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Exhibit 99.2
GLIATECH RELEASES RESPONSES TO FORM FDA 483
CLEVELAND - October 16, 2000 - Gliatech Inc. (Nasdaq: GLIA) today released its
response to the Food and Drug Administration ("FDA"), which addresses the
observations cited in the Form FDA 483 received by the Company on August 23,
2000. Gliatech has filed a Form 8-K with the Securities and Exchange Commission,
which includes a redacted copy of the response filed with the FDA on September
14, 2000.
"Gliatech takes the FDA observations seriously and, in its response, answered
each FDA observation and addressed the issues in a comprehensive manner. In its
report, Gliatech also described the improved procedures it is now using and the
additional staffing and supervision Gliatech has added and plans to add to the
process," said Rodney E. Dausch, Chief Operating Officer of Gliatech Inc.
After discussions with the FDA, Gliatech withdrew the PMA supplement. In
addition, Gliatech has proposed re-evaluating the magnetic resonance imaging
("MRI") data for the entire patient population under controlled conditions by an
independent, trained and blinded evaluator. Gliatech proposed that this review
be conducted by an independent third-party Contract Research Organization to
ensure accuracy and impartiality. Gliatech intends to obtain FDA concurrence
with the study protocol.
Gliatech is also in the process of retaining consultants to perform a
comprehensive evaluation of its process for clinical studies management and
training. In addition, Gliatech has added several managers and staff members to
its clinical research and quality assurance departments.
Gliatech also noted that it believes the pre-clinical, clinical and human
experiences with ADCON(R)-L to date has demonstrated the safety and
effectiveness of the product in inhibiting postsurgical scarring and adhesions.
ADCON(R)-L has now been used in over 165,000 procedures worldwide. As previously
disclosed, the Form FDA 483 observations do not restrict Gliatech's ability to
continue to market ADCON(R)-L in the U.S. and worldwide.
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"We continue to believe that ADCON(R)-L is safe product and a significant
medical breakthrough. It is our responsibility to demonstrate continually the
value and reliability of our products and our operations, and we are fully
committed to doing so," said Clark E. Tedford, Vice President of Research and
Development.
Gliatech is engaged in the discovery and development of biosurgery and
therapeutic products to improve surgical outcomes and to treat neurological
disorders. The biosurgery products include the ADCON(R) family of products,
which are designed to inhibit postsurgical scarring and adhesions, and a
proprietary monoclonal antibody to treat anti-inflammatory disorders. Gliatech's
neurological disorders programs are focused on development of small molecule
drug candidates to modulate the cognitive state of the nervous system and to
treat the symptoms of schizophrenia.
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 continued profitability of Gliatech, uncertainty of regulatory approvals,
the timing and content of decisions by the FDA, including the decisions with
respect to the recent inspectional observations by the FDA, the uncertainty of
market conditions and other risk factors detailed in Gliatech's SEC filings.
