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Agreements

Date: 2013-04-10

Type of information: R&D agreement

Compound: multispecific Anticalin program

Company: Sanofi (France) Pieris (Germany)

Therapeutic area:

Type agreement:

R&D
licensing

Action mechanism:

Anticalin-branded proteins represent a novel generation of targeted protein therapeutics derived from human lipocalins, rationally engineered to solve for the pharmacological and pharmaceutical limitations of both protein- and non-protein-based drug platforms. The multispecific approach, whereby the DNA of individual Anticalins can be pieced together to yield a fusion protein, offers the potential for creating new biology and synergistic efficacy by addressing multiple targets with a single drug. Additional benefits include improved convenience, accelerated development timelines, ease of manufacturing and reduced cost.

Disease:

Details:

* On April 10, 2013,  Pieris AG and Sanofi have jointly agreed to expand their ongoing discovery and development partnership to include a novel multispecific Anticalin program. In September 2010, Pieris, Sanofi and Sanofi Pasteur have signed a collaboration and license agreement, under which Pieris has applied its proprietary Anticalin technology to discover novel Anticalin drugs against multiple targets, with further development undertaken by Sanofi-Aventis and Sanofi-Pasteur.  The collaboration initially involved two targets nominated by Sanofi-Aventis and Sanofi-Pasteur, and included the option for four additional targets. Sanofi and Pieris will now continue to advance both existing and new programs.

Financial terms:

Under the existing framework of the 2010 agreement, the new program will entitle Pieris to an upfront payment from Sanofi and committed research funding as well as payments for the achievement of research, preclinical, regulatory and commercial milestones. Specific financial terms were not disclosed.

The 2010 agreement included a € 3.5 million in an upfront payment for the first two targets, plus committed research funding and payments for the achievement of research, preclinical, regulatory and commercial milestones.  Overall, the agreement could encompass for Pieris, per each product resulting from the collaboration, up to € 26.5 million in development milestones for the first therapeutic application and € 18 million in commercial milestones.  Further milestones would be received by Pieris with respect to the same product in the case of development of that product in additional therapeutic applications. Payments will also include tiered royalties on sales of products resulting from the collaboration. Sanofi-Aventis and Sanofi Pasteur will have exclusive marketing rights worldwide for all such products.

Latest news:

* On December 1, 2014, Pieris  announced the successful handover of a multispecific Anticalin® preclinical drug candidate from Pieris to Sanofi, who will be responsible for further development of the program, triggering an undisclosed payment to Pieris. The decision to advance the program is based on a positive review of a broad range of in vitro, in vivo and CMC data for the program. The multispecific polypeptide, comprising several unique Anticalins in one protein, is able to simultaneously engage several therapeutic targets.

Is general: Yes