- 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.  » Read more...

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.

- 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.  » Read more...

- 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.  » Read more...

MediGene AG has signed a license and supply agreement with Meditrina Pharmaceuticals for the supply and commercialization of Veregen® in Greece and Cyprus. Meditrina will promote and distribute Veregen® for the treatment of genital warts in both territories. Upon the achievement of specific milestones, MediGene will be entitled to successive payments totaling up to 900 thousand euros, and will receive the first milestone payment upon the initiation of the approval procedure in Greece. In addition, MediGene will supply Meditrina with finished product and will receive double-digit royalties on net sales. MediGene believes that Greece is the sixth largest potential European market for Veregen® sales volume.

MediGene has already entered into marketing partnerships for Veregen® with Nycomed, Inc. for the USA, Solvay (acquired by Abbott on February 15, 2010) for Germany, Austria and Switzerland, Juste S.A.Q.F for Spain and Portugal and Teva Pharmaceuticals Industries Ltd. for Israel. For further information, please click here.

Also today, ProBioGen has announced that it has been granted a divisional patent on its prorietary AGE1 cell line.
The patent covers the production of Modified Vaccinia Ankara (MVA) in duck cell lines. As these cells are free from endogenous particle-associated retrovirus activity, they are superior to current production substrates derived from chicken. The discovery has wide implications for the industrial production of one of the most promising recombinant vaccine vectors against infectious disease challenges such as HIV and malaria. Read more here.  » Read more...