Erytech Pharma: First Potential Graspa Approval In 2016

Very happy news year
The next year could be transformational for Erytech Pharma, (ERYP.PA) with pivotal data anticipated during Q414 from its unique Graspa product for acute leukaemias. This could lead to first approval in Europe 2016, with partner Recordati well-placed for successful commercialisation. Build-out of the earlier stage pipeline and technologies, in particular Graspa in solid tumours, could provide additional momentum during 2014.

Getting a grasp of Graspa
Graspa provides a simple but elegant solution to the problem of severe toxicity with well-established leukaemia treatment L-asparaginase. L-asp has been used for nearly 30 years as a treatment for childhood leukaemia, starving leukaemia cells of asparagine needed for survival. However, serious allergic reactions and side effects preclude its use in adults. Graspa is L-asparaginase encapsulated within red blood cells (erythrocytes), which can maintain efficacy while reducing side effects.

First potential Graspa approval in 2016
Graspa is a potential treatment for acute lymphoblastic (ALL) and acute myeloid leukaemia (AML). It has already demonstrated proof-of-concept in both front-line elderly and relapsed/refractory ALL patients, with Graspa leading to fewer allergic reactions, and a single injection as efficacious as eight injections of native L-asp. A European Phase III is ongoing with data due Q414, which if positive should allow for filing in early 2015 and first approval in early 2016 with partner Recordati. There are around 40,000 acute leukaemia patients in the US and Europe.

Solid tumours and broader technology applications
Graspa is also being investigated as a potential treatment for solid tumours, and a Phase I pancreatic cancer trial has recently been completed. Plans to initiate a Phase II pancreatic trial have been announced. A number of solid tumours have been identified that could benefit from asparagine depletion. In addition, the red blood cell encapsulation technology could have applicability in a number of other areas, including cancer immunotherapy and immune system tolerance induction.

Valuation: Current EV of c €40m
End-September €16.6m cash suggests a current EV of only c €40m with a Phase III, partnered asset. Underlying cash burn of c €3.5m in H113 suggests cash should be sufficient to fund operations into 2016, beyond key value inflexion points.

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