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Given Imaging Announces InScope Cooperation Agreement to End
Company to Record Income of Approximately $26 Million Over the Next Three Quarters
| Source: Given Imaging
YOQNEAM, ISRAEL--(Marketwire - November 8, 2007) - Given Imaging Ltd. (NASDAQ : GIVN ) today
announced that InScope, a division of Ethicon Endo-Surgery, Inc., a Johnson
& Johnson company, has ended its agreement to market and sell Given
Imaging's PillCam® ESO in the U.S. Ethicon Endo-Surgery cited a shift in
its strategic priorities within gastroenterology and other areas as the
reason for ending the relationship.
InScope will pay Given Imaging $7.6 million in fees associated with the
termination. InScope will continue to support reimbursement activities for
PillCam ESO and maintain its market development field force for up to six
months. InScope has also agreed to continue to fund ongoing clinical
trials associated with esophageal diseases.
"With the release of PillCam ESO 2, the improved ingestion procedure, a
growing body of positive clinical data and reimbursement coverage momentum,
we are confident about PillCam ESO's potential," said Homi Shamir,
president and CEO of Given Imaging. "At the start of this year, Given and
InScope adjusted the way we worked together in the field and, as a result,
our U.S. sales and marketing teams have worked side-by-side with InScope's
market development group to educate gastroenterologists and hepatologists.
We are, therefore, well positioned to assume full sales and marketing
responsibility now. I would like to thank InScope for being an excellent
partner for PillCam ESO product over the last three years."
As a result, the company will record income of approximately $13.5 million
in the fourth quarter of 2007 and additional income of approximately $12.5
million during the first two quarters of 2008.
The original agreement was signed in May of 2004. Given Imaging received
FDA clearance for PillCam ESO in 2004 and for PillCam ESO2, the next
generation of the capsule endoscope, in 2007.
About Given Imaging Ltd.
Given Imaging is redefining gastrointestinal diagnosis by developing,
producing and marketing innovative, patient-friendly products for detecting
gastrointestinal disorders. The company's technology platform is the
PillCam® Platform, featuring the PillCam video capsule, a disposable,
miniature video camera contained in a capsule, which is ingested by the
patient, a sensor array, data recorder and RAPID® software. Given Imaging
has a number of available capsules: the PillCam SB video capsule to
visualize the entire small intestine which is currently marketed in the
United States and in more than 60 other countries; the PillCam ESO video
capsule to visualize the esophagus; the Agile™ patency capsule to
determine the free passage of the PillCam capsule in the GI tract and the
PillCam COLON video capsule to visualize the colon that has been cleared
for marketing in the European Union, and is pending clearance with the
United States Food and Drug Administration. More than 600,000 patients
worldwide have benefited from the PillCam capsule endoscopy procedure.
Given Imaging's headquarters, manufacturing and R&D facilities are located
in Yoqneam, Israel. It has operating subsidiary companies in the United
States, Germany, France, Japan and Australia. For more information, visit
http://www.givenimaging.com.
This press release contains forward-looking statements within the meaning
of the "safe harbor" provisions of the U.S. Private Securities Litigation
Reform Act of 1995. These forward-looking statements include, but are not
limited to, projections about our business and our future revenues,
expenses and profitability. Forward-looking statements may be, but are not
necessarily, identified by the use of forward-looking terminology such as
"may," "anticipates," "estimates," "expects," "intends," "plans,"
"believes," and words and terms of similar substance. Forward-looking
statements involve known and unknown risks, uncertainties and other factors
which may cause the actual events, results, performance, circumstances or
achievements of the Company to be materially different from any future
events, results, performance, circumstances or achievements expressed or
implied by such forward-looking statements. Factors that could cause
actual events, results, performance, circumstances or achievements to
differ from such forward-looking statements include, but are not limited
to, the following: (1) satisfactory results of clinical trials with PillCam
Colon (2) our ability to receive regulatory clearance or approval to market
our products or changes in regulatory environment, (3) our success in
implementing our sales, marketing and manufacturing plans, (4) protection
and validity of patents and other intellectual property rights, (5) the
impact of currency exchange rates, (6) the effect of competition by other
companies, (7) the outcome of future litigation, including patent
litigation with Olympus Corporation, (8) the reimbursement policies for our
product from healthcare payors, (9) quarterly variations in operating
results, (10) the possibility of armed conflict or civil or military unrest
in Israel, and (11) other risks and factors disclosed in our filings with
the U.S. Securities and Exchange Commission, including, but not limited to,
risks and factors identified under such headings as "Risk Factors,"
"Cautionary Language Regarding Forward-Looking Statements" and "Operating
Results and Financial Review and Prospects" in the Company's Annual Report
on Form 20-F for the year ended December 31, 2006. You are cautioned not
to place undue reliance on these forward-looking statements, which speak
only as of the date of this press release. Except for the Company's
ongoing obligations to disclose material information under the applicable
securities laws, it undertakes no obligation to release publicly any
revisions to any forward-looking statements, to report events or to report
the occurrence of unanticipated events.