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Several key milestones have now been
reached with regards to the Company’s ICVT pipeline. A
number of formulations have been proven in vitro, in vivo
and in man and so far three licensing agreements have been
signed with partner companies.
Previous international collaborations have enabled the
Company to gain a broad-based experience and a better
understanding of both the clinical and commercial
potential of ICVT, which has led to the granting of three
licensing agreements to date.
The structure of the licensing agreements is in line with
industry convention and typically comprises:
(a) An up-front payment from the partner company;
(b) Milestone payments during clinical development; and
(c) Royalties on sale.
The three current licensing agreements are described in
further detail below.
Licensing agreement – Cutanea Life Sciences
Cutanea Life Sciences (‘CLS’) is a US-based speciality
pharmaceutical company, focussed entirely on the
development of dermatology products. Its interest is in
the Company’s skin warts formulations.
CLS signed a license with Henderson Morley in September
2006. It will pay over $6.75m on the successful completion
of key milestones as well as royalties to the Company once
marketing approval has been gained for certain
dermatological applications of ICVT.
The CLS license covers the North American trading block
only. Henderson Morley retains the IPR for the rest of the
world.
In addition to a treatment for warts of the skin and feet,
,the agreement with CLS should help develop a treatment
for molluscum conagiosum, a common childhood skin
infection (which affects 3%-5% of all children in the
European Union and USA) for which there are no treatments
available or in development, and Bowen’s disease, a form
of skin cell cancer. Current treatments for Bowen’s
disease are destructive in their nature.
Licensing agreement – Amistad Pharma
Amistad Pharma (‘AP’) is a privately-owned French
pharmaceutical company, which has enjoyed aggressive
growth in recent years.
AP signed a license with Henderson Morley in July 2006,
which commits to the further clinical and commercial
development of ICVT for the treatment of herpes simplex
infections (cold sores and genital herpes) as well as
dysplasias of the genital tract (abnormal tissue changes
caused by HPV) on a global basis.
The working arrangement with AP has proven to be very
sound, with a keen desire by both parties to accelerate
the clinical development of specific formulations.
Licensing agreement – Croma Pharma
Croma Pharma (‘CP’) is an Austrian ophthalmic company,
which signed a licensing agreement with Henderson Morley
in May 2003.
The license was taken in respect of all EU and South
American territories for the treatment of viral eye
infections. CP has completed successful Phase 1 trials and
is currently in discussions with licensing authorities
with regard to the further clinical development of ICVT in
eye applications.
Other virus infections of the eye are also being
considered as opportunities for development, e.g. herpes
simplex infections in the eye.
Other potential licensing agreements
Whilst the Company has agreed a number of licensing
agreements for ICVT in recent years, these agreements
still leave several key applications and territories still
available for license. These include:
(a) North America and Japan for ophthalmic indications;
and
(b) The EU and Japan for several dermatological
indications.
(c) Global rights for orphan indications
(d) Global rights for injectable formulation and treatment
of genital warts
In addition to the above, there are also other virus
infections that fall outside of the currently licensed
applications and these may present opportunities for
further development and licensing. |
