Download 54th Annual Interscience Conference on Antimicrobial Agents and

54th Annual Interscience Conference
on Antimicrobial Agents and
Chemotherapy (ICAAC®)
Washington, D.C.
5-9 September 2014
ICAAC Presentation Guide
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 is positioned to address the complex problems associated with multi-drug
resistant infections. The research projects, development programs, and marketed products span the
spectrum of infections caused by gram-positive bacteria including MRSA, and gram-negative infections
including Acinetobacter, carbapenem-resistant Enterobacteriaceae and other dangerous multi-drugresistant pathogens. The investigational product pipeline includes CarbavanceTM (meropenem/
RPX7009), RPX-602 (a new formulation of MINOCIN® (minocycline) for injection), and a pre-clinical
developmental program of novel investigational agents. ORBACTIV™ and MINOCIN® are two antibiotics
approved for use in the US. The product portfolio has the potential to offer clinicians and patients a suite of
innovative new antibiotic approaches to tackle many of the most vexing problems in infectious disease
today. A total of 19 presentations describing the clinical and nonclinical data of ORBACTIV and
Carbavance will be delivered during ICAAC.
ORBACTIV – 11 presentations
Carbavance – 8 presentations
Complete versions of the abstracts are available at the ICAAC website
ORBACTIV™ (oritavancin) for Injection
ORBACTIV (oritavancin) for injection is indicated for the treatment of adult patients with acute bacterial
skin and skin structure infections (ABSSSI) caused by susceptible isolates of the following Gram-positive
microorganisms: Staphylococcus aureus (including methicillin-susceptible and methicillin–resistant
isolates), Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus dysgalactiae,
Streptococcus anginosus group (includes S. anginosus, S. intermedius, and S. constellatus), and
Enterococcus faecalis (vancomycin-susceptible isolates only). ORBACTIV is the first and only singledose antibiotic approved for commercial use in the US. The EMA accepted for review the Marketing
Authorization Application (MAA) for ORBACTIV in Q1 2014, for which the Company is seeking approval
for the treatment of complicated skin and soft tissue infections (cSSTI). Please see Important Safety
Information for ORBACTIV below.
Eleven abstracts evaluating efficacy, safety, microbiology and pharmacokinetics/ pharmacodynamics
will be presented.
Presentation
Number
Session Title
Presentation Title
Authors
Session
Type
Location
Date/Time
F-973
Glycopeptides and
Conjugates
Efficacy and Safety
Outcomes by Subgroups
in Studies of a Single Dose
of Oritavancin for the
Treatment of Acute
Bacterial Skin and Skin
Structure Infections
(ABSSSI)
G.R. Corey,
S. Good,
H. Jiang,
G. Moeck,
M. Wikler
Poster
Exhibit
Hall B
7 Sept
2014;
11:00–
13:00
F-972
Glycopeptides and
Conjugates
Concordance Between
Early and Late Clinical
Response with a Single
Dose of Oritavancin in the
SOLO Studies
G.R. Corey,
S. Good,
H. Jiang,
G. Moeck,
M. Wikler
for the SOLO I
and SOLO II
investigators
Poster
Exhibit
Hall B
7 Sept
2014;
11:00–
13:00
F-961
Glycopeptides and
Conjugates
Comparison of Oritavancin
(ORI) In vitro Susceptibility
of Staphylococcus aureus
(SA) isolates from Phase 3
Studies for Acute Bacterial
Skin and Skin-structure
Infections and from a
Surveillance Study in the
US and Europe
F.F. Arhin,
G. Moeck,
D.F. Sahm
Poster
Exhibit
Hall B
7 Sept
2014;
11:00–
13:00
C-825
Susceptibility to
newer anti Grampositive molecules
In Vitro Activity of
Oritavancin (ORI) and Key
Comparators Against
Gram-Positive Pathogens
Isolated from the USA and
Europe: 2011–2013
M. Hackel,
T. Lynch,
G. Moeck,
F.F. Arhin,
D.F Sahm
Poster
Exhibit
Hall B
7 Sept
2014;
11:00–
13:00
2014 ICAAC Presentation Guide
The Medicines Company
Page 2
This ICAAC Presentation Guide is intended as reference information for U.S. investors and analysts.
Presentation
Number
Session Title
Presentation Title
Authors
Session
Type
Location
Date/Time
C-823
Susceptibility to
newer anti Grampositive molecules
Oritavancin activity against
Gram-positive pathogens
responsible for
documented infections in
US hospitals (2012–2013)
R. E. Mendes,
D. J. Farrell,
H. S. Sader,
P. R. Rhomberg,
R. N. Jones
Poster
Exhibit
Hall B
7 Sept
2014;
11:00–
13:00
C-824
Susceptibility to
newer anti Grampositive molecules
In Vitro Activity of
Oritavancin against GramPositive Pathogens
Isolated in Canadian
Hospitals from 2011 to
2013
J. A. Karlowsky,
H. Adam,
M. Baxter,
B. Weshnoweski,
R. Vashisht,
D. Hoban and
G. G. Zhanel
Poster
Exhibit
Hall B
7 Sept
2014;
11:00–
13:00
L-1725
Clinical Studies in
Skin and Skin
Structure Infections
Microbiological Responses
by Pathogen in Phase 3
Studies of Single Dose
Oritavancin for Acute
Bacterial Skin and Skin
Structure Infection
(ABSSSI)
G. Moeck,
F. F. Arhin,
H. Jiang,
C. Fiset
Poster
Exhibit
Hall B
8 Sept
2014;
11:00–
13:00
2014 ICAAC Presentation Guide
The Medicines Company
Page 3
This ICAAC Presentation Guide is intended as reference information for U.S. investors and analysts.
Presentation
Number
Session Title
Presentation Title
Authors
Session
Type
Location
Date/Time
A-1309
Clinical
Pharmacology and
therapeutic drug
monitoring of
Vancomycin and
newer
Lipoglycopeptides/Li
popeptides
Oritavancin (ORI)
PharmacokineticPharmacodynamic (PK-PD)
Analyses for Efficacy
Based on Data from
Patients with Acute
BacterialSkin and Skin
Structure Infections
(ABSSSI) Enrolled in SOLO
I and II
S.M. Bhavnani,
J.P. Hammel,
C.M. Rubino,
G. Moeck,
H. Jiang,
S.E. Bellibas,
P.G. Ambrose
Poster
Exhibit
Hall B
8 Sept
2014;
11:00–
13:00
A-1308
Clinical
Pharmacology and
therapeutic drug
monitoring of
Vancomycin and
newer
Lipoglycopeptides/Li
popeptides
Population
Pharmacokinetic (PPK)
Analysis for Oritavancin
(ORI) Based on Data from
Patients with Acute
Bacterial Skin and Skin
Structure Infections
(ABSSSI)
C.M. Rubino,
S.M. Bhavnani,
G. Moeck,
S.E. Bellibas,
P.G. Ambrose
Poster
Exhibit
Hall B
8 Sept
2014;
11:00–
13:00
L-1729
Clinical Studies in
Skin and Skin
Structure Infections
Efficacy And Safety Of
Single Dose Oritavancin
Compared To 7-10 Days Of
Vancomycin In Patients
With Acute Bacterial Skin
And Skin Structure
Infections Treated In The
Outpatient Setting
K. LaPensee K,
W. Fan,
H.Jiang,
T. Lodise
Poster
Exhibit
Hall B
8 Sept
2014;
11:00–
13:00
A-1307
Clinical
Pharmacology and
therapeutic drug
monitoring of
Vancomycin and
newer
Lipoglycopeptides/Li
popeptides
The Effects of
Supratherapeutic Dose of
Oritavancin on ECG
intervals: A thorough QT
Study in Healthy
Volunteers
S.E. Bellibas,
N.Y Huang,
B. Darpo,
C. Sanabria,
K. Fusaro,
S. Good,
J. Mason
Poster
Exhibit
Hall B
8 Sept
2014;
11:00–
13:00
2014 ICAAC Presentation Guide
The Medicines Company
Page 4
This ICAAC Presentation Guide is intended as reference information for U.S. investors and analysts.
Carbavance™ (meropenem/ RPX7009)
Carbavance (meropenem/ RPX7009), an investigational agent not approved for commercial use in any
market, is a combination of meropenem and RPX7009 administered as a fixed combination by IV infusion
and is being developed to treat serious gram-negative infections, such as cUTIs, including those infections
caused by bacteria resistant to currently available carbapenems.
Carbavance was designed to address gram-negative bacteria that produce new beta-lactamase
enzymes that have spread in the US and Europe, including strains producing the Klebsiella pneumoniae
carbapenemase (KPC) enzyme. KPC-producing bacteria are the predominant form of carbapenemresistant Enterobacteriaceae (CRE) in the US and are classified by the CDC to be an urgent antimicrobial
resistance threat.
The FDA has designated Carbavance as a Qualified Infectious Disease Product (QIDP). The QIDP
designation provides Carbavance priority review by the FDA, eligibility for the FDA's "fast track" status, and
an additional five years of any non-patent exclusivity upon approval of the product for intravenous use in
six indications. These include complicated urinary tract and intra-abdominal infections, hospital-acquired
bacterial pneumonia/ventilator-associated bacterial pneumonia, and febrile neutropenia. The QIDP
designation was granted pursuant to the Generating Antibiotic Incentives Now (GAIN) Act, included in the
FDA Safety and Innovation Act (FDASIA) that was signed into law in 2012.
Eight abstracts reporting on Phase 1 safety and pharmacokinetics, microbiology and pharmacokinetics/
pharmacodynamics will be presented.
Presentation
Number
Session Title
Presentation Title
Authors
Session
Type
Location
Date/Time
C-103
009-I'll take Potpouri
for 1000, Alex
Characterization of
Mutants Selected In Vitro
Using Sub-optimal
Exposures of Meropenem
Alone and With RPX7009
D. Sun,
D. Rubio-Aparicio,
M. N. Dudley
and
O. Lomovskaya
Poster
Exhibit
Hall B
6 Sept 2014;
12:00–14:00
C-777
Ceftaroline and New
Beta-Lactam/BetaLactamase Inhibitor
Combinations: The
Real Efficacy
Effect of the β-lactamase
inhibitor RPX7009
combined with meropenem
tested against a large
collection of KPCproducing
Enterobacteriaceae
M. Castanheira,
H.K. Becker,
P.R. Rhomberg,
R.N. Jones
Poster
Exhibit
Hall B
7 Sept 2014;
11:00–13:00
2014 ICAAC Presentation Guide
The Medicines Company
Page 5
This ICAAC Presentation Guide is intended as reference information for U.S. investors and analysts.
Presentation
Number
Session Title
Presentation Title
Authors
Session
Type
Location
Date/Time
C-1193
New Insights into the
Beta-Lactamase
Inhibitors
Combination
Losing My Resistance:
Loss of KPC Following
Exposure of KPCProducing Strains of
Klebsiella pneumonia to
Carbapenems in
Combination with RPX7009
D. Sun,
D. Rubio-Aparicio,
D. Griffith,
M. N. Dudley,
O. Lomovskaya
Talk
Room 207
B
7 Sept 2014;
15:00–17:00
C-1194
New Insights into the
Beta-Lactamase
Inhibitors
Combination
The Effect of Trp105
Substitutions in KPC on
Interactions with the Novel
Beta-lactamase
Inhibitor RPX7009
R. Tsivkovsky
and
O. Lomovskaya
Talk
Room 207
B
7 Sept 2014;
15:00–17:00
F-960
Beta-Lactamase
inhibitors: Defeating
bacterial defenses
A Phase 1 Study of the
Safety, Tolerability, and
Pharmacokinetics of a
Single dose of the
Beta-lactamase inhibitor
RPX7009 Alone,
Meropenem Alone, and
both in Combination
(Carbavance) in Healthy
Adult Subjects
D. C. Griffith,
M. Rubino,
J. S. Loutit,
E. E. Morgan,
D. White,
M. N. Dudley
Poster
Exhibit
Hall B
7 Sept 2014;
11:00–13:00
F-959
Beta-Lactamase
inhibitors: Defeating
bacterial defenses
Efficacy of Simulated
Human Exposures of
Carbavance (MeropenemRPX7009) against
Carbapenem-resistant
Enterobacteriaceae in an In
Vitro Hollow Fiber Model
Z. Tarazi,
M. Sabet,
D. Rubio-Aparicio,
T. Nolan,
J. Parkinson,
O. Lomovskaya,
M.N. Dudley,
D.C. Griffith
Poster
Exhibit
Hall B
7 Sept 2014;
11:00–13:00
2014 ICAAC Presentation Guide
The Medicines Company
Page 6
This ICAAC Presentation Guide is intended as reference information for U.S. investors and analysts.
Presentation
Number
Session Title
Presentation Title
Authors
Session
Type
Location
Date/Time
F-958
Beta-Lactamase
inhibitors: Defeating
bacterial defenses
In Vivo Efficacy of
Carbavance
(meropenem/RPX7009)
against KPC-producing
Enterobacteriaceae
M. Sabet,
Z. Tarazi,
T. Nolan,
J. Parkinson,
D. Rubio-Aparicio,
O. Lomovskaya,
M.N. Dudley,
D. C. Griffith
Poster
Exhibit
Hall B
7 Sept 2014;
11:00–13:00
F-938
Beta-Lactamase
inhibitors: Defeating
bacterial defenses
Meropenem/RPX7009 MIC
Quality Control Ranges
Using CLSI MultiLaboratory M23-A3 Study
Design
J.E. Ross,
M. Castanheira,
R. K. Flamm,
R.N. Jones
Poster
Exhibit
Hall B
7 Sept 2014;
11:00–13:00
2014 ICAAC Presentation Guide
The Medicines Company
Page 7
This ICAAC Presentation Guide is intended as reference information for U.S. investors and analysts.
ORITAVANCINTM (oritavancin) for Injection
IMPORTANT SAFETY INFORMATION
Contraindications
Use of intravenous unfractionated heparin sodium is contraindicated for 48 hours after ORBACTIV
administration because the activated partial thromboplastin time (aPTT) test results are expected to
remain falsely elevated for approximately 48 hours after ORBACTIV administration.
ORBACTIV is contraindicated in patients with known hypersensitivity to ORBACTIV.
Warnings and Precautions
Concomitant warfarin use: Co-administration of ORBACTIV and warfarin may result in higher exposure of
warfarin, which may increase the risk of bleeding. Use ORBACTIV in patients on chronic warfarin therapy
only when the benefits can be expected to outweigh the risk of bleeding.
Coagulation test interference: ORBACTIV has been shown to artificially prolong aPTT for up to 48 hours,
and may prolong PT and INR for up to 24 hours.
Hypersensitivity reactions have been reported with the use of antibacterial agents including ORBACTIV.
Discontinue infusion if signs of acute hypersensitivity occur. Monitor closely patients with known
hypersensitivity to glycopeptides.
Infusion-related reactions have been reported. Slow the rate or interrupt infusion if infusion reaction
develops.
Clostridium difficile-associated colitis: Evaluate patients if diarrhea occurs.
Osteomyelitis: Institute appropriate alternate antibacterial therapy in patients with confirmed or suspected
osteomyelitis.
Prescribing ORBACTIV in the absence of a proven or strongly suspected bacterial infection is unlikely to
provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.
Adverse Reactions
The most common adverse reactions (≥ 3%) in patients treated with ORBACTIV were headache, nausea,
vomiting, limb and subcutaneous abscesses, and diarrhea.
Please see www.orbactiv.com for the full prescribing information.
Forward-Looking Statements
Statements contained in this ICAAC presentation guide about The Medicines Company that are not
purely historical, and all other statements that are not purely historical, may be deemed to be forwardlooking 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" and
“potential” and similar expressions, are intended to identify forward-looking statements. These forwardlooking 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 extent of the commercial success of the Company’s products,
the Company's ability to develop its global operations and penetrate foreign markets, whether the
Company's products will advance in the clinical trials process on a timely basis or at all, whether the
Company will make regulatory submissions for product candidates on a timely basis, whether its
regulatory submissions will receive approvals from regulatory agencies on a timely basis or at all, whether
physicians, patients and other key decision makers will accept clinical trial results 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 4,
2014, which are incorporated herein by reference. The Company specifically disclaims any obligation to
update these forward-looking statements.
2014 ICAAC Presentation Guide
The Medicines Company
Page 8
This ICAAC Presentation Guide is intended as reference information for U.S. investors and analysts.