STOCKHOLM--(BUSINESS WIRE)--Regulatory News:
Medivir AB (STO:MVIR-B) announces that Adasuve now will be launched for the treatment of mild to moderate agitation of patients with schizophrenia or bipolar disorder. Medivir entered a license and distribution agreement for the commercialization of Adasuve with Ferrer in September 2013. Adasuve is a brand new inhalable treatment of agitation and is approved by EMA (European Medicines Agency) for sale in Europe.
“It is gratifying to be able to launch Adasuve in the four main Nordic countries as a complement to our existing product portfolio” comments Henrik Krook EVP Commercial, Medivir.
More than eight million of the European adult population lives with schizophrenia and bipolar disorder. Market research in the European territory indicates that 15-20 percent of those with schizophrenia and bipolar disorder experience an average of two episodes of agitation each year. The goal of treatment of agitation is to help the patient to gain control of their emotions or anxiety, and to avoid enforcement action that might otherwise have to be used to manage the patient's condition. The standard treatment for acute agitation today consists of antipsychotic drugs, sometimes in combination with benzodiazepines.
Adasuve is the first inhalable drug in psychiatry. Adasuve is a non-invasive, fast acting alternative to currently used therapies. Because of its non-invasive form of treatment Adasuve can bring benefits to both patients and caregivers. Adasuve combines the proprietary Staccato system with loxapine, an antipsychotic medicinal product. The Staccato system is a hand-held inhaler that delivers a drug aerosol to the deep lung resulting in intravenous-like pharmacokinetics and rapid systemic effects.
Medivir is an emerging research-based pharmaceutical company focused on infectious diseases. Medivir has world class expertise in polymerase and protease drug targets and drug development which has resulted in a strong infectious disease R&D portfolio. The Company’s key pipeline asset is simeprevir, a novel protease inhibitor for the treatment of hepatitis C that is being developed in collaboration with Janssen R&D Ireland. The company is also working with research and development in other areas, such as bone disorders and neuropathic pain. Medivir has also a broad product portfolio with prescription pharmaceuticals in the Nordics.
For more information, please visit www.medivir.com.
Ferrer is a privately-held European R&D-based pharmaceutical company headquartered in Barcelona. It is active in the pharmaceutical, health, fine chemicals and food sectors in Europe, Latin America, Africa, the Middle East, Asia and the United States. In total, Ferrer's human healthcare products are commercialized in more than 90 countries, through 23 international affiliates (including joint ventures) and 70 partners and distributors.
Ferrer carries out activities throughout the full pharmaceutical value chain, from R&D to international marketing, including fine chemical development and the manufacturing of both raw materials and finished pharmaceuticals. Its research centers in Spain and Germany, and manufacturing sites in Europe and Latin America cover the pharmaceutical, diagnostics, vaccine, fine chemical, food and feed sectors. Ferrer holds the commercial rights for Adasuve in Europe, Latin America and the Commonwealth of Independent States countries.
About Alexza Pharmaceuticals, Inc. (Nasdaq: ALXA)
Alexza Pharmaceuticals is focused on the research, development and commercialization of novel, proprietary products for the acute treatment of central nervous system conditions. Alexza's products are based on the Staccato® system, a hand-held inhaler designed to deliver a drug aerosol to the deep lung, providing rapid systemic delivery and therapeutic onset, in a simple, non-invasive manner.
Adasuve is Alexza's first commercial product, which was approved by the U.S. Food and Drug Administration in December 2012 and by the European Commission in February 2013. Teva Pharmaceuticals USA, Inc. is Alexza's commercial partner for ADASUVE in the U.S. Grupo Ferrer Internacional, S.A. is Alexza's commercial partner for Adasuve in Europe, Latin America and the Commonwealth of Independent States countries. Adasuve® and Staccato® are registered trademarks of Alexza Pharmaceuticals, Inc.
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