Debiopharm Group grants an exclusive licence for the development, manufacture and commercialisation of Debio 025 - A potent, first-in-class antiviral agent for the treatment of Hepatitis C -

Lausanne (ots) - Debiopharm Group[TM] (Debiopharm), a Swiss-based
global biopharmaceutical group of companies with a focus on the
development of prescription drugs that target unmet medical needs,
today announced the signature of an exclusive licence agreement with
Novartis for the development, manufacture and commercialisation of
Debio 025 (alisporivir), a selective, first-in-class cyclophilin
(Cyp) inhibitor with a potent anti-hepatitis C virus (HCV) effect.
The product is currently in phase 2b clinical development for the
treatment of hepatitis C. Debiopharm granted Novartis worldwide
commercialisation rights to Debio 025 except for Japan.

Under the terms of the agreement, Novartis will pay Debiopharm an
upfront, development and sales milestones as well as royalties. This
transaction is subject to customary regulatory approvals.

According to the World Health Organization 170 million people
suffer from HCV in the world. "Sadly only 20% of those patients are
treated adequately," said Rolland-Yves Mauvernay, President and
Founder of Debiopharm Group[TM]. "At Debiopharm, we have a strong
commitment to providing HCV sufferers with an efficacious cure and
are confident about the potential of an innovative, first-in-class
compound such as Debio 025, which may represent a breakthrough in the
treatment of Hepatitis C. We are very happy to be working alongside
Novartis, a partner with a strong dedication to HCV."

About Debio 025

Debio 025 is an oligopeptide that has some chemical features in
common with cyclosporine A, but is devoid of its immunosuppressive
pharmacological effects. It has a very potent inhibitory effect on
HCV replication both in vitro and in vivo. Debio 025 has excellent
antiviral activity against a broad range of genotypes (1, 2, 3 and
4); a high barrier to the development of resistance; and the
possibility for once daily dosing. It is expected to have a superior
safety and efficacy profile to standard of care, and to be

efficacious in patients not responding to the standard treatment.

Its potent inhibitory activity on the HCV replication was shown in
the following clinical studies. Results of a phase Ib study
demonstrate that Debio 025 monotherapy for 15 days induced a strong
anti-HCV effect (3.6 log10 reduction) in HIV-1/HCV co-infected
patients (Hepatology, 47:817-26). Results of a phase IIa study with
Debio 025 indicate that Debio 025 shows an important additive
anti-HCV effect (4.6 log10 reduction) when co-administered with
peg-IFN-alpha-2a for four weeks to treatment-naïve HCV patients
(Hepatology, 2009 May;49(5):1460-8).

About HCV

HCV, in combination with hepatitis B, now accounts for 75% of all
cases of liver disease around the world. HCV is considered by the
World Health Organization as an epidemic. Because HCV can infect a
patient for decades before being discovered, it is often called the
"silent" epidemic. Studies suggest that in the US alone, nearly 4
million people are or have been infected with HCV and of these, 2.7
million have an ongoing chronic infection, the majority being between
40 to 60 years old.

About Debiopharm Group[TM]

Debiopharm Group[TM] is a Swiss-based global biopharmaceutical
group of companies with a focus on the development of prescription
drugs that target unmet medical needs. The group in-licenses and
co-develops promising biological and small molecule drug candidates
having reached clinical development phases I, II or III. It develops
its products for global registration and maximum commercial
potential. The products are out-licensed to pharmaceutical partners
for sales and marketing.

Debiopharm independently funds the worldwide development of all of
its products while providing expertise in pre-clinical and clinical
trials, manufacturing, drug delivery and formulation, and regulatory
affairs.

Founded in 1979 and headquartered in Lausanne, Switzerland,
Debiopharm has developed four products with global combined sales of
$2.6 billion in 2008.

For more information on Debiopharm Group[TM], please visit:
www.debiopharm.com

ots Originaltext: Debiopharm Group
Internet: www.presseportal.ch

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E-Mail: [e-mail]

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