Guilford Pharmaceuticals Announces Initiation of Phase III Clinical Development for AQUAVAN(R) Injection

Guilford Pharmaceuticals Announces Initiation of Phase III
Clinical Development for AQUAVAN(R) Injection
Company Meets with FDA, Completes Phase II Study of AQUAVAN(R) 


BALTIMORE, May 10  /PRNewswire-FirstCall/ -- Guilford Pharmaceuticals, Inc. 
announced today that the Company has initiated a Phase III clinical development
program for AQUAVAN(R) Injection, a novel sedative/hypnotic.  The program is
consistent with feedback received from the Division of Anesthetic, Critical
Care and Addiction Drug Products of the U.S. Food & Drug Administration.

Craig Smith, M.D., Chairman, President and Chief Executive Officer of Guilford,
remarked, "We held an end-of-Phase II meeting with the FDA.  During the meeting
we discussed our proposed indication, clinical trial plan, and other
requirements for a potential future New Drug Application (NDA) for AQUAVAN(R). 
Based on these discussions it is our intention to complete the necessary
clinical trials and file a NDA as soon as possible.  We intend to seek approval
for AQUAVAN(R) for mild to moderate sedation for brief diagnostic and
therapeutic procedures such as colonoscopy, bronchoscopy, interventional
cardiology and minor surgical and therapeutic procedures."

The Company also announced today that it has completed a Phase II study of
AQUAVAN(R) designed to test the efficacy of the dose regimen of AQUAVAN(R),
which the Company plans to use in the Phase III program.  The Phase II study
enrolled a total of 64 patients who received AQUAVAN(R) for procedural sedation
during colonoscopy.  The Company plans to release the data in the third
quarter.

About the Phase III Program for AQUAVAN(R) Injection

The Phase III program will consist of four Phase III trials and a series of
smaller studies in special patient populations.  The four Phase III trials will
be conducted in patients undergoing 1) colonoscopy, 2) bronchoscopy, 3) cardiac
procedures, and 4) minor surgical procedures.  The first two trials will be
randomized comparisons with midazolam.  All patients will receive fentanyl
citrate for analgesia.  The primary endpoint will be success of sedation as
determined by a score of less than 4 using the Modified Observer's Assessment
of Alertness/Sedation (OAA/S) scale.  Secondary endpoints will include time to
fully alert and time to fully recovered and duration of sedation.  It is
anticipated that the investigator's medical staff will administer AQUAVAN(R) in
the Phase III program.

The FDA recommended Guilford also conduct a series of smaller studies in
special patient populations such as burn patients, patients undergoing upper
endoscopy prior to liver transplant and patients having an arterovenous shunt
placed for renal dialysis.  Guilford anticipates approximately 900 patients
will be enrolled in upcoming studies and data from approximately 1200 patients
will be included in the NDA submission for AQUAVAN(R).

About AQUAVAN(R) Injection

AQUAVAN(R) Injection is a proprietary water-soluble prodrug of propofol
exclusively licensed by Guilford from ProQuest Pharmaceuticals.  Unlike
propofol, which is formulated in an oil or lipid-based emulsion, AQUAVAN(R)
Injection is formulated in a clear aqueous solution and is rapidly converted by
an enzyme in the body called alkaline phosphatase into propofol after
intravenous injection.

About Guilford

Guilford Pharmaceuticals Inc. is a fully integrated pharmaceutical company
engaged in the research, development and commercialization of products that
target the hospital market.  Presently, Guilford markets two commercial
products, GLIADEL(R) Wafer (polifeprosan 20 with carmustine implant), for the
treatment of brain cancer, and AGGRASTAT(R) Injection (tirofiban
hydrochloride), a glycoprotein GP IIb/IIIa receptor antagonist used for the
treatment of acute coronary syndrome (ACS).  Guilford's product pipeline
includes a novel anesthetic, AQUAVAN(R) Injection, and drugs for treating
Parkinson's disease and post-prostatectomy erectile dysfunction.

For additional information about GLIADEL Wafer, please visit
http://www.guilfordpharm.com/ under Products / Marketed Products / GLIADEL; and
for AGGRASTAT, please see http://www.aggrastat.com/.

This press release contains forward-looking statements that involve risks and
uncertainties, including those described in the section entitled "Risk Factors"
contained in the Company's Registration Statement on Form S-3/A filed with the
SEC on April 9, 2004, that could cause the Company's actual results and
experience to differ materially from anticipated results and expectations
expressed in these forward-looking statements.  Among other things, there can
be no assurance that AQUAVAN(R) Injection will continue to advance through
clinical development or receive regulatory approval for commercialization
either in the United States or in international markets.

  Contact:  Stacey Jurchison, Director, Corporate Communications -
            410.631.5022
            Internet Address:  http://www.guilfordpharm.com/

DATASOURCE: Guilford Pharmaceuticals Inc.



CONTACT:  Stacey Jurchison, Director, Corporate Communications, Guilford

Pharmaceuticals, [phone]



Web site:  http://www.aggrastat.com/ 

Web site:  http://www.guilfordpharm.com/ 



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