PRESS RELEASE: Independent DSMB Recommends Continuation of Santhera's Phase III Trial of Catena(R) in Duchenne …

-1 of 2- 16 Apr 2013 05:15:00 UTC *DJ Independent DSMB Recommends Continuation of Santhera's Phase III Trial of Catena(R) in Duchenne Muscular Dystrophy

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April 16, 2013 01:15 ET (05:15 GMT)- - 01 15 AM EDT 04-16-13

-2 of 2- 16 Apr 2013 05:15:00 UTC PRESS RELEASE: Independent DSMB Recommends Continuation of Santhera's Phase III Trial of Catena(R) in Duchenne Muscular Dystrophy

Santhera Pharmaceuticals Holding AG / Independent DSMB Recommends Continuation of Santhera's Phase III Trial of Catena(R) in Duchenne Muscular Dystrophy . Processed and transmitted by Thomson Reuters ONE. The issuer is solely responsible for the content of this announcement.

Liestal, Switzerland, April 16, 2013 - Santhera Pharmaceuticals (SIX: SANN) announced today that the Phase III DELOS study of orally administered Catena(R) in patients with Duchenne Muscular Dystrophy (DMD) successfully passed a planned futility and safety analysis. The independent Data Safety Monitoring Board (DSMB) for DELOS informed Santhera that the study has a reasonable chance of achieving its primary endpoint for improving or delaying the loss of respiratory function in Duchenne patients not using corticosteroids and since no safety issues were detected, recommended that the study should continue as planned.

"I am very enthusiastic about this news, which is important for the DMD community as it indicates that Catena(R) eventually may evolve into a real treatment for all patients with this devastating disease. Importantly it suggests that the DELOS data are consistent with the outcome of the Phase II DELPHI study, which showed that treatment with Catena(R) resulted in a significant increase in peak expiratory flow and may improve early signs of respiratory weakness and dysfunction" commented Gunnar Buyse M.D., Ph.D., Professor of Child Neurology at the University Hospitals Leuven (Belgium) and Principal Investigator for the DELOS study. "Some promising therapies for DMD have failed to demonstrate clinical benefit in late-stage development, so it is encouraging to see that we now may be on track to clear this hurdle for this patient group".

"This futility analysis is particularly relevant since it included primary efficacy variable data after at least 6 months of treatment from 80%, and final outcome data after 12 months of treatment from over 60% of the planned total number of patients in the corticosteroid non-using cohort. This increases the probability of a positive outcome in the final analysis of this cohort", said Dr. Nick Coppard, Santhera's Senior VP Development. "Since DELOS is not restricted to patients with a specific mutational or ambulatory status, the potential benefit in respiratory function may extend to all Duchenne patients".

Santhera has previously announced that it explores strategic and financing options including product licensing and the possibility of a merger or acquisition. The Company's ability to complete the DELOS program is contingent upon the availability of the financial resources required. To this end, Santhera has started the process to seek a development or licensing partner for Catena(R) in DMD outside Europe, where commercialization rights have been licensed to Takeda.

The European Medicines Agency (EMA) and US Food and Drug Administration (FDA) have both granted orphan drug status to Santhera's program with Catena(R) in DMD in the European Union and the United States of America, respectively.

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PRESS RELEASE: Independent DSMB Recommends Continuation of Santhera's Phase III Trial of Catena(R) in Duchenne ...