New Interferon Formulations Promise to Eliminate Injections in Multiple Sclerosis Treatment

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Mon Jan 12, 2009 3:01am EST

  SAN DIEGO, CA, Jan 12 (MARKET WIRE) -- 
Nerveda Inc. and Aegis Therapeutics LLC today announced preclinical
results from their joint collaboration aimed at developing non-injectable
formulations of the beta-interferons. The beta interferons, beta-1a
(tradename Rebif(R)), and beta 1b (tradenames Betaseron(R) and
Betaferon(R)) are closely related injectable protein drugs in the
interferon family that are used to treat both the relapsing-remitting and
secondary-progressive forms of multiple sclerosis (MS). The beta
interferons are currently administered by subcutaneous injection and have
been proven clinically to slow the advance of multiple sclerosis and
reduce the frequency of attacks. Current worldwide combined annual sales
of Rebif(R), Betaseron(R) and Betaferon(R) are approximately $4 Billion.

    Because proteins are large and fragile molecules, they cannot be
administered orally and are typically administered by injection. They are
often subject to instability due to aggregation of the protein molecules
-- particularly upon storage and handling at non-refrigerated
temperatures. The resulting protein aggregates are more poorly absorbed
into the blood stream upon injection due to their increased size, and
induce development of circulating antibodies to interferon in patients
that reduce the effectiveness of the drug over time.

    Leading medical scientists at Johns Hopkins University, expert in the
treatment of neurological diseases, in collaboration with Nerveda and
Aegis have applied Aegis' Intravail(R) transmucosal absorption
enhancement, and ProTek(R) protein stabilization technologies to address
these problems and have demonstrated for the first time that the beta
interferons can be administered intranasally to prevent nerve damage in
preclinical animal models of multiple sclerosis. In addition, the new
formulations were shown to reduce or eliminate the immunogenicity of
Betaseron(R) and Rebif(R), administered either by injection or
intranasally, while substantially increasing stability in a stress test
involving constant agitation at elevated temperatures for extended
periods of time.

    Dr. Edward Maggio, Ph.D., CEO of Aegis Therapeutics, who participated in
the research, said, "since interferons will continue to be the foundation
of MS therapy, it is critical that non-invasive delivery options for
patients be developed." Maggio also indicated, "the reduction in
immunogenicity and the increase in stability also address a significant
unmet need of the currently available beta-interferon therapies."

    Nerveda plans to begin testing the new formulation in clinical trials in
early 2009 in collaboration with clinicians and scientists at John Hopkins
University Medical Center and other sites.

    * Rebif(R) is a registered trademark of Pfizer, Inc.

    * Betaseron(R) is a registered trademark of Bayer Healthcare
Pharmaceuticals

    * Betaferon(R) is a registered trademark of Bayer Schering Pharma AG

    * Intravail(R) and ProTek(R) are registered trademarks of Aegis
Therapeutics, LLC

    About Nerveda Inc.

    Nerveda is a privately funded specialty pharmaceutical and diagnostic
company focused on improving the quality of life for patients suffering
from neurodegenerative diseases and their caregivers. Nerveda supports the
clinical development of products licensed from Johns Hopkins University,
including neuroprotective compounds and stem cell therapeutics that show
promise in treating auto-immune disorders.

    About Aegis Therapeutics

    Aegis Therapeutics LLC is a drug delivery technology company
commercializing its patented or proprietary drug delivery and drug
formulation technologies through product-specific licenses. Our patented
Intravail(R) drug delivery technology enables the non-invasive delivery of
a broad range of protein, peptide and non-peptide macromolecular
therapeutics that can currently only be administered by injection. Aegis'
Intravail(R) absorption enhancement agents provide exceptionally high and
unmatched bioavailability performance, comparable in efficiency to
subcutaneous injection, via the intranasal administration route.
Intravail(R) has also been successfully applied to buccal, oral, and
rectal administration of small molecule, peptide, and nucleotide-analog
type drugs. Our patented ProTek(R) technology allows creation of
proprietary, easily manufacturable, and stable aqueous or lyophilized
dosage forms that maintain the integrity and physiological activity of
many protein and peptide therapeutics. ProTek(R) technology is applicable
to injectable, intranasal, and other dosage forms of peptide or protein
therapeutics.

    For more information about Aegis, please visit the Aegis website at:
http://www.aegisthera.com.

    

Contact:
Nerveda Inc.
Cam Gallagher
CEO
1-(858) 705-2365
Email: Email Contact

Contact:
Aegis Therapeutics LLC
Ralph Barry
Chief Business Officer
1-858-618-1400 Ext. 102
Email: Email Contact

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