TIDMHIK
RNS Number : 3599E
Hikma Pharmaceuticals Plc
05 November 2020
London, 5 November , 2020 - Hikma Pharmaceuticals PLC (Hikma),
the multinational pharmaceu tical company, has launched Icosapent
Ethyl Capsules , 1gm, in the US through its US affiliate, Hikma
Pharmaceuticals USA Inc.
Following an earlier than expected favorable court ruling, Hikma
has accelerated the launch of its Icosapent Ethyl Capsules in order
to quickly provide patients with access to this important medicine.
Initially, Hikma will be releasing limited quantities to ensure a
consistent supply for customers. The Company is working to scale up
manufacturing and increase availability as soon as possible.
"Hikma's launch of this important medicine for US patients and
healthcare providers once again underscores our ability to put
better health, within reach, every day for millions of people who
rely on our medicines," said Brian Hoffmann, President of Hikma
Generics. "Today's launch demonstrates Hikma's ability to
successfully challenge patents and launch complex products,
bringing greater value to our customers and patients."
Hikma's FDA-approved I cosapent Ethyl C apsule product is
indicated for the following indication: as an adjunct to diet to
reduce triglyceride levels in adult patients with severe (>=500
mg/dL) hypertriglyceridemia. Hikma's product is not approved for
any other indication for the reference listed drug VASCEPA(R).
- ENDS -
Enquiries
Hikma Pharmaceuticals PLC
Susan Ringdal +44 (0)20 7399 2760/ +44 7776
EVP, Strategic Planning and Global Affairs 477050
uk-investors@hikma.uk.com
Steve Weiss +1 732 720 2830/ +1 732 788
David Belian 8279
US Communications and Public Affairs +1 732 720 2814/+1 848 254 4875
u scommunications @hikma.com
About Hikma
(LSE: HIK) (NASDAQ Dubai: HIK) (OTC: HKMPY) (rated BBB-/stable
S&P, BBB-/stable Fitch and Ba1/stable Moody's)
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 are 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 8,600 colleagues are helping to
shape a healthier world that enriches all our communities. We are a
leading licensing partner, 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 Icosapent Ethyl Capsules,
1gm:
CONTRAINDICATIONS
Icosapent ethyl is contraindicated in patients with known
hypersensitivity (eg, anaphylactic reaction) to icosapent ethyl or
any of its components.
WARNINGS AND PRECAUTIONS
-- Atrial Fibrillation/Flutter
In a double-blind, placebo-controlled trial, icosapent ethyl was
associated with an increased risk (3% vs 2%) of atrial fibrillation
or atrial flutter requiring hospitalization. The incidence of
atrial fibrillation was greater in patients with a previous history
of atrial fibrillation or atrial flutter.
-- Potential for Allergic Reactions in Patients With Fish Allergy
It is not known whether patients with allergies to fish and/or
shellfish are at increased risk of an allergic reaction to
icosapent ethyl. Inform patients with known hypersensitivity to
fish and/or shellfish about the potential for allergic reactions
and advise them to discontinue use and seek medical attention if
any reactions occur.
-- Bleeding
In a double-blind, placebo-controlled trial, icosapent ethyl was
associated with an increased risk (12% vs 10%) of bleeding. The
incidence of bleeding was greater in patients receiving concomitant
antithrombotic medications, such as aspirin, clopidogrel or
warfarin.
ADVERSE REACTIONS
The following important adverse reactions are described in the
full Prescribing Information for Icosapent Ethyl capsules:
-- Atrial Fibrillation or Atrial Flutter
-- Potential for Allergic Reactions in Patients With Fish Allergy
-- Bleeding
Common adverse reactions (incidence >=3% on icosapent ethyl
and >=1% more frequent than placebo) included musculoskeletal
pain, peripheral edema, constipation, gout and atrial
fibrillation.
In hypertriglyceridemia trials, adverse reactions reported with
icosapent ethyl (incidence >=1% more frequent than placebo)
included arthralgia and oropharyngeal pain.
DRUG INTERACTIONS
-- Increased Bleeding Risk With Anticoagulants and Antiplatelet Agents
Monitor patients receiving icosapent ethyl and concomitant
anticoagulants and/or antiplatelet agents for bleeding.
USE IN SPECIFIC POPULATIONS
-- Lactation
Lactating women receiving oral omega-3 fatty acids for
supplementation have resulted in higher levels of omega-3 fatty
acids in human milk. There are no data on the effects of omega-3
fatty acid ethyl esters on the breastfed infant or on milk
production. The developmental and health benefits of breastfeeding
should be considered, along with the mother's clinical need for
icosapent ethyl and any potential adverse effects on the breastfed
child from icosapent ethyl or from the underlying maternal
condition.
-- Pediatric Use
Safety and effectiveness in pediatric patients have not been
established.
-- Hepatic Impairment
In patients with hepatic impairment, alanine aminotransferase
and aspartate aminotransferase levels should be monitored
periodically during therapy with icosapent ethyl.
INDICATIONS AND USAGE
Icosapent ethyl is indicated:
-- as an adjunct to diet to reduce triglyceride levels in adult
patients with severe (>=500 mg/dL) hypertriglyceridemia.
Limitations of use
The effect of icosapent ethyl on the risk for pancreatitis in
patients with severe hypertriglyceridemia has not been
determined.
For more information, please see the full Prescribing
Information and Medication Guide.
You are encouraged to report negative side effects of
prescription drugs to the FDA. Visit https://www.fda.gov/medwatch
or call 1-800-FDA-1088.
Manufactured by: Catalent Pharma Solutions, LLC., St.
Petersburg, Florida 33716
Distributed by: Hikma Pharmaceuticals USA Inc., Eatontown, NJ
07724
Document Identification Number: WW40034v4
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