8-K

 

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of Earliest Event Reported): March 24, 2005

Guilford Pharmaceuticals Inc.
__________________________________________
(Exact name of registrant as specified in its charter)

Delaware	000-23736	52-1841960
_____________________ (State or other jurisdiction	_____________ (Commission	______________ (I.R.S. Employer
of incorporation)	File Number)	Identification No.)
6611 Tributary Street, Baltimore, Maryland		21224
_________________________________ (Address of principal executive offices)		___________ (Zip Code)

Registrant’s telephone number, including area code: 410-631-6300

Not Applicable
______________________________________________
Former name or former address, if changed since last report

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

[  ]  Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
[  ]  Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
[  ]  Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
[  ]  Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Item 8.01. Other Events.

On March 24, 2005, the Registrant issued a press release announcing the results of a Phase III study of AQUAVAN(R) Injection in patients undergoing elective colonoscopy procedures. A copy of the Registrant's press release is attached as Exhibit 99.1 to this Current Report on Form 8-K.

Item 9.01. Financial Statements and Exhibits.

Exhibit 99.1-Press Release issued by the Registrant on March 24, 2005.

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

	Guilford Pharmaceuticals Inc.
March 24, 2005	By:	Asher M. Rubin
		Name: Asher M. Rubin
		Title: Senior Vice President, General Counsel and Secretary

Exhibit Index

Exhibit No.	Description
99.1	Press Release dated March 24, 2005

EX-99.1

FOR IMMEDIATE RELEASE

GUILFORD PHARMACEUTICALS ANNOUNCES
PHASE III AQUAVAN^® TRIAL MEETS PRIMARY ENDPOINT

BALTIMORE, MD, March 24, 2005 — Guilford Pharmaceuticals Inc. (Nasdaq: GLFD) today announced that a Phase III study of AQUAVAN® Injection in patients undergoing elective colonoscopy procedures met its primary efficacy endpoint without any serious adverse events. The results were based on a randomized, open-label study designed to assess the efficacy of AQUAVAN® and its safety versus midazolam HCl for sedation in patients undergoing colonoscopy procedures. A total of 278 patients were enrolled and randomly assigned to receive AQUAVAN® (N=209) or midazolam (N=69).

The primary efficacy endpoint in the trial was success of sedation, defined as three consecutive Modified Observer’s Assessment of Alertness/Sedation (MOAA/S) scores less than or equal to 4, and completing the procedure without employing alternative sedative medications and without requiring manual or mechanical ventilation. Treatment with AQUAVAN® resulted in a sedation success rate of 96%. In general, patients who received AQUAVAN® experienced deeper levels of sedation for longer sustained periods than patients who received midazolam, which led to a higher level of adverse events in the AQUAVAN® treatment group. Patients treated with AQUAVAN® showed a median time to sedation of 2 minutes and a median time to full recovery from the end of the procedure of 11 minutes.

Dean J. Mitchell, President and Chief Executive Officer of Guilford, remarked, “Market research supports the need for a new procedural sedation agent that provides rapid onset and recovery from sedation, is easy to administer and control, and can be safely administered without the need for a dedicated anesthesiologist. Based on these results, we believe AQUAVAN® can satisfy that product profile; however, a lower dose than used in this Phase III trial would be more appropriate to meet the characteristics of a drug ideal for procedural sedation. Our intention is to ensure the highest probability of regulatory and commercial success for AQUAVAN®. Accordingly, we have voluntarily suspended enrolling patients in our ongoing clinical trials in order to review dosing levels. With the dosing level data from other trials, in addition to the colonoscopy data, we plan to meet with the Food and Drug Administration within the next several weeks to determine the optimal clinical plan to obtain approval and achieve our desired label. While these activities may modestly extend our timeline for filing the NDA, we think it will best enhance the product’s commercial opportunity.”

Webcast

A detailed review of the results of the Phase III trial will be presented via webcast on April 6, 2005 beginning at approximately 12:15 p.m. E.T. To participate in the webcast, log on to Guilford’s website at www.guilfordpharm.com at least 10 minutes prior to the start of the webcast. An icon that will launch the webcast will be available under the ‘Investors’ section under ‘Presentations.’

About AQUAVAN® Injection

AQUAVAN® Injection is a proprietary water-soluble prodrug of propofol. Unlike propofol, which is formulated in an oil or lipid-based emulsion, AQUAVAN® 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® Wafer (polifeprosan 20 with carmustine implant), for the treatment of brain cancer, and AGGRASTAT® Injection (tirofiban hydrochloride), a glycoprotein GP IIb/IIIa receptor antagonist used for the treatment of acute coronary syndrome (ACS). For additional information about GLIADEL® and AGGRASTAT®, please see 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, 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 that AQUAVAN® would not gain regulatory approval without further studies at a lower dose level, there is uncertainty that the Company will be successful in designing a clinical program that meets the regulatory requirements of FDA or achieves an appropriate dose level and there can be no assurance that the NDA filing will not be significantly delayed.

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Contact: Stacey Jurchison / 410-631-5022 / jurchisons@guilfordpharm.com