On March 31, 2014 Otsuka Pharmaceutical reported an agreement with Eisai to acquire rights to the hematological cancer treatment Dacogen and to an enzyme inhibitor, E7727 (Press release Otsuka, MAR 31, 2014, View Source [SID:1234500356]).
Rights Acquired From Eisai:
Exclusive rights to the development and sale of DNA methylation inhibitor Dacogen, an intravenous formulation of decitabine (generic name), in the U.S., Canada, and Japan in addition to the licensing rights worldwide excluding Mexico. Eisai will retain the rights in Mexico. Janssen Pharmaceutical Companies will retain its worldwide development and commercialization rights (excluding the U.S., Canada, Mexico and Japan).
Patent rights to metabolic enzyme inhibitor E7727, currently in pre-clinical development by Otsuka’s U.S. subsidiary Astex Pharmaceuticals, Inc. E7727 is in development together with decitabine to form the combination product ASTX727 (an oral hypomethylating agent), which if approved would become the first oral formulation of decitabine.

Otsuka will continue its existing decitabine-related business through Astex Pharmaceuticals, a U.S. subsidiary, concurrent with advancing clinical development of ASTX727 with the aim to provide an alternative, early-stage option in the treatment of MDS.

On March 31, 2014 GlaxoSmithKline reported that it has withdrawn its application to the European Medicines Agency (EMA) for a variation to the Marketing Authorisation for Votrient (pazopanib) (Press release GlaxoSmithKline, MAR 31, 2014, View Source;votrient—pazopanib–as-maintenance-therapy-.html [SID:1234500354]). This application, made in August 2013, was related to the additional indication for the maintenance treatment of women with FIGO stage II-IV epithelial ovarian, fallopian tube or primary peritoneal cancer who had not progressed after receiving first-line chemotherapy.
GSK has taken the decision because the data from the planned second interim Overall Survival (OS) analysis of the phase III study (NCT01227928) did not support the overall benefit:risk for Votrient in this indication. The hazard ratio for OS was 1.076 (p=0.4985; 95% CI: 0.868; 1.333).These data will be submitted for presentation at an upcoming medical congress. GSK does not intend to progress further with this indication in other countries.
The regulatory submission for Votrient in this indication was based on the results from AGO-OVAR-16 (VEG110655), a randomised, double-blind, phase III, placebo-controlled study which evaluated the efficacy and safety of pazopanib monotherapy as compared with placebo in women with FIGO stage II-IV epithelial ovarian, fallopian tube, or primary peritoneal cancer whose disease had not progressed after first-line chemotherapy.

On March 31, 2014 Curis reported that the U.S. Food and Drug Administration (FDA) has notified the Company that its complete response submission to the November 2013 partial clinical hold on CUDC-427 has been reviewed and that the FDA has determined that it is safe to proceed under the IND (Press release Curis, MAR 31, 2014, View Source [SID:1234500345]). The FDA also indicated that detailed official correspondence regarding the determination will be released in the near future. Curis will provide additional details, if applicable, based upon further communications from the FDA as they become available.
In November 2013, CUDC-427’s Phase 1 study (NCT01908413) in patients with solid tumors or lymphoma was placed on partial clinical hold following the death of a patient who progressed to liver failure approximately one month following the discontinuation of CUDC-427 dosing. Under the partial clinical hold, no new patients were to be enrolled in the study until Curis provided the FDA with the requested data and analyses of all patients treated with CUDC-427, together with a protocol amendment found to be acceptable to the FDA.