Debiopharm and DeveloGen Announce Partnering of Myasthenia Gravis
Program

LAUSANNE, Switzerland and GOETTINGEN, Germany, August 16

Debiopharm S.A., the independent drug development company
specialising in oncology, endocrinology and niche products and
DeveloGen AG, a biopharmaceutical company focusing on novel
treatments for metabolic disorders, today announced an exclusive
worldwide collaboration and licensing agreement, by which Debiopharm
will develop PTR-262, a novel peptide drug for the treatment of
myasthenia gravis (MG), before out-licensing to global partners for
commercialisation.

Under the terms of the agreement, DeveloGen will receive
milestone payments and, upon commercialisation of the product,
royalties based on Debiopharm's revenues from worldwide sales.

Rolland-Yves Mauvernay, President and CEO of Debiopharm
said, "PTR-262 is a novel approach that may replace the currently
used immunosuppressive drugs and avoid the side-effects that
myasthenia gravis sufferers may experience.

PTR-262 will be the first disease-modifying drug for the treatment of
myasthenia gravis, as it aims at specifically abrogating the
production of disease-causing antibodies. This represents a
significant improvement over current therapies and a promising
treatment for myasthenia gravis patients".

Guenther Karmann, CEO of DeveloGen said: "We are very pleased
that Debiopharm has chosen to continue the development of PTR-262 as
a potential treatment for this debilitating disease. We are
confident that Debiopharm's extensive experience will ensure the
rapid advancement of PTR-262 into the market".
The PTR-262 program
PTR-262, discovered at the laboratories of Professors Michael
Sela and Edna Mozes at the Weizmann Institute of Science, Rehovot
Israel, is a
synthetic peptide which down regulates immune responses associated
with myasthenogenic peptides. PTR-262 is derived from the
myasthenogenic epitopes of the acetylcholine receptor (AChR) alpha-
subunit, which specifically arrests the autoimmune destruction of
AChR.
In preclinical models of MG, treatment by PTR-262 creates a
shift in the immune system from a Th1 to a Th2/Th3 response,
resulting in significant improvement of a number of clinical
parameters including grip strength and electromyography.
Furthermore, in peripheral blood serum derived from MG patients, PTR-
262 inhibits the proliferation of T-cell populations that are
responsible for myasthenogenic autoimmune mediated reactions and
thus the development of MG.
About Myasthenia Gravis
MG comes from the Greek and Latin words meaning, "grave muscular
weakness." The most common form of MG is a chronic autoimmune
neuromuscular
disorder that is characterized by fluctuating weakness of the
voluntary
muscle groups. MG is characterized by T-cell mediated autoantibody
attacks on
the AChR at neuromuscular junctions, causing weakness and fatigue of
cranial
and skeletal muscles. MG has a prevalence of 15/100,000 population,
with
approximately 36,000 cases in the United States. Available treatment
options
include cholinesterase inhibitors, immunosuppressive medication,
plasma
exchange and thymectomy, all with substantial side effects and which
do not
address the underlying cause of the disease. MG meets the criteria
for an
orphan disease with significant unmet medical need.
About Debiopharm
Debio is an established group of five complementary companies,
Debiopharm, Debioinnovation, Debio R.P., Debioclinic and H3 Pharma.
Debiopharm, founded in 1979 in Lausanne, Switzerland, focuses on
evaluating
compounds with promising in-vivo results in animals to in-license,
develop
for global registration, and out-license to sales and marketing
pharmaceutical partners. Debiopharm has proven expertise in drug
development,
having registered three products: Eloxatin(R), one of sanofi-
aventis' leading
marketed products, Decapeptyl(R), the leading product of Ipsen, and
Trelstar(R) (1-and 3-month) a registered trademark of Watson
Pharmaceuticals,
Inc. Together, their combined sales were in excess of $1.8 bn in
2004.
Debioinnovation was set up to complement the core business
objectives of
Debiopharm through addressing the financing and partnering needs of
biotechnology, pharmaceutical start-up companies and life science
incubators.
Debio R.P. is a leader in polymer-based controlled release
technologies that
allow certain drugs like proteins, peptides and anti-cancers to be
delivered
in customized, sustained-release formulation. From its FDA-inspected
manufacturing facility in Martigny, Switzerland, Debio R.P. also
conducts
feasibility studies, formulation selection, optimization, scale-up
and cGMP
manufacturing from clinical trial supplies to commercial scale.
Debioclinic,
based in Paris, is a contract research organization, specialized in
oncology
and dedicated to clinical development, providing regulatory,
biometric and
clinical support in line with cGCP. Montreal-based H3 Pharma is a
pharmaceutical product development company, focusing on oncology and
endocrinology. For more information on Debiopharm, please visit:
www.debio.com.
About DeveloGen
DeveloGen is a biopharmaceutical company focusing on the
development of
treatments for metabolic disorders, such as diabetes, obesity and
metabolic
syndrome. DeveloGen has a rich and innovative pipeline from lead
discovery to
phase II clinical development. DeveloGen's lead product DiaPep277
for the
treatment of type 1 diabetes and LADA (Latent Autoimmune Diabetes in
Adults)
is currently in late phase II clinical trials. DiaPep277 is a novel
immunomodulatory peptide derived from the heat shock protein hsp60,
which
protects the insulin producing beta cells from autoimmune
destruction. The
product Somatoprim is currently in preclinical development for the
treatment
of diabetic retinopathy. Further drug discovery approaches focus on
the
development of functional Pax4 agonists, secreted proteins and
synthetic
compounds aimed at the regeneration of the pancreatic beta-cell mass
for the
treatment of type 1 and type 2 diabetes. Proprietary targets in key
metabolic
pathways and inhibitors of key metabolic enzymes are developed by
functional
genomics based drug discovery for the treatment of type 2 diabetes,
obesity
and the metabolic syndrome. DeveloGen is headquartered in
Goettingen, with
additional sites in Rehovot, Israel, and Erkrath, Germany. For more
information on DeveloGen, please visit our website at
www.develogen.com.

SOURCE Debiopharm S.A.

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