TIDMHIK
Hikma Pharmaceuticals Plc
01 May 2019
London, 1 May 2019 - Hikma Pharmaceuticals PLC (Hikma, Group)
(LSE: HIK) (NASDAQ Dubai: HIK) (OTC: HKMPY) (rated Ba1 Moody's /
BB+ S&P, both stable) the multinational pharmaceutical company,
today launched its 100(th) injectable medicine in the United States
with the introduction of Vancomycin Hydrochloride for Injection,
USP, 5g, 10g and 750mg, through its US affiliate, Hikma
Pharmaceuticals USA Inc.(1)
"Vancomycin Hydrochloride for Injection is an essential
antibiotic used by hospitals to treat patients who have failed to
respond to a number of other antibiotics, and it's another
important addition to our growing US portfolio," said Dan Motto,
Executive Vice President, Commercial and Development, Injectables.
"This launch marks a great milestone - Hikma's 100(th) injectable
medicine in the US - and it demonstrates our commitment to
providing doctors and hospitals with a broad range of high-quality
medicines needed to treat the current and future needs of
patients."
Hikma's Vancomycin Hydrochloride for Injection, USP is indicated
for:
-- the treatment of serious or severe infections caused by
susceptible strains of methicillin-resistant (<BETA>-lactam-
resistant) staphylococci;
-- patients who cannot receive or who have failed to respond to
other drugs, including the penicillins or cephalosporins, and for
infections caused by Vancomycin-susceptible organisms that are
resistant to other antimicrobial drugs;
-- initial therapy when methicillin-resistant staphylococci are
suspected, but after susceptibility data are available, therapy
should be adjusted accordingly;
-- the treatment of staphylococcal endocarditis. Its
effectiveness has been documented in other infections due to
staphylococci, including septicemia, bone infections, lower
respiratory tract infections, skin and skin structure infections.
When staphylococcal infections are localized and purulent,
antibiotics are used as adjuncts to appropriate surgical
measures;
and has been:
-- reported to be effective alone or in combination with an
aminoglycoside for endocarditis caused by S. viridans or S. bovis.
For endocarditis caused by enterococci (e.g., E. faecalis), has
been reported to be effective only in combination with an
aminoglycoside;
-- reported to be effective for the treatment of diphtheroid endocarditis;
-- used successfully in combination with either rifampin, an
aminoglycoside, or both in early-onset prosthetic valve
endocarditis caused by S. epidermidis or diphtheroids.
Specimens for bacteriologic cultures should be obtained in order
to isolate and identify causative organisms and to determine their
susceptibilities to Vancomycin.
To reduce the development of drug-resistant bacteria and
maintain the effectiveness of Vancomycin Hydrochloride for
Injection, USP and other antibacterial drugs, Vancomycin
Hydrochloride for Injection, USP should be used only to treat or
prevent infections that are proven or strongly suspected to be
caused by susceptible bacteria. When culture and susceptibility
information are available, they should be considered in selecting
or modifying antibacterial therapy. In the absence of such data,
local epidemiology and susceptibility patterns may contribute to
the empiric selection of therapy.
The parenteral form of Vancomycin Hydrochloride may be
administered orally for treatment of antibiotic-associated
pseudomembranous colitis produced by C. difficile and for
staphylococcal enterocolitis. Parenteral administration of
Vancomycin Hydrochloride alone is of unproven benefit for these
indications. Vancomycin is not effective by the oral route for
other types of infection.
According to IQVIA, US sales of Vancomycin Hydrochloride for
Injection, USP, 5g, 10g and 750mg were approximately $247 million
in the 12 months ending February 2019.
"Our portfolio of 100 injectable medicines now covers many
vital, large and growing therapeutic areas including oncology,
anti-infectives, anaesthesia and pain management," continued Mr.
Motto. "We are expecting to launch 15 additional products this
year, further strengthening Hikma's position as a top manufacturer
and supplier in the US generic injectable market with a strong
portfolio that can't easily be replicated."
(1) Hikma Pharmaceuticals USA Inc. was formerly known as
West-Ward Pharmaceuticals Corp.
"Our customers prefer to work with manufacturers that have a
large product portfolio and a long record of successful FDA
inspections," said Riad Mechlaoui, Hikma's President of
Injectables. "Over the years Hikma has established a strong
reputation for quality products and reliability. We have made
significant investments to build flexible manufacturing
capabilities allowing us to shift capacity to where it is needed
most, and enabling us to quickly address changing market demands,
including US drug shortage situations as they arise."
Hikma is the third largest US supplier of generic injectable
medicines by volume, with a growing portfolio of 100 products.
Today one in every six injectable generic medicines used in US
hospitals is a Hikma product.
--S -
Enquiries
Hikma Pharmaceuticals PLC
Susan Ringdal +44 (0)20 7399 2760/ +44 7776
EVP, Strategic Planning and Global 477050
Affairs uk-investors@hikma.com
Steven Weiss +1 732 720 2830/ +1 732 788 8279
Senior Director, Communications sweiss@hikma.com
and Public Affairs
FTI Consulting
Ben Atwell/Andrew Ward +44 (0)20 3727 1000
About Hikma
Hikma helps put better health within reach every day for
millions of people in more than 50 countries around the world. For
more than 40 years, we've been creating high-quality medicines and
making them accessible to the people who need them. Headquartered
in the UK, we're a global company with a local presence across the
United States (US), the Middle East and North Africa (MENA) and
Europe, and we use our unique insight and expertise to transform
cutting-edge science into innovative solutions that transform
people's lives. We're committed to our customers, and the people
they care for, and by thinking creatively and acting practically,
we provide them with a broad range of branded and non-branded
generic medicines. Together, our 8,400 colleagues are helping to
shape a healthier world that enriches all our communities. We are a
leading licensing partner in the MENA region, and through our
venture capital arm, are helping bring innovative health
technologies to people around the world. For more information,
please visit www.hikma.com.
Important Safety Information for Vancomycin Hydrochloride for
Injection, USP, 5g, 10g, and 750mg:
WARNINGS AND PRECAUTIONS
The following warnings and precautions should be taken when
administering Vancomycin Hydrochloride for Injection, USP:
-- A pharmacy bulk package is a container of a sterile
preparation for parenteral use that contains many single doses. The
contents of this pharmacy bulk package are intended for use by a
pharmacy admixture service for addition to suitable parenteral
fluids in the preparation of admixtures for intravenous infusion.
FURTHER DILUTION IS REQUIRED. NOT FOR DIRECT INFUSION.
-- Mixtures of solutions of Vancomycin and beta-lactam
antibiotics have been shown to be physically incompatible. The
likelihood of precipitation increases with higher concentrations of
Vancomycin. It is recommended to adequately flush the intravenous
lines between the administration of these antibiotics. It is also
recommended to dilute solutions of Vancomycin to 5 mg/mL or
less.
-- Although intravitreal injection is not an approved route of
administration for Vancomycin, precipitation has been reported
after intravitreal injection of Vancomycin and Ceftazidime for
endophthalmitis using different syringes and needles. The
precipitates dissolved gradually, with complete clearing of the
vitreous cavity over two months and with improvement of visual
acuity.
-- Vancomycin Hydrochloride for Injection should be administered
in a diluted solution over a period of not less than 60 minutes to
avoid rapid-infusion-related reactions.
-- Monitor renal function in all patients, especially patients
with underlying renal impairment, patients with co-morbidities that
predispose to renal impairment, and patients receiving concomitant
therapy with a drug known to be nephrotoxic.
-- Clostridium difficile associated diarrhea (CDAD) has been
reported with use of nearly all antibacterial agents. Careful
observation of the patient is essential.
-- Hemorrhagic occlusive retinal vasculitis, including permanent
loss of vision, occurred in patients receiving intracameral or
intravitreal administration of Vancomycin during or after cataract
surgery.
-- Reversible neutropenia has been reported in patients
receiving Vancomycin Hydrochloride for Injection.
-- Must be given by a secure IV route of administration.
-- Infusion-related events may be minimized by the
administration of Vancomycin as a 60-minute infusion prior to
anesthetic induction.
-- Prescribing Vancomycin Hydrochloride for Injection in the
absence of a proven or strongly suspected bacterial infection or a
prophylactic indication is unlikely to provide benefit to the
patient and increases the risk of the development of drug-resistant
bacteria.
-- Concomitant administration of Vancomycin and anesthetic
agents has been associated with erythema and histamine-like
flushing and anaphylactoid reactions.
-- Vancomycin should be given to a pregnant woman only if clearly needed.
-- Caution should be exercised when Vancomycin Hydrochloride for
Injection is administered to a nursing woman.
-- Confirm desired Vancomycin serum concentrations in pediatric patients.
-- Patients should be counseled that antibacterial drugs
including Vancomycin Hydrochloride for Injection should only be
used to treat bacterial infections.
Vancomycin Hydrochloride for Injection is contraindicated in
patients with known hypersensitivity to this antibiotic.
The following adverse reactions have been reported:
anaphylactoid reactions, flushing of the upper body, acute kidney
injury, pseudomembranous colitis symptoms, hearing loss, vertigo,
reversible neutropenia, inflammation at the injection site, drug
fever, nausea, chills, rashes, and vasculitis. Chemical peritonitis
has been reported following intraperitoneal administration.
Postmarketing reports include skin and subcutaneous tissue
disorders, drug rash with eosinophilia and systemic symptoms
(DRESS).
Vancomycin is poorly removed by dialysis. Hemofiltration and
hemoperfusion with polysulfone resin have been reported to result
in increased Vancomycin clearance. To obtain up-to-date information
about the treatment of overdose, a good resource is your certified
Regional Poison Control Center.
For additional information, please refer to the Package Insert
here
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=86950e7c-0114-47e9-8891-e09e595c48c3
for the vial and the Package Insert here
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=cae9e5f3-b89a-4a7f-93f7-9471c74a3559
for the pharmacy bulk pack for full prescribing information,
available on www.hikma.com.
You are encouraged to report negative side effects of
prescription drugs to the FDA. Visit MedWatch or call
1-800-FDA-1088.
Manufactured by:
HIKMA FARMACÊUTICA (PORTUGAL) S.A.
Estrada do Rio da Mó nos.8, A/B
2705-906 Terrugem SNT
Portugal
Distributed by:
WEST-WARD
A HIKMA COMPANY
Eatontown, NJ 07724 USA
Document Identification Number: WW30336
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END
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