Date: 2015-07-08
Type of information: Licensing agreement
Compound: blood-based companion diagnostic tool for Aramchol™
Company: Galmed Pharmaceuticals (Israel) One Way Liver Genomics (Spain)
Therapeutic area: Hepatic diseases - Liver diseases
Type agreement: development - licensing
Action mechanism: companion diagnostic
Disease: NASH (non-alcoholic steatohepatitis)
Details:
- • On July 8, 2015, Galmed Pharmaceuticals announced that it has entered into a research, option and license agreement and a share purchase agreement with One Way Liver Genomics (OWL) for the development of a non-invasive, blood-based companion diagnostic tool. Galmed and OWL will work together during Galmed's Phase IIb ARREST study to develop a non-invasive blood test including metabolic markers that could potentially predict therapeutic responses to Aramchol™, Galmed's once-daily, oral therapy for the treatment of Non-Alcoholic Steato-Hepatitis, or NASH.
- The development of this proprietary non-invasive companion diagnostic for Aramchol™ serves a dual purpose:
- - commercializing a companion diagnostic for Aramchol™ that could replace liver biopsy in testing the ongoing efficacy of treatment, which may enhance Aramchol™ market penetration,
- improving NASH patient selection for Aramchol™, including for Galmed's potential future Phase III study.
Financial terms:
- Under the terms of the agreement, OWL will develop a proprietary companion diagnostic exclusive for Aramchol™, which will be co-funded by Galmed up to €437,000 over the course of the ARREST Study and paid based on reaching development milestones. Upon commercialization, OWL may earn 10% royalties on annual net sales of the companion diagnostic product.
- Separately, under the terms of the share purchase agreement, OWL stands to earn two milestone payments during the ARREST Study: The first payment of €75,000 will be paid upon the successful completion of the ARREST Study's interim results expected during the first half of 2016; the second milestone payment of €100,000 will be paid upon the successful completion of the ARREST Study. Through these two milestone payments, totaling €175,000, Galmed shall receive shares of OWL based on its most recent valuation. Finally, OWL has granted Galmed an option to purchase additional shares up to 19.9% of OWL.
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