Israeli achievement in Japan: After a two-year process, Israeli company Given Imaging is set to be granted approval by the Japanese drug authority, the Pharmaceutical and Medical Device Agency (PMDA), to market its "wonder-pill" in Japan, Israel's leading newspaper Yedioth Ahronoth reported Thursday.
Given Imaging has developed the PillCam SB Capsule Endoscope, a naturally ingested device for use in the gastrointestinal tract, used
to diagnose gastrointestinal diseases painlessly and effectively. The approval in Japan pertains to a capsule used in the small intestine.
According to estimates, the anticipated approval is worth tens of millions of dollars in revenues for the company. Following news of the permit, Given Imaging's stock rose by 4.5 percent at the opening of trade in the Nasdaq exchange on Wednesday.
Owned by Elron of the IDB Group, Given Imaging markets similar products to the PillCam used to diagnose problems in the stomach, the large intestine and the gullet.
During the first three quarters of 2005, the company registered revenues of USD 62.3 million, and a net profit of USD 2.8 million.
Should Given's additional capsules be cleared for marketing in Japan, the company is expected to enjoy annual revenues of approximately USD 1 billion, though only in a few years' time.
Given Imaging is currently in negotiations with an American insurance company in a bid to include its capsules in the insurer's medicine basket, Yedioth Ahronoth has learned. Given's pills have already been granted FDA approval for its gullet and the small intestine.
_a.jpg "Photo: Israel Hadari")
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