Healthcare Industry News: orally disintegrating tablet
News Release - July 3, 2007
Azur Pharma Announces the Acquisition of FazaClo for $42 Million Plus Contingent MilestonesAdds 73 Person CNS Specialty Infrastructure
DUBLIN, July 3 (HSMN NewsFeed) -- Azur Pharma Limited ("Azur") today announced it has signed a definitive agreement with Avanir Pharmaceuticals ("Avanir") (NASDAQ: AVNR ) to acquire worldwide rights to the antipsychotic drug FazaClo® (clozapine, USP). The product is indicated for the management of severely ill schizophrenic patients who fail to respond adequately to standard drug treatments for schizophrenia. FazaClo is also indicated for reducing the risk of recurrent suicidal behaviour in patients with schizophrenia or schizoaffective disorders. FazaClo was approved by the FDA, and launched in the U.S. market, in 2004. The transaction is subject to certain closing conditions and is expected to close by the end of July 2007.
Under the terms of the agreement, Azur will pay $42 million to Avanir at the close of the transaction and up to $10 million in contingent payments during 2009. In addition, Azur will pay up to $2 million in future royalties based on 3% of annual net product revenues for FazaClo in excess of $17 million. Azur also assumes certain of Avanir's earn-out obligations to the original developer of the product, Alamo Pharmaceuticals, which arise upon the achievement of sales related milestones.
FazaClo generated gross revenues of $16.5 million and $10.1 million in the year ended 31 December 2006 and the five months ended 31 May 2007, respectively. The product is exhibiting strong growth and Azur expects that it will generate gross revenues of over $25 million for 2007.
Azur is acquiring the worldwide rights to FazaClo and assuming the related assets such as marketing, sales, patient registry and medical affairs infrastructure. Azur will add 73 employees with this acquisition, including 65 sales representatives and commercial support staff who market FazaClo in the U.S. and provide field based support to psychiatrists and their patients.
Mr. Seamus Mulligan, Chairman and Chief Executive of Azur, stated "We are pleased to add FazaClo, an important therapeutic for the management of severely ill schizophrenic patients, to our portfolio. FazaClo is our third acquisition having previously purchased Gastrocrom and Pharmelle in January 2006 and February 2007, respectively. We have taken an important step in reaching critical mass in the U.S. With this transaction, we will have 90 sales representatives covering CNS and urology/women's health. We plan to add new products and development projects in these fields to further leverage our infrastructure. We will commence additional FazaClo reformulation activities with a view to enhancing the product."
Mr. Mulligan further commented, "The FazaClo team have been very successful with this product and we welcome them to Azur. We intend continuing to build on their focus and dedication so prescribers will obtain the support they require to ensure this treatment option continues to be available for appropriate patients. Our initial focus will be to launch the recently approved DuraSolv® presentation of FazaClo. The new DuraSolv formulation was approved by the FDA in May 2007 and will be launched later this year."
Azur is a privately held pharmaceutical company dedicated to enhancing patients' lives by developing and marketing pharmaceutical products in specialist therapeutic areas. Azur's strategy is to identify, evaluate, selectively acquire and enhance the value of late stage development and approved pharmaceutical products. (Website: www.azurpharma.com)
Of the estimated two-and-a-half million Americans who suffer from schizophrenia, approximately one-third are termed treatment-resistant because they derive little or no benefit from conventional antipsychotic medications. FazaClo is the only orally disintegrating form of clozapine for the management of severely ill schizophrenic patients who fail to respond adequately to standard schizophrenia drug treatments. FazaClo is also indicated for reducing the risk of suicidal behaviour in patients with schizophrenia or schizoaffective disorder who are judged to be at risk of suicide. FazaClo is supplied as an innovative orally disintegrating tablet that uses proprietary formulation technologies licensed from Cima Labs Inc. FazaClo has a pleasant mint flavour and is designed to disintegrate in the mouth in about 30 seconds and is swallowed reflexively in saliva. The benefits of an orally disintegrating tablet can be important in treating a disease such as schizophrenia where patient non-compliance is a significant problem often leading to relapse and hospitalisation. FazaClo requires a Patient Registry because of the risk of rare, but severe adverse events such as agranulocytosis and granulocytopenia associated with the use of clozapine. Prescribing health care practitioners, dispensing pharmacists and FazaClo patients can be registered in the FazaClo Patient Registry, which will compare patient information against the National Non-Rechallenge Masterfile and maintain a continuing record of total white blood cell (WBC) counts and absolute neutrophil count (ANC) values and related information for patients who receive the FazaClo brand of clozapine. Please see full Prescribing Information including BOXED WARNINGS regarding agranulocytosis, seizures, myocarditis, dementia-related psychosis in elderly patients, and other adverse cardiovascular and respiratory effects at www.fazaclo.com.
Source: Azur Pharma
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