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news.Quantum Genomics has signed a strategic agreement with PCAS Pharma Synthesis, for the manufacture of the first batch of its QCC001 drug candidate for hypertension.
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Under the terms of the agreement, PCAS will prepare the first batch of Quantum Genomics’s (QGC) lead molecule QCC001. According to QGC, this compound exploits a new biological mechanism with a huge potential to facilitate control of blood pressure in patients suffering from hypertension.
QGC has said that PCAS will use its expertise in producing current good manufacturing practices (cGMP) batches of drug substances. The company will also be required to conduct stability studies in compliance with standard conditions defined by the International Conference on Harmonization. Quantum Genomics is expecting an initial cGMP batch of several kilograms of QGC001 from PCAS.
Upon conclusion of the manufacturing phase, QGC will go through regulatory preclinical development, followed by investigational medicinal product and investigational new drug applications processes. QGC expects to start the first clinical trial of its hypertension resistant drug in humans by early 2009.
Lionel Segard, chairman and CEO of QGC, said: “PCAS has excellent technical skills and a solid reputation for providing quality services in manufacturing pharmaceutical active ingredients.”