Hikma Granted Right to Sell Authorized Generic of Xyrem in
2023
DUBLIN, April 5, 2017 /PRNewswire/ -- Jazz
Pharmaceuticals plc (Nasdaq: JAZZ) today announced that certain of
its subsidiaries have entered into agreements with Hikma
Pharmaceuticals PLC and related entities ("Hikma") resolving patent
litigation related to Xyrem® (sodium oxybate) oral
solution. The litigation, which has been pending in the U.S.
District Court for the District of New
Jersey since 2010, resulted from the submission by Roxane
Laboratories, Inc. (which was subsequently acquired by Hikma) of an
Abbreviated New Drug Application (ANDA) to the U.S. Food and Drug
Administration (FDA) seeking approval to market a generic version
of Xyrem.
In connection with the settlement, Jazz has granted Hikma and
its wholly owned subsidiary, West-Ward Pharmaceuticals Corp.
(West-Ward), the right to sell an authorized generic (AG) version
of Xyrem in the U.S. under the Xyrem New Drug Application (NDA),
commencing on January 1, 2023, or
earlier under certain circumstances customary for settlement
agreements of this nature. The AG product will be marketed
through the Xyrem Risk Evaluation and Mitigation Strategy (REMS)
program. The initial term of the AG arrangement is six months,
and Hikma has the option to continue the sale of the AG
product for up to a total of five years. Jazz will receive a
meaningful royalty on net sales of the AG product, with the royalty
rate increasing during the initial AG term based on increased AG
sales. There will be a substantial increase in the royalty
rate should the AG term be extended beyond one year. Jazz will
also be paid for supply of the AG product and will be reimbursed
for a portion of the service costs associated with the operation of
the Xyrem REMS and distribution of the AG. Specific financial
and other terms related to the AG product are confidential. Hikma
has been granted a license to sell its generic sodium oxybate
product under its ANDA at the end of the AG term.
"This settlement arrangement provides additional clarity related
to our Xyrem intellectual property as we continue our strategy to
expand and diversify our product portfolio and R&D pipeline, in
line with our goal of delivering new clinically meaningful
therapeutic options for patients," said Bruce Cozadd, chairman and chief executive
officer of Jazz Pharmaceuticals. "We are pleased that this
settlement positions us to facilitate the safe distribution of
West-Ward's AG of Xyrem through the Xyrem REMS."
As required by law, Jazz Pharmaceuticals and Hikma will submit
the settlement agreement to the U.S. Federal Trade Commission (FTC)
and the U.S. Department of Justice (DOJ) for review.
Similar patent litigation brought by Jazz Pharmaceuticals
against four other companies that have filed ANDAs with the FDA
seeking approval to market a generic version of Xyrem remains
pending in the U.S. District Court for the District of New Jersey.
For additional information related to the settlement between
Jazz Pharmaceuticals and Hikma, please refer to the Current Report
on Form 8-K to be filed by Jazz Pharmaceuticals with the Securities
and Exchange Commission.
About Jazz Pharmaceuticals
Jazz Pharmaceuticals plc
(Nasdaq: JAZZ) is an international biopharmaceutical company
focused on improving patients' lives by identifying, developing and
commercializing meaningful products that address unmet medical
needs. The company has a diverse portfolio of products and
product candidates, with a focus in the areas of sleep and
hematology/oncology. In these areas, Jazz Pharmaceuticals
markets Xyrem® (sodium oxybate) oral solution, Erwinaze®
(asparaginase Erwinia chrysanthemi) and Defitelio®
(defibrotide sodium) in the U.S. and markets Erwinase® and
Defitelio® (defibrotide) in countries outside the U.S. For
more information, please visit www.jazzpharmaceuticals.com.
About Xyrem
Xyrem® (sodium oxybate) oral solution,
CIII, is indicated for the treatment of cataplexy in narcolepsy and
for the treatment of excessive daytime sleepiness (EDS) in
narcolepsy. Xyrem may only be dispensed to patients enrolled in the
Xyrem REMS Program. Xyrem was first approved in the U.S. in
2002.
IMPORTANT SAFETY INFORMATION
Xyrem (sodium
oxybate) is a Central Nervous System (CNS) depressant. In
clinical trials at recommended doses, obtundation and clinically
significant respiratory depression occurred in Xyrem-treated
patients. Almost all of the patients who received Xyrem during
clinical trials in narcolepsy were receiving central nervous
system stimulants.
Xyrem (sodium oxybate) is the sodium salt of gamma
hydroxybutyrate (GHB). Abuse of GHB, either alone or in combination
with other CNS depressants, is associated with CNS adverse
reactions, including seizure, respiratory depression, decreases in
the level of consciousness, coma, and death.
Because of the risks of CNS depression, abuse, and misuse,
Xyrem is available only through a restricted distribution program
called the Xyrem REMS Program using the central pharmacy
that is specially certified. Prescribers and patients must
enroll in the program. Further information is available at
www.XYREMREMS.com or
1-866-XYREM88® (1-866-997-3688).
Xyrem is contraindicated in combination with sedative hypnotics
or alcohol and in patients with succinic semialdehyde dehydrogenase
deficiency. Use caution when considering the concurrent use of
Xyrem with other CNS depressants. Healthcare providers should
caution patients against hazardous activities requiring complete
mental alertness or motor coordination within the first 6 hours of
dosing or after first initiating treatment until certain that Xyrem
does not affect them adversely. Xyrem is a Schedule III controlled
substance. The rapid onset of sedation, coupled with the amnestic
features of Xyrem, particularly when combined with alcohol, has
proven to be dangerous for the voluntary and involuntary user (e.g.
assault victim). Monitor patients for emergent or increased
depression and suicidality and for impaired motor/cognitive
function. Episodes of sleepwalking should be fully evaluated and
appropriate interventions considered. Consider the amount of daily
sodium intake in each dose of Xyrem in patients sensitive to salt
intake.
In three controlled clinical trials, the most common adverse
reactions (incidence ≥ 5% and twice the rate of placebo) in
Xyrem-treated patients were nausea (20%), dizziness (15%), vomiting
(11%), somnolence (8%), enuresis (7%), and tremor (5%).
Please click here to see the full Prescribing
Information for Xyrem, including BOXED Warning.
"Safe Harbor" Statement under the Private Securities
Litigation Reform Act of 1995
This press release contains
forward-looking statements, including, but not limited to,
statements related to anticipated results and actions to be taken
under the settlement agreement and the transactions contemplated
thereby, review of the settlement agreement by the FTC and DOJ, the
anticipated dismissal of related pending litigation, the company's
strategy to expand and diversify its product portfolio and R&D
pipeline and its goal of delivering new clinically meaningful
therapeutic options for patients, and other statements that are not
historical facts. These forward-looking statements are based
on the company's current plans, objectives, estimates, expectations
and intentions and inherently involve significant risks and
uncertainties. Actual results and the timing of events could
differ materially from those anticipated in such forward-looking
statements as a result of these risks and uncertainties, which
include, without limitation, risks and uncertainties associated
with: approval of the settlement agreement and dismissal of related
pending litigation by the U.S. District Court for the District of
New Jersey; review of the
settlement arrangement by the FTC and DOJ; regulatory restrictions
and requirements applicable to Xyrem; ongoing patent litigation and
related proceedings; the regulatory approval process; protecting
and enhancing the company's intellectual property rights; whether
additional third parties may seek to market generic versions of
Xyrem, including the risk that any company or companies may decide,
before applicable ongoing patent litigation is concluded, to launch
a generic sodium oxybate product at risk of potentially being held
liable for damages; delays or problems in the supply or manufacture
of the company's products and product candidates; complying with
applicable U.S. and non-U.S. regulatory requirements; government
investigations and other actions; and other risks and uncertainties
affecting the company, including those described from time to time
under the caption "Risk Factors" and elsewhere in Jazz
Pharmaceuticals plc's Securities and Exchange Commission filings
and reports (Commission File No. 001-33500), including the
company's Annual Report on Form 10-K for the period ended
December 31, 2016 and future filings
and reports by the company. Other risks and uncertainties of
which the company is not currently aware may also affect the
company's forward-looking statements and may cause actual results
and the timing of events to differ materially from those
anticipated. The forward-looking statements herein are made
only as of the date hereof or as of the dates indicated in the
forward-looking statements, even if they are subsequently made
available by the company on its website or otherwise. The
company undertakes no obligation to update or supplement any
forward-looking statements to reflect actual results, new
information, future events, changes in its expectations or other
circumstances that exist after the date as of which the
forward-looking statements were made.
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