Ferrer and Medivir Enter Agreement for Commercializing a New Treatment for Agitation Associated with Schizophrenia and Bipolar Disease in the Nordics Business Wire HUDDINGE, Sweden -- September 18, 2013 Regulatory News: Medivir AB (Nasdaq OMX: MVIR) (STO:MVIR-B) and Ferrer today announced that they have entered a license and distribution agreement for the commercialization of ADASUVE® (Staccato® Loxapine) in the Nordic region. In Europe, ADASUVE is approved for the treatment of mild to moderate agitation of patients with schizophrenia or bipolar disease. Under the terms of the agreement, Ferrer grants to Medivir the exclusive rights to promote, market, sell and distribute ADASUVE in the Nordic region – including Denmark, Finland, Norway, Iceland and Sweden. ADASUVE is a hand-held inhaler designed to deliver the drug to the deep lung, providing rapid systemic delivery in a simple, non-invasive manner. Medivir thus becomes the exclusive supplier of this new treatment therapy for the treatment of mild to moderate agitation of patients with schizophrenia or bipolar disease. In return, Ferrer will receive an up-front payment upon signature, and milestone payments conditional upon cumulative sales performance. “This licensing agreement is in line with our strategy to add new products to our Nordic portfolio. ADASUVE is the first addition to the portfolio, which now consists of 16 prescription pharmaceuticals” said Mr Maris Hartmanis, Medivir’s CEO. He added, “ADASUVE is a very interesting product based on a novel administration technology addressing an unmet medical need, which expands our present offering to psychiatrists, Lithionit. We are excited about having secured the commercial rights to ADASUVE for the Nordic region and the partnership with Ferrer”. “We belive that ADASUVE will be a breakthrough in the treatment of agitation and is going to change the way in which the condition is viewed by both healthcare professionals and patients”, said Mr. Antoni Villaró, Chief Operating Officer of Ferrer. He added, “We are excited to be introducing ADASUVE to the European psychiatric and hospital treatment community as ADASUVE is now available in Germany, and thank to this agreement soon in the Nordic countries.” “We take pride in developing a strong network of partners that, along with our commercial resources, contribute to bring to the market innovative products aimed at underserved conditions”, said Mr. Pedro de Antonio, Ferrer’s International Director for Europe, Asia, Middle East and Africa. About agitation Agitation is a severe, disruptive, and morbid complication suffered by patients with schizophrenia and bipolar disorders. Patients who experience agitation describe feeling an inner distress that progresses to an outwardly apparent dysfunctional state manifested by verbal abuse, hostility, difficulty controlling impulses, uncooperative behavior and increased potential for violence. While the time after which agitation requires treatment can be variable (minutes, hours or days), once the patient escalates to this point, urgent treatment is always required. Currently, the standard of care in the treatment of acute agitation is pharmacological tranquilization with antipsychotics, sometimes combined with benzodiazepines. ADASUVE, an inhaled formulation of the antipsychotic drug loxapine, begins to control patients’ agitation in less than 10 minutes, intercepting the onset of agitation in a noninvasive manner. About ADASUVE (Staccato Loxapine) 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. ADASUVE has been approved for marketing in the EU by the European Commission. For more information about ADASUVE, including the Summary of Product Characteristics and Patient Information Leaflet approved in the EU please visit: http://www.adasuve.com/index-eu.php About Medivir 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 in late phase III clinical development for hepatitis C that is being developed in collaboration with Janssen R&D Ireland. Medivir has also a broad product portfolio with prescription pharmaceuticals in the Nordics. For more information, visit www.medivir.com About Ferrer 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, Russia and the Commonwealth of Independent States countries. ADASUVE® and Staccato® are registered trademarks of Alexza Pharmaceuticals, Inc. For more information, visit www.ferrergrupo.com This information was brought to you by Cision http://news.cision.com Contact: Medivir AB Rein Piir Mobile: +46 (0)708 537 292 or Ferrer Communication Nick Russell +34 93 6000 3860 firstname.lastname@example.org or For partnering information: FerrerBusiness Development Ana Aliaga +34 93600 3867 email@example.com
Ferrer and Medivir Enter Agreement for Commercializing a New Treatment for Agitation Associated with Schizophrenia and Bipolar
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