The Medicines Company to Present Inclisiran Data from ORION-9 & ORION-10 Pivotal Phase 3 Clinical Studies at American Heart A...
November 06 2019 - 4:30PM
Business Wire
- 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20191106005074/en/
Investor Relations Krishna Gorti, M.D. Investor Relations
+1 973 290 6122 krishna.gorti@themedco.com
Media Inquiries Michael Blash Communications +1 973 290
6100 michael.blash@themedco.com
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