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Guilford Announces Receipt of Broad New Patents In FKBP-Neuroimmunophilin Ligand Program, Compounds That Promote Nerve Growth.

BALTIMORE, Sept. 2 /PRNewswire/ -- Guilford Pharmaceuticals Inc. (NASDAQ:GLFD) today announced that the Company has been issued four new U.S. patents in its FKBP-neuroimmunophilin ligand neurotrophic program, including broad methods for treating neurological diseases with immunophilin ligands. These patents relate to compounds which are orally-active small molecules that cross the blood-brain-barrier and induce regeneration and protection of neuronal cells. Guilford's compounds have demonstrated activity in a number of animal models of Parkinson's disease and other acute and chronic neurological diseases and conditions. Results from some of these studies have been published in The Proceedings of the National Academy of Sciences and Nature Medicine, and presented at the 1997 meeting of the Society for Neuroscience. With these issuances, Guilford now owns or has exclusive rights to a total of eight issued U.S. patents relating to neuroimmunophilin ligands and their neurotrophic or other neurological uses, and has over 50 U.S. and several hundred international patent applications pending in the field. The newly issued patents are as follows:

• U.S. Patent No. 5,795,908, "Small Molecule Inhibitors of Rotamase Enzyme Activity", claims methods of using a broad class of small molecule non-immunosuppressive FKBP ligands to treat neurological disorders (including Alzheimer's disease, Parkinson's disease, amyotrophic lateral sclerosis (ALS), and peripheral neuropathies), promote neuronal regeneration and growth, and prevent neurodegeneration.
• U.S. Patent No. 5,798,355, "Inhibitors of Rotamase Enzyme Activity", claims methods of using a broad class of non-immunosuppressive FKBP ligands, including a number of compounds previously published in the patent and scientific literature, to treat neurological disorders (including Alzheimer's Disease, Parkinson's Disease, peripheral neuropathies, stroke, brain and spinal cord injuries, and ALS), stimulate growth of damaged peripheral nerves, and promote neuronal regeneration and growth.
• U.S. Patent No. 5,801,197, "Rotamase Enzyme Activity Inhibitors", claims methods of using certain non-immunosuppressive FKBP ligands which have been previously published in the patent literature, to stimulate the growth of damaged nerves.
• U.S. Patent No. 5,801,187, "Heterocyclic Esters and Amides", claims novel non-immunosuppressive compounds (compositions of matter) designed by Guilford and their neurotrophic and neurological uses, including for the treatment of Alzheimer's Disease, Parkinson's Disease, peripheral neuropathies, stroke, brain and spinal cord injuries, and ALS.

Additional scientific presentations are planned for later this year, at the Cambridge Healthtech Institute meeting on Acute Neuronal Injury: New Therapeutic Opportunities on September 23-24 in Las Vegas, Nevada, and the Society for Neuroscience on November 7-12 in Los Angeles, California.

"Guilford scientists are pioneers in the field of using small molecule non-immunosuppressive immunophilin ligands for the treatment of acute and chronic neurological disorders," commented Dr. Craig Smith, Guilford's President and C.E.O. "We are committed to pursuing the strongest and broadest possible intellectual property protection for our discoveries, in this and all of our other fields of research. Together with our academic and corporate partners, we continue to vigorously file new patent applications for these remarkable compounds, including both additional composition of matter claims for the novel compounds we invent, as well as novel method of use claims for compounds known from the patent and scientific literature. We look forward to continuing to work with our corporate partner, Amgen, to initiate clinical trials in this program as soon as possible."

In August, 1997, Guilford entered into a major collaboration with Amgen Inc. to develop and commercialize Guilford's FKBP-neuroimmunophilin ligands for up to ten target indications, including Parkinson's disease, Alzheimer's disease, stroke, peripheral neuropathies, traumatic brain injuries, traumatic spinal cord injuries and multiple sclerosis, and three additional undisclosed non-neurological indications. Under the terms of this agreement, Guilford received $35 million up front, of which $15 million was a one time cash rights payment, $15 million related to Amgen's purchase of Guilford's common stock and $5 million related to the purchase of warrants. Guilford is also receiving up to $13.5 million in research funding over three years, will receive royalties on any future product sales, and is eligible to receive up to $392 million in development milestones if all ten indications are successfully developed. Amgen will pay and be responsible for all clinical and other development, manufacturing, and marketing expenses.

Guilford Pharmaceuticals Inc. is a biopharmaceutical company engaged in the development of polymer-based therapeutics for cancer, and novel products for the diagnosis and treatment of neurological diseases, including Parkinson's disease, Alzheimer's disease, stroke, severe head trauma, spinal cord injuries, multiple sclerosis, peripheral neuropathies, and cocaine addiction.

Internet address: http://www.guilfordpharm.com For Press Releases: http://www.prnewswire.com

This press release contains forward-looking statements that involve risk and uncertainties, including those described in the section entitled "Risk Factors" contained in the Company's Annual Report on Form 10-K for the year ended December 31, 1997 on file with the Securities and Exchange Commission, that could cause the Company's actual results and experience to differ materially from anticipated results and expectations expressed in these forward-looking statements. In particular, there can be no assurance that the Company and its corporate collaborator will ultimately be able to successfully develop product candidates into safe and effective FDA-cleared drugs, and the patentability, scope, validity, priority, enforceability, and non-infringement of claims made in patents granted to and patent applications filed by the Company in the U.S. and abroad cannot be assured.  
 

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