SemBioSys Genetics Inc. (TSX:SBS) provided an update today on its progress on plant-produced Apo AI(Milano) in light of the Apo AI(Milano) license agreement between Pfizer Inc. and The Medicines Company, of Parsippany, New Jersey.
"The Medicines Company's acquisition of the exclusive rights to Pfizer's Apo AI(Milano) program is a strong endorsement of Apo AI(Milano) and its potential to rapidly reduce atherosclerotic plaque. The asset is now in the hands of pharmaceutical company that will actively develop the compound with access to the financial means to do so," said James Szarko, Chief Executive Officer of SemBioSys. "The Medicines Company, which specializes in acute cardiac care, recognizes the potential benefit and value of Apo AI(Milano) to address one of the most significant areas of unmet clinical need in the cardiovascular market today. While The Medicines Company did not address a manufacturing solution in their disclosure surrounding the transaction, it is clear that the success of this drug candidate will be highly dependent upon manufacturing technology that can provide Apo AI(Milano) at high purity and at a reasonable cost. Although SemBioSys' Apo AI(Milano) product is different and distinct from that in-licenced by The Medicines Company, our proprietary manufacturing technology is perfectly suited to making their in-licenced product as well as the natural forms of Apo AI."
In collaboration with leading cardiologists and cardiovascular researchers, SemBioSys has confirmed the activity of plant-derived Apo AI(Milano) in seven preclinical models. The Company has demonstrated the anti-atherosclerotic effects of Apo AI(Milano) based on cholesterol mobilization from the arterial wall, lipid content of atherosclerotic plaques, and the reduction of overall volume of atherosclerotic plaque after multiple injections. This year, the Company harvested more than 20 tonnes of safflower containing Apo AI(Milano) from outdoor production operations in Chile and the United States which provided surplus material for the manufacturing scale up at its pilot facility. SemBioSys has also completed a pre-IND (Investigational New Drug) meeting during which the U.S. Food and Drug Administration confirmed the development plan presented by SemBioSys to file an IND application and addressed the proposed design of clinical trials for Apo AI(Milano). SemBioSys continues to conduct discussions with potential partners on its proprietary, plant-derived Apo AI(Milano) product.