Guilford Pharmaceuticals Restarts AQUAVAN(R) Clinical Development Program

Guilford Pharmaceuticals Restarts AQUAVAN(R) Clinical Development
Program 


BALTIMORE, April 21  /PRNewswire-FirstCall/ -- Guilford Pharmaceuticals Inc.
(NASDAQ:GLFD) today announced that it has met with the Division of Anesthetic,
Critical Care and Addiction Drug Products of the Food and Drug Administration
(FDA) and reached agreement on a revised clinical development strategy for the
Company's lead product candidate, AQUAVAN(R) Injection (GPI 15715), a novel
sedative/hypnotic being developed for use in procedural sedation.

Dean J. Mitchell, President and Chief Executive Officer of Guilford, commented,
"Following a very collaborative discussion with the FDA, we have agreed on a
more focused clinical development strategy that reduces the number of clinical
trials from 13 to 5 and includes a dose ranging study in colonoscopy.  We
expect that the dose ranging study will result in our identifying a dose of
AQUAVAN(R) that will maximize our ability to achieve our desired label.  In
addition, we believe that this less complex clinical plan increases the
probability of FDA approval within an optimal timeframe."

Under the revised strategy, Guilford will immediately re-initiate its
previously planned studies for ICU sedation and potential drug interactions.
The design of the dose ranging trial in colonoscopy is being finalized in
consultation with the FDA.  Based on the findings of this study, Guilford
expects to commence two pivotal trials, one in colonoscopy and the other in
minor surgical procedures.  Guilford continues to expect to file its New Drug
Application (NDA) for AQUAVAN(R) during the second half of 2006.

Mr. Mitchell continued, "We are strongly committed to the successful and
expeditious development of AQUAVAN(R).  The unique pharmacological profile of
AQUAVAN(R) is optimally aligned with patient and physician needs in the
procedural sedation market and offers a compelling value proposition which we
believe will confer significant pharmacoeconomic benefit."

About AQUAVAN(R) Injection

AQUAVAN(R) Injection is a proprietary water-soluble prodrug of propofol. Unlike
propofol, which is formulated in an oil or lipid-based emulsion, AQUAVAN(R) 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 pharmaceutical company engaged in the
research, development and commercialization of proprietary pharmaceutical
products that target the hospital and neurology 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).  For
additional information about GLIADEL(R) and AGGRASTAT(R), please see
http://www.guilfordpharm.com/ under Products / Marketed Products.

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 Annual Report on Form 10-K filed with the SEC on
March 7, 2005 and Current Report on Form 8-K filed with the SEC on April 6,
2005, 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 is a significant risk as
to whether AQUAVAN(R) will continue to progress though clinical trials, whether
the FDA will approve the product for commercial sale, and if the product is
approved, whether the Company will be able to successfully commercialize
AQUAVAN(R).  Additionally, there can be no assurance that the Company will not
be significantly delayed from its projected timelines for the filing of an NDA
for AQUAVAN(R).

Contact:  Stacey Jurchison / 410-631-5022 /  

DATASOURCE: Guilford Pharmaceuticals Inc.



CONTACT:  Stacey Jurchison, Guilford Pharmaceuticals, [phone],





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



Company News On-Call:  http://www.prnewswire.com/comp/112882.html

Copyright