EmbryoSure® - commencement of clinical programme based on new improved terms
ORIGIO a/s, a listed medtech company on the Oslo Stock Exchange (OSE: ORO) today announces it has successfully negotiated new terms with Novocellus, involving increasing Novocellus’ contribution to risk sharing and commencement of the EmbryoSure® clinical programme.
The amended agreement is the outcome of discussions with Novocellus to review options for progressing the trials, as mentioned in ORIGIO’s third quarter report for 2011.
ORIGIO entered in 2009 an agreement with Novocellus Ltd. to license non-invasive embryo selection technology called EmbryoSure®. The technology is based on amino acid profiling and discovered by Professor Henry Leese at the University of York, UK. Pilot clinical studies completed to date have shown that amino acid profiling appears valuable in identifying those embryos most likely to lead to a successful pregnancy.
Currently, the selection of embryos for transfer back to the uterus is based on subjective visual/morphological assessment of embryo quality and viability. As a result many embryologists find it necessary to transfer multiple embryos at a time in order to increase the probability of success. However, this can lead to the birth of multiplets with possible adverse effects on mother and child. Consequently, the trend today is to improve selection methods with the aim of transferring only one embryo in order to reduce the adverse effects and still maintain or even improve the chances of a pregnancy.
For single embryo transfer to replace multiple transfers world-wide, an improved and documented selection method of the best embryo(s) by objective measures is important. ORIGIO and Novocellus have planned a human study program to investigate the extent to which EmbryoSure® is superior to current visual techniques in selecting the most implantation competent embryos.
The clinical programme will consist of a retrospective human clinical trial carried out in 5 centres in UK aiming for a total of 400 patients. The retrospective study will start shortly and be conducted with expected completion mid-year 2013. In the event that this study has a positive outcome in terms of defining a relevant algorithm for superior selection of embryos for transfer, then a prospective human efficacy trial will be initiated.
In case of positive results are obtained from the full retrospective study, CE marking of the culture medium completed and an analysis module ready, ORIGIO will launch EmbryoSure® in the UK market. This launch is targeted by mid-year 2014.
Terms
Novocellus and ORIGIO have according to the new improved terms decided to share the risk of the clinical programme. Depending on the outcome, Novocellus will contribute up to £0.5 million to costs related to the retrospective study and development of the analysis module.
Novocellus will in the best case receive £4.5 million in predominantly sales related milestone payments and royalty payments of 25% of net sales of EmbryoSure®.
Financial guiding
The total cost of the retrospective study is estimated to be DKK 3.0 – 3.5 million. In case of positive results are obtained from the full retrospective study, ORIGIO will pay the full cost, while if unsuccessful Novocellus will pay the full cost of the study.
For further information, please contact:
Jesper Funding Andersen, CEO: +45 4073 0963 or email: jfandersen@origio.com
Jakob Brix Christensen, Director Investor Relations: +45 2144 4811 or email, jbrix@origio.com
About ORIGIO a/s
ORIGIO a/s is a world leader in Assisted Reproductive Technology (ART) solutions. Through research and innovation, ORIGIO aims to provide the best products to medical professionals to help the #1 dream of every infertile couple come true. ORIGIO currently comprises the three product families, MediCult Media, Humagen Pipets and MidAtlantic Devices that cater for the broadest range of ART requirements. The Medtech company ORIGIO, which is headquartered in Måløv, Denmark, and has subsidiaries in 10 countries, is listed on the Oslo Stock Exchange under the symbol, ORO. For further information, please visit www.origio.com.
Forward-Looking Statements
Certain statements in this announcement contain forward-looking statements that involve a number of risks and uncertainties. Our actual results could differ materially from those results expressed in, or implied by, these forward-looking statements. There can be no assurance that any of the forward-looking statements identified in this announcement will occur. Conducting studies for investigational products are subject to risks and uncertainties. There can be no assurance that planned studies can be initiated, that planned or ongoing studies can be successfully concluded or concluded in accordance with ORIGIO’s anticipated schedule. These factors, and other factors including, but not limited to, those described in ORIGIO’s most recent annual report, could cause future results to differ materially from the expectations expressed in this announcement. The forward-looking statements contained in this announcement may become outdated over time. ORIGIO does not assume any responsibility for updating any forward-looking statements.
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