Milan District Court Confirms the Validity of Alfa Wassermann’s Rifaximin-alpha Patents

June 12, 2014

BOLOGNA, Italy, June 12, 2014 /PRNewswire/ –

Normix(R) is the only authorized Gastrointestinal antibiotic based on

Rifaximin-alpha. No generic version is allowed.

With the judgment entered last April 18, the district court of Milan, Italy – the
court having original jurisdiction on the matter -denied a request from generic
manufacturers to declare Alfa Wassermann’s patents on Rifaximin polymorphs invalid.
Instead, the court upheld Alfa Wassermann’s claim, asserting the Rifaximin-alpha patent
and prohibiting any further counterfeit production, advertising and marketing. The
announcement is made by Alfa Wassermann, the Bologna-based Italian pharmaceutical
multinational that developed Rifaximin-alpha, marketed under the trade name Normix(R) in
Italy, Xifaxan(R), Flonorm(R), Rifacol(R), Spiraxin(R) and other trade names in other
countries. Approved in 34 countries including the US, Rifaximin-alpha is an oral
gut-selective antibiotic indicated for most bacterial diarrheas, including travelers’
diarrhea, and other gastrointestinal (GI) disorders. Recently, Rifaximin-alpha was also
approved for Hepatic Encephalopathy (HE) in the US and in Europe.

http://photos.prnewswire.com/prnh/20140612/690926 )

“We welcome the court decision that has confirmed the uniqueness of Rifaximin-alpha,
which is Alfa Wassermann R&D’s most prestigious product and one of the top selling Italian
medicines in the US,” said Andrea Golinelli, Chief Strategy Officer, Alfa Wassermann. “The
court ruling is a landmark decision for the protection of intellectual property (IP) and
the recognition of its crucial value for pharmaceutical R&D and innovation. Without IP
protection no scientific innovation nor progress to improve people’s health is possible.”
concluded Golinelli.

Alfa Wassermann

Alfa Wassermann is an international Italian pharmaceutical Group with a sixty-year
tradition in R&D, production and distribution of medicines of primary importance for
people’s health. Its medicines have taken Alfa Wassermann to a leading position in a
number of medical areas including Gastroenterology, Vascular medicine, Orthopedics,
Rheumatology and Gynecology.

The Group is headquartered in Bologna, Italy, which is also the location of its
long-standing R&D facilities. The Group’s international division is in Milan. The Group’s
production facilities in Alanno (Pescara, Italy) are some of Europe’s most technologically
advanced and make 50 million packaged items annually.

Alfa Wassermann operates globally through 12 subsidiaries in as many world markets.
The Group employs 1,400 people and markets products in over 60 countries. In 2013 Alfa
Wassermann consolidated sales aggregated to some EUR400 million.

Alfa Wassermann R&D’s most successful product is Rifaximin-alpha, an oral antibiotic
for gastrointestinal disorders that is the market leader in Italy, but is also available
in many other world countries, including the US. Rifaximin-alpha approval by the US Food
and Drug Administration (FDA) has been a highly prestigious recognition for a medicine
that is the fruit of Italian R&D.

For further information please visit http://www.alfawassermann.com

        Media contact:
        Angela Del Giudice



SOURCE Alfa Wassermann

Source: PR Newswire

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