Corline Biomedical AB («Corline») announced in november 2016, the EU commission decided to allocate about eur 2.4 MILLION (about MSEK 23.1) to the company’s clinical study within the kidney transplant with the drug candidate Renaparin
. A first payout from the H2020 programme for Corline of about eur 1.2 MILLION carried out in march 2017. Corline has now compiled a report to the EU commission, which stipulates that all milestones in the project’s first phase is achieved. Thus, the commission has decided whether to continue the support and a second installment of approximately eur 1 MILLION will be paid shortly.
Corline receives the envelope for the implementation of the planned clinical phase 1 study for Renaparin® which is under development in order to improve kidney transplant. The first phase of the project has included the GMP-production of the medicinal substance and the preparation of clinical trial application and submission of same to the Agency. All milestones in the first phase of the project have been met and reporting on these have now been reviewed and approved by the EUROPEAN commission. On the basis of this review, approved the project for continued funding in phase 2, which main activity includes the implementation of the clinical trial.
The project budget for Renaparin®project is through the allocation to 100 % funded. This means that all project costs are covered by the budget allocation, both the company’s internal costs external costs for consultants, GMP-production and other external expenses, and that no co-financing from the Corline is required.
The company estimates that the market potential for Renaparin® amounts to SEK 4 billion on an annual basis for the treatment of the approximately 35 000 kidneys that are annually transplanted in the EUROPEAN union and the united states.
Henrik Nittmar, PRESIDENT of Corline Biomedical AB, comments
«It is a very good news, we are now in the EU-the commission approves our H2020 projects for continued payment before the implementation of phase 2 and the clinical study. The approval is a clear sign that we have a competent organization with the ability to deliver results in advanced development projects and we so far have managed to implement Renaparin®-the development in accordance with our goals.»
For questions, please contact
Henrik Nittmar, CEO
Telephone: 018-71 30 90
Subsequently, the Brokerage is Corlines Certified Adviser.
This information is such information that Corline Biomedical AB is obliged to publish under the EU marknadsmissbruksförordning. The information was submitted, by the above contact person in the government, for publication on 31 July 2018.
Corline Biomedical AB
working with the endogenous substance heparin and has developed a portfolio of candidate drugs for use in conjunction with organ — and cell transplantation. The company is planning clinical studies in type 1 diabetes and kidney transplant, for which the Corline also has received särläkemedelsstatus («Orphan Drug»). Within the framework of a wholly owned subsidiary of Corline Pharma AB evaluated the in vivo administration of Corlines heparinsubstans.
180731_PM — Corline — Corline receives second tranche of the EU
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Source: Corline Biomedical AB via Globenewswire