Lupin Licenses US Rights for Proprietary Bioadhesive Technology for Rifaximin to Salix Pharmaceuticals
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Lupin Licenses US Rights for Proprietary Bioadhesive Technology for Rifaximin
to Salix Pharmaceuticals
Lupin and Salix to Collaborate in the Development and Commercialization of an
Extended Release Rifaximin Product
MUMBAI, India, Oct. 5 /PRNewswire-FirstCall/ -- Pharma Major, Lupin Ltd today
announced that it has granted Salix Pharmaceuticals, Ltd. (Nasdaq: SLXP) the
exclusive rights for the United States to its bioadhesive drug delivery
technology for use with Rifaximin.
Lupin and Salix have entered into an agreement under which the two companies
will collaborate in the development and commercialization of an extended
release product incorporating Rifaximin and utilizing Lupin's proprietary
bioadhesive technology. In connection with this agreement, Lupin and Salix
have also entered into an exclusive agreement in the United States for supply
of Rifaximin active pharmaceutical ingredient (API). Salix has made a $5
million up-front payment and will make additional regulatory milestone
payments to Lupin. In addition, Salix will pay royalties on net sales of the
bioadhesive Rifaximin product to Lupin.
Nilesh Gupta, Group President and Executive Director, Lupin, stated "We are
very pleased to enter into this collaboration with Salix. We believe our
proprietary bioadhesive drug delivery technology, which combines
controlled-release as well as slowed gastrointestinal transit, would provide
an extended release formulation of rifaximin that will be an important
component of Salix's lifecycle management strategy for rifaximin. This
formulation coupled with Salix's commercialization capabilities gives us the
opportunity to jointly bring a great product to the marketplace. Importantly,
this alliance further validates Lupin's increasing capabilities in the drug
delivery space."
Carolyn Logan, President and CEO, Salix, commented, "We are pleased to enter
into this strategic collaboration with Lupin. This collaboration to develop
and commercialize an extended release formulation of rifaximin is a
significant advancement in rifaximin's lifecycle management strategy. With
this collaboration Salix embarks on the development of our next generation
rifaximin product incorporating Lupin's proprietary drug delivery platform
with our proprietary gut-targeted antibiotic. We believe this novel delivery
approach, which combines controlled-release as well as slowed gastrointestinal
transit of rifaximin, might prove to provide a number of clinical advantages
including patient compliance and patient convenience. The acquisition of
these rights to Lupin's proprietary bioadhesive drug delivery technology
should serve to further protect this important Company asset."
About XIFAXAN® (Rifaximin)
Rifaximin is a gut-selective antibiotic with negligible systemic absorption
(<0.4%) and broad-spectrum activity in vitro against both gram-positive and
gram-negative pathogens. Rifaximin has a similar tolerability profile to that
of placebo. XIFAXAN revenue for 2008 was approximately $80 million.
Rifaximin tablets 200 mg, which Salix markets in the United States under the
trade name XIFAXAN® (Rifaximin) tablets 200 mg, currently is approved for the
treatment of patients, 12 years of age or older, with travelers' diarrhea (TD)
caused by non-invasive strains of Escherichia coli. XIFAXAN (Rifaximin) is a
gut-selective antibiotic with negligible systemic absorption (<0.4%) and
broad-spectrum activity in vitro against both gram-positive and gram-negative
pathogens. Rifaximin has a similar tolerability profile to that of placebo and
has activity against the most common TD pathogens. XIFAXAN should not be used
in patients with diarrhea complicated by fever or blood in the stool or
diarrhea due to pathogens other than Escherichia coli. XIFAXAN should be
discontinued if diarrhea symptoms get worse or persist more than 24-48 hours
and alternative antibiotic therapy should be considered. In clinical trials,
XIFAXAN was generally well tolerated. The most common side effects (vs.
placebo) were flatulence 11.3% (versus 19.7%), headache 9.7% (versus 9.2%),
abdominal pain 7.2% (versus 10.1 %) and rectal tenesmus 7.2% (versus 8.8%).
Rifaximin has been used in Italy for 24 years and is approved in 33 countries.
Salix acquired rights to market Rifaximin in North America from Alfa
Wassermann S.p.A. in Bologna, Italy. Alfa Wassermann markets Rifaximin in
Italy under the trade name Normix®.
About Lupin
Headquartered in Mumbai, India, Lupin Limited is an innovation led
transnational pharmaceutical company producing a wide range of quality,
affordable generic and branded formulations and APIs for the developed and
developing markets of the world. The Company today has significant market
share in key markets in the Cardiovasculars (prils and statins), Diabetology,
Asthma, Pediatrics, CNS, GI, Anti-Infectives and NSAIDs therapy segments, not
to mention global leadership positions in the Anti-TB and Cephalosporins. The
Company's R&D endeavors have resulted in significant progress in its NCE
program. The Company's foray into Advanced Drug Delivery Systems has resulted
in the development of platform technologies that are being used to develop
value-added generic pharmaceuticals.
Our Drugs and products reach over 70 countries in the world. Today, Lupin has
the unique distinction of being the fastest growing top 10 Generics players in
the two largest pharmaceutical markets of the world -- The U.S. (ranked 9th by
prescriptions & growing at 92 %) and Japan (ranked 7th and growing at 23%).
The company is also the fastest growing, top 5 pharmaceutical players in India
(ORG IMS - March 2009) and the fastest growing Generic player in South Africa
(ranked 6th and growing at over 30 % YoY - IMS)
For the financial year ended March 2009, Lupin's Consolidated Revenues and
Profit after Tax were Rs.39,145 million and Rs. 5015 million respectively.
BSE : 500257 NSE: Lupin REUTERS: LUPN.BO BLOOMBERG: LPC IN
About Salix Pharmaceuticals
Salix Pharmaceuticals, Ltd., headquartered in Raleigh, NC, develops and
markets prescription pharmaceutical products for the treatment of
gastrointestinal diseases. Salix's strategy is to in-license late-stage or
marketed proprietary therapeutic drugs, complete with any required development
and regulatory submission of these products, and them through the Company's
gastroenterology specialty sales and marketing team.
For further information contact:
Shamsher Gorawara
Head - Corporate Communications
Lupin Limited
shamshergorawara@lupinpharma.com
Mobile: +91 9820338555
OR
Sonia Mansata
Text 100
sonia.mansata@text100.co.in
Mobile: +91 9820112481
Safe Harbor Statement under the U. S. Private Securities Litigation Reform Act
of 1995:
This release contains forward-looking statements that involve known and
unknown risks, uncertainties and other factors that may cause actual results
to be materially different from any future results, performance or
achievements expressed or implied by such statements. Many of these risks,
uncertainties and other factors include failure of clinical trials, delays in
development, registration and product approvals, changes in the competitive
environment, increased government control over pricing, fluctuations in the
capital and foreign exchange markets and the ability to maintain patent and
other intellectual property protection. The information presented in this
release represents management's expectations and intentions as of this date.
Lupin expressly disavows any obligation to update the information presented in
this release.
SOURCE Lupin Limited
Shamsher Gorawara, Head - Corporate Communications of Lupin Limited,
shamshergorawara@lupinpharma.com, Mobile: +91-9820338555; or Sonia Mansata of
Text 100, sonia.mansata@text100.co.in, Mobile: +91-9820112481
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