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Vanda Pharmaceuticals Reports Second Quarter 2011 Results
Date:8/4/2011

dicines Agency (EMA) notified Vanda that it had accepted for evaluation the Marketing Authorization Application (MAA) for oral iloperidone tablets.  It is estimated that schizophrenia affects approximately 5 million Europeans or 1.0% of the European Union (EU) population.  

On July 11, 2011, Vanda announced it had entered into an exclusive license agreement with Probiomed for the commercialization of Fanapt® in Mexico.  Under the terms of the agreement, Probiomed will seek regulatory approval for Fanapt® in Mexico.  With $9.3 billion in annual sales, Mexico is the second largest pharmaceutical market in Latin America and the 14th largest pharmaceutical market in the world.

On August 1, 2011, Vanda announced it had entered into an exclusive license agreement with Biotoscana for the commercialization of Fanapt® in Argentina.   On July, 28, 2011, Biotoscana filed for market approval of Fanapt® with the Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica (ANMAT).  With over $5 billion in annual sales, Argentina is the fourth largest pharmaceutical market in Latin America.

Enrollment continues in the first pivotal efficacy study of tasimelteon for the treatment of N24HSWD in blind individuals with no light perception.  An investigator meeting was held in May 2011 for the new German investigative sites.

Preparation for a tasimelteon Phase IIb/III study in major depression is ongoing and it is our expectation that the study will begin enrollment in the second half of 2011.CONFERENCE CALLVanda has scheduled a conference call for today, Thursday, August 4, 2011, at 10:00 AM ET.  During the call, Mihael H. Polymeropoulos, M.D., President and CEO, and James P. Kelly, Senior Vice President and CFO, will discuss the second quarter 2011 results and other corporate activities.  Investors can call 1-866-314-5232 (domestic) and 1-617-213-8052 (international) prio
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SOURCE Vanda Pharmaceuticals Inc.
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3. Vanda Pharmaceuticals Receives FDA Acceptance of Iloperidone New Drug Application
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5. Phase III Data Show Vanda Pharmaceuticals Tasimelteon (VEC-162) Significantly Improves Sleep in Patients with Chronic Insomnia
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