Japan Approves Given Imaging’s PillCam Earlier Than Expected

Israeli company Given Imaging Ltd., which makes cameras that can be swallowed for gastrointestinal imaging, earned approval from Japan’s Pharmaceuticals & Medical Devices Agency (PMDA) for its PillCam Colon. The device us a capsule-shaped swallow-able miniaturized camera that is designed to see a patient’s entire colon, assess its health, and identify the occurrence of polyps.

This approval came earlier than expected, according to Bloomberg, and subsequently caused the company’s shares to jump to their highest value in nine months in New York. Japan’s decision wasn’t expected before November and will help boost sales next year, according to Jeremy Feffer, an analyst at Cantor Fitzgerald LP.

“They basically bought themselves two quarters,” Feffer, who has a buy rating on Given Imaging, told Bloomberg. “This will probably enable them to hit the ground running in 2014 pretty effectively, and you should get a nice, steady ramp in sales.”

Given Imaging’s CEO Homi Shamir said that the company expects U.S. Food and Drug Administration approval of PillCam Colon between the end of the third quarter and the beginning of the fourth quarter, this year.

“We thank the PMDA for its very efficient review process and for granting a broad indication for PillCam Colon,” Shamir said “The clearance of PillCam Colon in Japan, the world’s second largest healthcare market, represents an important accomplishment for Given Imaging. The decision could expand our potential customer base in Japan from approximately 1,000 today to potentially 10,000 and will help in enhancing adherence to screening guidelines for over one million potential patients.”

Screening guidelines in Japan call for everyone older than 40 to undergo a fecal occult blood test (FOBT). Compliance with screening remains low and only approximately 25 percent of the population actually get tested, according to Japan’s Ministry of Health, Labor and Welfare, 2007 Health Review of Japanese Households. After a physician identifies blood in a patient’s feces (which can be a strong indication of colon cancer or other diseases), only 54.7 percent of these patients2 proceed to have a recommended colonoscopy to confirm the diagnosis due to a variety of reasons, as reported in a 2008 study in the Journal of Gastroenterol Cancer Screening.

“The number of deaths due to colorectal cancer in Japan continues to increase at an alarming rate,” said Akira Terano, M.D., Ph.D., president emeritus of Dokkyo Medical University and president of the Japanese Association for Capsule Endoscopy (JACE). “Colorectal cancer is now the leading cause of cancer death in women in Japan and the incidence rate for colorectal cancer in men and women is expected to be at the top of the list in the population of Japan by 2020.”

Terano went on to say that because PillCam Colon is less invasive, it would be able to drive higher compliance and therefore contribute to early detection and treatment of colon cancer in Japan. He also said that JACE would undertake the central role in research, education and the upgrading of the medical system for the capsule endoscopy of the colon.

“Our top priority is to provide physicians and patients with an alternative colorectal exam option to ensure every patient, including those who are unable or unwilling to get a colonoscopy, has the opportunity to undergo a colorectal exam,” Shamir said. “Meaningful sales of PillCam Colon capsule will commence immediately after obtaining reimbursement.”

Reimbursement in Japan is expected to become effective during the first half of 2014, subject to government discretion. PillCam Colon received the CE mark in September 2009 and is commercially available throughout Europe, Latin America, Canada and parts of Asia.