Dermagen Reports Successful Phase I/IIa Clinical Trial for Atopic Dermatitis

By Dermagen Ab, PRNE
Tuesday, December 1, 2009

LUND, Sweden, December 2 - DermaGen AB - part of the Karolinska Development dermatology
and wound healing company "Pergamum" - today announced that Dermagen AB has
received promising results from a clinical Phase I/IIa study. DermaGen AB is
developing a novel antimicrobial peptide (AMP) treatment for atopic
dermatitis. Atopic dermatitis is a chronic inflammatory skin disease where
dry skin and the skin's weakened barrier function make patients susceptible
to colonization by microorganisms, a triggering or exacerbating factor of the
disease. The AMP has shown a broad spectrum of activity and is both
bactericidal and fungicidal. In the clinical trial, the company's candidate
drug clearly reached its primary objective, demonstrating a significant
reduction of total microbes in eczemas compared to placebo. In addition to
good safety and tolerability performance, the candidate drug also showed a
trend towards improved eczema status. This is the first time a study has
shown efficacy of AMPs for atopic dermatitis in man.

Commenting on the study, DermaGen's Managing Director, Jan
Alenfall
, said, "Achieving such promising results from a first-time-in-man
trial is very pleasing. The observed trend towards improvement of the disease
condition provides particular encouragement. We will now initiate further
clinical studies to substantiate this. Skin infection is recognized as an
aggravating factor of atopic dermatitis. The development of a new class of
treatment, capable of eradicating microbes with limited risk of microbial
resistance development, is likely to have significant market appeal within
this and other dermatological indications."

Jorgen Thorball, Pergamum's Chairman, stated, "DermaGen is a
very exciting company with a strong technology platform. These promising
clinical results go a long way towards establishing proof of concept within
atopic dermatitis. They also strengthen the company's position as it explores
additional, first-in-class opportunities for the candidate drug and other
compounds for the topical treatment of dermatological infections, such as
impetigo and infected wounds and burns."

The rapid resistance development by microbes limits the use of classical
antibiotics for indications such as atopic dermatitis, especially for topical
applications. DermaGen's AMP is derived from natural endogenous human
proteins and there is low probability that it will induce resistance as it
lack a specific molecular target on bacteria and other microbes.
Anti-infective treatments represent the most important component of the
global dermatology market, accounting for 31% of total market value,
approximately USD 4 billion.

Conny Bogentoft, CEO of Karolinska Development, said,
"Pergamum and its Operating Units form an important part of the Karolinska
Development portfolio. They represent a strong offering in dermatology and
wound healing markets with products targeting indications with significant
unmet medical needs. It is encouraging to see the progress they are making in
their clinical development programs."

About DermaGen

DermaGen AB is a specialty pharmaceutical company and world
leader in the research and development of endogenous antimicrobial peptides.
Founded in 2004, DermaGen focuses on the development of topically applied
products for the prevention and treatment of bacterial and fungal skin
infections. Novel antimicrobial peptides are modified to increase their
potency and stability, facilitating the development of pharmaceutical
products that fulfill unmet medical needs and significantly improve quality
of life for patients. DermaGen partners with leading international
pharmaceutical companies in the dermatological field to ensure rapid and
cost-efficient development. The company is based in Lund, Sweden and is part
of the Pergamum group of companies.

www.dermagen.se

About Pergamum

Pergamum AB is a new kind of biopharmaceutical company
focusing solely on dermatology and wound healing markets. The company
currently has four Operating Units, which it supports with strategic
management, business development, drug development and operational assistance
as required. Pergamum is a Karolinska Development AB company.

www.pergamum.com

About Karolinska Development

Karolinska Development manages one of the largest portfolios
of life science companies in Europe. Using a unique, highly cost-efficient
business model, the management team guides the commercialization of
world-class life science innovations, helping to shape the next-generation
pharma industry. Since 2003, Karolinska Development has built a portfolio of
some 40 companies; among the company's projects 12 compounds are undergoing
clinical trials. The portfolio also includes a total of 19 potential
first-in-class products.

www.karolinskadevelopment.com

About Atopic Dermatitis

Atopic dermatitis (AD) is a chronic inflammation of the skin that occurs
in persons of all ages but is more common in children. AD is a chronic,
itching, inflammatory skin disease, which is associated with asthma and/or
hay fever and a familial occurrence of these conditions.

The prevalence of AD has risen 3-4-fold over the last 30 years and is now
a major public health problem in the seven major markets, with 3% of the US
population suffering from AD. It has been reported to affect 10 % of children
and accounts for between 10 and 20 % of all visits to dermatologists.

There is considerable evidence that colonization or infection with S.
aureus is a triggering or exacerbating factor in AD. Superantigens produced
by the bacteria stimulate keratinocytes and T-lymphocytes, and trigger the
inflammatory process. The inflammation leads to an impaired skin barrier
function. Furthermore, endogenous antimicrobial peptides are low in patients
with AD, leading to a vicious cycle of S. aureus involvement in the disease.
Superantigens also act as potent inhibitors of steroid action, possibly
leading to steroid resistance.

The use of topically administered AMPs for control and normalization of
the bacterial and fungal flora is therefore a logical and attractive method
for interfering with the pathogenesis of AD. It is well established that
treatment of AD with steroids in combination with antibiotics is more
effective than use of steroids alone. In the light of current therapies,
endogenous AMPs will add an important new and significant therapeutic
modality to current treatments with a very low probability of inducing
bacterial resistance.

    For further information, please contact:

    Jan Alenfall, Managing Director, DermaGen AB
    Phone: +46(0)46-192-197 / Mobile: +46(0)709-315-115
    E-mail: jan.alenfall@dermagen.se

    Jorgen Thorball, Chairman, Pergamum AB
    Phone: + 45(0)307-786-27
    E-mail: jorgen.thorball@pergamum.com

    Conny Bogentoft, CEO, Karolinska Development AB
    Phone: +46(0)70-668-61-43
    E-mail: conny.bogentoft@karolinskadevelopment.com

For further information, please contact: Jan Alenfall, Managing Director, DermaGen AB, Phone: +46(0)46-192-197 / Mobile: +46(0)709-315-115, E-mail: jan.alenfall at dermagen.se; Jorgen Thorball, Chairman, Pergamum AB, Phone: + 45(0)307-786-27, E-mail: jorgen.thorball at pergamum.com; Conny Bogentoft, CEO, Karolinska Development AB, Phone: +46(0)70-668-61-43, E-mail: conny.bogentoft at karolinskadevelopment.com

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