Horizon Pharma plc (NASDAQ:HZNP), a biopharmaceutical company
focused on improving patients’ lives by identifying, developing,
acquiring and commercializing differentiated and accessible
medicines that address unmet medical needs, today announced that
the United States District Court for the District of New Jersey
upheld the validity of two Horizon Pharma patents covering VIMOVO®
(naproxen/esomeprazole magnesium), and that Dr. Reddy’s
Laboratories Inc. and Dr. Reddy’s Laboratories Ltd. (“Dr.
Reddy’s”), Mylan Pharmaceuticals Inc., Mylan Laboratories Ltd., and
Mylan Inc. (“Mylan”), and Lupin Ltd. and Lupin Pharmaceuticals Inc.
(“Lupin”) would infringe at least one of the two patents with their
proposed generic naproxen/esomeprazole magnesium products.
On April 21, 2011, July 25, 2011, and June 28, 2013, Horizon
filed patent infringement lawsuits in District
Court against Dr. Reddy’s, Lupin, and Mylan,
respectively, related to Abbreviated New Drug Applications filed
with the U.S. Food and Drug Administration to market
generic versions of VIMOVO. The lawsuits claim infringement
of Horizon's U.S. Patent Nos. 8,557,285 (‘285 patent) and 6,926,907
(‘907 patent) titled “Pharmaceutical Compositions for the
Coordinated Delivery of NSAIDs,” which cover VIMOVO. The
District Court’s decision was made based on the validity of Horizon
Pharma’s ‘285 and ‘907 patents for VIMOVO and the Court’s judgment
will prevent Dr. Reddy’s, Mylan, and Lupin from launching generic
versions of VIMOVO in the United States.
VIMOVO has 14 Orange Book listed patents with terms that extend
to 2031. The ‘285 patent expires in May 2022 and the ‘907
patent expires in February 2023.
About VIMOVOVIMOVO (naproxen/esomeprazole
magnesium) is a fixed-dose combination of delayed-release
enteric-coated naproxen, a non-steroidal anti-inflammatory drug
(NSAID), and immediate-release esomeprazole magnesium, a stomach
acid-reducing proton pump inhibitor (PPI), approved for the relief
of signs and symptoms of osteoarthritis, rheumatoid arthritis and
ankylosing spondylitis and to decrease the risk of developing
gastric ulcers in patients at risk of developing NSAID-associated
gastric ulcers. VIMOVO is not interchangeable with the
individual components of naproxen and esomeprazole magnesium.VIMOVO
is not recommended for use in children younger than 18 years of
age. VIMOVO is not recommended for initial treatment of acute
pain because the absorption of naproxen is delayed compared to
absorption from other naproxen-containing products.
Controlled studies do not extend beyond six months. VIMOVO
should be used at the lowest dose and for the shortest amount of
time as directed by your health care provider. For Full
Prescribing Information please see www.VIMOVO.com.
Important Safety Information
- Nonsteroidal anti-inflammatory drugs (NSAIDs),
including naproxen, a component of VIMOVO, may increase the chance
of a heart attack or stroke, which can be fatal. This chance
increases with longer use and in people who have heart disease or
risk factors for heart disease.
- VIMOVO should not be used before or after a type of
heart surgery called coronary artery bypass graft
(CABG).
- NSAID-containing medications like VIMOVO may increase
the chance of stomach and intestinal problems, such as bleeding or
an ulcer. These problems can happen without warning and can
lead to death. Older patients may have a greater chance of
developing these problems.
VIMOVO is not right for everyone, including patients who have
had an asthma attack, hives or other allergic reaction with aspirin
or any other NSAID medicine, patients who are allergic to any of
the ingredients in VIMOVO or women in late stages of pregnancy.
Serious allergic reactions, including skin reactions, can occur
without warning and can be life-threatening; discontinue use of
VIMOVO at the first appearance of a skin rash or if you develop
sudden wheezing; swelling of the lips, tongue or throat; fainting
or problems swallowing.
VIMOVO should be used at the lowest dose and for the shortest
amount of time as directed by your health care provider.
Tell your health care provider right away if you develop signs
of active bleeding from any source.
VIMOVO can lead to onset of new hypertension or worsening of
existing high blood pressure, either of which may contribute to an
increased risk of a heart attack or stroke.
Speak with your health care provider before starting VIMOVO if
you
- Have a history of ulcers or bleeding in the stomach or
intestines
- Have heart problems, high blood pressure, or are taking high
blood pressure medications
- Have kidney or liver problems
Tell your doctor about all of the medicines you take,
prescription and non-prescription drugs, including clopidogrel,
vitamins and herbal supplements. VIMOVO may affect how other
medicines work and other medicines may affect how VIMOVO works.
VIMOVO may increase your risk of getting severe diarrhea.
Call your doctor right away if you have watery stool, stomach pain
and fever that does not go away.
Talk to your health care provider about your risk for bone
fractures and developing low levels of magnesium if you take VIMOVO
for a long period of time.
Talk to your health care provider about your risk for developing
low levels of magnesium if you take VIMOVO for a long period of
time.
The most common side effects of VIMOVO include:
inflammation of the lining of the stomach, indigestion, diarrhea,
stomach ulcers, abdominal pain and nausea.
For more information on VIMOVO, please see the Medication
Guide and Full Prescribing Information.
About Horizon Pharma plcHorizon Pharma plc is a
biopharmaceutical company focused on improving patients' lives by
identifying, developing, acquiring and commercializing
differentiated and accessible medicines that address unmet medical
needs. The Company markets 11 medicines through its orphan,
rheumatology and primary care business units. For more
information, please visit www.horizonpharma.com.
Follow @HZNPplc on Twitter or view careers on
our LinkedIn page.
Forward-Looking Statements This press release
contains forward-looking statements, including statements regarding
the impact of the District Court’s ruling on Horizon Pharma’s ‘907
and ‘285 patents. These forward-looking statements are based
on management expectations and assumptions as of the date of this
press release, and actual results may differ materially from those
in these forward-looking statements as a result of various factors.
These factors include risks regarding whether the defendants
appeal the District Court’s decision and whether the decision is
upheld on such an appeal and other factors described in Horizon
Pharma's filings with the United States Securities and Exchange
Commission, including those factors discussed under the caption
"Risk Factors" in those filings. Forward-looking statements
speak only as of the date of this press release and Horizon Pharma
does not undertake any obligation to update or revise these
statements, except as may be required by law.
Contacts:
Tina Ventura
Senior Vice President, Investor Relations
Investor-relations@horizonpharma.com
Ruth Venning
Executive Director, Investor Relations
Investor-relations@horizonpharma.com
U.S. Media Contacts:
Geoff Curtis
Senior Vice President, Corporate Affairs and Chief Communications Officer
media@horizonpharma.com
Ireland Media Contact:
Ray Gordon
Gordon MRM
ray@gordonmrm.ie
Horizon Therapeutics Pub... (NASDAQ:HZNP)
Historical Stock Chart
From Aug 2024 to Sep 2024
Horizon Therapeutics Pub... (NASDAQ:HZNP)
Historical Stock Chart
From Sep 2023 to Sep 2024