Alpha-synuclein and TDP-43 PET Imaging Tracers
– Collaboration with Biogen
In April 2016, we entered into a non-exclusive
research and development agreement with Biogen International GmbH, or Biogen. Under the agreement, we and Biogen have agreed
to collaborate in the research and early clinical development of our alpha-synuclein PET Tracer program for Parkinson’s disease
and other synucleinopathies, and a second program for the identification, research and development of novel PET ligands against
TDP-43, a protein recently linked to neurodegeneration in diseases such as amyotrophic lateral sclerosis. In addition, we have
agreed to share the costs of the collaboration with Biogen, with Biogen primarily funding the majority of research costs, subject
to a cap, which includes an upfront technology access fee and funding towards research and development personnel and activities. We
will own all intellectual property rights to any invention relating to alpha-synuclein or TDP-43 PET tracers.
The collaboration will expire in April
2019. AC immune is committed to pursue the development of the first-generation alpha-synuclein PET tracer and our lead candidate
will enter into clinical development in H1 2019.
Recombinant protein therapeutic candidate
– Collaboration with Essex Bio-Technology Limited
On May 19, 2017, we entered into a Research
Project Agreement with Essex Bio-Technology Limited, or Essex, to develop a recombinant protein therapeutic candidate acting on
a unique neuroprotective mechanism for treatment of neurological diseases, such as Alzheimer’s disease and frontotemporal
dementia. Essex will provide a joint research commitment as well as financial support to AC Immune for the pre-IND development
of the biological agent.
As part of this agreement, the parties
thereto have agreed to an initial two-year Research Plan, which intends to develop a basic Fibroblast Growth Factor as a therapeutic
for the treatment of neurodegenerative diseases and to generate novel antibody therapeutics.
Under the terms of the agreement, Essex
will provide support to AC Immune until the selection of a collaboration product by the Joint Steering Committee, up to a maximum
of CHF 750 thousand per year.
Tau Morphomer Small Molecule – Collaboration
with Eli Lilly
In December 2018, we entered into
a license agreement with Lilly to research and develop Tau Morphomer small molecules for the treatment of Alzheimer’s
disease and other neurodegenerative diseases. Under the terms of the agreement, we will conduct the development of Tau
Morphomer small molecules through the completion of Phase 1, starting in the second quarter of 2019. Lilly will fund and lead
further clinical development and will retain global commercialization rights for all indications, including
Alzheimer’s disease and other neurodegenerative diseases.
Under the agreement, we may
become eligible to receive payments totaling up to approximately CHF 1.8 billion, excluding royalties. The agreement
includes an upfront payment as well as various conditional milestone payments. In addition, the Company will receive royalties
on sales of licensed products. The effectiveness of, and any payment to us under, the agreement was conditioned upon
customary antitrust review and the receipt of Hart-Scott-Rodino (“HSR”) clearance. This clearance was provided subsequent
to the year end and the agreement was deemed effective on January 23, 2019.
The structure of the agreement
is as follows:
• An exclusive license
granted by us to Lilly under certain of our intellectual property to develop, manufacture and commercialize products containing
Tau Morphomer small molecules throughout the world in any indication;
• Clinical milestone payments within
10 business days after Lilly’s completion of its pre-clinical activities period and 60 days after the first dosing of a patient
in a phase 3 clinical study;
milestone payments within 60 days after obtaining regulatory approval for any licensed product in the the first
indication and any licensed product in certain additional indications in the U.S., Europe and Japan, respectively;
• Commercialization milestones payable
upon achieving certain commercial sales milestones; and
• Royalties on sales with royalty
rated differing based on the level of annual sales of licensed products.
The agreement will terminate by the date
of expiration of the last royalty term for the last licensed product. However, under the terms of the agreement, Lilly may terminate
the agreement at any time after completion of the Lilly pre-clinical activities period by providing three months’ notice