Date: 2015-07-30
Type of information: Company acquisition
Acquired company: Coretherapix (Spain)
Acquiring company: Tigenix (Belgium)
Amount: € 6.7 million and up to €318.5 million
Terms:
- • On June 12, 2017, TiGenix announced a €5 million milestone payment in new TiGenix shares to Genetrix in relation to the cardiac platform acquisition that took place in July 2015. Under this agreement (see below), Genetrix is entitled to receive a €5 million milestone payment upon the study report of the CAREMI trial becoming available. In accordance with the Coretherapix contribution agreement, the €5 million milestone payment will be made in new TiGenix shares on the basis of the average closing share price on Euronext Brussels 90 days prior to the study report becoming available on June 9, 2017, which will result in the issue of 6,538,329 new ordinary TiGenix shares to Genetrix. The new shares will in principle be issued by mid-August.
- • On July 30, 2015, TiGenix announced the acquisition of cardiology-focused cell therapy company Coretherapix, currently owned by Genetrix. This acquisition expands TiGenix' pipeline into cardiology indications and is expected to be closed on July 31, 2015, subject to certain conditions precedent.TiGenix acquires Coretherapix for an upfront payment of approximately €1.2 million in cash and approximately €5.5 million in new TiGenix shares. Additionally, Genetrix may receive up to €15 million in new TiGenix shares depending on the results of the ongoing clinical trial of Coretherapix. Based on and subject to future sales milestones, Genetrix may receive in addition up to €245million plus certain percentages of the direct net sales of the first product, or certain percentages of any third party royalties and sales milestones for the first product. Sales milestones start when annual net sales reach €150 million and the last one will be payable once annual net sales are above €750 million. Also, Genetrix will receive a €25 million milestone payment per additional product reaching the market. The new shares to be issued on closing of the transaction will be subject to lock-up undertakings for up to 12 months, part of which will be gradually released from the lock-up over the 12-months´ period.
Details:
- Coretherapix is a cardiology-focused cell therapy company currently owned by Genetrix S.L. Its lead programme, AlloCSC-01, is an allogeneic cardiac stem cell product currently in a Phase II clinical trial in acute myocardial infarction (AMI). The ongoing randomised, placebo-controlled, multicentre Phase II study in AMI is being conducted in 9 hospitals in Belgium and Spain. After a successful open-label dose escalation phase of 6 patients, the clinical trial is aiming at recruiting 49 additional patients who will be randomised 2:1 to receive either AlloCSC-01 or placebo by intracoronary injection 5 to 8 days after the myocardial infarction. The primary endpoint is all-cause mortality and MACE (Major Adverse Cardiac Events) at 30 days. Secondary endpoints include efficacy MRI parameters (evolution of infarct size and evolution of biomechanical parameters), clinical parameters (including the 6 minute walking test and the New York Heart Association scale) and all-cause mortality and MACE, all measured at 6 and 12 months. More than 60% of patients have already been recruited and the final results are expected in the first half of 2017. A six-month interim analysis is expected to provide data in the second half of 2016. Efficacy and safety data of AlloCSC-01 has been gathered in relevant pre-clinical studies in swine and rodents. In the pig infarct model, PET data shows strong cardiac tropism, coronary clearance and myocardial retention of AlloCSC-01. MRI efficacy data in the same animal model has proven that the product significantly prevents cardiac remodeling after infarction, preserving heart function. Histological analysis shows that AlloCSC-01 reduces scar sizethereby preserving cardiac tissue. The product is also in pre-clinical development for another cardiac disease.
- This acquisition strengthens Tigenix' pipeline with a new Phase II programme.“ “Strategically, it allows us to enter completely new markets with a platform of cardiac stem cells which could be developed in several attractive cardiology indications. We have Cx601 delivering Phase III results in the treatment of perianal fistulas in Crohn’s disease patients, later this quarter and preparing for a second Phase III in the US, and we have Cx611 ready to enter into Phase II in severe sepsis and early rheumatoid arthritis around the end of the year. The addition of AlloCSC-01, finalizing the recruitment of this Phase II in AMI and already being studied in other cardiac indications clearly positions TiGenix pipeline as one of the most advanced and diverse in the industry. This acquisition is an important step towards our ambition to become one of the world leaders in the cell therapy space”, commented Eduardo Bravo, CEO of TiGenix.
Related: Cell therapy
Is general: Yes
