TSX symbol: SBS
CALGARY, Dec. 24 /PRNewswire-FirstCall/ - 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.
Calgary, Alberta-based SemBioSys is focused on leveraging its unique proprietary platform to manufacture high-value proteins and oils. SemBioSys' seed-based protein production system can provide for its partners product enablement, exceptionally low cost and unprecedented scalability. SemBioSys is applying the platform with high selectivity to products with tremendous clinical promise and value potential. The Company's current pharmaceutical development programs include insulin (SBS-1000, regulated as a biosimilar in Europe) and Apo AI(Milano), a next-generation cardiovascular therapy. SemBioSys is listed on the Toronto Stock Exchange under the ticker SBS. More information is available at www.sembiosys.com.
This press release contains certain forward-looking statements, including, without limitation, statements containing the words "believe", "may", "plan", "will", "estimate", "continue", "anticipate", "intend", "expect" and other similar expressions which constitute "forward-looking information" within the meaning of applicable securities laws. Forward-looking statements reflect the Company's current expectation and assumptions, and are subject to a number of risks and uncertainties that could cause actual results to differ materially from those anticipated. These forward-looking statements involve risks and uncertainties including, but not limited to, the obtaining of court and other regulatory approvals and consents, any adjustment with respect to the amount of the non-dilutive financing, including the market price of the securities to be received by New SemBioSys, the satisfaction of closing conditions, and other risks detailed from time-to-time in the Company's ongoing filings with the Canadian securities regulatory authorities which filings can be found at www.sedar.com. Given these risks and uncertainties, readers are cautioned not to place undue reliance on such forward-looking statements. The Company undertakes no obligation to publicly update or revise any forward-looking statements either as a result of new information, future events or otherwise, except as required by applicable Canadian securities laws.
SOURCE SemBioSys Genetics Inc.
|SOURCE SemBioSys Genetics Inc.|
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