SAN RAFAEL, Calif.,
April 13, 2017 /PRNewswire/
-- BioMarin Pharmaceutical Inc. (NASDAQ: BMRN), today
announced that it has entered into a settlement agreement with Par
Pharmaceutical that resolves patent litigation in the United States (U.S.) related to BioMarin's
Kuvan® (sapropterin dihydrochloride) 100mg oral tablets and powder
for oral solution in 100mg packets.
Under the terms of the settlement, BioMarin will grant Par a
non-exclusive license to its patents related to Kuvan to allow Par
to market a generic version of sapropterin dihydrochloride 100mg
tablets and powder for oral solution in 100mg and 500 mg sachets in
the U.S. for the indications approved for Kuvan beginning
October 1, 2020 or earlier under
certain circumstances. Additional details of the agreement remain
confidential.
BioMarin continues to vigorously enforce its intellectual
property related to Kuvan. BioMarin holds patents in
Europe related to Kuvan that are
valid until at least 2024.
As required by law, BioMarin and Par will submit the Agreement
to the U.S. Federal Trade Commission and the U.S. Department of
Justice.
Important Safety Information about Kuvan
It is not possible to know if KUVAN will work for you without a
trial of the medicine.
Your doctor will check your blood Phe levels when you start
taking KUVAN to see if the medicine is working.
Starting KUVAN does not eliminate the need for ongoing dietary
management. Any change to your diet may impact your blood Phe
level. Follow your doctor's instructions carefully. Your doctor and
dietitian will continue to monitor your diet and blood Phe levels
throughout your treatment with KUVAN to make sure your blood Phe
levels are not too high or too low. If you have a fever, or if
you are sick, your Phe level may go up. Tell your doctor and
dietitian as soon as possible so they can make any necessary
changes to your treatment.
Children younger than 7 years old treated with KUVAN doses of 20
mg/kg per day are at an increased risk for low levels of blood Phe
compared with children 7 years and older. Frequent blood monitoring
is recommended in this population to ensure that blood Phe levels
do not fall too low.
Tell your doctor if you have ever had liver or kidney problems,
have poor nutrition or have a loss of appetite, are pregnant or
plan to become pregnant, or are breastfeeding or plan to
breastfeed.
KUVAN is a prescription medicine and should not be taken by
people who are allergic to any of its ingredients. KUVAN and other
medicines may interact with each other. Tell your doctor about
all the medicines you take, including prescription and
over-the-counter medicines, vitamins, herbal and dietary
supplements.
If you forget to take your dose of KUVAN, take it as soon as you
remember that day. Do not take 2 doses in a day. If you take too
much KUVAN, call your doctor for advice.
The most common side effects reported when using KUVAN are
headache, runny nose and nasal congestion, sore throat, diarrhea,
vomiting, and cough. Additional adverse reactions reported in
connection with worldwide marketing include sore throat, heartburn
or pain in the esophagus, inflammation of the lining of the
stomach, indigestion, stomach pain, and nausea. These are not all
the possible side effects seen with KUVAN. Call your doctor for
medical advice about side effects. You may report side effects to
FDA at 1-800-FDA-1088.
KUVAN can cause serious side effects, including:
- Severe allergic reactions. Stop taking KUVAN and get
medical help right away if you develop any of these symptoms of
a severe allergic reaction:
-
- Wheezing or trouble breathing
- Nausea
- Flushing
- Lightheadedness or fainting
- Coughing
- Rash
- Inflammation of the lining of the stomach (gastritis).
Gastritis can happen with KUVAN and may be severe. Call your
doctor right away if you have any:
-
- Severe upper stomach-area discomfort or pain
- Blood in your vomit or stool
- Nausea and vomiting
- Black, tarry stools
- Too much or constant activity (hyperactivity) can happen
with KUVAN. Tell your doctor if you have any signs of
hyperactivity, including fidgeting, moving around or talking too
much.
To access full Patient Information, go to
http://kuvan.com/patient-information/.
About BioMarin
BioMarin is a global biotechnology company that develops and
commercializes innovative therapies for patients with serious and
life-threatening rare and ultra-rare genetic diseases. The
company's portfolio consists of five commercialized products and
multiple clinical and pre-clinical product candidates. For
additional information, please visit www.BMRN.com.
Forward-Looking Statement
This press release contains forward-looking statements about the
business prospects of BioMarin Pharmaceutical Inc., including,
without limitation, statements about: possible launch dates for
generic versions of Kuvan in both the
United States and the European Union, and ongoing litigation
related to generic versions of Kuvan. These forward-looking
statements are predictions and involve risks and uncertainties such
that actual results may differ materially from these statements.
These risks and uncertainties include, among others: the review of
the settlement agreement with Par Pharmaceutical by the U.S.
Federal Trade Commission and the U.S. Department of Justice; the
outcome of current litigation with Dr. Reddy's Laboratories,
possible future ANDA filings related to Kuvan tablets or Kuvan
powder for oral solution; and those factors detailed in BioMarin's
filings with the Securities and Exchange Commission, including,
without limitation, the factors contained under the caption "Risk
Factors" in BioMarin's 2016 Annual Report on Form 10-K, and the
factors contained in BioMarin's reports on Form 10-Q. Stockholders
are urged not to place undue reliance on forward-looking
statements, which speak only as of the date hereof. BioMarin is
under no obligation, and expressly disclaims any obligation to
update or alter any forward-looking statement, whether as a result
of new information, future events or otherwise. For additional
information, please visit www.BMRN.com. Information on BioMarin's
website is not incorporated by reference into this press
release.
Contacts:
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|
Investors
|
Media
|
Traci
McCarty
|
Debra
Charlesworth
|
BioMarin
Pharmaceutical
Inc.
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BioMarin
Pharmaceutical Inc.
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(415)
455-7558
|
(415)
455-7451
|
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SOURCE BioMarin Pharmaceutical Inc.