Date: 2017-02-27
Type of information: Development agreement
Compound: therapeutic antibodies based on arGEN-X\'s SIMPLE Antibody™ technology
Company: Argen-X (The Netherlands-Belgium) Shire (UK-USA)
Therapeutic area: Rare diseases - Genetic diseases
Type agreement: development
Action mechanism:
Disease:
Details:
- • On February 29, 2012, arGEN-X announced that it has entered into an alliance with Shire to create novel therapeutic antibody products against multiple targets submitted by Shire. Using its cutting edge SIMPLE Antibody™ discovery technology, arGEN-X will isolate and characterize human antibodies against the targets that Shire has identified and that are known to contribute to the pathophysiology of severe, rare genetic diseases. arGEN-X will also bring its state-of-the-art antibody capabilities to the collaboration for the preclinical characterization of therapeutic leads. Shire has the option to license the most promising leads for further preclinical and clinical development and commercialization worldwide. Under the terms of the agreement, arGEN-X will receive an upfront technology access fee, research funding and preclinical success payments. In return for its option to develop and commercialize products on an exclusive basis, Shire will pay fees, milestones and royalties on product sales. Specific details of the financial terms were not disclosed.
Financial terms:
- Shire will make a total upfront investment of €15 million (US$20.4 million) in arGEN-X, consisting of €3 million in cash and €12 million in equity. In addition, it will fund the collaborative research programs at arGEN-X and pay fees, clinical, regulatory and sales milestones, as well as single digit royalties on therapeutic product sales. Shire will be responsible for clinical development and commercialization of products, with arGEN-X having the right to license any programs not pursued by Shire into its own development pipeline.
Latest news:
- • On February 27, 2017, argenx announced the extension of its strategic partnership with Shire to advance the discovery and development of novel human therapeutic antibodies for diverse rare and unmet diseases for a further year until May 30, 2018. Under the terms of this agreement extension announced, the parties will continue to progress preclinical development of the most promising programs to have arisen from the collaboration to date. Upon attainment of specified development criteria, Shire may exercise options - accompanied by a milestone payment to argenx on a per program basis - to take over product development and commercialization. argenx will thereafter receive milestone payments as programs proceed through clinical development and royalties on eventual product sales. argenx shall have the right to in-license any products falling outside Shire's areas of focus on pre-agreed financial terms. Further details of the extension agreement were not disclosed.
- • On December 11, 2014, arGEN-X announced that its partner Shire has exercised its option to advance into preclinical development one or more product candidates created out of a 2012 therapeutic antibody alliance between the two companies. As a result of the exercise, arGEN-X will receive a milestone payment from Shire.
- • On June 4, 2014, arGEN-X announced it has entered into a long-term strategic alliance with Shire Pharmaceuticals. Under the agreement, arGEN-X will bring its entire suite of human antibody discovery technologies to a partnership focused on multiple targets aligned with Shire’s therapeutic focus. The multi-year initiative aimed at helping augment the Shire development pipeline follows an initial research and development collaboration undertaken in March 2012.
- • On January 13, 2014, arGEN-X has announced the attainment of two important success milestones in its SIMPLE Antibody™ research and product development collaboration with Shire. The milestones, which trigger undisclosed payments from Shire, relate to demonstration of in vivo proof of concept for one of the ongoing antibody discovery programs.
- • On September 19, 2013, arGEN-X has announced it has attained a key success milestone in its SIMPLE Antibody™ research and product development collaboration with the Human Genetic Therapies division of Shire Pharmaceuticals. The milestone, which triggered an undisclosed payment from Shire, was the first demonstration of in vivo proof of concept for one of the antibody discovery programs undertaken in the collaboration. Under their February 29, 2012 agreement, the companies are collaborating to create human therapeutic antibodies against complex targets involved in severe, rare genetic diseases. Shire has an option to license the most promising antibody leads from each collaborative program for further development and commercialization worldwide, in return for milestone and royalty payments. Under the terms of the license, arGEN-X has already received technology access fees and research funding and is eligible to receive preclinical success payments.
- • On January 7, 2013, arGEN-X has announced that it is broadening its therapeutic antibody collaboration with Shire. Building upon the success of the partnership to date, the companies have now instigated an additional discovery program, addressing a new and exciting therapeutic opportunity. arGEN-X continues to be responsible for all antibody discovery and certain preclinical activities, while Shire will conduct all disease-relevant preclinical work, as well as clinical and commercial development of therapeutic antibody products. arGEN-X receives research funding and success-based payments, as well as milestones and royalties on products developed under the collaboration.
Is general: Yes
