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Agreements

Date: 2015-08-12

Type of information: Termination of an agreement

Compound: novel Antibody Targeted Amanitin Conjugates (ATACs)

Company: Heidelberg Pharma (Germany) Roche (Switzerland)

Therapeutic area: Cancer - Oncology

Type agreement:

termination of an agreement

Action mechanism:

antibody drug conjugate. ?-Amanitin is a bicyclic peptide naturally occurring in the green Death Cap mushroom. It potently inhibits the biosynthesis of RNA, a mechanism that is critical for the survival of cells. Accordingly, Antibody Targeted Amanitin Conjugates (ATACs) exhibit comparable activity against proliferating and resting tumour cells. This proliferation independent activity differentiates ATACs from other ADCs, which preferentially target proliferating tumour cells. As an additional advantage ATACs could offer a substantial capability to overcome the resistance mechanisms that might limit the efficacy of other antibody drug conjugates. The ATACs tested so far have shown strong anti-tumour activity in several preclinical tumour models.

Disease:

Details:

* On September 2, 2013,  Wilex has announced that its subsidiary Heidelberg Pharma has signed a license agreement with Roche covering the development of a novel class of antibody drug conjugates (ADCs) based on Heidelberg Pharma’s patented technology to couple alpha-Amanitin to antibodies. The license agreement covers initial joint research to apply this technology to multiple Roche antibodies towards the identification of development candidates with favourable efficacy/safety profiles.
Heidelberg Pharma will receive regular payments for granting access to its technology and providing research services. Roche will subsequently have the opportunity to exercise options for licenses to develop and market selected Antibody Targeted Amanitin Conjugates (ATACs). Heidelberg Pharma will manufacture these substances and receive customary upfront payments, milestone payments and royalties for each development candidate selected by Roche.
Alpha-Amanitin is a bicyclic peptide naturally occurring in the green Death Cap mushroom. It potently inhibits the biosynthesis of RNA, a mechanism which is critical for the survival of cells. Accordingly, ATACs exhibit comparable activity against proliferating and resting tumour cells. This proliferation independent activity differentiates ATACs from other ADCs, which preferentially target proliferating tumour cells. As an additional advantage ATACs could offer a substantial capability to overcome the resistance mechanisms which might limit the efficacy of other antibody drug conjugates. The ATACs tested so far have shown strong anti-tumour activity in several preclinical tumour models.

Financial terms:

Latest news:

* On August 12, 2015, Wilex was informed that Roche is discontinuing its partnership with the Wilex subsidiary Heidelberg Pharma GmbH with respect to their collaboration in the field of antibody-targeted amanitin conjugates (ATACs). The licence agreement was signed in 2013 and expanded in October 2014. Roche has recently increased the focus of its oncology research strategy on cancer immunotherapies and deprioritised other internal and external oncology research programmes accordingly. Affected by this deprioritisation are the collaborative research efforts with Heidelberg Pharma, which in recent years have progressed well, on schedule, and in a mutually satisfactory manner. As a consequence of the termination of existing collaborative efforts to develop and identify novel antibody-targeted amanitin conjugates (ATACs), Wilex revised its financial outlook for the current financial year. Due to lower sales revenues Wilex’s cash reach is reduced from the end of the second quarter 2016 to the first quarter of 2016.

* On October 14, 2014, Wilex announced that its subsidiary Heidelberg Pharma and Roche extended the existing 2013 licence agreement to apply the antibody drug conjugate (ADC) technology for the further development of Roche antibodies. The aim is to identify and develop novel Antibody Targeted Amanitin Conjugates (ATACs) based on Heidelberg Pharma’s patented technology to couple ?-Amanitin to antibodies. Under the extended licence agreement, Heidelberg Pharma will receive an upfront payment and further regular payments for granting access to its technology and providing research services to Roche, which has the opportunity to exercise options for licences to develop and market selected ATACs. Heidelberg Pharma will manufacture these substances for clinical research and receive undisclosed milestone payments and royalties for each development candidate selected.

Furthermore, exclusive rights to one additional undisclosed tumour target will be granted to Roche. For this target Heidelberg Pharma could potentially receive up to € 52 million in upfront and milestone payments for successful clinical development and regulatory approval plus royalties.

Is general: Yes