,590 of the Units were purchased for cash, with the balance of
9,962,961 Units issued in consideration for the conversion of all of the
Company’s $10.544 million in outstanding bridge loan indebtedness. Net
cash proceeds to the Company, after expenses relating to closing the
transaction, are estimated to be approximately $14.5 million.
As a condition to the Agreement, the Company’s 2004 Note in the
principal amount of $5.0 million was amended to, among other things,
extend the maturity date to December 31, 2008 from September 30, 2007
and to set the interest rate at 10% from the prior rate of prime rate
plus 4.5% (currently 12.75%). A more detailed description of this
equity financing may be reviewed in the Company’s Form 8-K filed with
the Securities and Exchange Commission.
Use of Proceeds
The Company will utilize a portion of the net proceeds from the
transaction described above to fund Study 105, the pivotal phase 3 trial
for OxyADF (oxycodone HCl and niacin) Tablets, its lead product
candidate utilizing Aversion® Technology. Study 105 is a randomized,
double-blind, placebo-controlled, multicenter, repeat-dose study of the
safety and efficacy of OxyADF Tablets for the treatment of acute,
moderate to severe postoperative pain following bunionectomy surgery in
adult patients. This is a 3-arm clinical trial comparing two dose
levels of OxyADF Tablets to placebo. Study medication will be
administered to patients every six hours for 48 hours following the
onset of moderate to severe pain following bunionectomy surgery.
Study 105 is targeted to enroll 135 patients per arm (approximately 405
patients in total). As previously announced, the Company executed
a Clinical Trial Development Agreement with a leading Contract Research
Organization and commenced preliminary Study 105 start-up activities.
However, initiation of patient enrollment in Study 105 remained
dependent upon the availability of adequate funding. Now that new
funding has been secured, the Company intends to proceed with patient
enrollment in Study 105. The Company believes the completion of Study
105 is the critical time and events path to a 505(b)(2) NDA submission
for OxyADF Tablets.
About Acura Pharmaceuticals, Inc.
Acura Pharmaceuticals, Inc. is a specialty pharmaceutical company
engaged in research, development and manufacture of innovative Aversion®
(abuse deterrent) Technology and related product candidates.
Forward Looking Statements
This press release contains "forward-looking statements" as defined in
the Private Securities Litigation Reform Act of 1995. These
statements are based on current expectations of future events. If
underlying assumptions prove inaccurate or unknown risks or
uncertainties materialize, actual results could vary materially from the
Company’s expectations and projections. The most significant of such
risks and uncertainties include, but are not limited to, the Company’s
ability to secure additional financing to fund operations, the Company’s
ability to enter into contractual arrangements with qualified
pharmaceutical partners to license, develop and commercialize the
Company’s technology and product candidates, the Company’s ability to
avoid infringement of patents, trademarks and other proprietary rights
or trade secrets of third parties, and the Company’s ability to fulfill
the FDA’s requirements for approving the Company’s product candidates
for commercial distribution in the United States, including, without
limitation, the adequacy of the results of the clinical studies
completed to date and the results of other clinical studies, to support
FDA approval of the Company’s product candidates, the adequacy of the
development program for the Company’s product candidates, changes in
regulatory requirements, adverse safety findings relating to the
Company’s product candidates, the risk that the FDA may not agree with
the Company’s analysis of its clinical studies and may evaluate the
results of these studies by different methods or conclude that the
results of the studies are not statistically significant, clinically
meaningful or that there were human errors in the conduct of the studies
or otherwise, the risk that further studies of the Company’s product
candidates are not positive, and the uncertainties inherent in
scientific research, drug development, clinical trials and the
regulatory approval process. You are encouraged to review other
important risk factors relating to the Company on our web site at
www.acurapharm.com under the link, “Company Risk Factors” and
detailed in Company filings with the Securities and Exchange Commission.
The Company is at development stage and may never have any products or
technologies that generate revenue. Acura Pharmaceuticals, Inc. assumes
no obligation to update any forward-looking statements as a result of
new information or future events or developments. All Acura
Pharmaceuticals, Inc. press releases may be reviewed at
www.acurapharm.com.
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维梧生技创业投资管理公司( Vivo Ventures)成立于1996年, 是一家专注于于生命科学领域的风险投资公司。 管理着超过六亿五千美金的维梧生技正通过旗下第六个基金对北美、亚洲,特别是大中华市场,极具潜力的生物科技、生命科学,制药,器械,及医疗健康服务公司进行投资。 与其他最近才开始关注中国市场的投资公司相比,我们对大中华地区有深层次的了解 更多
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