Alexza Pharmaceuticals and Spanish pharmaceutical company Grupo Ferrer International have formed a partnership to register, distribute, and promote the Adasuve Staccato loxapine inhaler for the treatment of agitation in patients with schizophrenia or bipolar disorder in Europe, Commonwealth of Independent States countries, and Latin America. The deal includes a $10 million upfront payment to Alexza with additional milestone payments based on future regulatory approvals and sales. Alexza expects to file a marketing authorization application (MAA) with the European Medicines Agency (EMA) by the end of 2011; after that, Grupo Ferrer will file regulatory applications in the rest of its territory.
“The treatment of agitation in patients with schizophrenia or bipolar disease continues to evolve in the field of psychiatry and we believe that Adasuve could represent an important new therapeutic option for these patients. Given Grupo Ferrer’s extensive experience registering and selling specialty pharmaceuticals in Europe and Latin America, and their ability to share our longer-term vision for Adasuve, we believe they represent an ideal multi-region partner for Alexza as we execute our global commercialization strategy,” said Thomas B. King, President and CEO of Alexza.
Grupo Ferrer CEO Jordi Ramentol commented, “We welcome the opportunity to bring this innovative technology to our markets. Adasuve fits perfectly into our specialty pharmaceutical portfolio. We strongly believe that the unique therapeutic benefits Adasuve provides will capture physicians’ and patients’ interest, and establish it as an important new tool in the treatment of agitation.”
In the US, Alexza resubmitted an NDA for Staccato loxapine in August of 2011 and announced a PDUFA goal date of February 4, 2012. The company had previously received a complete response letter for the product in October 2010.
Read the Alexza press release.
