EXHIBIT 99.1
ELITE ANNOUNCES SUCCESSFUL RESULTS ON ABUSE RESISTANT
TECHNOLOGY FOR NARCOTIC ANALGESICS
Thursday December 8, 10:50 am ET
NORTHVALE, N.J.--(BUSINESS WIRE)--Dec. 8, 2005--Elite Pharmaceuticals, Inc.
(AMEX: ELI - NEWS) announced positive results from their completed pilot Phase I
study under its Investigational New Drug Application (IND), designed to test
Elite's proprietary abuse resistant technology ("ART(TM)") for use with opioids.
The product tested, OxyNal(TM), uses a pharmacological agonist-antagonist
combination approach of sustained release agonist oxycodone hydrochloride,
intended for use in patients with moderate to severe chronic pain, and an
antagonist naltrexone hydrochloride formulated to deter abusers of the drug.
"We are very pleased with the positive results we obtained from this study which
not only meets a significant milestone in the development of this program in
pain management but also validates Elite's pharmacological approach for our
ART(TM)," stated Bernard Berk, chairman and chief executive officer of Elite
Pharmaceuticals. "It gives us a great deal of added confidence in our next steps
when we meet with the FDA to present the overall NDA developmental program.
Encouraged with these promising results, we are expediting the developmental
time lines. This achievement is yet another step forward for Elite to establish
itself as a leader and innovator in pain management. Our goal is to address this
large unmet medical need and to provide better, safer, and more abuse-resistant
pain products that positively affect people who are suffering from chronic
pain."
The studies were conducted on sixteen healthy human volunteers. Test subjects
were given a single dose of intact and crushed forms of OxyNal(TM) under fasted
conditions. Oxycodone and naltrexone levels were measured in the subjects'
blood. The following results were achieved:
Performance of Intact Capsules: This study was designed to evaluate the
pharmacokinetics of OxyNal's(TM) formulation when it was administered to the
subjects in its unaltered form. The results showed that no quantifiable blood
levels of naltrexone were released at a limit of quantification ("LOQ") of 7.5
pg/mL while the oxycodone showed a typical release profile for a 12-hour
product, thus provides the desired effect of pain relief. This data is
consistent with the premise of Elite's ART(TM), that essentially no naltrexone
is released and absorbed when administered as intended.
TABLE 1. Summary of average plasma level data for the intact OxyNal(TM) test
product.
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DRUGS HOURS; PLASMA CONCENTRATIONS OF OXYCODONE AND NALTREXONE (PG/ML); N = 16;
FASTED SUBJECTS; ADMINISTRATION OF INTACT OXYNAL(TM)
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0 0.25 1.00 2.00 4.00 6.00 8.00 10.00 12.00 16.00 24.00
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Oxycodone BLLOQ BLLOQ 4.20 6.90 8.00 7.30 5.20 3.40 2.00 0.90 0.14
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Naltrexone BLLOQ BLLOQ BLLOQ BLLOQ BLLOQ BLLOQ BLLOQ BLLOQ BLLOQ BLLOQ BLLOQ
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BLLOQ = Below level of quantitation
Performance of Crushed Capsules: Sustained release opioids are typically abused
by crushing and taking orally or nasally. This study was designed to evaluate
the pharmacokinetics of OxyNal's(TM) formulation when it was administered to the
subjects after it was physically altered by removing the pellets from the
capsules and crushing the pellets. The data showed as anticipated, the
naltrexone is released along with the oxycodone and would provide the desired
effect of negating the euphoric high sought by abusers. The average naltrexone
blood level measured was over 1,800 pg/mL at 15 minutes post dosing.
TABLE 2. Summary of average plasma level data for the crushed OxyNal(TM) test
product.
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DRUGS HOURS; PLASMA CONCENTRATIONS OF OXYCODONE AND NALTREXONE (PG/ML); N = 16;
FASTED SUBJECTS; ADMINISTRATION OF CRUSHED OXYNAL(TM)
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0 0.25 1.00 2.00 4.00 6.00 8.00 10.00 12.00 16.00 24.00
==============================================================================================================
Oxycodone 0 3.40 14.50 11.80 8.00 4.90 3.20 2.20 1.40 0.60 0.14
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Naltrexone 1.00 1,868 2,671 1,792 841 465 278 189 191 90 41
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BLLOQ = Below level of quantitation
About Elite Pharmaceuticals
Elite Pharmaceuticals is a specialty pharmaceutical company principally engaged
in the development of oral, controlled release products. The Company's strategy
includes developing generic versions of controlled release drug products with
high barriers to entry and assisting partner companies in the life cycle
management of products to improve off-patent drug products. Elite's technology
is applicable to develop delayed, sustained or targeted release capsules or
tablets. Elite has one product currently being sold commercially and a pipeline
of seven drug products under development in the therapeutic areas that include
pain management, allergy, cardiovascular and infection. The addressable market
for Elite's current pipeline of products exceeds $6 billion. Elite also has a
GMP and DEA registered facility for research, development, and manufacturing
located in Northvale, NJ.
This news release contains forward-looking statements, including those related
to the preliminary nature of the clinical program results and the potential for
further product development, that involve known and unknown risks, delays,
uncertainties and other factors not under the control of Elite or Pliva, which
may cause actual results, performance or achievements of the companies to be
materially different from the results, performance or other expectations implied
by these forward-looking statements. In particular, because substantial future
testing will be required prior to approval, the results described above may not
be supported by additional data or by the results of subsequent trials. These
risks and other factors, including the timing or results of pending and future
clinical trials, regulatory reviews and approvals by the Food and Drug
Administration and other regulatory authorities, and intellectual property
protections and defenses, are discussed in the Elite's filings with the
Securities and Exchange Commission such as the 10K, 10Q and 8K reports. The
companies undertake no obligation to update any forward-looking statements.
CONTACT:
Elite Pharmaceuticals, Inc.
Dianne Will, 518-398-6222
dwill@willstar.net
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www.elitepharma.com
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or
Investor Relations
The Investor Relations Group
Dian Griesel/John Nesbett/Antima "Taz" Sadhukhan
212-825-3210
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Source: Elite Pharmaceuticals, Inc.