- Adds 73 Person CNS Specialty Infrastructure
DUBLIN, Ireland, July 3 - - 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(R) (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(R) presentation of FazaClo. The new DuraSolv formulation was
approved by the FDA in May 2007 and will be launched later this year."
About Azur
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)
About FazaClo
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.
