SOURCE: The Medicines Company

The Medicines Company

November 14, 2011 16:30 ET

The Medicines Company's MDCO-216 (ApoA-I Milano Complex) Demonstrates Capacity to Clear Cholesterol From Cells in Preclinical Model

Data Presented at American Heart Association Scientific Sessions 2011

ORLANDO, FL--(Marketwire - Nov 14, 2011) - Researchers from The Medicines Company (NASDAQ: MDCO) today presented the first data of MDCO-216 (ApoA-I Milano Complex) sourced from an improved manufacturing process. MDCO-216 is an investigational, naturally occurring variant of a protein called ApoA-I found in human high-density lipoprotein, or HDL, which is designed to enable lipids like cholesterol and triglycerides to be transported from inside cells outward to the bloodstream, to the liver and eventually out of the body in a process called reverse cholesterol transport.

Here at The American Heart Association Scientific Sessions 2011, the researchers reported that MDCO-216 demonstrated in an animal model a dose dependent ability to cause cholesterol efflux, the first step in reverse cholesterol transport. This is the first report in the scientific literature where researchers confirmed the mechanistic pathway of exogenously administered MDCO-216 in the preclinical model. They confirmed that in the preclinical model MDCO-216 induced cholesterol efflux via ABCA1 and SR-BI, which are cellular transporters involved with clearing cholesterol out of cells. It was also reported that the treatment was well tolerated up to the highest dose tested.

Dimitrios Goundis, PhD, head of R&D at The Medicines Company said, "We plan to advance MDCO-216 back into clinical trials in 2012 while continuing to improve the manufacturing efficiency that would allow us to make sufficient high quality material for clinical development. We believe that MDCO-216 has the potential to reverse plaque buildup in arteries in patients with acute coronary syndromes, so it fits nicely into our portfolio of acute and intensive care hospital compounds."

About MDCO-216
MDCO-216, an investigational agent not approved for commercial use in any market, is a naturally occurring variant of apolipoproteinA-I (ApoA-I), the main protein component of the HDL lipoprotein particle. The variant has been found in approximately 45 individuals from Limone sul Garda, a small village in northern Italy. Carriers of this variant appear to have reduced risk of cardiovascular disease.

In multiple preclinical models, ApoA-I Milano rapidly removed excess cholesterol from artery walls, thereby stabilizing and regressing atherosclerotic plaque. A phase I/II study in 36 patients conducted prior to MDCO's acquisition of rights to the product demonstrated statistically significant reductions of coronary plaque volume by 4.2% in six weeks. These findings were published in the Journal of the American Medical Association.

Since acquiring rights to MDCO-216 in December 2009, The Medicines Company has actively developed manufacturing methodologies that the Company believes will improve the yield (the manufacturing efficiency) and enable sufficient material for clinical development.

About The Medicines Company
The Medicines Company (NASDAQ: MDCO) provides medical solutions to improve health outcomes for patients in acute and intensive care hospitals worldwide. These solutions comprise medicines and knowledge that directly impact the survival and well being of critically ill patients.

Statements contained in this press release about The Medicines Company that are not purely historical, and all other statements that are not purely historical, may be deemed to be forward-looking statements for purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995. Without limiting the foregoing, the words "believes," "anticipates," "plans" and "expects" and similar expressions are intended to identify forward-looking statements. These forward-looking statements involve known and unknown risks and uncertainties that may cause the Company's actual results, levels of activity, performance or achievements to be materially different from those expressed or implied by these forward-looking statements. Important factors that may cause or contribute to such differences include whether the Company's products will advance into clinical trials or through the clinical trials process on a timely basis or at all, whether results of preclinical studies and clinical trials such as the results described above will be indicative of results in later clinical trials, whether clinical trial results will warrant submission of applications for regulatory approval, whether the Company will be able to obtain regulatory approvals, whether physicians, patients and other key decision-makers will accept clinical trial results, and such other factors as are set forth in the risk factors detailed from time to time in the Company's periodic reports and registration statements filed with the Securities and Exchange Commission including, without limitation, the risk factors detailed in the Company's Quarterly Report on Form 10-Q filed on November 9, 2011, which are incorporated herein by reference. The Company specifically disclaims any obligation to update these forward-looking statements.

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