- This is the largest investment by a Singapore pharmaceutical manufacturer for clinical trial development
- ICM Pharma will have exclusive manufacturing and marketing rights for RESCAP® used in cardiothoracic surgery for the Asia Pacific
- Phase 3 clinical trials to be conducted in Singapore and other countries with NUHS Group to take lead in multi-centre trial
Utrecht/Singapore, 31 May 2016 – Dutch based Alloksys Life Sciences BV has signed and closed agreements with the fastest growing local pharmaceutical company in Singapore, ICM Pharma,Pte. Ltd. to invest €5.25 million (approximately S$8.1 million) for a minority stake in Alloksys and an exclusive license to market and produce RESCAP® (RESCuing Alkaline Phosphatase*) for prevention and treatment of ischemic injury and inflammation mediated complications in cardiothoracic surgery in Asia. The participation of ICM will boost the development of RESCAP® in acute clinical settings (like in cardiothoracic surgery) by Alloksys and registration for acute therapeutic applications in general.
STRATEGIC STEP TO IMPROVE QUALITY OF LIFE
“We have been following and supporting Alloksys for some time before taking this strategic step to strengthen our position as a major producer and marketer of pharmaceuticals. We are strongly committed to invest in the development of RESCAP® for further therapies, in addition to our own capabilities for GMP manufacturing and marketing here in Asia”, said Dr Stuart Koe, Managing Director of ICM Pharma.
Koos van Haasteren, CEO of Alloksys added “We are expecting to see improved quality of life for patients post-surgery and consequently reduced cost of health care for society. ICM is the ideal partner for us to bring this to reality”.
CLINICAL TESTS AND REGISTRATION
ICM Pharma’s investment will help support the Phase 3 clinical trials for Alloksys to develop RESCAP® in acute clinical settings like cardiothoracic surgery, and the registration for acute therapeutic applications in general. Upon the successful completion of the clinical trials, ICM Pharma will seek regulatory approvals from the various markets in the Asia Pacific. Every year, some 1.2 million patients worldwide undergo cardiothoracic surgery and earlier clinical and preclinical work has shown that the use of RESCAP® in cardiothoracic surgery prevents ischemic injury, thereby reducing morbidity and mortality, potentially saving many lives and substantially reducing healthcare costs.
Alloksys expects the Phase 3 clinical trials for 1,050 patients in clinics in Singapore, The Netherlands, Belgium, Italy, Germany and Portugal to be completed in approximately 48 months, with additional clinical centres to be included. The National University Heart Centre, Singapore (“NUHCS”) will take the lead in this multi-centre trial, with Associate Professor Theodoros Kofidis as the principal investigator.
With this new pipeline of innovative, first in its therapeutic class, life-saving treatments based on the RESCAP® platform, ICM will strengthen its already impressive range of over 200 OTC and generic pharmaceuticals. Combining its manufacturing expertise in creams and liquid mixtures, and leveraging on more than three decades of excellence in quality pharmaceutical manufacturing and a strong safety track record, ICM Pharma has emerged not only as the largest homegrown pharmaceutical company, but also one of Singapore’s most trusted ones, with best-selling, award-winning brands such as Growell, Lactus and Aqurea that can be found in almost every household in Singapore.
* Alkaline Phosphatase is a protein that is naturally occurring in all tissues throughout the entire human body. It is particularly concentrated in liver, (bile duct), kidney and bone. Furthermore it is present at all locations with a physiological barrier function, like in intestines the lung, placenta and brain.