Tag: MediGene

Company News: MediGene Presents Overall Survival Data from a Phase II Trial of EndoTAG®-1 in Triple-Negative Breast Cancer (TNBC)

– Positive efficacy trend of EndoTAG®-1/Paclitaxel combination therapy confirmed
– Subgroup analysis reveals encouraging overall survival data with EndoTAG®-1 plus paclitaxel combination therapy

MediGene AG today announced median overall survival data from its phase II trial of EndoTAG®-1 for the treatment of triple-negative breast cancer (TNBC), which was presented at the San Antonio Breast Cancer Symposium in San Antonio, USA. The secondary endpoint data confirm the positive efficacy trend of EndoTAG®-1 in combination therapy with standard weekly paclitaxel, which was previously reported by the primary endpoint data (progression-free survival rate at 16 weeks). Furthermore, an additional analysis of a subgroup of patients not predefined in the study protocol (119 of 140 patients: ECOG 0/1, first-line therapy for advanced cancer) showed encouraging overall survival data with EndoTAG®-1/paclitaxel combination therapy. The data were presented by Prof. Dr. Ahmad Awada, principal investigator of this trial and Head of the Medical Oncology Clinic at Jules Bordet Institute in Brussels, Belgium.

140 patients diagnosed with TNBC participated in the phase II clinical trial. Patients were randomized to three groups and received either EndoTAG®-1 in combination with weekly paclitaxel (55 patients) or EndoTAG®-1 monotherapy (57 patients). The third group (28 patients) only received weekly paclitaxel. The patients treated with combination therapy received 22 mg/m2 EndoTAG®-1 plus 70 mg/m2 paclitaxel once per week. EndoTAG®-1 monotherapy was administered twice per week, in a dosage of 44 mg/m2 per treatment. The paclitaxel monotherapy consisted of a once weekly 90 mg/m2 dose. The clinical trial was conducted in more than 30 centers in several European countries and in India. The study was not powered for intergroup comparisons.

Median overall survival time (as at reference date “visit week 41” of the last patient treated) for those 133 patients with TNBC status confirmed by central lab was 13.0 months in the EndoTAG®-1/paclitaxel combination therapy arm (51 patients), 11.9 months in the EndoTAG®-1 monotherapy arm (57 patients), and 10.1 months in the paclitaxel monotherapy arm (25 patients). Further data analysis of this group was done for those 124 patients treated per protocol. Median overall survival in this group was 15.1 months in the EndoTAG®-1 combination therapy arm (48 patients), 12.5 months in the EndoTAG®-1 monotherapy arm (52 patients), and 8.9 months in the paclitaxel monotherapy arm (24 patients).
Additionally, MediGene analyzed a subgroup of patients that was not predefined in the study protocol. This included patients with centrally confirmed TNBC status, ECOG performance status of 0/1 at the start of the clinical trial and who received first-line treatment after tumor relapse (119 patients). Median overall survival in this group was 17.8 months in the EndoTAG®-1 combination therapy arm (45 patients), 11.7 months in the EndoTAG®-1 monotherapy arm (50 patients), and 10.1 months in the paclitaxel monotherapy arm (24 patients).

Data regarding the primary endpoint of the trial (progression-free survival rate at week 16), the secondary endpoints progression-free survival rate, clinical benefit rate, and best overall response, as well as safety and tolerability of EndoTAG®-1 have previously been published and are available at http://www.medigene.de/presse_en/endotagTNBC.

Company News: MediGene Sells Full European Rights for Eligard® to Astellas for EUR 25 Million and Ongoing Royalties

MediGene AG (Frankfurt, Prime Standard, MDG, TecDAX) has announced the sale of full European marketing and distribution rights to Eligard® (leuprolide acetate, for the treatment of hormone-dependent prostate cancer) to Astellas Pharma Europe Ltd. (London, “Astellas”), previously MediGene’s European marketing partner for Eligard®. Astellas will make one-off payments totalling EUR 25 million, while MediGene remains entitled to royalties. There will be no further costs to MediGene. The sales price reflects the full NPV of all future Eligard® revenues while allowing MediGene to benefit from continued Eligard® growth. For more information, please see the full press release.


Company News: MediGene Expands Commercialization of Veregen to China and South Korea

– Closing of two additional license and supply agreements for the commercialization and marketing of Veregen® –

MediGene AG (Frankfurt, Prime Standard, TecDAX) has signed two further license and supply agreements for the commercialization and marketing of Veregen®. These have been signed with GC-Rise Pharmaceutical Co., Ltd. in China and JS Bio Pharm Co., Ltd. in South Korea.

GC-Rise will conduct the clinical trials of Veregen® (for the treatment of genital warts) that are required for approval of the ointment in China, and will be responsible for all the regulatory and approval procedures thereafter. MediGene will receive a one-time payment upon execution of the agreement and a further milestone payment upon initiation of the first clinical trial in China. In addition, MediGene will profit from supplying GC-Rise with the drug product. GC-Rise expects market launch in China at the end of 2013.

JS Bio Pharm will promote and distribute Veregen® for the treatment of genital warts, and will also be responsible for all regulatory procedures and for obtaining approval of the drug in South Korea. MediGene will receive royalties and a milestone payment contingent on the level of sales achieved. In addition, MediGene will profit from supplying JS Bio Pharm with the drug product. JS Bio Pharm expects to launch the drug on the South Korean market during 2012.

Please click here for more information.

Company News: MediGene Publishes First, Preliminary Results from a Phase II Clinical Trial of EndoTAG-1 for the Treatment of Triple Receptor-negative Breast Cancer

– Study Meets Primary Endpoint –

MediGene today announced first preliminary results from its Phase II clinical trial of EndoTAG(TM)-1 for the treatment of triple receptor-negative breast cancer. The trial in 140 patients was conducted to show efficacy of EndoTAG(TM)-1 against this extremely difficult to treat cancer type, and to further investigate the safety of the drug candidate. The primary endpoint was a progression-free survival rate at 16 weeks of at least 30% of EndoTAG(TM)-1 monotherapy treated patients, and at least 30% of EndoTAG(TM)-1 plus paclitaxel combination treated patients respectively.

Trial results: The group of patients treated with EndoTAG(TM)-1 and paclitaxel combination therapy showed a progression-free survival rate after 16 weeks of treatment of 59.1% (95% confidence interval: 43.2% – 73.7%). The progression-free survival rate of the group with EndoTAG(TM)-1 monotherapy was 34.2% (18,6 % – 51,4 %). In the group that received paclitaxel monotherapy, the progression-free survival rate was 48%. (27,8 % – 68,7%).

Further data, including secondary endpoints, are currently being evaluated and will be published within the next few weeks. Upon conclusion of this analysis, an overall trial evaluation will therefore be possible. The data published today are based on a centralized image evaluation of the trial results regarding progression-free survival. For more information, please see the full press release.

1 2