Salix Announces Acceptance of NDA Filing For Budesonide Foam in Patients with Distal Ulcerative Colitis

  Salix Announces Acceptance of NDA Filing For Budesonide Foam in Patients
  with Distal Ulcerative Colitis

                   PDUFA Action Date is September 15, 2014

Business Wire

RALEIGH, N.C. -- January 30, 2014

Salix Pharmaceuticals, Ltd. (NASDAQ:SLXP) today announced that the Food and
Drug Administration (FDA) has accepted for filing a New Drug Application (NDA)
for Budesonide 2 mg Rectal Foam for the induction of remission in patients
with active mild to moderate distal ulcerative colitis extending up to 40 cm
from the anal verge. The FDA has issued an action date of September 15, 2014
under the Prescription Drug User Fee Act (PDUFA).

Bill Forbes, Executive Vice President, Medical and Research and Development
and Chief Development Officer, Salix, stated, “Patients with distal ulcerative
colitis, also known as proctitis or proctosigmoiditis, are often difficult to
treat and present the most challenging subset of patients given the
limitations of available treatment options. For these patients with disease
limited to the rectum and sigmoid areas of the colon, treatment with currently
approved oral therapies is often ineffective due to insufficient distribution
of active drug to the distal colon. Distal ulcerative colitis remains an unmet
medical need, and we believe the availability of a rectally administered
corticosteroid such as budesonide foam may help overcome limitations of
existing products to treat this condition.”

About Budesonide Foam

Budesonide is a high potency corticosteroid that was developed to minimize the
systemic adverse consequences of classic corticosteroids, such as
hydrocortisone, which have higher levels of systemic absorption. In several
large studies budesonide 2 mg rectal foam was highly effective in the
treatment of distal ulcerative colitis. Clinical trials suggest that the
budesonide foam formulation demonstrates improved reach (or spread) and rapid
distribution of budesonide to the sigmoid colon and the rectum, without the
difficulties and inconvenience associated with retention of enema
formulations. These trials also suggest that the foam provides more immediate
and targeted therapy for distal ulcerative colitis than is available with oral
therapies. The oral foam formulation for rectal administration was designed to
improve both the patient’s ability to retain the drug in the rectum following
administration as well as distribution of the active drug to the rectum and
sigmoid colon. Salix licensed this budesonide foam product from Dr. Falk
Pharma. The product was approved in Europe in 2006 and is marketed in Europe
by Dr. Falk Pharma.

About Salix

Salix Pharmaceuticals, Ltd., headquartered in Raleigh, North Carolina,
develops and markets prescription pharmaceutical products and medical devices
for the prevention and treatment of gastrointestinal diseases. Salix’s
strategy is to in-license late-stage or marketed proprietary therapeutic
products, complete any required development and regulatory submission of these
products, and market them through Salix’s gastroenterology specialty sales and
marketing team.

Salix trades on the NASDAQ Global Select Market under the ticker symbol
“SLXP”.

For more information, please visit our Website at www.salix.com or contact
Salix at 919-862-1000. Follow us on Twitter (@SalixPharma) and Facebook
(www.facebook.com/SalixPharma). Information on our Twitter feed, Facebook page
and web site is not incorporated in our filings with the SEC.

Please Note: The materials provided herein that are not historical facts are
or might constitute forward-looking statements under the safe harbor
provisions of the Private Securities Litigation Reform Act of 1995. Although
we believe the expectations reflected in such forward-looking statements are
based on reasonable assumptions, our expectations might not be attained.
Forward-looking statements involve known and unknown risks that could cause
actual results to differ materially from expected results. Factors that could
cause actual results to differ materially from our expectations expressed in
the report include, among others: the high cost and uncertainty of the
research, clinical trials and other development activities involving
pharmaceutical products; the unpredictability of the duration and results of
regulatory review of New Drug Applications and Investigational New Drug
Applications; the uncertainty of market acceptance of our products; intense
competition, including from generics in an increasingly global market; the
possible impairment of, or inability to obtain intellectual property rights
and the costs of obtaining such rights from third parties in an increasingly
global market; general economic conditions; our need to maintain
profitability; the uncertainty of obtaining, and our dependence on, third
parties to manufacture and sell our products; results of ongoing and any
future litigation and investigations and other risk factors detailed from time
to time in our other SEC filings.

Contact:

Salix Pharmaceuticals, Ltd.
Adam C. Derbyshire, 919-862-1000
Executive Vice President
and Chief Financial Officer
or
G. Michael Freeman, 919-862-1000
Associate Vice President, Investor Relations
and Corporate Communications
 
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