NEW DELAYS IN THE FDA APPROVAL PROCEDURE FOR BIOHIT'S PEPSINOGEN I AND II TESTS
BIOHIT OYJ STOCK EXCHANGE RELEASE ON 25 NOVEMBER 2008 AT 7:00 PM
NEW DELAYS IN THE FDA APPROVAL PROCEDURE FOR BIOHIT'S PEPSINOGEN I AND II TESTS
The US Food and Drug Administration (FDA) has not approved the further
clarification related to Biohit's application for the GastroPanel Pepsinogen I
and II tests. Biohit delivered this clarification to the FDA in October this
year. According to FDA, the clarification contains insufficient information. To
continue the process, more comprehensive research data and a new submission is
required.
As per FDA's request, two patient studies have been made in the USA. The
research data acquired, however, proved to be insufficient according to FDA
criteria.
The FDA has already earlier granted authorisation to GastroPanel's Gastrin-17
and Helicobacter pylori antibodies tests. No other company has previously
received FDA approval for Pepsinogen I and II. Biohit had to supplement its
original application in the United States with two studies that compared the
results of Biohit's Pepsinogen I and II to the histology of several biopsies
taken through gastroscopy (a normal finding or atrophic gastritis, - i.e. loss
of glands and function of the stomach mucosa). In other countries, patient
trials with GastroPanel have given good results.
Biohit will continue the authorisation process by making a plan to get further
clarifications that will meet the requirements of FDA.
Biohit Oyj
Osmo Suovaniemi
President & CEO
Further information:
Osmo Suovaniemi, M.D., Ph.D., Professor
President & CEO
Tel: +358-9-773 861
GSM: +358-40-745 5605
Email: osmo.suovaniemi@biohit.com
Distribution:
Helsinki Exchanges
Central storage facility (www.oam.fi)
Press
www.biohit.com
About Biohit Oyj
Biohit Oyj develops, manufactures and markets liquid handling products and
diagnostic test systems for use in research, health care and industrial
laboratories.
Liquid handling products include electronic and mechanical pipettes and
dispensers, and disposable tips, as well as pipette maintenance and calibration
services. Diagnostics business comprises products and analysis systems for
diagnosing, screening and prevention of gastrointestinal diseases, e.g. the
blood-sample based GastroPanel and GastroView, for diagnosing diseases of the
stomach and associated risks, as well as quick tests for the diagnosis of
lactose intolerance, H. pylori infection and fecal occult blood.
Biohit Oyj is headquartered in Finland. Biohit has subsidiaries in France,
Germany, the UK, Russia, China, Japan and the USA. Additionally, Biohit's
products are sold by approximately 450 distributors in 70 countries. Biohit's
share (BIOBV) is quoted on NASDAQ OMX Helsinki.
Read more at www.biohit.com