- Forest acquires exclusive rights to
Saphris® in the United States for the treatment of schizophrenia
and acute bipolar mania in adults for $240 million plus sales-based
milestones and on-going supply payments
- Saphris is complementary to Forest’s
existing CNS franchise and commercial infrastructure
- Agreement is expected to be immediately
accretive to Forest
Forest Laboratories Holdings Limited, a wholly owned subsidiary
of Forest Laboratories, Inc. (NYSE:FRX) today announced that the
company is acquiring exclusive rights in the United States for
Saphris® (asenapine) sublingual tablets, a treatment for adult
patients with schizophrenia or acute bipolar mania, from Merck
Sharp & Dohme B.V., a wholly owned subsidiary of Merck &
Co., Inc. (NYSE:MRK).
Under the terms of the agreement, Forest will make an upfront
payment of $240 million and additional payments to Merck based on
defined sales milestones. Merck will remain responsible for product
supply. Forest will assume responsibility for continued
commercialization, including completing certain post marketing
studies of Saphris following a transition period, and will be the
marketing authorization holder. Other details of the financial
terms of the agreement were not disclosed. The agreement is
expected to close in early CY2014 pending regulatory review and
satisfaction of all closing conditions.
Saphris is an atypical antipsychotic approved by the US Food and
Drug Administration (FDA) and launched in 2009. Merck recorded net
sales of $150 million in the 12month period ending September
2013.
“We are pleased to gain access to another commercial product in
the CNS category. With Viibryd and our soon to be launched product,
Fetzima, Saphris complements our current position in psychiatry and
gives us access to the important schizophrenia segment as we
continue to work toward registering and commercializing cariprazine
with our partner Gedeon Richter," said Brent Saunders, chief
executive officer and president of Forest Laboratories. "This deal
is immediately accretive to Forest's earnings and makes us more
relevant to our customers, as well as our current and future
business partners in the CNS category."
"The decision to divest Saphris in the U.S. is part of our
ongoing strategy to sharpen our commercial and R&D focus and
improve our operational effectiveness," said Jay Galeota,
president, Hospital and Specialty Care at Merck. "This agreement
will allow Merck to focus both R&D and commercial resources on
other opportunities, while complementing Forest’s product portfolio
and allowing for continued access to Saphris for physicians and
patients."
Schizophrenia and acute bipolar mania are significant areas of
unmet medical need and it is important to have treatment options
available for physicians and patients.
About Saphris®
Saphris is approved by the U.S. Food and Drug Administration for
the treatment of schizophrenia in adults, and for the acute
treatment of manic or mixed episodes associated with bipolar I
disorder in adults, as monotherapy or as adjunctive therapy with
either lithium or valproate.
Important Safety Information
WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH
DEMENTIA-RELATED PSYCHOSIS Elderly patients with
dementia-related psychosis treated with antipsychotic drugs are at
an increased risk of death. Analyses of 17 placebo-controlled
trials (modal duration of 10 weeks), largely in patients taking
atypical antipsychotic drugs, revealed a risk of death in the
drug-treated patients of between 1.6 to 1.7 times that seen in
placebo-treated patients. Over the course of a typical 10-week
controlled trial, the rate of death in drug-treated patients was
about 4.5 percent, compared to a rate of about 2.6 percent in the
placebo group. Although the causes of death were varied, most of
the deaths appeared to be either cardiovascular (e.g., heart
failure, sudden death) or infectious (e.g., pneumonia) in nature.
SAPHRIS® (asenapine) is not approved for the treatment of patients
with dementia-related psychosis.
Hypersensitivity Reactions: SAPHRIS is contraindicated in
patients with known hypersensitivity to the product.
Hypersensitivity reactions including anaphylaxis, angioedema,
hypotension, tachycardia, swollen tongue, dyspnea, wheezing and
rash have been observed.
Cerebrovascular Adverse Events: In placebo-controlled
trials with risperidone, aripiprazole, and olanzapine in elderly
subjects with dementia, there was a higher incidence of
cerebrovascular adverse reactions (cerebrovascular accidents and
transient ischemic attacks) including fatalities compared to
placebo-treated subjects. SAPHRIS is not approved for the treatment
of patients with dementia-related psychosis.
Neuroleptic Malignant Syndrome (NMS): NMS, a potentially
fatal symptom complex, has been reported with administration of
antipsychotic drugs, including SAPHRIS. NMS can cause hyperpyrexia,
muscle rigidity, altered mental status, irregular pulse or blood
pressure, tachycardia, diaphoresis and cardiac dysrhythmia.
Additional signs may include elevated creatine phosphokinase,
myoglobinuria (rhabdomyolysis) and acute renal failure. Management
should include immediate discontinuation of antipsychotic drugs and
other drugs not essential to concurrent therapy, intensive
symptomatic treatment and medical monitoring, and treatment of any
concomitant serious medical problems.
Tardive Dyskinesia (TD): The risk of developing TD and
the potential for it to become irreversible may increase as the
duration of treatment and the total cumulative dose increase.
However, the syndrome can develop, although much less commonly,
after relatively brief treatment periods at low doses. Prescribing
should be consistent with the need to minimize TD. If signs and
symptoms appear, discontinuation should be considered.
Hyperglycemia and Diabetes Mellitus: Hyperglycemia, in
some cases associated with ketoacidosis, hyperosmolar coma or
death, has been reported in patients treated with atypical
antipsychotics. Patients with risk factors for diabetes mellitus
who are starting treatment with atypical antipsychotics should
undergo fasting blood glucose testing at the beginning of and
during treatment. Any patient treated with atypical antipsychotics
should be monitored for symptoms of hyperglycemia including
polydipsia, polyuria, polyphagia and weakness. Patients who develop
symptoms of hyperglycemia during treatment with atypical
antipsychotics should also undergo fasting blood glucose testing.
In some cases, hyperglycemia has resolved when the atypical
antipsychotic was discontinued; however, some patients required
continuation of anti-diabetic treatment despite discontinuation of
the antipsychotic drug.
Weight Gain: Patients receiving SAPHRIS should receive
regular monitoring of weight. There were differences in mean weight
gain between SAPHRIS-treated and placebo-treated patients in
short-term schizophrenia trials (1.1 kg vs. 0.1 kg) and in bipolar
mania trials (1.3 kg vs. 0.2 kg). In a 52 week study, the
proportion of patients with an equal to or greater than 7 percent
increase in body weight was 14.7 percent.
Orthostatic Hypotension and Syncope and Other Hemodynamic
Effects: SAPHRIS may induce orthostatic hypotension and
syncope. SAPHRIS should be used with caution in patients with known
cardiovascular disease, cerebrovascular disease, conditions which
would predispose them to hypotension and in the elderly. SAPHRIS
should be used cautiously when treating patients who receive
treatment with other drugs that can induce hypotension,
bradycardia, respiratory or central nervous system depression.
Monitoring of orthostatic vital signs should be considered in all
such patients, and a dose reduction should be considered if
hypotension occurs.
Leukopenia, Neutropenia, and Agranulocytosis: In clinical
trial and postmarketing experience, events of
leukopenia/neutropenia have been reported temporally related to
antipsychotic agents, including SAPHRIS. Patients with a
pre-existing low white blood cell count (WBC) or a history of
leukopenia/neutropenia should have their complete blood count (CBC)
monitored frequently during the first few months of therapy, and
SAPHRIS should be discontinued at the first sign of a decline in
WBC in the absence of other causative factors.
QT Prolongation: SAPHRIS was associated with increases in
QTc interval ranging from 2 to 5 msec compared to placebo. No
patients treated with SAPHRIS experienced QTc increases of equal to
or greater than 60 msec from baseline measurements, nor did any
experience a QTc of equal to or greater than 500 msec. SAPHRIS
should be avoided in combination with other drugs known to prolong
QTc interval, in patients with congenital prolongation of QT
interval or a history of cardiac arrhythmias, and in circumstances
that may increase the occurrence of torsade de pointes and/or
sudden death in association with the use of drugs that prolong the
QTc interval.
Hyperprolactinemia: Like other drugs that antagonize
dopamine D2 receptors, SAPHRIS can elevate prolactin levels, and
the elevation can persist during chronic administration.
Galactorrhea, amenorrhea, gynecomastia and impotence have been
reported in patients receiving prolactin-elevating compounds.
Seizures: SAPHRIS should be used cautiously in patients
with a history of seizures or with conditions that lower seizure
threshold, e.g., Alzheimer’s dementia.
Potential for Cognitive and Motor Impairment: Somnolence
was reported in patients treated with SAPHRIS. Patients should be
cautioned about performing activities requiring mental alertness,
such as operating hazardous machinery or operating a motor vehicle,
until they are reasonably certain that SAPHRIS therapy does not
affect them adversely.
Body Temperature Regulation: Appropriate care is advised
when prescribing SAPHRIS for patients who will be experiencing
conditions that may contribute to an elevation in core body
temperature, e.g., exercising strenuously, exposure to extreme
heat, receiving concomitant medication with anticholinergic
activity, or being subject to dehydration.
Suicide: The possibility of suicide attempt is inherent
in psychotic illnesses and bipolar disorder. Close supervision of
high-risk patients should accompany drug therapy. Prescriptions for
SAPHRIS should be written for the smallest quantity of tablets in
order to reduce the risk of overdose.
Dysphagia: Esophageal dysmotility and aspiration have
been associated with antipsychotic drug use. Aspiration pneumonia
is a common cause of morbidity and mortality in elderly patients,
in particular those with advanced Alzheimer’s dementia. SAPHRIS is
not indicated for the treatment of dementia-related psychosis, and
should not be used in patients at risk for aspiration
pneumonia.
Hepatic Impairment: SAPHRIS is not recommended in
patients with severe hepatic impairment.
Drug Interactions: The risks of using SAPHRIS in
combination with other drugs have not been extensively evaluated.
Given the primary CNS effects of SAPHRIS, caution should be used
when it is taken in combination with other centrally-acting drugs
or alcohol. Co-administration of SAPHRIS with strong CYP1A2
inhibitors (fluvoxamine) or compounds which are both CYP2D6
substrates and inhibitors (paroxetine) should be done with
caution.
Adverse Reactions:Commonly Observed Adverse Reactions
(incidence equal to or greater than five percent and at least twice
that for placebo) were:
In short-term schizophrenia trials with SAPHRIS 5 or 10 mg BID
vs. placebo: akathisia (6% vs. 3%), oral hypoesthesia (numbing of
the tongue [5% vs. 1%]), and somnolence (13% vs. 7%). The safety
profile of SAPHRIS in the maintenance treatment of schizophrenia
was similar to that seen with acute treatment.
In short-term bipolar mania (monotherapy) trials with SAPHRIS 5
or 10 mg BID vs. placebo: somnolence (24% vs. 6%), dizziness (11%
vs. 3%), extrapyramidal symptoms other than akathisia (7% vs. 2%)
and weight increase (5% vs. less than 1%).
In the short term bipolar mania (adjunctive) therapy trial with
SAPHRIS 5 or 10 mg BID vs. placebo: somnolence (22% vs. 10%) and
oral hypoesthesia (5% vs. 0%).
Postmarketing Experience:
Application site reactions, primarily in the sublingual area,
have been reported. These application site reactions included oral
ulcers, blisters, peeling/sloughing, and inflammation. In many
cases, the occurrence of these application site reactions led to
discontinuation of therapy.
About Forest Laboratories and Its Products
Forest Laboratories (NYSE: FRX) is a leading, fully integrated,
specialty pharmaceutical company largely focused on the United
States market. The Company markets a portfolio of branded drug
products and develops new medicines to treat patients suffering
from diseases principally in five therapeutic areas: central
nervous system, cardiovascular, gastrointestinal, respiratory, and
anti-infective. Our strategy of acquiring product rights for
development and commercialization through licensing, collaborative
partnerships and targeted mergers and acquisitions allows us to
take advantage of attractive late-stage development and commercial
opportunities, thereby managing the risks inherent in drug
development. The Company is headquartered in New York, NY. To learn
more, visit www.FRX.com.
This release contains forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995.
These statements involve a number of risks and uncertainties,
including the difficulty of predicting FDA approvals, the
acceptance and demand for new pharmaceutical products, the impact
of competitive products and pricing, the timely development and
launch of new products, and the risk factors listed from time to
time in Forest Laboratories’ Annual Report on Form 10-K, Quarterly
Reports on Form 10-Q and any subsequent SEC filings. Forest assumes
no obligation to update forward-looking statements contained in
this release to reflect new information or future events or
developments.
Forest Laboratories, Inc.Frank J. Murdolo, 1-212-224-6714Vice
President - Investor Relationsmedia.relations@frx.com
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