Collaboration with Allergan: sub-licensing of the most advanced program to Bristol-Myers Squibb

ExonHit successfully continues its collaboration with Allergan dedicated to the identification, development and commercialization of drugs for the treatment of neurodegenerative diseases, pain and ophthalmology.

EHT/AGN 0001, the lead compound in the most advanced program of the Allergan collaboration, as well as EHT/AGN 0002 and its associated back-up compounds were sub-licensed by Allergan to Bristol-Myers Squibb in March 2010.

EHT/AGN 0003, an ExonHit internal neuro-related program, was added to the collaboration in February 2010.

AclarusDx?„?: CE marking and initiation of a study in real clinical setting in France

AclarusDx?„? is a blood-based test intended to help in the diagnosis of Alzheimer's disease (AD). It detects biomarkers specific for AD in peripheral blood. ExonHit just announced its CE marking and is preparing in France a study in a real clinical setting which could support use of AclarusDx?„? among the diagnostic algorithm currently used by Memory Centers to diagnose AD. To support the French launch, ExonHit has set up a well-recognized Scientific Advisory Board chaired by Professor Fran?§oise Forette. Regarding US market entry, ExonHit is currently assessing different options from "laboratory-developed test" to FDA clearance.

EHT Dx14: clinical validation is ongoing before its introduction as an Investigational Use Only product for cancer centers in 2H 2011

EHT Dx14 is a novel breast cancer diagnostic biomarker. When assessing a suspicious mass discovered during mammography, the EHT Dx14 test should allow the accurate reading of samples obtained by fine-needle aspiration in cases where the standard analysis returns an inconclusive result. The validation of EHT Dx14 is ongoing. This validation is made in two steps. First, the initial performances of the test (as published in Lancet Oncology are being validated on samples that are either positive or negative according to the standard analysis. In a second step, it will be necessary to evaluate the added value of the test in inconclusive samples. At the end of this second step, ExonHit plans to put EHT Dx14, as an Investigational Use Only product, at the disposal of major cancer centers in France, in the second half of 2011.

Collaboration with bioM?©rieux

Study design for new prostate cancer biomarkers is under discussion.

2011 Outlook: Focus on implementation

Being present both in diagnostics and therapeutics enables ExonHit to operate with great synergy between its competencies in these two domains. 2011 will be focusing on two objectives:

The first market introductions of diagnostic products: it is a new chapter in the history of ExonHit with, in addition to its current R&D activities, the beginning of marketing for its first diagnostic tests. In 2011, ExonHit will focus its efforts on the introduction of AclarusDx?„? in the French IVD market and of EHT Dx14 as an Investigational Use Only product for cancer centers. Becoming a key player in molecular diagnostics: thanks to its unique Genome-Wide SpliceArray?„? discovery platform, ExonHit intends to focus more and more on securing new partnerships. With its know-how, ExonHit can offer to key pharmaceutical industry players custom development of biomarkers and companion diagnostics to reduce both the duration and the risk of the clinical studies of their drug candidates.

Source: ExonHit Therapeutics