– Investigational First-in-Class PCSK9 Synthesis Inhibitor Achieves
up to 83% Maximal and 64% Mean Maximum LDL-C Lowering, Comparable to
Published Results with Anti-PCSK9 Monoclonal Antibodies, but with
Clinically Significant Reductions in LDL-C Clamped Down for More than
140 Days after Just a Single Dose –
– ALN-PCSsc Generally Well Tolerated with No Clinically Significant
Drug-Related Adverse Events to Date –
– Program Lead Transitions from Alnylam to The Medicines Company, who
Together Launch “ORION™” Development Program, with Initial Phase 2 Start
Planned by End-2015 and Phase 3 Start Expected in 2017; ORION to Include
Comparative Study with Anti-PCSK9 Monoclonal Antibodies–
– Companies to Host Conference Call Today, Sunday, August 30th, at
9:30 a.m. ET to Discuss Results –
Company Website:
http://www.alnylam.com
CAMBRIDGE, Mass. -- (Business Wire)
Alnylam
Pharmaceuticals, Inc. (Nasdaq:ALNY), a leading RNAi therapeutics
company, and The
Medicines Company (Nasdaq:MDCO), a global biopharmaceutical company
focusing on saving lives, alleviating suffering and contributing to the
economics of healthcare by focusing on the world’s leading
acute/intensive care hospitals, announced today positive
initial results from their ongoing Phase 1 clinical trial with
ALN-PCSsc at ESC Congress 2015 held August 29 – September 2, 2015, in
London. ALN-PCSsc is an investigational RNAi therapeutic targeting PCSK9
– a genetically validated protein regulator of LDL receptor metabolism –
being developed for the treatment of hypercholesterolemia. In contrast
to anti-PCSK9 monoclonal antibodies (MAbs) that bind to PCSK9 in blood,
ALN-PCSsc is a first-in-class investigational medicine that acts by
turning off PCSK9 synthesis in the liver.
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In the Phase 1 study, subcutaneous administration of ALN-PCSsc resulted
in an up to 83% lowering of LDL-C, with an up to 64 ± 5% mean maximum
reduction, comparable to published results for anti-PCSK9 MAbs (Zhang
XL., et al., BMC Med, 2015). Similar reductions in LDL-C
were seen in patients on and off concomitant statin therapy. The effects
of ALN-PCSsc were highly durable, with clinically significant and
clamped reductions in LDL-C maintained for over 140 days, supportive of
a once-quarterly and possibly bi-annual subcutaneous dose regimen.
Maximal lowering effects on LDL-C were consistently achieved at a dose
of 300 mg associated with a low injection volume of 1.5 mL; this dose
was significantly below the 800 mg top dose studied per the Phase 1
protocol. Importantly, ALN-PCSsc was generally well tolerated with no
clinically significant drug-related adverse events. The development
leadership of ALN-PCSsc now transitions from Alnylam to The Medicines
Company, who together announce today initiation of the ORIONTM
development program, with an initial Phase 2 study planned to begin by
end-2015 and a Phase 3 study expected to begin by end-2017. ORION is
also expected to include a comparative study of ALN-PCSsc with
anti-PCSK9 MAbs.
“Our initial Phase 1 results with ALN-PCSsc, a first-in-class
investigational PCSK9 synthesis inhibitor, demonstrate robust,
dose-dependent, and durable reductions in LDL-C of up to 83%.
Remarkably, significant and clamped lowering of LDL-C is achieved for
over 140 days after a single dose. At the 300 mg dose – which we believe
is optimal, with fully saturating effects on both LDL-C lowering and
PCSK9 knockdown – an injection volume of 1.5 mL and possibly lower can
be achieved. Accordingly, we believe that these results support a
quarterly, and possibly bi-annual, low volume subcutaneous dose regimen
for further development,” said Akshay Vaishnaw, M.D., Ph.D., Executive
Vice President of R&D and Chief Medical Officer at Alnylam.
“Importantly, ALN-PCSsc was generally well tolerated with no clinically
drug-related significant adverse events to date. Based on these positive
results, we believe that ALN-PCSsc potentially represents an innovative,
differentiated, and well validated approach for the treatment of
hypercholesterolemia. We very much look forward to our continued
partnership with The Medicines Company as they now take the lead in
developing ALN-PCSsc in the ORION program.”
“Based on these initial Phase 1 results, we believe that ALN-PCSsc has a
highly competitive profile as compared with anti-PCSK9 monoclonal
antibodies that are labeled for twice-monthly dosing. In particular, we
believe that a maximally efficacious and well tolerated quarterly or
potentially bi-annual, low volume subcutaneous dosing regimen could
address the unmet needs for hypercholesterolemia management in a
massive, at-risk, often non-adherent population worldwide. Moreover, we
imagine that ALN-PCSsc has the potential to open new innovation horizons
with patients, providers, and payers by linking the temporal cycle of
LDL-C monitoring with administration of therapy,” said David Kallend,
MBBS, Vice President and Global Medical Director at The Medicines
Company. “We are now initiating our broad-based ORION development
program to advance ALN-PCSsc toward approval and the market. We expect
to start our initial Phase 2 study by end of this year, and plan to
start our Phase 3 registration studies in 2017. In addition, we plan on
performing studies directly comparing ALN-PCSsc with anti-PCSK9 MAbs to
confirm the important features and potential benefits of this
first-in-class investigational PCSK9 synthesis inhibitor.”
“Elevated LDL-C remains a major risk factor for coronary artery disease,
and new therapies are needed for patients who are refractory or
intolerant to current approaches for management of their LDL-C levels.
PCSK9 therapies have now emerged as a new class of drugs for treatment
of hypercholesterolemia, and I believe that these agents have the
potential to make a meaningful difference for patients,” said John J.P.
Kastelein, M.D., Ph.D., Professor of Medicine and Chairman of the
Department of Vascular Medicine at the Academic Medical Center (AMC) of
the University of Amsterdam. “I am very encouraged by these initial
clinical data with ALN-PCSsc, especially the durability of LDL-C
lowering effects. If the safety and efficacy of this novel
investigational PCSK9 synthesis inhibitor can be confirmed in larger
studies to support approval, it may offer an important treatment option
for patients, physicians, and payers.”
The Phase 1 trial of ALN-PCSsc is being conducted in the U.K. as a
randomized, single-blind, placebo-controlled, single ascending- and
multi-dose, subcutaneous dose-escalation study. Enrollment in the study
has been completed, but the study is ongoing with continued data
collection and subject follow up. The study was designed to enroll up to
76 volunteer subjects with elevated baseline LDL-C (≥ 100 mg/dL), with
subjects randomized 3:1, drug: placebo. The study was performed in two
phases: a single ascending dose (SAD) phase and a multiple dose (MD)
phase. The MD phase also includes subjects both on and off statin
co-medication. The primary objective of the Phase 1 study is to evaluate
the safety and tolerability of ALN-PCSsc. Secondary objectives include
assessment of clinical activity as determined by knockdown of plasma
PCSK9 levels and lowering of serum LDL-C levels, as well as
pharmacokinetics of ALN-PCSsc.
All results
are based on data in the database as of August 4, 2015. A total of 69
subjects were enrolled in the study, with a mean baseline LDL-C of 146
mg/dL. A total of 24 subjects were enrolled in five SAD cohorts and
received placebo (N=6) or study drug at fixed doses from 25 mg to 800 mg
(N=3, per group; N=6 for the 800 mg cohort). A total of 45 subjects were
enrolled in six MD cohorts, with subjects receiving: placebo (N=12);
four doses of 125 mg once weekly (N=6); two doses of 250 mg once every
two weeks (N=6); two doses of 300 mg once every four weeks (N=6); two
doses of 300 mg once every four weeks with statin co-medication (N=4);
two doses of 500 mg once every four weeks (N=6); and two doses of 500 mg
once every four weeks with statin co-medication (N=5).
In the SAD cohorts, ALN-PCSsc administration was associated with potent,
dose-dependent, and highly durable knockdown of PCSK9 and lowering of
LDL-C. An up to 86% maximal knockdown of PCSK9 relative to baseline was
achieved, with an up to 82 ± 2% mean maximum PCSK9 knockdown (p<0.001,
compared to placebo). Even in the lowest dose group of 25 mg,
significant knockdown of PCSK9 was observed. Maximal effects toward
PCSK9 were achieved at the 300 mg dose, with further dose escalation
yielding minimal additive effects; the volume of drug at the 300 mg dose
was 1.5 mL. Knockdown of PCSK9 was highly durable, with a 62 ± 5% mean
effect (p<0.05, compared to baseline) in the 300 mg cohort maintained at
140 days after a single dose.
In the SAD cohorts, an up to 78% maximal lowering of LDL-C was achieved,
with an up to 58 ± 4% mean maximum LDL-C lowering (p<0.01, compared to
placebo); absolute levels of LDL-C as low as 30 mg/dL were observed. As
with PCSK9 knockdown, maximal, fully saturating effects on LDL-C
lowering were achieved at the 300 mg dose. Reductions in LDL-C were
highly durable, with a 44 ± 1% mean lowering (p<0.001, relative to
baseline) in the 300 mg cohort maintained at 140 days after a single
dose; data collection beyond 140 days is ongoing. The least squares mean
(LSM) % reduction in LDL-C from baseline at 12 weeks – a measure used in
studies of anti-PCSK9 MAbs – was 50.1% in the 300 mg cohort; this is
comparable to the 50-60% range of values reported for MAbs, but was
achieved after just a single dose. The durable effects of ALN-PCSsc
support a once quarterly, and possibly bi-annual, low volume
subcutaneous dose regimen for evaluation in further clinical studies.
Results are summarized in the table below.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
SAD Group
|
|
|
Maximum % PCSK9 Knockdown
|
|
|
Mean Maximum % PCSK9 Knockdown# |
|
|
Mean % PCSK9 Knockdown at Day 140^ |
|
|
Maximum % LDL-C Lowering
|
|
|
Mean Maximum % LDL-C Lowering# |
|
|
Mean % LDL-C Lowering at Day 140^ |
Placebo (N=6)
|
|
|
38
|
|
|
29 ± 4
|
|
|
N/A
|
|
|
25
|
|
|
19 ± 2
|
|
|
N/A
|
25 mg (N=3)
|
|
|
60
|
|
|
54 ± 3
|
|
|
14
|
|
|
44
|
|
|
34 ± 5
|
|
|
15
|
100 mg (N=3)
|
|
|
73
|
|
|
49 ± 16
|
|
|
-4 ± 41
|
|
|
60
|
|
|
43 ± 9
|
|
|
39 ± 1*
|
300 mg (N=3)
|
|
|
82
|
|
|
78 ± 2***
|
|
|
62 ± 5*
|
|
|
67
|
|
|
53 ± 7
|
|
|
44 ± 1***
|
500 mg (N=3)
|
|
|
86
|
|
|
76 ± 7***
|
|
|
66 ± 9
|
|
|
78
|
|
|
55 ± 12*
|
|
|
39 ± 20
|
800 mg (N=6)
|
|
|
86
|
|
|
82 ± 2***
|
|
|
Ongoing
|
|
|
69
|
|
|
58 ± 4**
|
|
|
Ongoing
|
#For mean maximum knockdown/reduction relative to baseline, p
values from pairwise comparisons vs. placebo using ANOVA model
^For
mean knockdown/reduction relative to baseline at Day 140, p values from
pairwise t-tests vs. baseline
*p less than 0.05
**p less than
0.01
***p less than 0.001
In the MD cohorts, ALN-PCSsc was associated with potent and highly
durable knockdown of PCSK9 and lowering of LDL-C, with similar effects
to those observed at lower study drug exposure in SAD cohorts. An up to
94% PCSK9 knockdown and an up to 83% LDL-C lowering were observed,
including absolute levels of LDL-C as low as 18 mg/dL. The LSM %
reduction in LDL-C from baseline at 12 weeks was 59.4% in the 300 mg
once-monthly dose cohort. All MD groups showed similar levels of PCSK9
knockdown and reductions in LDL-C, indicating that all doses achieved a
fully saturating effect for a PCSK9 synthesis inhibitor with an
approximately 80% knockdown of PCSK9 and an approximately 60% LDL-C
lowering. Also, PCSK9 knockdown and LDL-C lowering were similar in
subjects with or without statin co-administration, suggesting that
ALN-PCSsc may be able to substantially reduce LDL-C in individuals
already on a statin and not at target levels. Data collection beyond 98
days is ongoing. Results are summarized in the table below.
|
|
|
|
|
|
|
|
|
|
|
|
|
MD Group
|
|
|
Maximum % PCSK9 Knockdown
|
|
|
Mean Maximum % PCSK9 Knockdown# |
|
|
Maximum % LDL-C Lowering
|
|
|
Mean Maximum % LDL-C Lowering# |
Placebo (N=11)^ |
|
|
63
|
|
|
29 ± 6
|
|
|
43
|
|
|
22 ± 3
|
125 mg qW x4 (N=6)
|
|
|
86
|
|
|
82 ± 1***
|
|
|
60
|
|
|
51 ± 2
|
250 mg q2W x2 (N=6)
|
|
|
85
|
|
|
81 ± 1***
|
|
|
70
|
|
|
60 ± 5***
|
300 mg qM x2 (N=6)
|
|
|
87
|
|
|
79 ± 3***
|
|
|
79
|
|
|
64 ± 5***
|
300 mg qM x2 w/ statin (N=3)^ |
|
|
88
|
|
|
86 ± 1***
|
|
|
69
|
|
|
52 ± 10
|
500 mg qM x2 (N=6)
|
|
|
86
|
|
|
81 ± 2***
|
|
|
69
|
|
|
55 ± 7**
|
500 mg qM x2 w/ statin (N=5)
|
|
|
94
|
|
|
88 ± 2***
|
|
|
83
|
|
|
60 ± 8***
|
#For mean maximum knockdown/reduction relative to baseline, p
values from pairwise comparisons vs. placebo using ANOVA model
*p
less than 0.05
**p less than 0.01
***p less than 0.001
^One
subject in the placebo group received only a single dose; one subject in
the 300 mg qM x2 with statin group received a single dose and
discontinued at day 14 due to incarceration; both were excluded
Additional Phase 1 clinical activity results – including further
durability data for PCSK9 knockdown and LDL-C lowering effects, as well
as changes in exploratory biomarkers such as total cholesterol, apoB,
non-HDL-C, and Lp(a) – are planned to be presented at a future date.
ALN-PCSsc was found to be generally well tolerated, with no clinically
significant drug-related adverse events to date. There were no serious
adverse events (SAEs) or drug-related discontinuations. All adverse
events (AEs) were mild or moderate in severity. At higher drug exposures
of 500 mg or greater, four subjects receiving ALN-PCSsc reported mild,
localized injection site reactions (ISRs) that resolved without medical
intervention. At or below the lowest maximally effective dose of 300 mg,
there were no ISRs noted in any SAD or MD cohort subjects (0/19). One
subject in the 500 mg MD group developed alanine transaminase (ALT)
elevations approximately 4 times upper limit of normal (ULN) without
change in bilirubin, but this was attributed to concomitant statin
therapy and improved upon statin discontinuation. There were no
clinically significant changes in other laboratory safety measurements,
including cytokine levels, or hematologic parameters. There were also no
clinically significant changes in renal function tests.
The lead development responsibility for ALN-PCSsc will now transition
from Alnylam to The Medicines Company, who together will be advancing
ALN-PCSsc in the ORION development program, a comprehensive global
clinical development plan designed to support ALN-PCSsc regulatory
approval and market access worldwide. ORION will begin with an initial
Phase 2 study that is expected to start by end of 2015. Further, the
companies expect that Phase 3 clinical trials will begin in 2017, and
that ORION will include a comparative study of ALN-PCSsc with anti-PCSK9
MAbs.
Alnylam and The Medicines Company are collaborating in the advancement
of ALN-PCSsc per the companies’ agreement formed in early 2013. Under
the terms of the agreement, Alnylam will complete certain pre-clinical
studies and a Phase 1 clinical study of ALN-PCSsc and The Medicines
Company is responsible for leading and funding development from Phase 2
forward as well as potential commercialization.
Conference Call Information
Alnylam and The Medicines Company will host a conference call today,
Sunday, August 30, at 9:30 a.m. ET to discuss these initial Phase 1
results with ALN-PCSsc and the ORION development program. A slide
presentation will also be available on the Investors page of the Alnylam
website, www.alnylam.com,
and on The Medicines Company website, www.themedicinescompany.com,
to accompany the conference call. To access the call, please dial
877-312-7507 (domestic) or 631-813-4828 (international) five minutes
prior to the start time and refer to conference ID 18857833. A replay of
the call will be available beginning at 12:30 p.m. ET. To access the
replay, please dial 855-859-2056 (domestic) or 404-537-3406
(international), and refer to conference ID 18857833.
About Hypercholesterolemia
Hypercholesterolemia is a condition characterized by very high levels of
cholesterol in the blood which is known to increase the risk of coronary
artery disease, the leading cause of death in the U.S. Some forms of
hypercholesterolemia can be treated through dietary restrictions,
lifestyle modifications (e.g., exercise and smoking cessation) and
medicines such as statins. However, a large proportion of patients with
hypercholesterolemia are not achieving adequate LDL-C levels with
currently available therapies including statins, including genetic
familial hypercholesterolemia (FH) patients, acute coronary syndrome
patients, high-risk patient populations (e.g., patients with coronary
artery disease, diabetics, symptomatic carotid artery disease, etc.) and
other patients that are statin intolerant. Severe forms of
hypercholesterolemia are estimated to affect more than 500,000 patients
worldwide, and as a result, there is a significant need for novel
therapeutics to treat patients with hypercholesterolemia whose disease
is inadequately managed by existing therapies.
About GalNAc Conjugates and Enhanced Stabilization Chemistry
(ESC)-GalNAc Conjugates
GalNAc-siRNA conjugates are a proprietary Alnylam delivery platform and
are designed to achieve targeted delivery of RNAi therapeutics to
hepatocytes through uptake by the asialoglycoprotein receptor. Alnylam's
Enhanced Stabilization Chemistry (ESC)-GalNAc-conjugate technology
enables subcutaneous dosing with increased potency and durability, and a
wide therapeutic index. This ESC-GalNAc-conjugate delivery platform is
being employed in nearly all of Alnylam's pipeline programs, including
ALN-PCSsc and several other programs in clinical development.
About RNAi
RNAi (RNA interference) is a revolution in biology, representing a
breakthrough in understanding how genes are turned on and off in cells,
and a completely new approach to drug discovery and development. Its
discovery has been heralded as “a major scientific breakthrough that
happens once every decade or so,” and represents one of the most
promising and rapidly advancing frontiers in biology and drug discovery
today which was awarded the 2006 Nobel Prize for Physiology or Medicine.
RNAi is a natural process of gene silencing that occurs in organisms
ranging from plants to mammals. By harnessing the natural biological
process of RNAi occurring in our cells, the creation of a major new
class of medicines, known as RNAi therapeutics, is on the horizon. Small
interfering RNA (siRNA), the molecules that mediate RNAi and comprise
Alnylam's RNAi therapeutic platform, target the cause of diseases by
potently silencing specific mRNAs, thereby preventing disease-causing
proteins from being made. RNAi therapeutics have the potential to treat
disease and help patients in a fundamentally new way.
About Alnylam Pharmaceuticals
Alnylam is a biopharmaceutical company developing novel therapeutics
based on RNA interference, or RNAi. The company is leading the
translation of RNAi as a new class of innovative medicines. Alnylam’s
pipeline of investigational RNAi therapeutics is focused in 3 Strategic
Therapeutic Areas (STArs): Genetic Medicines, with a broad pipeline of
RNAi therapeutics for the treatment of rare diseases; Cardio-Metabolic
Disease, with a pipeline of RNAi therapeutics toward genetically
validated, liver-expressed disease targets for unmet needs in
cardiovascular and metabolic diseases; and Hepatic Infectious Disease,
with a pipeline of RNAi therapeutics that address the major global
health challenges of hepatic infectious diseases. In early 2015, Alnylam
launched its “Alnylam 2020” guidance for the advancement and
commercialization of RNAi therapeutics as a whole new class of
innovative medicines. Specifically, by the end of 2020, Alnylam expects
to achieve a company profile with 3 marketed products, 10 RNAi
therapeutic clinical programs – including 4 in late stages of
development – across its 3 STArs. The company’s demonstrated commitment
to RNAi therapeutics has enabled it to form major alliances with leading
companies including Merck, Medtronic, Novartis, Biogen, Roche, Takeda,
Kyowa Hakko Kirin, Cubist, GlaxoSmithKline, Ascletis, Monsanto, The
Medicines Company, and Genzyme, a Sanofi company. In addition, Alnylam
holds an equity position in Regulus Therapeutics Inc., a company focused
on discovery, development, and commercialization of microRNA
therapeutics. Alnylam scientists and collaborators have published their
research on RNAi therapeutics in over 200 peer-reviewed papers,
including many in the world’s top scientific journals such as Nature,
Nature Medicine, Nature Biotechnology, Cell, New England Journal of
Medicine, and The Lancet. Founded in 2002, Alnylam maintains
headquarters in Cambridge, Massachusetts. For more information about
Alnylam’s pipeline of investigational RNAi therapeutics, please visit www.alnylam.com.
Alnylam Forward Looking Statements
Various statements in this release concerning Alnylam's future
expectations, plans and prospects, including without limitation,
Alnylam's views with respect to the potential for RNAi therapeutics,
including ALN-PCSsc for the treatment of hypercholesterolemia and the
potential clinical activity and durability of ALN-PCSsc, expectations
regarding the initiation of clinical studies, including studies as part
of the ORION development program, expectations regarding the continued
development of ALN-PCSsc by The Medicines Company, expectations
regarding Alnylam’s STAr pipeline growth strategy, and its plans
regarding commercialization of RNAi therapeutics, including ALN-PCSsc,
constitute forward-looking statements for the purposes of the safe
harbor provisions under The Private Securities Litigation Reform Act of
1995. Actual results may differ materially from those indicated by these
forward-looking statements as a result of various important factors,
including, without limitation, Alnylam's ability to discover and develop
novel drug candidates and delivery approaches, successfully demonstrate
the efficacy and safety of its drug candidates, the pre-clinical and
clinical results for its product candidates, which may not be replicated
or continue to occur in other subjects or in additional studies or
otherwise support further development of product candidates, actions of
regulatory agencies, which may affect the initiation, timing and
progress of clinical trials, obtaining, maintaining and protecting
intellectual property, Alnylam's ability to enforce its patents against
infringers and defend its patent portfolio against challenges from third
parties, obtaining regulatory approval for products, competition from
others using technology similar to Alnylam's and others developing
products for similar uses, Alnylam's ability to manage operating
expenses, Alnylam's ability to obtain additional funding to support its
business activities and establish and maintain strategic business
alliances and new business initiatives, Alnylam's dependence on third
parties, including The Medicines Company, for development, manufacture,
marketing, sales and/or distribution of products, the outcome of
litigation, and unexpected expenditures, as well as those risks more
fully discussed in the "Risk Factors" filed with Alnylam's most recent
Quarterly Report on Form 10-Q filed with the Securities and Exchange
Commission (SEC) and in other filings that Alnylam makes with the SEC.
In addition, any forward-looking statements represent Alnylam's views
only as of today and should not be relied upon as representing its views
as of any subsequent date. Alnylam explicitly disclaims any obligation
to update any forward-looking statements.
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.
The Medicines Company 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 ALN-PCSsc 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 ALN-PCSsc 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 August 7, 2015, which are incorporated herein by reference. The
Company specifically disclaims any obligation to update these
forward-looking statements.
View source version on businesswire.com: http://www.businesswire.com/news/home/20150830005024/en/
Contacts:
Alnylam Pharmaceuticals, Inc.
Michael Mason, 617-551-8327
Vice
President, Finance & Treasurer
or
Spectrum
Liz Bryan,
202-955-6222 x2526 (Media)
or
The Medicines Company
Neera
Dahiya Ravindran, M.D., 973-290-6044
Vice President, Investor
Relations & Strategic Planning
neera.ravindran@themedco.com
or
Bob
Laverty, 609-558-5570 (Media)
Vice President, Communications
robert.laverty@themedco.com
Source: Alnylam Pharmaceuticals, Inc.
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