Under the License Agreement, Vanda granted Taro a non-exclusive license to manufacture and commercialize Taro's version of Fanapt® in the U. S. effective
The License Agreement is subject to review by the
About
Vanda is a specialty pharmaceutical company focused on the development and commercialization of novel therapies to address high unmet medical needs and improve the lives of patients. For more on
About Fanapt®
Fanapt® is an atypical antipsychotic agent indicated for the treatment of schizophrenia in adults. In choosing among treatments, prescribers should consider the ability of Fanapt® to prolong the QT interval and the use of other drugs first. Prescribers should also consider the need to titrate Fanapt® slowly to avoid orthostatic hypotension, which may lead to delayed effectiveness compared to some other drugs that do not require similar titration.
IMPORTANT WARNINGS and PRECAUTIONS: increased mortality in elderly patients with dementia-related psychosis; QT prolongation; neuroleptic malignant syndrome; tardive dyskinesia; hyperglycemia and diabetes mellitus; weight gain; seizures; orthostatic hypotension and syncope; leukopenia, neutropenia and agranulocytosis; hyperprolactinemia; body temperature regulation; dysphagia; suicide; priapism; potential for cognitive and motor impairment.
COMMONLY OBSERVED ADVERSE REACTIONS of FANAPT® (>=5% and 2x placebo): dizziness, dry mouth, fatigue, nasal congestion, orthostatic hypotension, somnolence, tachycardia, and weight increased.
For full U.S. Prescribing Information, including Boxed Warnings and Important Safety Information, visit our Web site at www.fanapt.com.
CAUTIONARY NOTE REGARDING Forward-Looking Statements
This press release contains forward-looking statements, including statements regarding the anticipated results and actions to be taken under the License Agreement, plans to submit the License Agreement for regulatory approval and the potential dismissal of the litigation. These 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 Vanda's forward-looking statements include, but are not limited to, risks regarding whether regulatory authorities challenge the enforceability of or seek to enjoin the entry into the License Agreement, whether the
Investor Contact:
Senior Vice President & Chief Financial Officer
(202) 734-3428
jim.kelly@vandapharma.com
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