LAVAL, QC, Oct. 23 /CNW Telbec/ - LAB Research Inc. ("LRI" or "LAB
Research") (TSX: LRI), a Canadian-based global non-clinical contract research
organization ("CRO"), announced that its Hungarian site ("LAB Hungary")
successfully completed its biennial Good Laboratory Practices ("GLP")
inspection by the Hungarian authorities (OGYI: National Institute of Pharmacy)
(the "Inspection"). Consequently, its GLP certificate remains in full force.
In addition, to the Inspection, the site was also subject to a favourable
audit of the chronic inhalation studies performed for one of its sponsors (the
"Audit"), last August by the US Food and Drug Administration ("FDA"). The
Audit was conducted in conjunction with the OGYI and did not alter the GLP
status of the site.
The Inspection was concluded yesterday and no major findings were noted
by the authorities. As it is customary, the GLP compliance certificate will be
issued by the authorities after submission by LAB Hungary and review and
acceptance by the authorities of corrective measures addressing the minor
findings and observations noted during the course of the 9-day Inspection. We
anticipate the certificate to be formally renewed in the coming months as no
major findings were noted. In the interim, the GLP status of the site remains
unchanged and in full standing. The biennial Inspection was performed in
conformity with the Organization for Economic Co-Operation and Development
("OECD") GLP Compliance Monitoring Requirements.
The FDA Audit
The Audit performed last August, was led by the OGYI with the
participation of a senior inspection representative from the FDA. The Audit
focused primarily on the two studies which had been previously rejected by the
FDA earlier this year. As part of the Audit, the inspectors also assessed the
GLP status of the site with particular emphasis on the areas or activities
which were specific to the chronic studies. The outcome of both the Inspection
and the Audit were positive for LAB Hungary as the site remained in full
compliance of its GLP certificate.
Mr. Luc Mainville, President and Chief Executive Officer stated "While
all European and North American laboratories are dealing with more stringent
regulatory scrutiny, the results of these regulatory Audit/Inspection are
highly satisfactory and send a clear message to our valued clientele regarding
the GLP status of our Hungarian operation. Of particular importance was the
fact that both regulatory teams complimented management on the changes that
had been implemented in Hungary since the last GLP Inspection which occurred
in 2006. As the GLP status of our sites represents the single most important
criteria for ensuring the success of our activities, we intend to eagerly
leverage these favourable events to boost the financial performance of both
our Hungarian operation and of the LAB Research platform."
"We take great pride in the fact that our Hungarian GLP certificate
remains in full force following the recent Inspection while several larger
CRO's have been recently subject to less favourable reviews. We invite all our
clients to visit each of our sites to assess for themselves the quality and
regulatory compliance of our operations" added Mr. Mainville.
LAB Research Denmark will also be subject to its regular biennial GLP
inspection by the Danish authorities later this month.
About LAB Research Inc.
LAB Research is a global non-clinical contract research organization that
provides contract research services to the pharmaceutical, biotechnology,
agro-chemical, petro-chemical and industrial markets. LAB Research supports
the development of its customers' products from three state-of-the-art
facilities located in Canada, Denmark and Hungary. LAB Research's shares trade
on the TSX under the symbol "LRI", with 18.1 million shares outstanding.
For further information:
For further information: LAB Research Inc.: Luc Mainville, Chief
Executive Officer, (450) 973-2240, Ext.: 1206, firstname.lastname@example.org;
Media and Investor: Echoes Financial Network Inc.: Dominic Sicotte, (866)
633-9551, (514) 842-9551, email@example.com