The Medicines Company Presents New Data Showing Remodeling Effect of MDCO-216 on HDL Particles in Coronary Artery Disease Patients

26 May 2015

The Medicines Company (NASDAQ:MDCO) presented the results of a Phase 1 study for MDCO-216 that showed that the drug had a significant remodeling effect on HDL particles, which correlated with increased ABCA1-mediated cholesterol efflux. This mechanism of HDL remodeling and increased cholesterol efflux may drive the removal of deposited cholesterol from vessel walls to reduce plaque burden in patients with atherosclerotic disease. The findings were presented at the 17th International Symposium on Atherosclerosis, May 23-26, in Amsterdam, The Netherlands.

MDCO-216 is a complex of dimeric recombinant apolipoprotein A-1 Milano (ApoA-1 Milano) and a phospholipid (POPC) which was developed in an attempt to mimic pre-beta HDL and induce cholesterol efflux, the first step in reverse cholesterol transport, causing removal of cholesterol from the artery walls.

A single infusion of MDCO-216 was shown to produce a rapid increase in ABCA1 mediated efflux, a potential marker of reverse cholesterol transport, and a marked increase in pre-beta 1 HDL. This was followed by and correlated with a decrease in smaller HDL particles and an increase in larger HDL particles which suggests significant and rapid HDL remodeling. This data provides a hypothesis for the mechanism by which MDCO-216 as a single infusion may increase the physiological process of reverse cholesterol transport and potentially reduce atherosclerotic plaque burden.

“This new data suggests that MDCO-216 may have a profound impact on the body’s ability to remove cholesterol from arterial walls,” said Clive Meanwell, MD, PhD, Chairman and CEO, The Medicines Company. “We continue to be excited about the potential of MDCO-216 to rapidly reverse atherosclerotic plaque buildup, Together with our first-in-class PCSK9 inhibitor, ALN-PCSsc, which has the potential to become the best-in-class therapeutic for the reduction of LDL cholesterol, we look forward to advancing these important compounds through clinical development.”

In other presentations at the conference of the Phase 1 data for MDCO-216,, investigators compared the pharmacokinetics and pharmacodynamics of MDCO-216 in healthy volunteers (HV’s) and CAD patients. MDCO-216 was found to profoundly stimulate the first step of reverse cholesterol transport at clinically achievable and well tolerated doses with similar PK profiles in both HV’s and coronary artery disease (CAD) patients, but with higher potency in terms of ABCA1 efflux in CAD patients.

In a separate presentation, investigators assessed the safety of newly manufactured MDCO-216 in HV’s and CAD patients. MDCO-216 was shown to be well tolerated with no serious events and no significant adverse safety findings. The most common adverse events were headache and fatigue. No dose dependent effect on any safety parameter was noted, including inflammatory markers, and there were no differences in safety parameters between HV’s and CAD patients.

About MDCO-216

MDCO-216, an investigational product not approved for commercial use in any market, is a complex of dimeric recombinant apolipoprotein A-1 Milano (ApoA-1 Milano) and a phospholipid (POPC) and is currently under development to improve cardiovascular outcomes by reducing plaque burden in patients with atherosclerotic disease. MDCO-216 mimics pre-beta HDL and induces cholesterol efflux, which is the first step in the reverse cholesterol transport, a process of removal of deposited cholesterol from vessel walls and therefore has a potential to reduce plaque burden in patients with CAD.

About The Medicines Company

The Medicines Company's purpose is to save lives, alleviate suffering and contribute to the economics of healthcare by focusing on 3000 leading acute/intensive care hospitals worldwide. Its vision is to be a leading provider of solutions in three areas: serious infectious disease care, acute cardiovascular care and surgery and perioperative care. The company operates in the Americas, Europe and the Middle East, and Asia Pacific regions with global centers today in Parsippany, NJ, USA and Zurich, Switzerland.

Forward-Looking Statements

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," "expects," “hopes” and “potential” 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 MDCO-216 will advance in the clinical trials process on a timely basis or at all, whether physicians, patients and other key decision makers will accept clinical trial results, whether the Company will make regulatory submissions for MDCO-216 on a timely basis or at all, whether its regulatory submissions will receive approvals from regulatory agencies on a timely basis or at all, the Company’s ability to successfully compete with potential competitors which may discover, develop or commercialize competing products more successfully than we do, 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 with the SEC on May 5, 2015, which are incorporated herein by reference. The Company specifically disclaims any obligation to update these forward-looking statements.


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The Medicines Company
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Neera.Ravindran@themedco.com

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