Alexza Pharmaceuticals collaborates with Biovail for schizophrenia drug

Alexza Pharmaceuticals, Inc. a specialty drug maker, has signed a collaboration agreement yesterday with Biovail Laboratories International SRL (BLS) to develop and commercialise a drug for schizophrenia or bipolar disorder.

Mountain View, California-based Alexza has signed a collaboration agreement with BLS, a subsidiary of Biovail Corporation, to develop and commercialise AZ-004 (Staccato(R) loxapine) in the US and Canada.

Under the deal, Alexza will receive an upfront cash payment of $40 million and up to $90 million in potential milestone payments upon achieving certain conditions.

Under the terms of the collaboration, Alexza will receive an upfront cash payment of $40 million and up to $90 million in potential milestone payments contingent on the successful approval of the first AZ-004 NDA, successful commercial manufacturing and successful completion of additional clinical trials, regulatory submission and approvals.

Biovail will make tiered, royalty payments of 10 to 25 per cent on net commercial sales of AZ-004. In addition to milestone payments and product royalties, Alexza will supply AZ-004 to BLS for all of its commercial sales, and will receive a per-unit transfer price, based upon annual product volume.

The collaboration provides for the development and commercialization of AZ-004 for multiple indications, including the proposed initial indication of treating agitation in schizophrenia and bipolar patients, as well as potential future clinical development in additional psychiatric and neurological indications and the symptoms associated with these indications.

Biovail will lead the commercialisation activities for AZ-004. Alexza will continue to manage the ongoing AZ-004 NDA review and approval process and has entered into a manufacturing and supply agreement to supply Biovail clinical and commercial product. Alexza has filed for US regulatory approval for AZ-004 in December.

Mississauga, Ontario, Canada-based Biovail with 2008 revenues of $757 million is a leading specialty pharmaceutical company engaged in the formulation, clinical testing, registration, manufacture and commercialisation of pharmaceutical products both directly and through partners.