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SEC Filings

20-F
AC IMMUNE SA filed this Form 20-F on 03/21/2019
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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;

 

  Regulatory 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 to us.

 

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