EXHIBIT 99.1
Elite Pharmaceuticals Announces Promising Results On Abuse Resistant Technology
For Narcotic Analgesics
NORTHVALE, N.J., Jan. 7 /PRNewswire-FirstCall/ -- Elite Pharmaceuticals, Inc.
("Elite" or the "Company") (Amex: ELI) announced that its subsidiary, Elite
Laboratories, Inc. ("Elite Labs"), received promising results from a clinical
program designed to test the Company's proprietary abuse resistant technology
("ART(TM)") for narcotic analgesics, such as OxyContin(R), utilizing naltrexone
as a narcotic antagonist. The pilot pharmacokinetic studies were conducted
during the fourth quarter of 2004 on twelve healthy human volunteers. Test
subjects were given a single dose of naltrexone formulated with the Company's
ART and the subjects' blood was then tested for naltrexone. The following
studies were conducted:
The first study was designed to evaluate the pharmacokinetics of the
Company's lead formulation when it was administered to the subjects in its
unaltered form and after it was physically altered by crushing. Results from the
unaltered formulation showed that no quantifiable blood levels of naltrexone
were released at a limit of quantification ("LOQ") of 7.5 pg/mL. The physically
altered formulation data showed that significant amounts of naltrexone were
released and absorbed with a Cmax of 3,330 pg/mL achieved at the 30 minute time
point. This data is consistent with the premise of Elite's ART according to
which no naltrexone is to be released and absorbed unless the formulation is
physically damaged. The table below provides a brief summary of this data:
Parameter Plasma Concentrations Released, pg/mL; Hours Post Dosing
Unaltered
Fasted
n = 12
Hours PD 0 0.50 0.75 1 1.5 2
pg/mL 0.00 0.00 0.00 0.00 0.00 0.00 0.00
Hours 4 6 8 10 12 16 24
pg/mL 0.00 0.00 0.00 0.00 0.00 0.00 0.00
Altered
Fasted
n = 12
Hours PD 0 0.50 0.75 1 1.5 2
pg/mL 0.00 1,107 3,330 3,167 3,122 2,378 1,999
Hours 4 6 8 10 12 16 24
pg/mL 905 466 299 197 193 68.4 11.3
A second study was designed to evaluate the effect of food on the absorption
of naltrexone. The subjects were given a standard meal prior to administering
the Company's lead formulation. Blood samples were drawn for a 24 hour period
and tested for naltrexone levels. As set forth in the table below, food did not
affect the performance of the formulation and no quantifiable levels of
Naltrexone were observed at an LOQ of 7.5 pg/mL.
Parameter Plasma Concentrations Released, pg/mL; Hours Post Dosing
Fasted
n=12
Hours PD 0 0.50 0.75 1 1.5 2
pg/mL 0.00 0.00 0.00 0.00 0.00 0.00 0.00
Hours 4 6 8 10 12 16 24
pg/mL 0.00 0.00 0.00 0.00 0.00 0.00 0.00
Fed
n=12
Hours PD 0 0.50 0.75 1 1.5 2
pg/mL 0.00 0.00 0.00 0.00 0.00 0.00 0.00
Hours 4 6 8 10 12 16 24
pg/mL 0.00 0.00 0.00 0.00 0.00 0.00 0.00
A third study was designed to observe the blood levels of Naltrexone for
seven days following dosing under fed conditions in six subjects. Table below
shows that no quantifiable blood levels of Naltrexone at an LOQ of 7.5 pg/mL
were observed during this seven day period.
Parameter Plasma Concentrations Released, pg/mL; Hours Post Dosing
Fed
n = 6
Hours PD 12 24 36 48 60
pg/mL 0.00 0.00 0.00 0.00 0.00 0.00
Hours 72 84 96 120 144 168
pg/mL 0.00 0.00 0.00 0.00 0.00 0.00
The Company believes that the results from these pilot studies support the
concept behind the development of its proprietary abuse resistant technology for
narcotic analgesics. Elite Labs plans to continue the clinical program on its
abuse resistance properties of naltrexone formulated utilizing the Company's
ART.
About Elite Pharmaceuticals
Elite Pharmaceuticals is a specialty pharmaceutical company principally
engaged in the development of oral, controlled release products. Elite develops
controlled release products internally using its proprietary technology and
licenses these 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 pellets, capsules, tablets, granules and powders.
Elite has a pipeline of six drug products under development in the therapeutic
areas that include cardiovascular, pain management, allergy and infection. The
addressable market for Elite's pipeline of products exceeds $2 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 product efficacy and product development, that involve known and
unknown risks, delays, uncertainties and other factors not under the Company's
control, which may cause actual results, performance or achievements of the
Company 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 Company's filings with the
Securities and Exchange Commission such as the 10K, 10Q and 8K reports. The
Company undertakes no obligation to update any forward-looking statements.
SOURCE Elite Pharmaceuticals, Inc.
WEB SITE: http://www.elitepharma.com