NeuroVive
Pharmaceutial AB, a leading mitochondrial medicine company, has signed
an exclusive global outlicensing agreement with the US biotechnology
company OnCore BioPharma, Inc. related to the development and
commercialization of NeuroVive’s drug candidate NVP018 for oral
treatment of chronic Hepatitis B Virus (HBV) infection. The agreement
can give NeuroVive in total $150 million in conditional milestone
payments plus royalties on future drug sales.
“After
extensive discussions with a number of leading pharmaceutical
companies, I am delighted to announce that we have signed this agreement
with OnCore, a strong partner that provides optimal resources to
develop NVP018 from a stage of a promising drug candidate to a complete
treatment for a global medical challenge. This confirms the financial
potential inherent in our pharmaceuticals portfolio, and the revenues
will allow us to further intensify our work in prioritized areas of mitochondrial medicine.
I would also like to take the opportunity to put the spotlight on our
COO Jan Nilsson, whose work has been critical to get this agreement in
place,” commented NeuroVive’s CEO Mikael Brönnegård.
The
licensing agreement provides OnCore with the exclusive global rights to
develop oral formulations of NVP018 for the treatment of chronic
Hepatitis B infection. The compensation to NeuroVive consists of an
initial upfront payment plus a number of conditional payments based on
pre-determined milestones and as well payments relating to sales targets. In
addition, NeuroVive will receive incremental royalty payments based on
gross revenue from future sales of NVP018. The total value of the
agreement is $150 million excluding royalty payments. The exact terms of
the agreement regarding payments and royalty figures are not disclosed.
“OnCore
stood out in the negotiations, which included several leading
pharmaceutical companies, because of its exclusive focus on Hepatitis B
and its plan to bring the drug candidate to market as quickly and
efficiently as possible. In addition, the company’s senior managers have
delivered exceptionally strong results in the form of a pioneering
treatment for Hepatitis C while working at Pharmasset. I am convinced
that OnCore is the right collaboration partner for us,” commented Jan
Nilsson, NeuroVive’s Chief Operating Officer.
“We
perceive considerable potential in NVP018 and consider this agreement
to be an important step towards developing a successful treatment for
chronic Hepatitis B. Our objective is to cure chronic Hepatitis B,
building on our success in Hepatitis C at Pharmasset.” commented Dr.
Michael Sofia, Chief Scientific Officer at OnCore.
Cyclophilin inhibitors and NVP018NVP018
is an orally-available, sangamide-based, second generation cyclophilin
inhibitor with a well-differentiated preclinical profile when compared
to other cyclophilin inhibitors. Data presented in April at The
International Liver Congress™ 2014, the annual meeting of the European
Association for the Study of the Liver (EASL), showed that NVP018
appears to inhibit the Hepatitis B virus by two mechanisms in vitro.
First, NVP018 directly inhibits several stages of viral replication in
liver cells and second, NVP018 acts indirectly by strengthening the host
immune response via interferon regulatory factors (IRFs), including
potent inhibition of an interaction between cyclophilin A and IRF9, a
key component of the Jak/Stat pathway that transports chemical signals
through the cell membrane. Data also indicates that the risk of
developing resistance, a significant clinical problem with current
therapies for Hepatitis B, is very low with NVP018.
Labels: cyclophilin inhibitors, drugs in development, NVP018