Licenses Cyclophilin Inhibitor Alisporivir (Debio 025) for Hepatitis
Switzerland's Debiopharm Group announced this week that
it has made an exclusive licensing agreement with Novartis
to develop and market alisporivir (Debio
025), an agent chemically similar to cyclosporine
but without its immunosuppressive effects. As
previously reported, a small study showed that alisporivir
produced a decrease in cyclophilin B, a binding protein
that plays a role in hepatitis C virus (HCV) replication,
leading to a decrease in HCV viral load. The drug has
also demonstrated minor activity against HIV in laboratory
studies and in HIV/HCV coinfected patients.
is an edited excerpt of a press release from Debiopharm describing
Group Grants an Exclusive License for the Development, Manufacture
and Commercialization of Debio 025
Potent, First-in-class Antiviral Agent for the Treatment of Hepatitis
Switzerland -- February 9 -- Debiopharm Group (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 license
agreement with Novartis for the development, manufacture and commercialization
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
commercialization rights to Debio 025 except for Japan.
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.
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. "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."
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.
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-naive HCV patients
Group 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.
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.
in 1979 and headquartered in Lausanne, Switzerland, Debiopharm
has developed four products with global combined sales of $2.6
billion in 2008.
more information on Debiopharm Group, please visit: www.debiopharm.com.
Group. Debiopharm Group Grants an Exclusive Licence for the Development,
Manufacture and Commercialisation of Debio 025. Press release.
February 9, 2010.