TIDMHIK
Hikma Pharmaceuticals Plc
20 March 2018
London, 20 March 2018 - Hikma Pharmaceuticals PLC (Hikma, Group)
(LSE: HIK) (NASDAQ Dubai: HIK) (OTC: HKMPY) (rated Ba1 Moody's /
BB+ S&P, both stable), the multinational generic pharmaceutical
company, announces that its wholly owned US subsidiary West-Ward
Pharmaceuticals Corp. (West-Ward), has launched Ritonavir Tablets
USP, 100 mg, the first AB-rated generic to Norvir(R)
tablets.(1)
According to the FDA product approval letter, West-Ward is
eligible for 180 days of generic drug exclusivity.
West-Ward's ritonavir is approved by FDA for use in combination
with other antiretroviral agents for treatment of human
immunodeficiency virus (HIV-1) infection.
Brian Hoffmann, President, Generics Division, said, "We are very
excited to be launching Ritonavir Tablets USP. This is an exciting
product which demonstrates the successful execution of our strategy
to develop differentiated products. We will be launching ritonavir
with additional patient support and co-pay assistance to ensure
more people are able to access this life-saving medicine."
West-Ward understands that this is a very unique market that
requires special consideration. It is engaging with advocacy groups
to better understand how to communicate and support patients and
healthcare providers. West-Ward is also launching an education and
awareness campaign, including a website and direct
communication.
According to IQVIA, US sales of Norvir(R) were approximately
$208.5 million in the 12 months ending December 2017.
Important Safety Information
BOXED WARNING: DRUG-DRUG INTERACTIONS LEADING TO POTENTIALLY
SERIOUS AND/OR LIFE-THREATENING REACTIONS
Co-administration of ritonavir with several classes of drugs
including sedative hypnotics, antiarrhythmics, or ergot alkaloid
preparations may result in potentially serious and/or
life-threatening adverse events due to possible effects of
ritonavir on the hepatic metabolism of certain drugs. Review
medications taken by patients prior to prescribing ritonavir or
when prescribing other medications to patients already taking
ritonavir.
Ritonavir is contraindicated in patients with known
hypersensitivity to ritonavir or any of its ingredients.
When co-administering ritonavir with other protease inhibitors,
see the full prescribing information for that protease inhibitor,
including contraindication information.
Co-administration of ritonavir is contraindicated with drugs
that are highly dependent on CYP3A for clearance and for which
elevated plasma concentrations are associated with serious and/or
life-threatening reactions, and with potent CYP3A inducers where
significantly reduced lopinavir plasma concentrations may be
associated with the potential for loss of virologic response and
possible resistance and cross-resistance. These contraindicated
drugs include: alfuzosin HCl, amiodarone, cisapride, colchicine,
dronedarone, dihydroergotamine, ergotamine, flecainide, lovastatin,
lurasidone, methylergonovine, midazolam (by mouth), pimozide,
propafenone, quinidine, ranolazine, sildenafil, simvastatin, St.
John's Wort (Hypericum perforatum), triazolam, and
voriconazole.
Consider drug-drug interaction potential to reduce risk of
serious or life-threatening adverse reactions. Refer to the full
prescribing information for a detailed list of potential drug-drug
interactions and recommendations regarding alterations in dose
regimen, drug level monitoring, or increased observation for
adverse events.
Hepatotoxicity, including some fatalities, has been observed in
patients receiving ritonavir. Monitor liver function before and
during therapy, especially in patients with underlying hepatic
disease, including hepatitis B and hepatitis C, or marked
transaminase elevations.
Pancreatitis, including some fatalities, has been observed in
patients receiving ritonavir; suspend therapy as clinically
appropriate.
Allergic reactions/hypersensitivity have been reported in
patients receiving ritonavir; discontinue treatment if severe
reactions develop.
Ritonavir should be used with caution in patients with heart
disease or when administering with other drugs that may prolong the
PR interval.
Treatment with ritonavir has resulted in substantial increases
in concentrations of total cholesterol and triglycerides. Monitor
lipids prior to therapy and periodically thereafter.
Patients receiving protease inhibitor therapy may develop new
onset or exacerbations of diabetes mellitus or hyperglycemia.
Immune reconstitution syndrome has been reported in patients
treated with combination antiretroviral therapy, including
ritonavir.
Redistribution/accumulation of body fat have been observed in
patients receiving antiretroviral therapy. The mechanism and
long-term consequences of these events are currently unknown.
There have been reports of increased bleeding in patients with
hemophilia treated with protease inhibitors.
Refer to the full prescribing information for information
regarding the use of ritonavir during pregnancy.
Mothers should be instructed not to breastfeed if they are
receiving ritonavir.
Various degrees of cross resistance among protease inhibitors
have been observed.
In combined Phase II/IV studies, the most frequently reported
adverse drug reactions among adult patients receiving ritonavir
alone or in combination with other antiretroviral drugs were
gastrointestinal (including diarrhea, nausea, vomiting and upper
and lower abdominal pain), neurological disturbances (including
paresthesia and oral paresthesia), rash, and fatigue/asthenia. In
clinical trials, vomiting, diarrhea, and skin rash/allergy were the
only drug-related moderate to severe adverse events observed in
>=2% of paediatric patients.
(1) Norvir(R) is a registered trademark of Abbvie
-- ENDS --
Enquiries
Hikma Pharmaceuticals PLC
Susan Ringdal, VP Corporate +44 (0)20 7399 2760/
Strategy and Investor Relations +44 7776 477050
Virginia Spring, Investor Relations +44 (0)20 3892 4389/
Manager +44 7973 679502
FTI Consulting
Ben Atwell/Brett Pollard +44 (0)20 3727 1000
About Hikma
Hikma helps puts better health within reach every day for
millions of people in more than 50 countries around the world. For
40 years, we've been creating high-quality medicines and making
them accessible to the people who need them. 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
8,500 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.
This information is provided by RNS
The company news service from the London Stock Exchange
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