UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
WASHINGTON,
D. C. 20549
____________
FORM
8-K
CURRENT
REPORT
Pursuant
to Section 13 or 15(d) of the
Securities
Exchange Act Of 1934
July
27, 2006
Date
of
Report (Date of earliest event reported)
___________________________________________________________
ACURA
PHARMACEUTICALS, INC.
(Exact
Name of Registrant as Specified in Charter)
___________________________________________________________
|
State
of New
York
|
1-10113
|
11-0853640
|
|
(State
of Other Jurisdiction of
Incorporation)
|
(Commission
File Number)
|
(I.R.S.
Employer Identification
Number)
|
616
N. North Court, Suite 120
Palatine,
Illinois 60067
(Address
of principal executive offices) (Zip Code)
(847)
705-7709
(Registrant’s
telephone number, including area code)
Check
the
appropriate box below if the Form 8-K filing is intended to simultaneously
satisfy the filing obligation of the registrant under any of the following
provisions (see General Instruction A.2. below):
o Written
communications pursuant to Rule 425 under the Securities Act (17 CFR
230.425)
o Soliciting
material
pursuant to Rule 14a-12 under the Exchange Act (17CFR 240.14a-12)
o Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act
(17CFR240.14d-2(b))
o Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17CFR
240.13e-4(c))
Item
2.02 Results
of Operations and Financial Condition
On
July
27, 2006, Acura Pharmaceuticals, Inc. (the "Company") issued a press release
disclosing the financial results for its second quarter ended June 30, 2006
and OxyADF™
Tablet
Development Status. A copy of the Company's
press release is attached as Exhibit 99.1 hereto.
Item
9.01 Financial
Statements and Exhibits
| Exhibit Number | Description | |
| 99.1 |
Press
Release dated July 27, 2006 Announcing Financial Results for Second
Quarter 2006 and OxyADF™
Tablet
Development
Status
|
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant
has
duly caused this report to be signed on its behalf by the undersigned thereunto
duly authorized.
| ACURA PHARMACEUTICALS, INC. | ||
| |
|
|
| Date: July 27, 2006 | By: | /s/ Peter A. Clemens |
|
Peter
A. Clemens
Senior
Vice President & Chief Financial Officer
|
||
Exhibit
Index
| Exhibit Number | Description | |
| 99.1 |
Press
Release dated July 27, 2006 Announcing Financial Results for Second
Quarter 2006 and OxyADF™
Tablet
Development
Status
|
CONTACT:
Acura
Pharmaceuticals, Inc.,
Investor
Relations, Peter A. Clemens, SVP & CFO 847-705-7709
FOR
IMMEDIATE RELEASE
ACURA
PHARMACEUTICALS, INC. ANNOUNCES
2ND
QUARTER 2006 FINANCIAL RESULTS AND OXYADF™ TABLET DEVELOPMENT
STATUS
Palatine,
IL, July 27, 2006:
Acura
Pharmaceuticals, Inc. (OTC.BB-ACUR) today announced a net loss of $2.6 million
or $0.01 per share for the quarter ending June 30, 2006 compared to a net loss
of $1.4 million or $0.06 per share for the same period in 2005. Included in
the
2006 and 2005 quarterly results is a non cash compensation charge of $1.3
million and $0.2 million, respectively, for stock compensation expense
pertaining to the Company’s issued and outstanding stock options and restricted
stock units. For the six months ended June 30, 2006 the Company had a net loss
of $6.8 million or $0.02 per share compared to a net loss of $3.3 million or
$0.15 per share in 2005. Included in the 2006 and 2005 six month results is
a
non cash compensation charge of $4.0 million and $0.6 million, respectively,
for
stock compensation expense pertaining to the Company’s issued and outstanding
stock options and restricted stock units. The 2006 weighted average number
of
outstanding common shares reflect the conversion of all outstanding preferred
shares into 305.4 million common shares during the fourth quarter of 2005.
Highlights of the Company’s consolidated balance sheets and statements of
operations appear below. Detailed financial statements are included in the
Company’s Form 10-Q for the quarter ended June 30, 2006 filed with the
Securities and Exchange Commission.
Cash
Reserves Update
The
Company estimates that its current cash reserves, including the net proceeds
from the June 2006 Bridge Loan, will fund product development and licensing
activities through
mid August, 2006.
To
continue operating thereafter, the Company must raise additional financing
or
enter into appropriate collaboration agreements with third parties providing
for
cash payments to the Company. No assurance can be given that the Company will
be
successful in obtaining any such financing or in securing collaborative
agreements with third parties on acceptable terms, if at all, or if secured,
that such financing or collaborative agreements will provide for payments to
the
Company sufficient to continue funding operations. In the absence of such
financing or third-party collaborative agreements, the Company will be required
to scale back or terminate operations and/or seek protection under applicable
bankruptcy laws.
OxyADF™
Tablet Development Status
The
Company’s lead product candidate, OxyADF™ tablets, formulated with the Company’s
proprietary Aversion® Technology, is an orally administered immediate release
tablet containing oxycodone HCl as its sole active analgesic ingredient with
an
anticipated indication for treating acute moderate to moderately severe pain.
Product candidates formulated with Aversion® Technology are intended to reduce
or discourage misuse of all three common routes of abuse of tablet and capsule
pharmaceutical products including (i) intravenous injection of dissolved tablets
or capsules, (ii) inhalation/nasal snorting of crushed tablets or capsules
and
(iii) intentional consumption of excessive numbers of tablets or capsules by
oral administration.
OxyADF™
tablets are being developed pursuant to an active investigational new drug
application (“IND”) on file with the United States Food and Drug Administration
(“FDA”). The FDA has confirmed that OxyADF™ is an appropriate product candidate
for submission as a 505(b)(2) new drug application (“NDA”) and have confirmed in
writing to the Company that no additional toxicology studies are required prior
to submission of such NDA. To date the Company, in concert with CROs, has
completed patient enrollment in one phase I clinical trial (Study AP-ADF-101),
one phase II clinical trial (Study AP-ADF-103), a pivotal bioequivalence trial
(Study AP-ADF-104) and a pivotal laboratory study relating to the development
of
OxyADF™. The results from studies AP-ADF-103, AP-ADF-104 and the pivotal
laboratory study are summarized below.
OxyADF™
contains a second active ingredient in a sub-therapeutic amount. This second
active ingredient has a well established side effect profile in long term
administration at doses more than ten-fold greater than the amount contained
in
the proposed maximum recommended daily dose of OxyADF™ tablets. When OxyADF™ is
administered at the intended recommended dose of 1 or 2 tablets every 4-6 hours,
then it is expected that legitimate acute pain patients will not feel the
affects this extra active ingredient. However, when either a legitimate acute
pain patient or a potential drug abuser consumes excess quantities of OxyADF™
tablets, we anticipate he/she will experience an unpleasant combination of
symptoms, including warmth or flushing, itching, sweating and/or chills,
headache and a general feeling of discomfort. It is expected that these symptoms
will begin approximately 10-15 minutes after the excess dose is consumed and
self-resolve approximately 75-90 minutes later. The Company does not expect
that
the undesirable effects from this extra active ingredient will be “fool-proof”
in discouraging excess oral consumption of OxyADF™ tablets but anticipates that
it will cause most patients or potential abusers to experience unpleasant
effects if excess quantities of OxyADF™ are consumed orally. As described below,
the Company is currently evaluating the effects of this second active ingredient
in clinical studies involving subjects with no history of opioid abuse as well
as in subjects with a history of opioid abuse.
Prospective
drug abusers may attempt to dissolve currently marketed oxycodone containing
tablets in water or other common solvents, filter the dissolved solution, and
then inject the resulting fluid intravenously to obtain a euphoric effect.
In
addition to its two active ingredients, OxyADF™ tablets also include several
inactive ingredients. These inactive ingredients are commonly used
pharmaceutical excipients with no therapeutic effect but with specific
non-therapeutic functions. When dissolved in water or other common solvents,
the
functional excipients in OxyADF™ tablets will form a viscous gel that traps the
oxycodone ingredient in the OxyADF™ tablet matrix. The Company believes this gel
forming feature will substantially limit the ability of prospective I.V. drug
abusers to extract oxycodone from an OxyADF™ tablet. The Company has compared
(as described below) the relative difficulty of extracting oxycodone from
OxyADF™ tablets to several currently marketed oxycodone containing
products.
In
addition, prospective drug abusers may easily crush or grind currently marketed
oxycodone containing products and snort or inhale the crushed powder. The
crushed powder may then be snorted and the oxycodone in the powder will be
rapidly absorbed through the nasal mucosa often resulting in a euphoric effect.
OxyADF™ tablets have three features intended to discourage nasal snorting.
First, OxyADF™ tablets are formulated with a functional excipient intended to
induce moderate burning and irritation of the nose and nasal mucosal membranes
if the tablets are crushed and the prospective drug abuser attempts to snort
the
crushed tablets. Second, when OxyADF™ tablets are crushed and snorted, the
Company expects the moisture in the nasal passages will form a viscous gel
with
the crushed tablet powder, trapping the oxycodone in the gel and therefore
reducing the amount of oxycodone available to be absorbed through the mucosal
membranes. Third, the Company expects that the viscous gel formed in the nasal
passages will result in a sticky mass producing an unpleasant sensation in
the
nose of the prospective abuser. Therefore, the Company expects potential nasal
abusers of OxyADF™ tablets to experience burning and irritation of the nasal
passages, a lower level of oxycodone available for mucosal absorption and a
physically unpleasant gelatinous mass in the nose.
Study
AP-ADF-103:
To
assess the safety and tolerability of OxyADF™ tablets in comparison to oxycodone
HCl tablets without an ingredient to discourage excess oral consumption, the
Company conducted a Phase II single-center, randomized, double-blind,
multiple-dose study in 66 healthy adult male and female volunteers (“Study
AP-ADF-103”). In Study AP-ADF-103, subjects were randomly assigned to one of
three treatment groups (n=22 per treatment group). A run-in phase was conducted
on an outpatient basis for five days and included at-home dosing four times
daily and adverse event and tolerability assessments. The treatment phase
followed the run-in phase and was conducted on an inpatient basis for five
days.
The treatment phase included dosing with OxyADF™ tablets (with or without the
second active ingredient) as well as post-treatment safety and tolerability
assessments. Efficacy (the tolerability of OxyADF™) was evaluated with a Side
Effects and Symptoms Questionnaire (SESQ) and a OxyADF™ Tolerability Rating
Scale. Safety was evaluated by Adverse Events and clinical laboratory and vital
signs assessments were conducted periodically during the study. During the
run-in phase, comparable tolerability was demonstrated in subjects who took
OxyADF™ tablets with and without the second active ingredient. The mean
post-dose SESQ total score during the run-in phase was very low in all groups
(highest possible score = 33; Group results = 0.84 - 1.6) indicating that
OxyADF™ was generally well-tolerated when taken at recommended doses. During the
treatment phase, 64% of subjects in Groups 2 and 3 (oxycodone HCl + the second
active ingredient) reported side effects and symptoms and 50% of subjects in
Group 1 (oxycodone alone) reported side effects and symptoms. Most of the side
effects and symptoms observed during the treatment phase were mild or moderate
in severity. Irrespective of treatment group, approximately three quarters
of
subjects reported either “no effect” or “easy to tolerate” on the OxyADF™
Tolerability Rating Scale. Oxycodone HCl administered four times a day, with
or
without the second active ingredient was determined to be well tolerated.
Adverse events were reported by 77% of subjects throughout both phases of the
study. The majority of subjects (55%) reported adverse events during the
treatment phase that were considered mild in severity. No severe adverse events
were reported in any treatment group and no clinically important trends over
time were observed in any treatment group for vital signs measurements (blood
pressure, heart rate, and respiratory rate). The Company intends to include
the
data and results from Study AP-ADF-103 in its 505(b)(2) NDA submission for
OxyADF™ to the FDA.
Study
AP-ADF-104:
In
addition to Study AP-ADF-101 and Study AP-ADF-103, the Company, in concert
with
a CRO, has completed a pivotal bioequivalence study for OxyADF™ (Study
AP-ADF-104) using tablets from batches manufactured by the Company at its Culver
Facility at a scale of sufficient size to fulfill the FDA’s requirements for a
505(b)(2) NDA submission. Study AP-ADF-104 was a pivotal, single-dose,
open-label, randomized, two-period crossover bioequivalence study conducted
under fasting conditions to compare the pharmacokinetic characteristics of
OxyADF™ tablets (oxycodone HCl 5mg) to the FDA reference listed drug,
Roxicodoneâ
tablets,15 mg. Subjects received two separate drug administrations in assigned
periods, one treatment per period, according to a randomization schedule. Dosing
days were separated by a washout period of at least 7 days. An equal number
of
subjects were randomly assigned to each possible sequence of treatments. Drug
administration consisted of an oral dose of OxyADF™ tablets (3 x 5mg) or
Roxicodone® tablets (1 x 15 mg). Thirty-nine (39) of forty (40) healthy adult
subjects completed the study. The results demonstrated that OxyADF™ tablets are
bioequivalent to Roxicodone® tablets. The 90% confidence intervals for peak
exposure based on ln(Cmax) and overall systemic exposure based on ln(AUClast)
and ln(AUCinf) of oxycodone were well within the FDA’s acceptable range for
bioequivalence. The Company intends to include the data and results of Study
AP-ADF-104 in its 505(b)(2) NDA submission for OxyADF™ to the FDA.
Pivotal
Laboratory Study:
The
Company, in concert with a leading independent laboratory CRO (the “Laboratory
CRO”), completed a pivotal study to assess certain properties of OxyADF™ using
tablets from batches manufactured by the Company at its Culver Facility at
a
scale of sufficient size to fulfill the FDA’s requirements for a 505(b)(2) NDA
submission. The
Laboratory CRO was contracted to quantitatively and qualitatively measure the
relative difficulty of extracting oxycodone HCl for purposes of intravenous
(IV)
injection from various opioid tablet products. The Laboratory CRO was provided
with a list of ingredients contained in each product, allotted 80 hours total
time to complete the evaluations and allowed to use any methodology desired
to
extract oxycodone HCl from the tablets. Products tested were OxyADF™ tablets,
Oxycontin® Tablets, 40mg, generic oxycodone HCl Tablets, 5 mg and Percocet®
Tablets (oxycodone HCl/acetaminophen, 5mg/325 mg). Results
were reported as (i) percent of drug extracted, (ii) time to extract drug and
(iii) difficulty to extract drug on a scale of 1-10, 1 being easy and 10 being
extremely difficult. Oxycontin® and generic oxycodone HCl tablets resulted in
71-92% drug extracted in 3- 6 minutes and were rated 1-2 in relative difficulty.
Percocet® tablets resulted in 75% oxycodone HCl extracted in 29 minutes and was
rated 3-4 in relative difficulty. OxyADF™ tablets resulted in a “trace” of
oxycodone HCl extracted in 355 minutes and was rated 10 in relative difficulty.
The Company intends to utilize the data and results from this pivotal laboratory
study in its 505(b)(2) NDA submission for OxyADF™ to the FDA.
Development
Plan:
In
written correspondence after the Company’s end of Phase II meeting for
OxyADF’
tablets,
the U.S. Food and Drug Administration (FDA) has stated that certain additional
clinical studies will be required prior to their acceptance of a 505(b)(2)
NDA
submission for OxyADF™ tablets. Additional required clinical studies include
completion of Study AP-ADF-102, a phase II clinical trial currently in progress
in approximately 25 subjects with a history of opioid abuse, Study AP-ADF-105,
a
placebo controlled, pivotal phase III clinical trial in approximately 300-400
acute pain patients, and four or five phase I clinical studies with
approximately 25-50 normal subjects per study. Estimating the dates of
initiation and completion of clinical studies and the costs to complete
development of the Company's product candidates, including OxyADF™ tablets,
would be speculative and potentially misleading. The Company expects to reassess
its future research and development plans pending review of data received from
current in progress development activities and the availability of cash
resources to fund such development activities. The cost and pace of future
research and development activities are linked and subject to change. At this
stage there can be no assurance that any of the Company’s research and
development efforts, including those for OxyADF™ tablets, will lead to a
505(b)(2) NDA submission or that if NDA submissions are made with the FDA,
that
any such submission will be approved by the FDA.
About
Acura Pharmaceuticals, Inc.
Acura
Pharmaceuticals, Inc., together with its subsidiary, is a specialty
pharmaceutical company primarily engaged in research, development and
manufacture of innovative abuse deterrent, abuse resistant and tamper resistant
formulations ("Aversion® Technology") intended for use in orally administered
opioid-containing pharmaceutical products.
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 continued product development and
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.
|
ACURA
PHARMACEUTICALS, INC.
|
|||||||||||||
|
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
|
|||||||||||||
|
(in
thousands, except per share data)
|
|||||||||||||
|
(unaudited)
|
(unaudited)
|
||||||||||||
|
Six
Months Ended
|
Three
Months Ended
|
||||||||||||
|
June
30
|
June
30
|
||||||||||||
|
2006
|
2005
|
2006
|
2005
|
||||||||||
|
Operating
Costs
|
|||||||||||||
|
Research
and Development
|
$
|
2,544
|
$
|
1,682
|
$
|
1,038
|
$
|
729
|
|||||
|
Marketing,
General and Administrative
|
3,724
|
1,492
|
1,303
|
537
|
|||||||||
|
Loss
from Operations
|
(6,268
|
)
|
(3,174
|
)
|
(2,341
|
)
|
(1,266
|
)
|
|||||
|
Other
Income (Expense)
|
|||||||||||||
|
Interest
Expense
|
(495
|
)
|
(263
|
)
|
(270
|
)
|
(137
|
)
|
|||||
|
Interest
Income
|
10
|
24
|
6
|
9
|
|||||||||
|
(Loss)
Gain on Asset Disposals
|
(17
|
)
|
83
|
(10
|
)
|
13
|
|||||||
|
Other
|
-
|
-
|
-
|
(1
|
)
|
||||||||
|
Net
Loss
|
$
|
(6,770
|
)
|
$
|
(3,330
|
)
|
$
|
(2,615
|
)
|
$
|
(1,382
|
)
|
|
|
Basic
and Diluted Loss Per Common Share
|
$
|
(0.02
|
)
|
$
|
(0.15
|
)
|
$
|
(0.01
|
)
|
$
|
(0.06
|
)
|
|
|
Weighted
Average Number of Outstanding Common Shares
|
329,443
|
22,773
|
329,577
|
22,949
|
|||||||||
|
ACURA
PHARMACEUTICALS, INC.
|
|||||||
|
CONDENSED
CONSOLIDATED BALANCE SHEETS
|
|||||||
|
(in
thousands)
|
|||||||
|
(unaudited)
|
(audited)
|
||||||
|
At
June 30
|
At
December 31
|
||||||
|
2006
|
2005
|
||||||
|
Current
Assets
|
$
|
900
|
$
|
444
|
|||
|
Property,
Plant and Equipment, Net
|
1,210
|
1,341
|
|||||
|
Other
Assets
|
7
|
7
|
|||||
|
Total
Assets
|
$
|
2,117
|
$
|
1,792
|
|||
|
Current
Liabilities
|
10,606
|
2,922
|
|||||
|
Long
Term Debt
|
20
|
5,032
|
|||||
|
Stockholders'
Deficit
|
(8,509
|
)
|
(6,162
|
)
|
|||
|
Total
Liabilities and Stockholders' Deficit
|
$
|
2,117
|
$
|
1,792
|
|||