Acura Pharmaceuticals, Inc. secures financing to fund pivotal Phase III clinical trial for lead Aversion® technology product candidate
August 20 2007
Palatine, IL - 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.
