Hikma Pharmaceuticals Plc Hikma's favourable ruling in generic Vascepa(R)
March 31 2020 - 1:00AM
RNS Non-Regulatory
TIDMHIK
Hikma Pharmaceuticals Plc
31 March 2020
London, March 31, 2020 - 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(R) (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(R) . 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 (R) 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 (R) were approximately
$919 million in the 12 months ending February 2020.
- 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 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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END
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