LONDON, March 31, 2020 /PRNewswire/ -- Hikma
Pharmaceuticals PLC (Hikma, Group), the multinational
generic pharmaceutical company, today confirms that the United States District Court for the
District of Nevada has ruled that
Hikma's generic version of Amarin Corporation's Vascepa®
(icosapent ethyl) 1 gm capsules does not infringe six United States
Patents, as asserted by Amarin, because the asserted claims of
these patents were held to be invalid.
Hikma is working closely with the U.S. Food and Drug
Administration (FDA) to gain approval for its Abbreviated New Drug
Application (ANDA) for its generic version of Vascepa®.
The company is evaluating its options for launching the product
following FDA approval, including an at-risk launch in the event
the District Court's decision is appealed.
"We are very pleased with the District Court's decision, which
demonstrates our continued ability to successfully litigate to
bring greater value to our customers and patients in the US," said
Brian Hoffmann, President of
Generics, Hikma. "We look forward to providing patients and health
care providers in the US with a generic version of this important
medicine."
Vascepa® is a prescription medicine that is
indicated, in part, as an adjunct to diet to reduce triglyceride
levels in adult patients with severe (≥500 mg/dL)
hypertriglyceridemia.
According to IQVIA, US sales of Vascepa® were
approximately $919 million in the 12
months ending February 2020.
Enquiries
Hikma Pharmaceuticals
PLC
Susan
Ringdal
EVP, Strategic
Planning and Global Affairs
|
+44 (0)20 7399 2760/
+44 7776 477050
uk-investors@hikma.uk.com
|
|
|
Steve
Weiss
David
Belian
US Communications and
Public Affairs
|
+1 732 720 2830/ +1
732 788 8279
+1 732 720 2814/+1
848 254 4875
uscommunications@hikma.com
|
About Hikma
(LSE: HIK) (NASDAQ Dubai: HIK) (OTC:
HKMPY) (rated Ba1/stable Moody's and BB+/positive S&P)
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
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SOURCE Hikma Pharmaceuticals