Prosensa Updates on Patent Position

Leiden, The Netherlands, 17 November 2011 – Prosensa, the Dutch com­pa­ny focus­ing on RNA mod­u­lat­ing ther­a­peu­tics for rare dis­eases with unmet med­ical needs, has been grant­ed two new patents for exon-skip­ping by the Japanese Patent Office and the United States Patent and Trademark Office, and has con­firmed its strong posi­tion in Europe dur­ing an oppo­si­tion pro­ce­dure which was con­clud­ed yes­ter­day.

The Japanese patent (no. 2002-529499), grant­ed in October 2011, describes meth­ods of induc­ing exon skip­ping in the mes­sen­ger RNA of eukary­ot­ic cells by the use of com­pounds called anti­sense oligonu­cleotides.  It cov­ers the broad port­fo­lio of Duchenne mus­cu­lar dys­tro­phy (DMD) com­pounds cur­rent­ly in devel­op­ment by Prosensa, where­as the US patent (no. 7,973,015), grant­ed in July 2011, describes a method for mul­ti­ple exon skip­ping. These patents fur­ther strength­en Prosensa’s intel­lec­tu­al prop­er­ty posi­tion.

Prosensa also announces the out­come of the Opposition Division of the European Patent Office (EPO) rul­ing regard­ing its European Patent EP1619249. The EPO Opposition Division, pre­sid­ing in oral pro­ceed­ings on 16 November 2011 in Munich, ruled that the patent was allow­able in an amend­ed form. The allowed patent describes, amongst oth­ers, the skip­ping of exon 51 in the DMD gene using a 14- to 40-mer anti­sense oligonu­cleotide as a poten­tial ther­a­py to treat DMD. The amend­ment is the result of an oppo­si­tion pro­ceed­ing brought by the US based com­pa­ny AVI BioPharma. With this rul­ing, the EPO con­firmed the strong IP posi­tion that Prosensa has built in the field of exon skip­ping in DMD.  The patent direct­ly pro­vides a strong pro­tec­tion for Prosensa’s lead prod­uct PRO051/GSK2402968.

Welcoming the deci­sion to uphold the most impor­tant claims in this Prosensa patent, Hans Schikan, CEO of Prosensa com­ment­ed:  “This is a pos­i­tive endorse­ment of the qual­i­ty of our patents. Prosensa has a strong intel­lec­tu­al prop­er­ty estate in the area of exon skip­ping and RNA mod­u­la­tion more wide­ly. We are firm­ly com­mit­ted to bring­ing inno­v­a­tive treat­ments to patients suf­fer­ing from rare dis­eases, and advanc­ing our com­pounds for Duchenne mus­cu­lar dys­tro­phy patients.”

Prosensa has the broad­est and most advanced exon skip­ping port­fo­lio of com­pounds in devel­op­ment for DMD.  PRO051/GSK2402968, devel­oped in col­lab­o­ra­tion with GlaxoSmithKline and designed for the skip­ping of exon 51 in spe­cif­ic pop­u­la­tions of DMD patients, is cur­rent­ly in phase III clin­i­cal tri­als. Moreover, Prosensa has 5 addi­tion­al exon skip­ping pro­grammes in clin­i­cal and pre­clin­i­cal devel­op­ment (tar­get­ing exons 44, 45, 53, 52 and 55). PRO051/GSK2402968 and PRO044 have been grant­ed Orphan Drug sta­tus in Europe and the US, which pro­vides addi­tion­al pro­tec­tion.

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