-----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, ODrHG+dcqrBxm2vqjDLQXAazUOeLfLnyjnKP3pfRtmJfCgvrh62NA1fzLGmge9QE +Ph4FJn4N3Hpad9UC5zasw== /in/edgar/work/20000614/0000950133-00-002584/0000950133-00-002584.txt : 20000919 0000950133-00-002584.hdr.sgml : 20000919 ACCESSION NUMBER: 0000950133-00-002584 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20000530 ITEM INFORMATION: ITEM INFORMATION: FILED AS OF DATE: 20000614 FILER: COMPANY DATA: COMPANY CONFORMED NAME: GUILFORD PHARMACEUTICALS INC CENTRAL INDEX KEY: 0000918066 STANDARD INDUSTRIAL CLASSIFICATION: [2834 ] IRS NUMBER: 521841960 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: SEC FILE NUMBER: 000-23736 FILM NUMBER: 654576 BUSINESS ADDRESS: STREET 1: 6611 TRIBUTARY ST CITY: BALTIMORE STATE: MD ZIP: 21224 BUSINESS PHONE: 4106316300 8-K 1 0001.txt FORM 8-K 1 ================================================================================ 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): May 30, 2000 GUILFORD PHARMACEUTICALS INC. ----------------------------- (Exact name of registrant as specified in its charter) Delaware 000-23736 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 (not applicable) - -------------------------------------------------------------------------------- (Former name or former address, if changed since last report) ================================================================================ 2 Item 5. Other Events. On May 30, 2000, Guilford Pharmaceuticals Inc. and Gliatech Inc. announced that they had reached a definitive merger agreement in a transaction expected to be a tax free reorganization and a pooling of interests for accounting purposes. Under an Agreement and Plan of Merger entered into between the parties, each outstanding share of Gliatech common stock will be converted into the right to receive 1.38 shares of Guilford common stock, and Gliatech will become a wholly-owned subsidiary of Guilford. The combined company will retain the Guilford name and will be based at Guilford's headquarters in Baltimore, Maryland. Consummation of the merger is subject to a number of conditions including approval by the stockholders of Guilford and Gliatech, and the receipt of all regulatory approvals. The press release issued by Guilford and Gliatech with respect to the announcement of the Merger Agreement is included as Exhibit 99.1 hereto. The foregoing description of and reference to the above-mentioned document is qualified in its entirety by reference to the complete text of the document, which is filed as an exhibit to this Current Report on Form 8-K. Item 7. Financial Statements, Pro Forma Financial Information and Exhibits. 99.1 Press Release, dated May 30, 2000. - 2 - 3 SIGNATURES Pursuant to the requirements of the Securities Exchange Act of 1934, as amended the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized. Guilford Pharmaceuticals Date: June 14, 2000 By: /s/ Thomas C. Seon ---------------------------------- Thomas C. Seon Senior Vice President, General Counsel and Secretary - 3 - 4 EXHIBIT INDEX Exhibit No. Description - ----------- ----------- 99.1 Press Release, dated May 30, 2000. - 4 - EX-99.1 2 0002.txt PRESS RELEASE 1 EXHIBIT 99.1 PRESS RELEASE, DATED MAY 30, 2000 - 5 - 2 For information contact: Stacey Jurchison Guilford Pharmaceuticals 410-631-5022 Adam Gridley Gliatech Inc. 216-831-3200 GUILFORD PHARMACEUTICALS ANNOUNCES DEFINITIVE MERGER AGREEMENT WITH GLIATECH INC. Merger Creates Specialty Pharmaceutical Company with Comprehensive Biopolymer and Neurological Product Pipeline BALTIMORE, MD AND CLEVELAND, OH -- May 30, 2000 -- Guilford Pharmaceuticals Inc. (NASDAQ: GLFD) and Gliatech Inc. (NASDAQ: GLIA) today announced that they have entered into a definitive merger agreement pursuant to which Guilford will acquire all of the outstanding common stock of Gliatech. The transaction combines the capabilities of both companies in biopolymer development and the development of novel drugs for the treatment of central nervous system disorders. The combined company will have three marketed products and nine product candidates in clinical development. "This is an exciting opportunity to combine our strengths and expertise and create a stronger, product-focused organization with tremendous growth potential," remarked Craig R. Smith, MD, President and Chief Executive Officer of Guilford. "The strategic combination of our two companies will allow us to realize greater competitive advantages, achieve operational synergies and efficiencies, provide greater access to capital and create greater critical mass with which to pursue our corporate objectives. Together, we have an excellent commercial platform with three marketed biopolymer products for the surgical marketplace and a broad and well-diversified pipeline of product candidates at every stage of clinical development." The combined company will consolidate its corporate and research operations in Baltimore, while maintaining a manufacturing facility in Solon, Ohio. Dr. Smith will retain his position as President and CEO and Thomas O. Oesterling, Ph.D., Chairman and CEO of Gliatech, will join the Board of Directors and the management team and lead strategic planning activities for the Company. - 6 - 3 "Our combined portfolio, which includes drug candidates at every stage of development, offers an exciting array of biopolymer-based products for surgeons and new potential treatments for neurological diseases," said Dr. Smith. "Gliatech's product pipeline significantly enhances our focus on biopolymers and small molecule therapeutics. It also significantly expands our commercial capacity and creates an important opportunity to increase top-line revenues from product sales." "We are delighted to join forces with Guilford in building a first-class biopharmaceutical company," commented Dr. Oesterling. "It quickly became apparent as we entered negotiations that the strategic fit was excellent -- both in terms of corporate structure and technology platform. As a combined entity, we are in a position to build a strong commercial enterprise with the ability to increase product-related revenues and nurture a strong development pipeline." Under the terms of the agreement, each shareholder of Gliatech will receive 1.38 shares of Guilford common stock for each share of Gliatech common stock. The transaction, which is subject to shareholder and regulatory approval, is expected to close in the third quarter of 2000. The merger is intended to qualify as a tax-free reorganization and will be accounted for as pooling of interests. The Boards of Directors of both companies have approved the merger. BIOPOLYMER PLATFORM The combined company's portfolio will include three marketed biopolymer products and five biopolymer products in various stages of clinical development. Commercial Platform: (1) ADCON(R)-L Gel - a polymer gel approved for the inhibition of post-surgical scarring and adhesions following lumbar spine surgery. ADCON(R)-L is currently available in the U.S. and 28 international markets and is the only product to receive FDA market clearance for this use. (2) GLIADEL(R) Wafer - a site-specific biopolymer-based chemotherapeutic approved to treat recurrent glioblastoma multiforme - a common form of malignant brain cancer. Since its approval by the FDA in 1996, GLIADEL(R) Wafer has received marketing authorizations in 21 countries. (3) ADCON(R)-T/N Gel - a polymer gel approved for the inhibition of post-surgical scarring and adhesions following tendon and peripheral nerve surgery. ADCON(R)-T/N Gel is currently available in 28 international markets, excluding the United States. - 7 - 4 Development Platform: (1) GLIADEL(R) Wafer - for first line therapy of glioblastoma multiforme. A Phase III clinical trial will be completed this summer. (2) ADCON(R)-P - a biopolymer liquid to inhibit post-surgical scarring following pelvic and gynecological surgeries. ADCON(R)-P is currently in pivotal trials. (3) ADCON(R)-A - a biopolymer liquid to inhibit post-surgical scarring following abdominal and colorectal surgeries. ADCON(R)-A has completed patient enrollment in a pilot study and is expected to enter pivotal trials this year. (4) PACLIMER(TM) Microspheres - a proprietary, site-specific biopolymer formulation of paclitaxel intended for the treatment of ovarian cancer. PACLIMER(TM) Microspheres is currently in Phase I clinical development. (5) ADCON(R)-I (using ADCON(R)-L gel) - to inhibit adhesions following breast augmentation and reconstructive surgery. ADCON(R)-I has recently completed enrollment in a pilot clinical trial. Neurological Platform In addition to its biopolymer platform, the combined company will have four neurological products in various stages of clinical development. Products in the company's neuroscience development pipeline will include: (1) PERCEPTIN(TM) - a selective histamine H3 receptor antagonist being investigated as a novel treatment for attention deficit hyperactivity disorder. Phase I studies have been completed and enrollment in a Phase II trial has begun. (2) Neuroimmunophilin ligands - novel small molecules that are being investigated for the promotion of nerve growth and repair. Guilford's development partner, Amgen, has recently completed Phase I studies with "NIL-A," the lead compound, and Guilford anticipates that Phase II development for Parkinson's disease will begin this year. (3) GPI-15715 - a novel pro-drug of propofol, currently the world's best selling general anesthetic. GPI-15715 is a water soluble pro-drug of propofol that may avoid some of the side effects associated with propofol. GPI-15715 is currently in late stage preclinical development. - 8 - 5 (4) GPI-5693 - a small molecule NAALADase inhibitor developed to treat neuropathic pain associated with diabetic peripheral neuropathy. Clinical development is scheduled to begin later this year. The combined company also has several neurological programs in its research pipeline. Its PARP and serine racemase programs aim to inhibit cell damage and death in acute and chronic neurodegenerative disorders including stroke, spinal cord trauma, Parkinson's disease and inflammation. The combined company is also developing compounds based on the activity of inflammation-producing glial cells to slow or inhibit the progression of Alzheimer's disease; H3 agonists for the treatment of anxiety and insomnia; inhibitors of glycine transporters for potential treatment in schizophrenia, and a monoclonal antibody that may be useful in inflammatory diseases. Corporate partners include Amgen for development of neuroimmunophilin ligands and Aventis S.A. which markets GLIADEL(R) Wafer. Prudential Vector Healthcare Group, a unit of Prudential Securities, Incorporated acted as financial advisor to Guilford, and SG Cowen Securities Corporation acted as financial advisor to Gliatech. CONFERENCE CALL NOTICE: Dr. Craig R. Smith, President and CEO of Guilford, and Dr. Thomas O. Oesterling, Chairman and CEO of Gliatech, will host a conference call at 10:00 a.m. E.S.T. today to discuss the proposed business combination. The dial-in number to participate is (212) 346-0231. For a playback, dial 1-800-633-8284, reservation number 15359622. ### Internet addresses: www.guilfordpharm.com www.gliatech.com The companies desire to take advantage of the "safe harbor" provision of the Private Securities Litigation Reform Act of 1995. This press release contains forward-looking statements that involve risks and uncertainties. The companies describe certain of these risks and uncertainties in their respective filings with the Securities and Exchange Commission, including their respective Annual Reports on Form 10-K (including the section entitled "Risk Factors" contained in Guilford's Form 10-K), their most recent quarterly reports on Form 10-Q and their Current Reports on Form 8-K. These risks and uncertainties could cause the companies' actual results and experience to differ materially from anticipated results and - 9 - 6 expectations expressed in these forward-looking statements. In particular, there can be no assurance that all of the steps necessary to consummate the merger (including regulatory and shareholder approvals) will occur, that the contemplated advantages will be achieved upon any consummation of the merger, or that all of the scientific, regulatory and chemistry, manufacturing and controls steps necessary for compounds to progress from preclinical to clinical development or from an earlier to a later stage of clinical development will be successfully completed. The companies are under no obligation to (and expressly disclaim any such obligation to) update or alter their forward-looking statements whether as a result of new information, future events or otherwise. - 10 - -----END PRIVACY-ENHANCED MESSAGE-----