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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.

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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.

Company News: Micromet Announces Global Collaboration with Boehringer Ingelheim for Multiple Myeloma BiTE Antibody and Reports First Quarter 2010 Financial Results

Micromet, Inc. (Nasdaq: MITI) and Boehringer Ingelheim announced today that they have entered into a collaboration agreement for the research, development and commercialization of a new BiTE antibody for the treatment of multiple myeloma.

Despite recent advances in the treatment of multiple myeloma, the disease remains largely incurable. While the majority of patients initially respond to treatment, almost all of these patients will eventually relapse.

Micromet and Boehringer Ingelheim will collaborate on the development of the BiTE antibody. Micromet is responsible for discovery of the BiTE antibody and will jointly conduct with Boehringer Ingelheim further pre-clinical studies. Boehringer Ingelheim is responsible for all manufacturing activities, clinical development and worldwide commercialization subject to Micromet’s co-promotion right in the U.S. Micromet will bear the costs up to a pre-defined amount for its preclinical activities. During commercialization Micromet will solely bear the costs for its sales force in the U.S. All other costs for research, development, manufacturing and commercialization of the BiTE antibody will be borne by Boehringer Ingelheim.

Under the terms of the agreement Boehringer Ingelheim will pay Micromet an upfront cash payment of 5 million euro (approximately $6.6 million). Micromet is eligible to receive development and regulatory milestone payments of up to 50 million euro (approximately $66 million) and tiered low double-digit royalties on product sales outside the U.S. In the U.S. Micromet and Boehringer Ingelheim will jointly co-promote the BiTE antibody with commercial terms commensurate with a profit split.

Moreover, Micromet today reported its financial results for the first quarter ended March 31, 2010. For further details, please visit Micromet´s corporate website.

Company News: Indivumed Achieves ISO-9001:2008 Certification and Offers the First Certified Biobank in the World

ISO norm guarantees highest biospecimen quality for pivotal studies

Hamburg-based Indivumed GmbH today has achieved ISO-9001:2008 certification. The company, which offers biobank products, clinical data and research services for the development of personalized cancer therapies, is now the world’s first ISO-certified provider of human biospecimens.

The certification guarantees that all processes at Indivumed are fully controlled and documented. Thereby, customers can expect identical quality levels for all tissues and other biospecimens, regardless of when and where they have been sampled. In addition, it proves that Indivumed’s preclinical and clinical services, the identification of drug targets and biomarkers, and drug profiling are subject to strict quality management.  Read more here

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