The Medicines Company Announces 5th Review of Un-blinded Data & Recommendation by Independent Data Monitoring Committee to Co...
January 07 2019 - 7:30AM
Business Wire
- 2019 is a momentous year for
inclisiran, a first in class therapy with the potential to deliver
potent, durable and consistent lowering of LDL-C levels via
twice-a-year dosing.
- With full commercial rights in all
geographies, The Medicines Company is well placed to harness the
intrinsic value of inclisiran.
- No material safety observations to date
as inclisiran enters final months of Phase 3 trials.
- To date, more than 2,450 patient-years
of inclisiran safety data have been accumulated in the ORION
program, a seven-fold (or 2,120 patient-year) increase over the
total patient exposure from the ORION Phase 1 and Phase 2
trials.
- At the time of IDMC review, all
patients in Phase 3 trials had received three doses of inclisiran
or placebo.
- Fourth and final study dosing will be
given within the next 6 months as countdown to Phase 3 results
begins.
The Medicines Company (NASDAQ: MDCO) today announced that the
5th review of un-blinded safety and efficacy data by the
Independent Data Monitoring Committee (IDMC) for inclisiran Phase 3
trials has been completed. The IDMC has once again recommended that
the trials continue as designed and conducted, without
modification.
“I am pleased and excited with the progress of the ORION program
as we count down to pivotal Phase 3 results in the 3rd quarter.
2019 is a momentous year for inclisiran, a first in class therapy
with the potential to deliver potent, durable and consistent
lowering of LDL-C levels via twice-a-year dosing. The potential to
address the world’s largest health problem and help patients around
the world is enormous. With full commercial rights in all
geographies, we are well placed to harness the intrinsic value of
inclisiran,” said Mark Timney, Chief Executive Officer of The
Medicines Company.
The ORION Phase 3 studies with 18-months treatment and follow-up
were fully enrolled between November 2017 and March 2018, with
3,660 patients randomized 1:1 across three trials, ORION-9 (482
patients randomized), ORION-10 (1,561 patients randomized) and
ORION-11 (1,617 patients randomized) to receive either inclisiran
or placebo. At the time of the IDMC review, it’s 5th since the
ORION Phase 3 program began, all randomized patients had been
treated with three doses, and approximately 2,000 patients had
completed a follow-up visit 60-days after the third dose of study
medication. To date, more than 2,450 patient-years of inclisiran
safety data have been accumulated in the ORION program, a
seven-fold (or 2,120 patient-year) increase over the total patient
exposure from the ORION Phase 1 and Phase 2 trials.
Commenting on the IDMC’s recommendation, David Kallend, Chief
Medical Officer of The Medicines Company said, “Once again, we are
highly encouraged by the IDMC’s clear recommendation, following its
5th review of unblinded data from the ORION Phase 3 trials. We
continue to advance the inclisiran Phase 3 program on a
highly-efficient basis, and now begin an exciting countdown as
patients receive their fourth and final dose of study medication,
and we progress to final data readout, as planned, in the second
half of 2019.”
Commercial opportunity
In the US alone, 67.5 million individuals are estimated to have
sufficient cardiovascular risk to warrant lipid-lowering therapy.
27.5 million of these individuals are at a significantly elevated
risk, either because of confirmed cardiovascular disease or LDL-C
levels above 190 mg/dl. Of this higher risk group, 15.1 million are
currently treated with lipid-lowering therapies, but only one
out of five (or 2.4 million) is successfully
reaching LDL-C targets with current therapies. This
implies a population of at least 12.7 million Americans who could
benefit from inclisiran, a first in class therapy with the
potential to deliver potent, durable and consistent lowering of
LDL-C levels via twice-a-year dosing.
About inclisiran
Inclisiran is an investigational GalNAc-conjugated RNA
interference therapeutic, which inhibits the synthesis of PCSK9
protein in liver cells, thereby reducing liver cell LDL-receptor
turnover, and lowering plasma LDL-C.
The Medicines Company and Alnylam Pharmaceuticals, Inc. are
collaborating in the advancement of inclisiran pursuant to their
2013 agreement. Under the terms of that agreement, Alnylam
completed certain pre-clinical studies and the Phase 1 clinical
study, with The Medicines Company leading and funding the
development of inclisiran from Phase 2 forward, as well as
potential commercialization.
About The Medicines Company
The Medicines Company is a biopharmaceutical company driven by
an overriding purpose – to save lives, alleviate suffering and
contribute to the economics of healthcare. The Company’s goal is to
create transformational solutions to address the most pressing
healthcare needs facing patients, physicians, and providers in
cardiovascular care. The Company is headquartered in Parsippany,
New Jersey.
Forward-Looking Statements
Statements in this press release about The Medicines Company
(the Company), the Company’s product candidate, inclisiran, the
timing of clinical trial results, and future opportunities for the
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,“
“expects," “intends," “estimates," “potential," “outlook,” “may,”
“will,” “would,””could,” and similar expressions are intended to
identify forward-looking statements. There are a number of
important factors that could cause actual results or events to
differ materially from those indicated by such forward looking
statements, including: whether, inclisiran, will advance in the
clinical trials process on a timely basis or at all; whether
clinical trial results will warrant submission of applications for
regulatory approval; whether inclisiran will receive approvals from
regulatory agencies; the extent of the commercial success of
inclisiran, if approved; and such other factors as are set forth in
the risk factors detailed from time to time in the Company’s
periodic and other reports and registration statements filed with
the Securities and Exchange Commission (SEC) including, without
limitation, the risk factors detailed in the Company’s Current
Report on Form 8-K filed with the SEC on December 12, 2018, which
are incorporated herein by reference. The Company specifically
disclaims any obligation to update these forward-looking statements
whether as a result of new information, future events or
otherwise.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20190107005565/en/
Investor RelationsKrishna
Gorti, M.D.Vice President, Investor Relations(973)
290-6122krishna.gorti@themedco.com
Medicines (NASDAQ:MDCO)
Historical Stock Chart
From Aug 2024 to Sep 2024
Medicines (NASDAQ:MDCO)
Historical Stock Chart
From Sep 2023 to Sep 2024