-- Fanapt (iloperidone), an antipsychotic therapy, is indicated in
US for the acute treatment of schizophrenia in adults, set for US
launch in early 2010 -- Addition of Fanapt will strengthen Novartis
psychiatry portfolio and build on history in schizophrenia --
Schizophrenia is a chronic, severe and disabling psychiatric
disorder estimated to affect more than two million adults in the US
and nearly 250,000 Canadians -- Rights to Fanapt acquired from
Vanda Pharmaceuticals Inc. for upfront payment of USD 200 million;
Vanda eligible for milestones and sales royalties EAST HANOVER,
N.J., Oct. 12 /PRNewswire-FirstCall/ -- Novartis Pharma AG has
entered into an agreement for exclusive US and Canadian rights to
Fanapt(TM) (iloperidone), a new oral medication that is approved by
the US Food and Drug Administration (FDA) for the acute treatment
of adults with schizophrenia. Novartis plans to launch Fanapt in
the US in early 2010. As part of the agreement with Vanda
Pharmaceuticals Inc., Novartis will have exclusive
commercialization rights to the oral formulation of this medicine
in the US and Canada as well as exclusive rights to develop and
commercialize a long-acting injectable (or "depot") formulation of
this medicine for these markets. Schizophrenia is a severe
psychiatric disorder that is estimated to affect more than 2
million adults in the US and nearly 250,000 Canadians. Fanapt
belongs to a class of medication for schizophrenia known as
atypical antipsychotics. "Schizophrenia remains one of the most
chronic and debilitating of the major psychiatric illnesses,
underscoring the need for new treatment options," said Ludwig
Hantson, PhD, Head of Pharma North America, CEO, Novartis
Pharmaceuticals Corporation. "With the launch of Fanapt in early
2010, we will broaden our presence in psychiatry and build on the
heritage of Novartis in offering innovative treatments for
devastating psychiatric diseases." In the 1970s, Novartis pioneered
the first atypical antipsychotic medication which was considered a
breakthrough for patients with treatment-resistant schizophrenia.
Novartis also offers medications for Alzheimer's disease, attention
deficit hyperactivity disorder (ADHD), Parkinson's disease and
multiple sclerosis. Vanda completed Phase III clinical trials in
2006 and gained US regulatory approval for this medicine in May
2009. Terms of the agreement Novartis will make an upfront payment
to Vanda of USD 200 million for the exclusive rights to
commercialize the oral tablet, which is already approved in the US,
in the territory of the US and Canada, as well as to develop and
commercialize a depot formulation of Fanapt for patients in this
territory. Vanda will be eligible for additional payments upon
achieving defined development and commercial milestones and will
also receive sales royalties. Vanda will retain rights to develop
and commercialize Fanapt outside the territory of US and Canada,
but Novartis has the option to enter into discussions with Vanda to
co-commercialize Fanapt or receive sales royalties outside this
territory. The consummation of the transaction is subject to the
receipt of customary regulatory approvals, which are expected by
the end of 2009. Important Safety Information Fanapt is indicated
for the acute treatment of schizophrenia in adults. Increased
Mortality: Elderly patients with dementia-related psychosis treated
with antipsychotic drugs are at an increased risk of death compared
to placebo. Fanapt is not approved for the treatment of patients
with dementia-related psychosis. QT Prolongation: In an open-label
QTc study in patients with schizophrenia or schizoaffective
disorder (N=160), Fanapt was associated with QTc prolongation of 9
msec at an iloperidone dose of 12 mg twice daily. This affect was
augmented by the presence of CYP450, 2D6 or 3A4 metabolic
inhibition. The use of Fanapt should be avoided in combination with
other drugs that are known to prolong QTc. Caution is warranted
when prescribing Fanapt with drugs that inhibit Fanapt metabolism.
Neuroleptic Malignant Syndrome (NMS):A potentially fatal symptom
complex, has been reported in association with administration of
antipsychotic drugs. Clinical manifestations include hyperpyrexia,
muscle rigidity, altered mental status, and evidence of autonomic
instability (irregular pulse or blood pressure, tachycardia,
diaphoresis and cardiac dysrhythmia). Additional signs may include
elevated creatine phosphokinase, myoglobinuria (rhabdomyolysis) and
acute renal failure. Tardive Dyskinesia (TD): The risk of
developing TD and the likelihood for it to become irreversible are
believed to increase as the duration of treatment and the total
cumulative dose increases. However, the syndrome can develop,
although much less commonly, after relatively brief treatment
periods at low doses. Given these considerations Fanapt should be
prescribed in a manner that is most likely to minimize the
occurrence of tardive dyskinesia. Hyperglycemia and Diabetes
Mellitus: Hyperglycemia, in some cases extreme and associated with
ketoacidosis, hyperosmolar coma or death, has been reported in
patients treated with atypical antipsychotics including Fanapt.
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 suspect
drug. Weight Gain: Based on the pooled data from the four
placebo-controlled, 4- or 6-week, fixed- or flexible-dose studies,
the proportions of patients having a weight gain of greater than or
equal to 7% body weight was 12% for Fanapt 10-16 mg/day, 18% for
Fanapt 20-24 mg/day, and 13% for Fanapt (combined doses) versus 4%
for placebo. Seizures: In short-term placebo-controlled trials (4-
to 6-weeks), seizures occurred in 0.1% (1/1344) of patients treated
with Fanapt compared to 0.3% (2/587) on placebo. As with other
antipsychotics, Fanapt should be used cautiously in patients with a
history of seizures or with conditions that potentially lower the
seizure threshold. Orthostatic Hypotension and Syncope: Fanapt can
induce orthostatic hypotension and syncope. Fanapt should be used
with caution in patients with known cardiovascular disease,
cerebrovascular disease, or conditions that predispose the patient
to hypotension. Leukopenia, Neutropenia, and Agranulocytosis: In
clinical trial and postmarketing experience, events of
leukopenia/neutropenia have been reported temporally related to
antipsychotic agents. Agranulocytosis (including fatal cases) have
been reported. 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 should discontinue Fanapt at the
first sign of a decline in WBC in the absence of other causative
factors. Hyperprolactinemia: As with other drugs that antagonize
dopamine D2 receptors, Fanapt elevates prolactin levels.
Galactorrhea, amenorrhea, gynecomastia and impotence have been
reported in patients receiving prolactin-elevating compounds. Body
Temperature Regulation: Disruption of the body's ability to reduce
core body temperature has been attributed to antipsychotic agents.
Appropriate care is advised when prescribing Fanapt for patients
who will be experiencing conditions which may contribute to an
elevation in core body temperature. 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. Suicide: The possibility of suicide attempt
is inherent in psychotic illnesses, and close supervision of
high-risk patients should accompany drug therapy. Prescriptions for
Fanapt should be written for the smallest quantity of tablets
consistent with good patient management in order to reduce the risk
of overdose. Priapism: Three cases of priapism were reported in the
pre-marketing Fanapt program. Severe priapism may require surgical
intervention Potential for Cognitive and Motor Impairment: Fanapt ,
like other antipsychotics, has the potential to impair judgement,
thinking, or motor skills. 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 Fanapt therapy does not affect them
adversely. Common adverse reactions include dizziness, dry mouth,
fatigue, nasal congestion, orthostatic hypotension, somnolence,
tachycardia and weight gain. For additional warnings, precautions
and complete prescribing information, go to Vanda's web site:
http://www.fanapt.com/. Disclaimer The foregoing release contains
forward-looking statements that can be identified by terminology
such as "set," "will," "eligible," "plans," "option," "expected,"
or similar expressions, or by express or implied discussions
regarding the potential consummation of the acquisition of Fanapt
by Novartis, potential additional marketing approvals for Fanapt
products, Novartis obtaining potential additional marketing rights
to Fanapt, or regarding potential future revenues from Fanapt. You
should not place undue reliance on these statements. Such
forward-looking statements reflect the current views of management
regarding future events, and involve known and unknown risks,
uncertainties and other factors that may cause actual results with
Fanapt to be materially different from any future results,
performance or achievements expressed or implied by such
statements. There can be no guarantee that the proposed Fanapt
acquisition will be completed in the expected form or within the
expected time frame or at all. Nor can there be any guarantee that
Fanapt products will be approved for sale in any additional markets
or that Novartis will obtain marketing rights to Fanapt in
additional markets. Neither can there be any guarantee that Fanapt
will achieve any particular levels of revenue in the future. In
particular, management's expectations regarding Fanapt could be
affected by, among other things, unexpected regulatory actions or
delays or government regulation generally; unexpected clinical
trial results, including unexpected new clinical data and
unexpected additional analysis of existing clinical data;
competition in general; government, industry and general public
pricing pressures; the company's ability to obtain or maintain
patent or other proprietary intellectual property protection; the
impact that the foregoing factors could have on the values
attributed to the Novartis Group's assets and liabilities as
recorded in the Group's consolidated balance sheet, and other risks
and factors referred to in Novartis AG's current Form 20-F on file
with the US Securities and Exchange Commission. Should one or more
of these risks or uncertainties materialize, or should underlying
assumptions prove incorrect, actual results may vary materially
from those anticipated, believed, estimated or expected. Novartis
is providing the information in this press release as of this date
and does not undertake any obligation to update any forward-looking
statements contained in this press release as a result of new
information, future events or otherwise. About Novartis
Pharmaceuticals Corporation Novartis Pharmaceuticals Corporation
researches, develops, manufactures and markets leading innovative
prescription drugs used to treat a number of diseases and
conditions, including those in the cardiovascular, metabolic,
cancer, organ transplantation, central nervous system,
dermatological, GI and respiratory areas. The company's mission is
to improve people's lives by pioneering novel healthcare solutions.
Located in East Hanover, New Jersey, Novartis Pharmaceuticals
Corporation is an affiliate of Novartis AG, which provides
healthcare solutions that address the evolving needs of patients
and societies. Focused solely on healthcare, Novartis offers a
diversified portfolio to best meet these needs: innovative
medicines, preventive vaccines, diagnostic tools, cost-saving
generic pharmaceuticals, and consumer health products. Novartis is
the only company with leading positions in these areas. In 2008,
the Group's continuing operations achieved net sales of USD 41.5
billion and net income of USD 8.2 billion. Approximately USD 7.2
billion was invested in R&D activities throughout the Group.
Headquartered in Basel, Switzerland, Novartis Group companies
employ approximately 98,000 full-time-equivalent associates and
operate in more than 140 countries around the world. For more
information, please visit http://www.novartis.com/. Novartis Media
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