þ
|
QUARTERLY
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE
ACT OF
1934.
|
¨
|
TRANSACTION
REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE
ACT OF
1934
|
New
York
|
11-0853640
|
(State
or other Jurisdiction
of
|
(I.R.S.
Employer
|
incorporation
or
organization)
|
Identification
No.)
|
616
N. North Court, Suite
120
|
|
Palatine,
Illinois
|
60067
|
(Address
of Principal Executive
Offices)
|
(Zip
Code)
|
Large
accelerated filer o
|
Accelerated
filer o
|
|
Non-accelerated
filer x
(Do not check if a smaller reporting company)
|
Smaller
reporting company o
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Page
No.
|
|||
PART 1. FINANCIAL INFORMATION | |||
Item
1.
|
Financial
Statements (Unaudited)
|
||
Consolidated
Balance Sheets
|
|||
March
31, 2008 and December 31, 2007
|
1
|
||
Consolidated
Statements of Operations
|
|||
Three
months ended March 31, 2008 and March 31, 2007
|
2
|
||
Consolidated
Statement of Stockholders’ Equity
|
|||
Three
months ended March 31, 2008
|
3
|
||
Consolidated
Statements of Cash Flows
|
|||
Three
months ended March 31, 2008 and March 31, 2007
|
4
|
||
Notes
to Consolidated Financial Statements
|
6
|
||
Item
2.
|
Management's
Discussion and Analysis of Financial Condition and Results of Operations
...
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12
|
|
Item
4.
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Controls
and Procedures
|
27
|
|
PART
II. OTHER INFORMATION
|
|||
Item
1A.
|
Risk
Factors Relating to the Company
|
27
|
|
Item
6.
|
Exhibits
|
27
|
|
Signatures
|
28
|
March
31
|
|
December
31,
|
|
||||
|
|
2008
|
|
2007
|
|||
ASSETS
|
|||||||
Current
Assets
|
|||||||
Cash
and cash equivalents
|
$
|
26,002
|
$
|
31,368
|
|||
Collaboration
revenue receivable
|
3,376
|
2,977
|
|||||
Short-term
investments
|
4,000
|
-
|
|||||
Prepaid
clinical study costs
|
-
|
388
|
|||||
Prepaid
insurance
|
172
|
202
|
|||||
Prepaid
expense and other current assets
|
233
|
47
|
|||||
Deferred
income taxes
|
4,620
|
9,600
|
|||||
Total
current assets
|
38,403
|
44,582
|
|||||
Property,
plant and equipment, net
|
1,063
|
1,046
|
|||||
Total
assets
|
$
|
39,466
|
$
|
45,628
|
|||
LIABILITIES
AND STOCKHOLDERS' EQUITY
|
|||||||
Current
Liabilities
|
|||||||
Deferred
program fee revenue - current portion
|
$
|
9,497
|
$
|
21,942
|
|||
Accrued
expenses
|
311
|
334
|
|||||
Total
current liabilities
|
9,808
|
22,276
|
|||||
Non-current
liabilities
|
|||||||
Deferred
program fee revenue - non current portion
|
3,368
|
4,632
|
|||||
Total
liabilities
|
13,176
|
26,908
|
|||||
Commitments
and contingencies
|
|||||||
Stockholders’
equity
|
|||||||
Common
stock - $.01 par value; 650,000 shares authorized;
|
|||||||
42,706
shares issued and outstanding
|
|||||||
at
March 31, 2008 and December 31, 2007, respectively
|
427
|
427
|
|||||
Additional
paid-in capital
|
340,274
|
340,153
|
|||||
Accumulated
deficit
|
(314,411
|
)
|
(321,860
|
)
|
|||
Total
stockholders’ equity
|
26,290
|
18,720
|
|||||
Total
liabilities and stockholders’ equity
|
$
|
39,466
|
$
|
45,628
|
See
accompanying notes to the consolidated financial
statements.
|
For
the Three Months
Ended
March 31,
|
|||||||
2008
|
2007
|
||||||
Revenues
|
|||||||
Program
fee revenue
|
$
|
13,707
|
$
|
-
|
|||
Collaboration
revenue
|
3,377
|
-
|
|||||
Total
revenue
|
17,084
|
-
|
|||||
Operating
expenses
|
|||||||
Research
and development expenses
|
4,082
|
1,196
|
|||||
Marketing,
general and administrative expenses
|
870
|
778
|
|||||
Total
operating expenses
|
4,952
|
1,974
|
|||||
Operating
income (loss)
|
12,132
|
(1,974
|
)
|
||||
|
|||||||
Other
income (expense)
|
|||||||
Interest
income (expense), net
|
297
|
(362
|
)
|
||||
Amortization
of debt discount
|
-
|
(1,692
|
)
|
||||
Loss
on fair value change of conversion features
|
-
|
(3,483
|
)
|
||||
Loss
on fair value change of common stock warrants
|
-
|
(1,668
|
)
|
||||
Gain
on asset disposals
|
-
|
20
|
|||||
Total
other income (expense)
|
297
|
(7,185
|
)
|
||||
Income
(loss) before income tax expense
|
12,429
|
(9,159
|
)
|
||||
Income
tax expense
|
4,980
|
-
|
|||||
Net
income (loss)
|
7,449
|
(9,159
|
)
|
||||
Earnings
(loss) per share:
|
|||||||
Basic
|
$
|
0.16
|
$
|
(0.26
|
)
|
||
Diluted
|
$
|
0.15
|
$
|
(0.26
|
)
|
||
Weighted
average shares used in computing :
|
|||||||
Basic
|
45,657
|
35,229
|
|||||
Diluted
|
49,439
|
35,229
|
Common
Stock
$0.01
Par Value -
Shares
|
Common
Stock
$0.01
Par Value -
Amount
|
Additional
Paid-in
Capital
|
Accumulated
Deficit
|
Total
|
||||||||||||
Balance
at December 31, 2007
|
42,706
|
$
|
427
|
$
|
340,153
|
$
|
(321,860
|
)
|
$
|
18,720
|
||||||
Net
income
|
-
|
-
|
-
|
7,449
|
7,449
|
|||||||||||
Stock
based compensation
|
-
|
-
|
121
|
-
|
121
|
|||||||||||
Balance
at March 31, 2008
|
42,706
|
$
|
427
|
$
|
340,274
|
$
|
(314,411
|
)
|
$
|
26,290
|
|
2008
|
2007
|
|||||
Cash
flows from Operating Activities:
|
|||||||
Net
income (loss)
|
$
|
7,449
|
$
|
(9,159
|
)
|
||
Adjustments
to reconcile net income (loss) to net cash used in operating
activities
|
|||||||
Depreciation
and amortization
|
42
|
29
|
|||||
Amortization
of debt discount
|
-
|
1,692
|
|||||
Loss
on fair value change of conversion features
|
-
|
3,483
|
|||||
Loss
on fair value change of common stock warrants
|
-
|
1,668
|
|||||
Common
stock issued for interest
|
-
|
364
|
|||||
Non-cash
stock compensation expense
|
121
|
442
|
|||||
Gain
on asset disposals
|
-
|
(20
|
)
|
||||
Deferred
income taxes
|
4,980
|
-
|
|||||
Impairment
reserve against fixed assets
|
(51
|
)
|
-
|
||||
Changes
in assets and liabilities
|
|||||||
Collaboration
revenue receivable
|
(400
|
)
|
-
|
||||
Prepaid
expenses and other current assets
|
232
|
81
|
|||||
Accrued
expenses
|
(24
|
)
|
430
|
||||
Deferred
program fee revenue
|
(13,708
|
)
|
-
|
||||
Net
cash used in operating activities
|
(1,359
|
)
|
(990
|
)
|
|||
Cash
flows from Investing Activities:
|
|||||||
Purchase
of investments
|
(4,000
|
)
|
-
|
||||
Capital
expenditures
|
(7
|
)
|
(27
|
)
|
|||
Proceeds
from asset disposals
|
-
|
20
|
|||||
Net
cash used in investing activities
|
(4,007
|
)
|
(7
|
)
|
|||
Cash
flows from Financing Activities:
|
|||||||
Proceeds
from issuance of senior secured term notes payable
|
-
|
1,296
|
|||||
Payments
on capital lease obligations
|
-
|
(6
|
)
|
||||
Net
cash provided by financing activities
|
-
|
1,290
|
|||||
(Decrease)
increase in cash and cash equivalents
|
(5,366
|
)
|
293
|
||||
Cash
and cash equivalents at beginning of period
|
31,368
|
228
|
|||||
Cash
and cash equivalents at end of period
|
$
|
26,002
|
$
|
521
|
|||
Cash
paid during the period for interest
|
$
|
-
|
$
|
2
|
1. |
Fixed
assets with a net book value of $51,000 under the impairment reserve
were
disposed.
|
2. |
The
Company issued 24,723 shares of common stock as payment of $207,000
of
Senior Secured Convertible Bridge Term Notes Payable accrued
interest.
|
3. |
The
Company issued 18,569 shares of common stock as payment of $157,000
of
Secured Term Note Payable accrued
interest.
|
4. |
Warrants
to purchase aggregate 41,009 shares of common stock were exercised
at
exercise prices between $1.20 and $6.60 per share in a series of
cashless
exercise transactions resulting in the issuance of aggregate 16,533
shares
of common stock.
|
5. |
The
issuance of $1,296,000 Senior Secured Convertible Bridge Term Notes
included conversion features measured at $1,188,000, which resulted
in an
equal amount of debt discount. The change in all separated conversion
feature’s fair value through March 30, 2007 resulted in a loss of
$3,483,000. Due to a debt agreement modification on March 30, 2007,
the
then current conversion feature fair value of $21,086,000 was reclassified
from liabilities to equity.
|
6. |
The
change in the common stock warrants’ fair value through March 30, 2007
resulted in a loss of $1,668,000. Due to a debt agreement modification
on
March 30, 2007, the then current fair value of all 1,592,100 outstanding
common stock warrants of $12,307,000 was reclassified from liabilities
to
equity.
|
Three
months ended
March
31,
|
|||||||
(in
thousands, except per share data)
|
2008
|
2007
|
|||||
Basic
earnings (loss) per share
|
|||||||
Numerator:
|
|||||||
Net
income (loss)
|
$
|
7,449
|
$
|
(9,159
|
)
|
||
Deemed
dividend from modification of debt
|
-
|
(3
|
)
|
||||
Net
loss allocable to common stockholders
|
$
|
7,449
|
$
|
(9,162
|
)
|
||
Denominator:
|
|||||||
Common
shares (weighted)
|
42,707
|
33,108
|
|||||
Vested
restricted stock units (weighted)
|
2,950
|
2,121
|
|||||
Weighted
average shares used in computing basic earnings (loss) per share
allocable
to common shareholder
|
45,657
|
35,229
|
|||||
Basic
earnings (loss) per share allocable to common shareholder
|
$
|
0.16
|
$
|
(0.26
|
)
|
||
Diluted
earnings per share
|
|||||||
Denominator:
|
|||||||
Common
shares (weighted)
|
42,707
|
-
|
|||||
Vested
restricted stock units (weighted)
|
2,950
|
-
|
|||||
Stock
options
|
1,448
|
-
|
|||||
Common
stock warrants
|
2,334
|
-
|
|||||
Weighted
average shares used in computing diluted earnings per share allocable
to
common shareholder
|
49,439
|
-
|
|||||
Diluted
earnings (loss) per share allocable to common shareholder
|
$
|
0.15
|
$
|
(0.26
|
)
|
||
Excluded
potentially dilutive securities:
|
|||||||
Common
stock issuable (see #1 below):
|
|||||||
Stock
options (vested and nonvested)
|
86
|
1,900
|
|||||
Nonvested
restricted stock units
|
-
|
737
|
|||||
Common
stock warrants
|
47
|
1,592
|
|||||
Convertible
term bridge notes
|
-
|
3,596
|
|||||
Total
excluded dilutive common stock equivalents
|
133
|
7,825
|
|||||
(1)
Number of common shares issuable is based on maximum number of common
shares issuable on exercise or conversion of the related securities
as of
period end. Such amounts have not been adjusted for the treasury
stock
method or weighted average outstanding calculations required if the
securities were dilutive.
|
Mar
31,
|
Dec
31,
|
||||||
2008
|
2007
|
||||||
Payroll,
payroll taxes and benefits
|
$
|
117
|
$
|
63
|
|||
Legal
fees
|
40
|
35
|
|||||
Audit
examination and tax preparation fees
|
61
|
120
|
|||||
Franchise
taxes
|
19
|
15
|
|||||
Property
taxes
|
39
|
34
|
|||||
Clinical,
regulatory, trademarks, and patent consulting fees
|
35
|
50
|
|||||
Other
fees and services
|
-
|
17
|
|||||
$
|
311
|
$
|
334
|
· |
research
and development
of product candidates utilizing our Aversion®
Technology;
|
· |
manufacture,
quality assurance testing and release, and stability studies of clinical
trial supplies and NDA submission batches of certain finished dosage
form
product candidates utilizing Aversion®
Technology;
|
· |
prosecution
of our patent applications relating to Aversion®
Technology with the United States Patent and Trademark Office (“USPTO”)
and foreign equivalents; and
|
· |
negotiation
and execution of license and development agreements with pharmaceutical
company partners providing that such licensees will further develop
certain finished dosage product candidates utilizing the
Aversion®
Technology and file for regulatory approval with the FDA and other
regulatory authorities and commercialize such
products.
|
· |
Capitalize
on our Experience and Expertise in the Research and Development of
Abuse
Deterrent Pharmaceutical Products.
Our approach is to utilize existing active pharmaceutical ingredients
with
proven safety and efficacy profiles that have known potential for
abuse,
and develop new products utilizing our proprietary Aversion® (“abuse
deterrent”) Technology. We believe that in most cases the FDA’s
505(b)(2)
NDA approval process may be used with these product candidates. While
there can be no assurance, we believe the use of the 505(b)(2) NDA
approval process may allow for more efficient and timely approvals
as
compared to standard NDA filings.
The 505(b)(2) NDA regulatory pathway is being utilized in the development
of Acurox™ Tablets, our lead product candidate utilizing Aversion®
Technology. In addition to Acurox™ Tablets, as of the date of this Report
we are engaged in the development of several additional product candidates
incorporating Aversion® Technology, including hydrocodone bitartrate with
acetaminophen tablets (marketed generically and by others under the
brand
names Vicodin®, Lortab®, and Lorcet®), hydromorphone HCl tablets (marketed
generically and by Abbott Laboratories under the brand name Dilaudid®) and
oxycodone HCl with acetaminophen (marketed generically and by others
under
the brand names of Percocet®, Tylox®, Endocet ®, and Roxicet®). We expect
to file an IND for our second Aversion® Technology opioid product
candidate in the first half of 2008.
|
· |
Maximize
Commercial Value of our Product Candidates Through Out-Licensing
to
Strategically Focused Pharmaceutical Partners. On
October 30, 2007, we and King entered into a License, Development
and
Commercialization Agreement (the “King Agreement”) to develop and
commercialize in the United States, Canada and Mexico (the "King
Territory") opioid analgesic products utilizing Aversion® Technology
including Acurox™ Tablets. We believe opportunities exist to enter into
similar agreements with other commercial partners for these same
opioid
products outside the King Territory and in the United States and
worldwide
for developing additional Aversion® Technology product candidates for
other abuseable drugs including tranquilizers, stimulants and sedatives.
By partnering with strategically focused companies with expertise
and
infrastructure in commercialization of pharmaceuticals, we are able
to
leverage our expertise, intellectual property rights and Aversion®
Technology without the need to build costly sales and manufacturing
infrastructure. We anticipate that our future revenue, if any, will
be
derived from milestone and royalty payments related to the
commercialization of products utilizing our Aversion®
Technology.
|
· |
Expand
the Aversion® Technology Intellectual Property Portfolio.
We
believe our patent granted by the United States Patent and Trademark
Office ("USPTO") in April 2007 for Aversion® Technology provides
protection in the U.S. against potential generic product competition
through March 2025 and is a key element for the appeal of our product
candidates to King for opioid analgesic product candidates and other
potential commercial partners for non-opioid product candidates.
We have
filed additional patent applications with the USPTO which, if issued,
will
compliment and broaden the scope of our granted patent claims. In
addition, we have filed corresponding Aversion® Technology patent
applications internationally. All of the Aversion® Technology intellectual
property, including all pending and issued patents was developed
internally by the Company and as of the date of this Report we believe
no
enabling licenses from others will be required.
|
· |
Remain
focused on Research, Development and Achieving Proof of Concept for
Product Candidates Incorporating the Aversion®
Technology while Minimizing Internal Fixed Costs through Outsourcing
High
Fixed Cost Elements of the Development Process. We
maintain a streamlined corporate infrastructure focused on:
|
· |
selection,
formulation development, laboratory evaluation, manufacture, quality
assurance and stability testing of certain finished dosage form product
candidates;
|
· |
development
and prosecution of our patent applications; and
|
· |
negotiation
and execution of license and development agreements with strategically
focused pharmaceutical partners. While we expect to expand our internal
staff to enable us to more rapidly develop multiple product candidates,
as
of the date of this Report we have only 15 employees, 9 of whom are
engaged in the research, development and manufacture of product candidates
utilizing the Aversion® Technology. We contract with CROs with expertise
in regulatory affairs, clinical trial design and monitoring, clinical
data
management, biostatistics, medical writing, laboratory testing and
related
services. Such CROs perform development services for Acurox™ Tablets and
other Aversion® product candidates under our direction. By outsourcing the
high fixed cost elements of our product development process, we believe
that we substantially reduce fixed overhead and capital investment
and
thereby reduce our business risk.
|
· |
Mild
burning and irritation
-if the tablets are crushed and the prospective drug abuser attempts
to
snort the crushed tablets a mild burning and irritation of the nasal
passages is
expected
to
occur
|
· |
Viscous
gel traps active ingredient
-when Acurox™ Tablets are crushed and snorted, we expect the moisture in
the nasal passages will form a viscous gel with the crushed tablet
powder
thereby trapping the oxycodone in the gel and reducing the amount
of
oxycodone available for absorption through the lining of the nasal
passages
|
· |
Gelatinous
mass
-
we believe that the viscous gel formed in the nasal passages will
result
in a sticky mass producing an unpleasant sensation in the nasal passages
of the prospective abuser
|
Opioid
Active Ingredients
(Generic
Names)
|
Frequently
Prescribed Opioid Analgesics
(Common
Brand Names)
|
|
Oxycodone
|
Percocet®,
OxyContin®, Roxicet®, Tylox®, Endocet®
|
|
Hydrocodone
|
Vicodin®,
Lortab®, Lorcet®
|
|
Morphine
|
Avinza®,
Kadian®, MSContin®
|
|
Hydromorphone
|
Dilaudid®
|
|
Codeine
|
Tylenol®
with Codeine
|
|
Tramadol
|
Ultram®,
Ultram® ER, Ultracet®
|
|
Propoxyphene
|
Darvon®,
Darvocet®
|
Category
|
During
Lifetime
(millions)
|
During
Past Year
(millions)
|
Frequently
Prescribed
(Common
Brand Names)
|
|||
CNS
Depressants
|
30.1
|
6.0
|
Valium®,
Xanax®, Halcion®, Klonopin®, Ativan®, Nembutal®
|
|||
Stimulants
|
20.1
|
3.4
|
Dexadrine®,
Adderall®, Ritalin®, Concerta®
|
Technical
and Pre-Clinical Development
|
Status
and Expectations
|
|
Formulation
development
|
Complete
|
|
Pilot
bioequivalence study
|
Complete
|
|
Pivotal
oxycodone laboratory extraction study
|
Complete
(results summarized in this Report)
|
|
Tablet
stability for NDA submission
|
Testing
in process. 24 month real time data demonstrates stability acceptable
for
NDA submission
|
|
Toxicology
studies
|
Not
required per FDA written guidance to
us
|
Regulatory
Affairs
|
Status
and Expectations
|
|
Investigational
New Drug Application (IND)
|
Active
|
|
End
of Phase II meeting with FDA
|
Complete
|
|
Factorial
design clinical studies
|
Not
required per FDA written guidance to us
|
|
Phase
III pivotal clinical trial
|
A
single phase III efficacy and safety trial is required per FDA written
guidance to us. Refer to status summary for Study AP-ADF-105 in this
Report.
|
|
Type
of regulatory submission for U.S. regulatory approval and commercial
distribution in the U.S.
|
Acurox™
Tablets are eligible for submission as a 505(b)(2) NDA per FDA written
guidance to us
|
|
505(b)(2)
NDA submission
|
Anticipate
submission prior to the end of 2008
|
Product
Tested,
Oxycodone
HCl Strength
and
Product Supplier
|
Approximate
laboratory time required to produce a form suitable for intravenous
injection
|
Extraction
Scheme
and
Yield
|
Difficulty
Rating
1
= Easy to
10
= Difficult
|
||||
OxyContin®
Tablets
1x
40mg tablet
Purdue
Pharma
|
3
minutes
|
3
steps
~92%
Yield
|
1
|
||||
Oxycodone
HCl Tablets
8
x
5mg tablets,
Mallinckrodt
|
6
minutes
|
3
Steps
~71%
Yield
|
2
|
||||
Percocet
Tablets
8
x
5/325mg tablets
Endo
Labs
|
<10
minutes
with
vacuum assisted filtration
|
3
Steps
~75%
Yield
|
3-4
|
||||
Acurox
Tablets
8
x
5/30mg tablets
Acura
Pharmaceuticals
|
355
minutes
with
no success
|
23
Steps
~0%
Yield
|
10
|
Clinical
Studies to Evaluate Pharmacokinetics in Normal
Subjects
|
Status
and Expectations
|
|||
AP-ADF-104
|
Phase
I:
Bioequivalence to non
Aversion® Technology Reference Listed Drug
|
Final
study report complete. Acurox™ Tablets are bioequivalent to the Reference
Listed Drug
|
||
AP-ADF-108
|
Phase
I: Single dose linearity
and food effect
|
Final
study report complete. Acurox™ Tablets demonstrate single dose linearity.
Absorption is delayed by food.
|
||
AP-ADF-109
|
Phase
I: Multi-dose linearity
|
Subject
enrollment complete
|
||
AP-ADF-110
|
Phase
I: Required only if there is not dose linearity in Study AP-ADF-108
and
Study AP-ADF-109
|
As
of the date of this Report, we do not anticipate this study will
be
required
|
Clinical
Studies to Evaluate Niacin Dose Response in Normal
Subjects
|
Status
and Expectations
|
|||
AP-ADF-101
|
Phase
I: Niacin dose-response (0-75mg)
|
Final
study report complete
|
||
AP-ADF-103
|
Phase
II: Repeat dose safety and tolerability
|
Final
study report complete.
Refer
to summary in this Report
|
||
AP-ADF-107
|
Phase
II: Niacin dose-response (0-600mg)
|
Final
study report complete.
Refer
to summary in this Report
|
Clinical
Studies to Evaluate Tolerability of Nasal Snorting and
Excess
Oral Doses in Subjects with a History of Opioid
Abuse
|
Status
and Expectations
|
|||
AP-ADF-106
|
Phase
I: Evaluate effects of nasal snorting in subjects with a history
of
snorting and nasal drug abuse
|
Expect
subject enrollment to commence in Q2-08
|
||
AP-ADF-102
|
Phase
II: Evaluate relative dislike of oxycodone HCl/niacin versus oxycodone
HCl
alone
|
Final
study report complete
Refer
to summary in this Report
|
||
AP-ADF-111
|
Phase
II: Evaluate abuse liability of oxycodone HCl/niacin versus oxycodone
HCl
alone
|
Subject
enrollment commenced in Q1-08
|
(1)
|
In
the fasting state, all three doses of niacin [240mg, 480mg and 600mg]
in
combination with oxycodone 40mg produced significant (p ≤ .05) disliking
scores compared to oxycodone 40mg alone. The linear regression across
niacin dose was not significant. No other subjective measure was
significantly affected by the niacin addition to
oxycodone.
|
|
|
(2)
|
The
high fat meal eliminated the niacin effect on oxycodone 40 mg. The
high
fat meal also delayed the time to oxycodone peak blood
levels.
|
|
|
(3)
|
The
addition of niacin to oxycodone alters the subjective response to
oxycodone as indicated by the significant responses on the disliking
scale. This observation in conjunction with the results from the
Treatment
Enjoyment Questionnaire indicates that the addition of niacin reduces
the
attractiveness of oxycodone to opiate abusers.
|
|
|
(4)
|
There
were no serious adverse events. Niacin produced a dose related attenuation
of pupillary constriction, diastolic blood pressure increase and
probably
systolic blood pressure increase produced by oxycodone. The alterations
by
niacin on the vital sign responses to oxycodone 40 mg were minimal,
were
seen primarily with the 600 mg niacin dose and were not clinically
significant.
|
Clinical
Study to Evaluate Efficacy and Safety in Patients with Moderate to
Severe
Pain
|
Status
and Expectations
|
|||
AP-ADF-105
|
Phase
III: Pivotal efficacy and safety
|
Special
Protocol Assessment (SPA) agreed by FDA. Patient enrollment is complete.
Top line results expected in July
2008.
|
Immediate
Release Products
|
Extended
Release Products
|
||
Dispensed
Rx’s 1
|
221
Million
|
14
Million
|
|
Ratio
of Dispensed Rx’s1
|
16:1
|
||
Ratio
of Abuse2
|
10:1
|
||
Estimated
Ratio of $ Market Potential3
|
4:1
|
||
Identified
Competitors
|
Acura
in collaboration with King
|
1. Alpharma
2. Pain
Therapeutics
3. Purdue
4. Endo
5. Elite
6. Neuromed
7. Collegium
|
Three Months Ended Mar
31,
|
|
Change
|
|||||||||||
($ in thousands):
|
2008
|
|
2007
|
|
Dollars
|
|
%
|
||||||
Revenue
- Program fee revenue
|
$
|
13,707
|
$
|
-
|
$
|
13,707
|
*
|
%
|
|
|
Three Months Ended Mar
31,
|
|
Change
|
|
|||||||
($ in thousands):
|
|
2008
|
|
2007
|
|
Dollars
|
|
%
|
|
|||
Revenue
- Collaboration fee revenue
|
|
$
|
3,377
|
|
$
|
-
|
|
$
|
3,377
|
|
*
|
%
|
|
|
Three Months Ended Mar
31,
|
|
Change
|
|
|||||||
($ in thousands):
|
|
2008
|
|
2007
|
|
Dollars
|
|
%
|
|
|||
Research
and development expenses
|
|
$
|
4,082
|
|
$
|
1,196
|
|
$
|
2,886
|
|
241
|
%
|
|
|
Three Months Ended Mar
31,
|
|
Change
|
|
|||||||
($ in thousands):
|
|
2008
|
|
2007
|
|
Dollars
|
|
%
|
|
|||
Marketing,
general & administrative expenses
|
|
$
|
870
|
|
$
|
778
|
|
$
|
92
|
|
12
|
%
|
|
|
Three Months Ended Mar
31,
|
|
Change
|
|
|||||||
($ in thousands):
|
|
2008
|
|
2007
|
|
Dollars
|
|
%
|
|
|||
Interest
income (expense), net
|
|
$
|
297
|
|
$
|
(362)
|
|
$
|
659
|
|
182
|
%
|
|
|
Three Months Ended Mar
31,
|
|
Change
|
|
|||||||
($ in thousands):
|
|
2008
|
|
2007
|
|
Dollars
|
|
%
|
|
|||
Net
income (loss)
|
|
$
|
7,449
|
|
$
|
(9,159)
|
|
$
|
16,608
|
|
181
|
%
|
Expected
cash payments on
contractual
obligations outstanding
at
March 31, 2008
|
Total
|
Due
in 2008
|
Due
in 2009
|
Due
Thereafter
|
|||||||||
Clinical
trials
|
$
|
2,404
|
$
|
2,404
|
$
|
-
|
$
|
-
|
|||||
Operating
leases
|
30
|
23
|
7
|
-
|
|||||||||
Employment
agreements
|
663
|
663
|
-
|
-
|
|||||||||
Total
contractual cash obligations
|
$
|
3,097
|
$
|
3,090
|
$
|
7
|
$
|
-
|
Expected
cash payments on
contractual
obligations entered into subsequent to March 31,
2008
|
Total
|
Due
in 2008
|
Due
in 2009
|
Due
Thereafter
|
|||||||||
Employment
agreements
|
$
|
508
|
$
|
218
|
$
|
290
|
$
|
-
|
31.1 |
Certification
of Periodic Report by Chief Executive Officer pursuant to Rule 13a-14
and
15d-14 of the Securities Exchange Act of
1934.
|
31.2 |
Certification
of Periodic Report by Chief Financial Officer pursuant to Rule 13a-14
and
15d-14 of the Securities Exchange Act of
1934.
|
32.1 |
Certification
of Periodic Report by the Chief Executive Officer and Chief Financial
Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to
Section
906 of the Sarbanes-Oxley Act of
2002.
|
April
30,
2008
|
ACURA PHARMACEUTICALS, INC. | |
|
|
|
/s/ Andrew D. Reddick | ||
Andrew
D. Reddick
President
& Chief Executive Officer
|
||
/s/ Peter A. Clemens | ||
Peter
A. Clemens
Senior
VP & Chief Financial
Officer
|