The Medicines Company to Present Inclisiran Data from ORION-9 and ORION-10 Pivotal Phase 3 Clinical Studies at American Heart Association Scientific Sessions 2019

06 Nov 2019
  • ORION-10 presentation on November 16 and ORION-9 presentation on November 18
  • Company also to sponsor educational sessions throughout AHA annual meeting
  • Company to host investor conference call and webcast on Monday, November 18, 12:00 pm EST, to discuss results of studies

The Medicines Company (NASDAQ:MDCO) today announced that detailed results from the ORION-9 and ORION-10 pivotal Phase 3 clinical studies of inclisiran will be presented during late-breaking science sessions at the American Heart Association (AHA) Scientific Sessions 2019, November 16-18, in Philadelphia. The Company will also be hosting and sponsoring educational sessions (click here for agenda) intended to help advance the cardiology community’s efforts to overcome the greatest global healthcare challenge and burden today – cardiovascular disease – and address cumulative exposure to low-density lipoprotein cholesterol (LDL-C), a leading risk factor for the development of atherosclerotic cardiovascular disease (ASCVD).

Inclisiran is The Medicines Company’s investigational twice-yearly therapy to reduce LDL-C and the first and only cholesterol-lowering therapy in the small-interfering RNA (siRNA) class. ORION is a comprehensive research program studying the efficacy and safety of inclisiran in patients with ASCVD and familial hypercholesterolemia and includes three pivotal Phase 3 LDL-C lowering studies, ORION-9, ORION-10 and ORION-11.

Findings from ORION-9 and ORION-10 will be discussed during the following late-breaking oral presentations:

  • “Safety and Efficacy of Inclisiran in Patients with ASCVD and Elevated LDL Cholesterol – Results from the Phase 3 ORION-10 Trial” on Saturday, November 16, 11:06 am EST in Main Event I during Late Breaking Science I: Outside the Box: New Approaches to CVD Risk Reduction. Data will be presented by study principal investigator R. Scott Wright, M.D., Professor of Medicine, Consultant in Cardiology, Mayo Clinic, Rochester, Minn. The company announced topline results of ORION-10 on September 25 (click here).
  • “Safety and Efficacy of Inclisiran in Patients With Heterozygous Familial Hypercholesterolemia – Results From the Phase 3 ORION-9 Trial” on Monday, November 18, 9:24 am EST in Main Event I during Late Breaking Science VI: New Frontiers in Lipid Therapy. Data will be presented by study principal investigator Frederick J. Raal, MBBCh, Ph.D., Professor and Head of the Division of Endocrinology and Metabolism, University of the Witwatersrand, Johannesburg. The company announced topline results of ORION-9 on September 25 (click here).

The Medicines Company is also hosting or sponsoring the following educational programs:

  • “siRNA and gene silencing: What clinicians should know about a new class of medications” discussion on Saturday, November 16, 10:00 am EST in the Health Innovation Pavilion.
  • “Emerging concepts in LDL-C: Can we alter the course of ASCVD?” satellite symposium on Sunday, November 17, 7:00 pm EST at the Westin Philadelphia.
  • “Adherence: Is it really intractable?” on Monday, November 18, at 10:15 am EST in the Cardiovascular Expert Theater.

Click here for more information and links to these events. The satellite symposium and Cardiovascular Expert Theater session are not part of the official Scientific Sessions 2019 as planned by the AHA Committee on Scientific Sessions Program.

ORION-9 and ORION-10 Investor Conference Call and Webcast Information

The Medicines Company will host a conference call and webcast for investors on Monday, November 18, 2019 at 12:00 pm EST. During the call, the Company’s management and ORION program clinical investigators will discuss results of the ORION-9 and ORION-10 Phase 3 clinical studies. The dial-in information to access the call is as follows:

U.S./Canada:

 

(877) 407-0312

International:

 

(201) 389-0899

Conference ID:

 

13696463

A taped replay of the conference call will be available after the call concludes, and may be accessed by telephone as follows:

U.S./Canada:

 

(877) 660-6853

International:

 

(201) 612-7415

Conference ID:

 

13696463

A live audio webcast of the conference call may be accessed in the “Investors” section of The Medicines Company website. An archived webcast will be available after the call concludes.

About Inclisiran

Inclisiran, the first and only cholesterol-lowering therapy in the siRNA (small-interfering RNA) class, is The Medicines Company’s investigational twice-yearly therapy in Phase 3 clinical development to evaluate its ability to reduce low-density lipoprotein cholesterol (also known as LDL-C). As a siRNA, inclisiran harnesses the body’s natural process of RNA interference to specifically prevent production of the PCSK9 protein in the liver, which enhances the liver’s ability to remove LDL-C from the bloodstream, thereby lowering LDL-C levels. Inclisiran is not yet approved by the FDA or any other regulatory authority. The Medicines Company obtained global rights to develop, manufacture and commercialize inclisiran under a license and collaboration agreement with Alnylam Pharmaceuticals.

Commercial Opportunity

Nearly 60 million people with ASCVD or FH across the U.S., the largest European countries, China and Japan are currently treated with lipid-lowering therapies to manage cardiovascular risk. More than 70% of these patients are not achieving LDL-C treatment goals with current therapies, and approximately two-thirds of patients do not adhere to available first-line cholesterol-lowering treatments after one year. This implies a population of more than 40 million people who could potentially benefit from the investigational candidate inclisiran in the aforementioned countries alone. Inclisiran is the first cholesterol-lowering siRNA with the potential to deliver potent and durable lowering of LDL-C levels via twice-yearly dosing that can help address two critical unmet needs – additional LDL-C lowering and poor adherence to therapy.

About The Medicines Company

The Medicines Company (NASDAQ:MDCO) is a biopharmaceutical company with a singular, relentless focus on addressing the greatest global healthcare challenge and burden today – cardiovascular disease. Our purpose is to halt the deadly progression of atherosclerosis and the cardiovascular risk created by high levels of LDL-C, or bad cholesterol. The Company is headquartered in Parsippany, New Jersey. For more information, please visit www.themedicinescompany.com and follow us on Twitter @MDCONews and LinkedIn.

Forward Looking Statements

Statements contained in this press release that are not purely historical, including, but not limited to, statements about the Company, the proposed offering described herein and the use of proceeds therefrom, are 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,” “expects,” “should,” 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 the ability of the Company to effectively develop inclisiran; whether inclisiran will advance in the clinical trials process on a timely basis or at all, or succeed in achieving its specified endpoints; whether the Company will make regulatory submissions for inclisiran on a timely basis; whether its regulatory submissions will receive approvals from regulatory agencies on a timely basis or at all; the extent of the commercial success of inclisiran, if approved; the strength, durability and life of the Company’s patent protection for inclisiran and whether the Company will be successful in extending exclusivity; 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 SEC, including, without limitation, the risk factors detailed in the Company's Quarterly Report on Form 10-Q filed with the SEC on October 30, 2019. The Company specifically disclaims any obligation to update these forward-looking statements.

$MDCO to present inclisiran data from ORION-9 and ORION-10 pivotal phase 3 clinical studies at #AHA19

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