Pharma firms develop first batch of hypertension drug candidate
The first batch of a hypertension drug candidate that exploits a new biological mechanism is being developed by biotech company Quantum Genomics Corp (QGC) and PCAS Pharma Synthesis.
The first batch of a hypertension drug candidate that exploits a new biological mechanism is being developed by biotech company Quantum Genomics Corp (QGC) and PCAS Pharma Synthesis.
QGC, which is involved in the development of new drugs for metabolic and cardiovascular diseases, will use its lead molecule QCC001. The molecule exploits a mechanism with a huge potential to control blood pressure in patients suffering from hypertension.
PCAS Pharma Synthesis, a world-class supplier of key intermediates and bulk actives to the pharmaceutical industry, will use its expertise in producing current Good Manufacturing Practices (cGMP) batches of drug substances. This is a highly critical procedure for the administration of any drug product in humans. The company will also be required to conduct stability studies in compliance with standard conditions defined by the International Conference on Harmonization (ICH). QGC is expecting an initial cGMP batch of several kilograms of QGC001 from PCAS.
"PCAS has excellent technical skills and a solid reputation for providing quality services in manufacturing pharmaceutical active ingredients," said Lionel Segard, chairman and ceo of QGC. "One of QGC's strengths in development of innovative drugs that address significant unmet medical needs is our ability to select the relevant contracting partner to manage a study and to obtain the product on time and on budget."
Cardiovascular diseases are one of the main causes of death in humans. Hypertension in particular is one of the major determining factors in premature death. The risk of myocardial infarction, stroke, kidney failure, heart failure or other complications doubles with every 20/10mmHg rise in blood pressure. At least 30% of people have hypertension. Hundreds of millions of people worldwide suffer from hypertension complications despite medical advice on food and health habits and the existence of several treatments. The market for hypertensive drugs is expected to double between 2005 and 2010.
Upon conclusion of the manufacturing phase, QGC will go through regulatory preclinical development, followed by Investigational Medicinal Product (IMPD) and Investigational New Drug (IND) Applications processes. QGC expects to start the first clinical trial of its hypertension resistant drug in humans by early 2009.