moksha8 and Watson Pharmaceuticals launch Kitapen® for schizophrenia and bipolar disease.
Six months after establishing a partnership to commercialize high quality branded generics in Latin America, moksha8 and U.S. generics leader Watson Pharmaceuticals, have launched Kitapen®, the first and only branded generic of quetiapine available in the Brazilian market. The drug was approved by ANVISA for the treatment of schizophrenia and bipolar disorder.
The launch of Kitapen® strengthens moksha8’s leadership position in the commercialization of high quality CNS medicines in Latin America. “This partnership marks moksha8’s entry into the rapidly growing branded generics market and immediately strengthens our position as a leader in the treatment of CNS disorders, including depression, anxiety, bipolar and schizophrenia,” stated moksha8’s CEO.
Kitapen® is classified as a branded generic product with demonstrated bioequivalence to the reference compound quetiapine and is more affordable for patients. Bioequivalence studies are designed to demonstrate that the generic product has the same efficacy, safety and quality as the reference product. Kitapen® is priced at approximately 50% of the price of the reference product and is manufactured in Canada where it is also approved and marketed for the treatment of schizophrenia and bipolar disorder.
“Drug therapy has a fundamental function in controlling both diseases and is crucial to restore quality of life of these patients. For most of them, this treatment, combined with psychosocial strategies, allows the reintegration into family, society and work,” says Dr. L. Alcioly T. Lacey, one of the founders of the Synapse Institute of Clinical Neurosciences. Several studies, for example, show that 50% of schizophrenic patients are hospitalized only once, and in 60% of these cases, with an appropriate treatment, they are able to achieve a social and professional reintegration.
In addition to Kitapen®, under its alliance with Watson, moksha8 currently commercializes Carbolim® (lithium) to treat bipolar disorder, Vicodil® (paracetamol and codeine) for moderate to severe pain and Fatig®, a multi-vitamin. Moksha8 is planning to launch three to four additional products in Brazil in 2011. These anticipated product launches will be high-quality affordable medicines to address significant mental health indications affecting a growing number of Brazilians, such as Alzheimer’s disease, bipolar disorder, schizophrenia and depression.
Schizophrenia and bipolar disorder affect over 2 million people in Brazil. Throughout the country, over 23 million people suffer from some kind of mental disorder. Providing safe effective medicines at an affordable price may help improve the lives of millions of people that would not otherwise be able to positively contribute to society.
Kitapen® (quetiapine) is part of a drug group known as atypical or second generation antipsychotics, which have a better tolerability (fewer side effects) compared to first-generation antipsychotics. Quetiapine is used to treat the symptoms of schizophrenia and is also used alone or with other medications to treat or prevent episodes of mania or depression in patients with bipolar disorder. Quetiapine works by changing the activity of certain natural substances in the brain.
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