Gliatech Receives Recommendation for ISO 9001 Recertification and Initiates Manufacturing Validation for Relaunch of ADCON(R)-L Outside of the U.S. in June 2001

Gliatech also expands European distributor network



Apr 18, 2001, 01:00 ET from Gliatech Inc.

    CLEVELAND, April 18 /PRNewswire/ -- Gliatech Inc. (Nasdaq:   GLIA) announced
 today that it has successfully completed an International Standards
 Organization (ISO) 9001 audit that was conducted by KEMA Registered Quality
 B.V. (KEMA), a European Notified Body.  In addition, the Company has completed
 process development work relating to a raw material used in the manufacture of
 ADCON(R)-L and initiated manufacturing validation runs.  The Company
 anticipates relaunch of ADCON(R)-L outside the U.S. in June 2001.
     Based on the results of the ISO audit, Gliatech has received a
 recommendation for recertification by KEMA for the development, manufacture
 and distribution of ADCON(R)-L and ADCON(R)-T/N (collectively ADCON(R) gel)
 outside the U.S. in accordance with ISO 9001.  KEMA, a 74 year-old testing and
 certification company, headquartered in the Netherlands, is a registered
 Notified Body of the European Economic Area and, in this capacity, is
 responsible for approving and assessing compliance with the European Union
 Medical Devices Directive.
     As previously announced in January 2001, Gliatech implemented a voluntary
 recall of ADCON(R) gel as a result of a voluntary recall by the supplier of a
 raw material component of the ADCON(R) gel.  The Company has completed process
 development work and the related testing associated with the change in
 packaging of the raw material used in ADCON(R) gel production outside of the
 U.S.   As a result of the completion of the process development work, the
 Company has now initiated manufacturing validation runs of ADCON(R) gel
 production.  Gliatech anticipates that these validation runs will be completed
 on schedule for the relaunch of ADCON(R)-L outside of the U.S. in June 2001.
 Relaunch of ADCON(R)-L in the U.S. is subject to the submission and approval
 of the additional data identified previously as part of the Food and Drug
 Administration's Application Integrity Policy status.
     Gliatech has also recently expanded its distribution network in Eastern
 Europe by entering into distribution agreements in Hungary and Poland.  Upon
 relaunch, ADCON(R)-L will be sold in 35 countries outside of the U.S.
     Gliatech Inc. is engaged in the discovery and development of biosurgery
 and pharmaceutical products.  The biosurgery products include ADCON(R) gel and
 ADCON(R) solution, which are proprietary, resorbable, carbohydrate polymer
 medical devices designed to inhibit scarring and adhesions following surgery.
 Gliatech's pharmaceutical product candidates include small molecule drugs to
 modulate the cognitive state of the nervous system and proprietary monoclonal
 antibodies designed to treat inflammatory disorders.
     Certain statements in this press release constitute "forward-looking
 statements" that are subject to risks and uncertainties which may cause the
 actual results of Gliatech to be different from expectations express or
 implied by such forward-looking statements. Such factors include, but are not
 limited to, uncertainty of market acceptance of Gliatech's products, the
 uncertainty of expenses associated with clinical trials and research efforts
 which may affect the profitability of Gliatech, the ability of Gliatech to
 obtain an adequate supply of the materials used in the manufacture of its
 ADCON(R) products, uncertainty of the success of the relaunch of ADCON(R)-L
 outside the U.S., uncertainty of regulatory approvals, the status of the
 Company with respect to AIP, the timing and content of decisions including
 review of data by the FDA, including the decisions with respect to sale of
 ADCON(R)-L, product recalls and the inspectional observations by the FDA, the
 uncertainty of market conditions and other risk factors detailed in Gliatech's
 SEC filings.
 
 

SOURCE Gliatech Inc.
    CLEVELAND, April 18 /PRNewswire/ -- Gliatech Inc. (Nasdaq:   GLIA) announced
 today that it has successfully completed an International Standards
 Organization (ISO) 9001 audit that was conducted by KEMA Registered Quality
 B.V. (KEMA), a European Notified Body.  In addition, the Company has completed
 process development work relating to a raw material used in the manufacture of
 ADCON(R)-L and initiated manufacturing validation runs.  The Company
 anticipates relaunch of ADCON(R)-L outside the U.S. in June 2001.
     Based on the results of the ISO audit, Gliatech has received a
 recommendation for recertification by KEMA for the development, manufacture
 and distribution of ADCON(R)-L and ADCON(R)-T/N (collectively ADCON(R) gel)
 outside the U.S. in accordance with ISO 9001.  KEMA, a 74 year-old testing and
 certification company, headquartered in the Netherlands, is a registered
 Notified Body of the European Economic Area and, in this capacity, is
 responsible for approving and assessing compliance with the European Union
 Medical Devices Directive.
     As previously announced in January 2001, Gliatech implemented a voluntary
 recall of ADCON(R) gel as a result of a voluntary recall by the supplier of a
 raw material component of the ADCON(R) gel.  The Company has completed process
 development work and the related testing associated with the change in
 packaging of the raw material used in ADCON(R) gel production outside of the
 U.S.   As a result of the completion of the process development work, the
 Company has now initiated manufacturing validation runs of ADCON(R) gel
 production.  Gliatech anticipates that these validation runs will be completed
 on schedule for the relaunch of ADCON(R)-L outside of the U.S. in June 2001.
 Relaunch of ADCON(R)-L in the U.S. is subject to the submission and approval
 of the additional data identified previously as part of the Food and Drug
 Administration's Application Integrity Policy status.
     Gliatech has also recently expanded its distribution network in Eastern
 Europe by entering into distribution agreements in Hungary and Poland.  Upon
 relaunch, ADCON(R)-L will be sold in 35 countries outside of the U.S.
     Gliatech Inc. is engaged in the discovery and development of biosurgery
 and pharmaceutical products.  The biosurgery products include ADCON(R) gel and
 ADCON(R) solution, which are proprietary, resorbable, carbohydrate polymer
 medical devices designed to inhibit scarring and adhesions following surgery.
 Gliatech's pharmaceutical product candidates include small molecule drugs to
 modulate the cognitive state of the nervous system and proprietary monoclonal
 antibodies designed to treat inflammatory disorders.
     Certain statements in this press release constitute "forward-looking
 statements" that are subject to risks and uncertainties which may cause the
 actual results of Gliatech to be different from expectations express or
 implied by such forward-looking statements. Such factors include, but are not
 limited to, uncertainty of market acceptance of Gliatech's products, the
 uncertainty of expenses associated with clinical trials and research efforts
 which may affect the profitability of Gliatech, the ability of Gliatech to
 obtain an adequate supply of the materials used in the manufacture of its
 ADCON(R) products, uncertainty of the success of the relaunch of ADCON(R)-L
 outside the U.S., uncertainty of regulatory approvals, the status of the
 Company with respect to AIP, the timing and content of decisions including
 review of data by the FDA, including the decisions with respect to sale of
 ADCON(R)-L, product recalls and the inspectional observations by the FDA, the
 uncertainty of market conditions and other risk factors detailed in Gliatech's
 SEC filings.
 
 SOURCE  Gliatech Inc.