Medivir AB, an emerging research-based pharmaceutical company, and Ferrer, a privately-held European R&D-based pharma company, have entered into 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 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 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 Pedro de Antonio, Ferrer’s International Director for Europe, Asia, Middle East and Africa.

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.

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 EC.