Salix Pharmaceuticals, Ltd. (NASDAQ:SLXP) and Alfa Wassermann S.p.A.
today announced that they have entered into an exclusive agreement by
which Salix has licensed rights in the United States and Canada to an
extended intestinal release (EIR) formulation of rifaximin for
gastrointestinal and respiratory indications, including Crohn's disease.
The EIR formulation of rifaximin has been designed to release the active
drug following passage through the stomach and provide a homogeneous
distribution of rifaximin in the intestinal tract. The EIR formulation
of rifaximin was designed to provide an efficient delivery of rifaximin
and will be studied for its potential to target difficult to treat
diseases of the intestinal tract such as Crohn's disease.
Financial terms of the transaction include a $10 million up-front
payment and a $25 million development milestone payment upon NDA
approval of an EIR formulation rifaximin product for Crohn's disease.
Salix also will pay sales-based milestones in respect of EIR formulation
rifaximin products for Crohn's disease, if sales targets are achieved,
plus royalties on product sales of all EIR formulation rifaximin
products. Alfa Wassermann will manufacture Salix's requirements of EIR
formulation rifaximin products.
Commenting on the transaction, Carolyn Logan, President and CEO, Salix,
stated, "We believe gastrointestinal-specific oral antibiotic rifaximin
has the potential to treat numerous gastrointestinal diseases. In
particular, we believe the EIR formulation we are acquiring in this
transaction could be ideally suited to treat patients with Crohn's
disease. Earlier this year in the Journal of Gastroenterology,
promising results were published of a Phase 2 Study which indicate that
EIR rifaximin might be beneficial in inducing remission in patients with
moderately active Crohn's disease. We intend to further develop EIR
rifaximin with the goal of securing FDA approval to market EIR rifaximin
for the treatment of Crohn's disease."
Salix is receiving the rights to EIR formulation rifaximin products as
part of a restructuring of long-standing arrangements between Alfa
Wassermann and Salix for the development and commercialization of
rifaximin products in the United States and Canada for gastrointestinal
and respiratory indications. The restructuring does not affect
arrangements for the rifaximin products currently approved in the Salix
territory, nor for any product for treatment of irritable bowel syndrome
that might be approved in the future. Under the new arrangements, Salix
has provided Alfa Wassermann with rights to obtain a license to develop
and commercialize, outside the United States and Canada for
gastrointestinal and respiratory indications, formulations of rifaximin
currently being developed by Salix and other new formulations of
rifaximin that Salix may develop in the future.
Salix Pharmaceuticals, Ltd.