-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, DMdZol23idij49lDq2oQ2WQ1m8+NJj7HMuwmquXSXlRXuCyxXXgCYRTzG6H+8QMX DJpcd5aqVOMlZvGyVtzcyA== 0000950133-04-001234.txt : 20040330 0000950133-04-001234.hdr.sgml : 20040330 20040330171334 ACCESSION NUMBER: 0000950133-04-001234 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20040330 ITEM INFORMATION: Other events ITEM INFORMATION: Financial statements and exhibits FILED AS OF DATE: 20040330 FILER: COMPANY DATA: COMPANY CONFORMED NAME: GUILFORD PHARMACEUTICALS INC CENTRAL INDEX KEY: 0000918066 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 521841960 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-23736 FILM NUMBER: 04702419 BUSINESS ADDRESS: STREET 1: 6611 TRIBUTARY ST CITY: BALTIMORE STATE: MD ZIP: 21224 BUSINESS PHONE: 4106316300 8-K 1 w95736e8vk.htm FORM 8-K e8vk
 


SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

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 30, 2004

GUILFORD PHARMACEUTICALS INC.
(Exact name of registrant as specified in its
charter)

         
Delaware  
0-23736
  52-1841960

(State or other jurisdiction of  
(Commission File
  (I.R.S. Employer
incorporation or organization)  
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


(Former name or former address, if changed since last report)


Exhibit Index is on Page 3

 


 

INFORMATION TO BE INCLUDED IN THE REPORT

Item 5. Other Events

     On March 30, 2004, Guilford Pharmaceuticals Inc. issued a press release announcing that Pfizer, Inc. has elected to terminate its agreement with Guilford granting Pfizer the exclusive right to develop NAALADase inhibitors worldwide. Under the agreement, Pfizer was to pay Guilford $10 million on or before March 31, 2004 in addition to $5 million that Pfizer previously paid Guilford upon execution of the agreement. As a result of Pfizer’s termination, all rights to develop and commercialize the NAALADase inhibitor technology granted to Pfizer will revert to Guilford and no further milestone payments or royalties are to be received from Pfizer.

Item 7. Financial Statements, Pro Forma Financial Information and Exhibits

             
   
(c)
    Exhibits
             
    99.1     Press Release of Guilford Pharmaceuticals Inc. issued March 30, 2004

1


 

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.
             
Date: March 30, 2004
  By:   /s/ Asher M. Rubin

Asher M. Rubin
Vice President, General Counsel
and Secretary
   

2


 

INDEX TO EXHIBITS

             
Exhibit        
Number  
Exhibit Description
  Page
             
99.1
  Press Release dated March 30, 2004  
4

3

EX-99.1 3 w95736exv99w1.htm EXHIBIT 99.1 exv99w1
 

Exhibit 99.1

FOR IMMEDIATE RELEASE

RIGHTS TO NAALADASE INHIBITOR TECHNOLOGY
RETURNED TO GUILFORD

Pfizer Terminates NAALADase License Agreement

BALTIMORE, MD, March 30, 2004 — Guilford Pharmaceuticals Inc. (Nasdaq: GLFD) announced today that it has regained from Pfizer all rights to develop and commercialize NAALADase inhibitors. In May 2003, Guilford and Pfizer entered into an exclusive license agreement, which provided Pfizer with research, development and commercialization rights to Guilford’s NAALADase inhibitor technology. The agreement included a $5 million payment to Guilford at signing and an additional $10 million milestone payment due on or before March 31, 2004. Pfizer has informed Guilford that the milestone payment will not be made and they are terminating the agreement.

“We enjoyed a good scientific and business relationship with Pfizer,” remarked Craig R. Smith, M.D., President and Chief Executive Officer of Guilford. “However, Pfizer was not successful in identifying a lead clinical candidate during the ten months our agreement was in effect and unfortunately we were unable to reach agreement on terms for an extension.”

Dr. Smith continued, “In preclinical studies we and Pfizer have consistently demonstrated robust efficacy in preclinical models of neuropathic pain. During 2003, Guilford initiated a collaboration with Dr. Howard Scher of Memorial Sloan-Kettering Cancer Center to study the use of NAALADase inhibitors as a potential treatment for prostate cancer. In preclinical studies NAALADase inhibitors were found to significantly retard the growth of prostate cancer cells. We also established a collaboration with the National Institute for Drug Addiction (NIDA) to evaluate the use of NAALADase inhibitors as a potential treatment for cocaine addiction. NIDA is presently conducting preclinical studies and plans to conduct clinical trials.”

NAALADase Inhibitor Program Background

NAALADase, or N-Acetylated-Alpha-Linked-Acidic-Dipeptidase, is a membrane- bound enzyme found principally in the central and peripheral nervous systems. Guilford has created several unique classes of NAALADase inhibitors and evaluated their potential therapeutic application in preclinical models of various acute and chronic neurodegenerative disorders, including diabetic peripheral neuropathy, neuropathic pain, Lou Gehrig’s Disease (ALS), head and spinal cord trauma, and stroke. Guilford has also shown that NAALADase inhibitors may have utility for diagnostic or therapeutic purposes in prostate cancer and drug addiction.

NAALADase is believed to play a role in modulating the release of glutamate, one of the most common chemical messengers between nerves. During conditions of acute injury or chronic neurodegenerative disorders, there may be a large increase in glutamate release that incites a cascade of biochemical events, ultimately leading to cell injury and death. NAALADase is the same protein as prostate specific membrane antigen (PSMA), a protein found on the surface of

 


 

prostate cancer cells. Guilford has also shown that its compounds may have utility for diagnostic or therapeutic purposes in prostate cancer.

Guilford has 37 issued US patents and 10 pending patent applications, and corresponding foreign counterparts protecting its NAALADase inhibitor technology.

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® Wafer (polifeprosan 20 with carmustine implant), for the treatment of brain cancer, and AGGRASTAT® Injection (tirofiban hydrochloride), a GP IIb/IIIa receptor antagonist used for the treatment of acute coronary syndrome (ACS). Guilford’s product pipeline includes a novel anesthetic, AQUAVAN® Injection, and drugs for treating Parkinson’s disease and peripheral nerve injury. 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 15, 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 the Company or its research partners will be successful in developing any NAALADase inhibitor compound into a pharmaceutical product that receives regulatory approval.

CONTACT: Stacey Jurchison, Director, Corporate Communications, Guilford Pharmaceuticals, (410) 631-5022; jurchisons@guilfordpharm.com. www.guilfordpharm.com.

 

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