Fanapt(TM) Launches in the U.S.
11 1월 2010 - 10:16PM
PR Newswire (US)
ROCKVILLE, Md., Jan. 11 /PRNewswire-FirstCall/ -- Vanda
Pharmaceuticals (NASDAQ:VNDA) today announced that Novartis
Pharmaceuticals Corporation has launched Fanapt(TM) (iloperidone)
in the U.S. Fanapt(TM) was approved by the U.S. Food and Drug
Administration on May 6, 2009 for the acute treatment of
schizophrenia in adults. In October 2009, Vanda and Novartis Pharma
AG entered into an agreement, pursuant to which Novartis has
exclusive U.S. and Canadian commercialization rights to Fanapt(TM).
Under this agreement, Vanda received an upfront payment of $200
million and is eligible for future payments totaling up to $265
million upon the achievement of certain commercial and development
milestones for Fanapt(TM), as well as royalties based upon net
sales. Novartis assumed the commercialization and further clinical
development activities in the U.S. and Canada, including the
development and commercialization of a long-acting injectable (or
depot) formulation of Fanapt(TM). Vanda retains the right to
commercialize Fanapt(TM) oral and depot formulations outside the
U.S. and Canada. At Novartis' option, the parties will enter into
good faith discussions relating to an agreement for the
co-commercialization of Fanapt(TM) outside of the U.S. and Canada
or, alternatively, Novartis will receive a royalty based upon net
sales. About Schizophrenia Schizophrenia is a chronic, severe and
disabling mental disorder, characterized by profound disruptions in
thinking, affecting language, perception, and the sense of self. It
often includes psychotic experiences, such as hearing voices or
delusions. Schizophrenia typically begins in late adolescence or
early adulthood and affects 2.4 million Americans or 1.1% of the
adult population. About Fanapt(TM) Fanapt belongs to a class of
medications for schizophrenia known as atypical antipsychotics. The
term "atypical" refers to the different mechanisms of action of
second-generation antipsychotics. The FDA approval of Fanapt was
supported by two placebo- and active-controlled short-term (4- and
6-week) trials and safety data derived from more than 2,000
patients. Both trials enrolled patients who met the DSM-III/IV
criteria for schizophrenia. Fanapt was shown to be superior to
placebo in controlling symptoms of schizophrenia across doses of 12
mg to 24 mg per day -- which is the recommended daily target dose
range. Titration to the target dose of 12 mg per day can be
achieved in 4 days. IMPORTANT SAFETY INFORMATION FOR FANAPT
(iloperidone) TABLETS Fanapt(TM) tablets are indicated for the
acute treatment of schizophrenia in adults. Elderly patients are at
an increased risk of death when compared with patients who are
treated with a placebo. Fanapt is not approved for the treatment of
elderly patients (aged 65 and older) with psychosis related to
dementia. Serious Side Effects Fanapt may change your heart rhythm
(meaning there is more time between heart beats). Heart rhythm
changes have occurred in patients taking Fanapt and are a risk
factor for serious, even life-threatening medical issues. You
should tell your doctor if you have or had heart problems. Call
your doctor right away if you feel faint or have unpleasant
feelings of irregular or forceful heart beats as any of these
feelings could be a sign of a rare, but serious side effect that
could be fatal. Very high fever, rigid muscles, shaking, confusion,
sweating, or increased heart rate and blood pressure. These may be
signs of a condition called neuroleptic malignant syndrome (NMS), a
rare but serious side effect which could be fatal. Abnormal or
uncontrollable movements of the face, tongue, or other parts of
body may be signs of a serious condition called tardive dyskinesia
(TD), which could become permanent. If you have diabetes or risk
factors for diabetes (for example, obesity, family history of
diabetes), or you have unexpected increases in thirst, urination,
or hunger, your blood sugar should be monitored. Increases in blood
sugar levels (hyperglycemia), in some cases serious and associated
with coma or death, have been reported in patients taking Fanapt
and medicines like it. Tell your doctor if you have a history of or
are at risk for seizures, have liver disease, or if you are
pregnant or intend to become pregnant. Tell your doctor about all
prescription and nonprescription medicines you are taking, since
there are some risks for drug interactions. Lightheadedness or
faintness caused by a sudden change in heart rate and blood
pressure when rising quickly from a sitting or lying position
(orthostatic hypotension) has been reported with Fanapt. Decreases
in white blood cells (infection-fighting cells) have been reported
in some patients taking antipsychotic agents, including Fanapt.
Patients with a history of a significant decrease in white blood
cell (WBC) count or who have experienced a low WBC count due to
drug therapy should have their blood tested and monitored during
the first few months of therapy. Fanapt can increase the level of
the hormone prolactin. Tell your doctor if you have signs of high
prolactin levels, such as breast enlargement, breast pain, or
breast discharge. Medicines like Fanapt can impact your body's
ability to reduce your temperature. You should avoid overheating.
You should drink fluids so that you do not become thirsty
(dehydrated). Fanapt and medicines like it have been associated
with swallowing problems (dysphagia). If you had or have swallowing
problems, you should tell your doctor. As with many conditions that
affect the way you think and feel, thoughts of suicide may occur.
If you get these feelings, seek help immediately from your doctor,
or local emergency room. For males, in the rare event you have a
painful or prolonged erection (priapism), lasting 4 or more hours,
stop using Fanapt and seek immediate medical attention. Fanapt and
medicines like it can affect your judgment, thinking, or motor
skills. You should not drive or operate hazardous machinery
including automobiles until you know how Fanapt affects you. Common
Side Effects The most common side effects include dizziness, dry
mouth, feeling unusually tired or sleepy, stuffy nose, orthostatic
hypotension, racing heart beat, and weight gain. The average weight
gain in clinical studies was 5 lbs. If you experience any of these
symptoms, talk with your doctor. When taking Fanapt, you should
avoid drinking alcohol, and you should not breastfeed. If you would
like more information, talk with your doctor. You can also visit
the Fanapt Web site at http://www.fanapt.com/ or call Novartis
Pharmaceuticals Corporation at: 1-888-NOW-NOVA (1-888-669-6682)
Monday-Friday, 8:30 am - 5:00 pm ET. About Vanda Vanda
Pharmaceuticals Inc. is a biopharmaceutical company focused on the
development and commercialization of clinical-stage products for
central nervous system disorders. For more on Vanda, please visit
http://www.vandapharma.com/. CAUTIONARY NOTE REGARDING
FORWARD-LOOKING STATEMENTS Various statements in this release are
"forward-looking statements" under the securities laws. Words such
as, but not limited to, "believe," "expect," "anticipate,"
"estimate," "intend," "plan," "targets," "likely," "will," "would,"
and "could," and similar expressions or words, identify
forward-looking statements. Forward-looking statements are based
upon current expectations that involve risks, changes in
circumstances, assumptions and uncertainties. Important factors
that could cause actual results to differ materially from those
reflected in the company's forward-looking statements include,
among others: the extent and effectiveness of the development,
sales and marketing and distribution support Fanapt(TM) receives;
Vanda's ability to successfully commercialize Fanapt(TM) outside of
the U.S. and Canada; delays in the completion of Vanda's clinical
trials; a failure of Vanda's products to be demonstrably safe and
effective; Vanda's failure to obtain regulatory approval for its
products or to comply with ongoing regulatory requirements for its
products; a lack of acceptance of Vanda's products in the
marketplace, or a failure to become or remain profitable; Vanda's
expectations regarding trends with respect to its costs and
expenses; Vanda's inability to obtain the capital necessary to fund
its commercial and research and development activities; Vanda's
failure to identify or obtain rights to new products; Vanda's
failure to develop or obtain sales, marketing and distribution
resources and expertise or to otherwise manage its growth; a loss
of any of Vanda's key scientists or management personnel; losses
incurred from product liability claims made against Vanda; a loss
of rights to develop and commercialize Vanda's products under its
license and sublicense agreements and other factors that are
described in the "Risk Factors" section (Part II, Item 1A) of
Vanda's quarterly report on Form 10-Q for the fiscal quarter ended
September 30, 2009 (File No. 001-34186). In addition to the risks
described above and in Part II, Item 1A of Vanda's quarterly report
on Form 10-Q, other unknown or unpredictable factors also could
affect Vanda's results. There can be no assurance that the actual
results or developments anticipated by Vanda will be realized or,
even if substantially realized, that they will have the expected
consequences to, or effects on, Vanda. Therefore, no assurance can
be given that the outcomes stated in such forward-looking
statements and estimates will be achieved. All written and verbal
forward-looking statements attributable to Vanda or any person
acting on its behalf are expressly qualified in their entirety by
the cautionary statements contained or referred to herein. Vanda
cautions investors not to rely too heavily on the forward-looking
statements Vanda makes or that are made on its behalf. The
information in this release is provided only as of the date of this
release, and Vanda undertakes no obligation, and specifically
declines any obligation, to update or revise publicly any
forward-looking statements, whether as a result of new information,
future events or otherwise. DATASOURCE: Vanda Pharmaceuticals Inc.
CONTACT: Investors, Stephanie R. Irish, , or Media, Cristina
Murphy, , both of Vanda Pharmaceuticals Inc., +1-240-599-4500 Web
Site: http://www.vandapharma.com/
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