Alexza Pharmaceuticals, Inc. ALXA and Grupo Ferrer International, S.A., announced today that they entered into a commercial partnership for Adasuve™ (Staccato® loxapine). ADASUVE is Alexza's lead program, based on the company's proprietary technology, the Staccato system. Grupo Ferrer is a leading pharmaceutical company in Europe with extensive operations in the Americas, and will be Alexza's partner in the registration, distribution and promotion of ADASUVE in Europe, Latin America, Russia and the Commonwealth of Independent States countries. Alexza plans to file the ADASUVE Marketing Authorization Application (MAA) with the European Medicines Agency (EMA) in the second half of 2011. ADASUVE is being developed for the rapid treatment of agitation in patients with schizophrenia or bipolar disorder.
"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," said Thomas B. King, Alexza's President and CEO. "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."
"We welcome the opportunity to bring this innovative technology to our markets," said Mr. Jordi Ramentol, CEO of Grupo Ferrer. "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."
Under the agreement, Alexza will receive an upfront payment of $10 million. Alexza is eligible to receive additional milestone payments based upon regulatory approvals, individual country commercial sales initiation and cumulative net sales targets. Alexza will be responsible for filing the ADASUVE MAA with the EMA. Grupo Ferrer will be responsible for all subsequent regulatory filings in the countries in its territories, as well as any required pricing and reimbursement filings and approvals. Assuming regulatory approvals are obtained, Grupo Ferrer will exclusively distribute, market and sell ADASUVE in the designated territory. Alexza will be the exclusive supplier of ADASUVE to Grupo Ferrer for all of its commercial sales, at a per-unit transfer price.
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