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Guilford Licenses U.S. Rights to GPI 1485 to Symphony Neuro
Development Company
BALTIMORE, June 18 /PRNewswire-FirstCall/ -- Guilford Pharmaceuticals Inc.
(NASDAQ:GLFD) announced today that it has licensed to Symphony Neuro
Development Company, a newly formed Delaware corporation ("SNDC"), its rights
to GPI 1485 for certain indications in the United States. SNDC will invest up
to $40 million to advance GPI 1485 through clinical development in four
indications: Parkinson's disease, post-prostatectomy erectile dysfunction
(PPED), HIV neuropathy, and HIV-dementia. The Parkinson's disease and PPED
indications are currently in Phase II clinical trials and the HIV indications
are currently in preclinical development. In addition to the grant of the
license, Guilford has issued to SNDC's investors five-year warrants to purchase
1.5 million shares of Guilford's common stock at $7.48 per share. Guilford has
received an exclusive purchase option from SNDC's investors allowing it to
acquire all of the equity of SNDC. This option is generally exercisable by
Guilford at any time beginning April 1, 2005 and ending March 31, 2007, at an
exercise price starting at $75.1 million in April 2005 and increasing to $119.8
million in March 2007. Guilford's decision to exercise the option is entirely
discretionary and whether Guilford exercises it may depend on the outcome of
clinical trials and other considerations. The option may be paid in cash or a
combination of cash and Guilford common stock, at Guilford's sole discretion,
provided that common stock may not constitute more than 50% of the option
exercise price.
RRD International, LLC ("RRD") of Rockville, MD, a product development company
providing clinical trials strategy, design and management expertise, will
manage SNDC and will sub-contract a portion of the ongoing development work to
Guilford and other vendors. Guilford will perform certain services for SNDC,
including GPI 1485 manufacturing, process development, toxicology, patent, and
regulatory affairs work.
Under the terms of the licensing agreement Guilford has one of five seats on
SNDC's board of directors. This seat will be filled initially by Craig R.
Smith, M.D., Guilford's Chairman, President and Chief Executive Officer.
Guilford intends to consolidate the financial activity of SNDC Holdings within
its financial statements.
In connection with the transaction, Dr. Smith said, "This licensing and
financing arrangement has several advantages for Guilford. First, we now have
experienced, knowledgeable partners to provide financial support for the GPI
1485 programs and share the risks and rewards associated with the ongoing and
planned clinical trials. We will be able to accelerate the clinical program and
prepare for Phase III without risking additional Guilford capital. Finally, the
programs will benefit from the superb clinical trial management capabilities of
RRD allowing Guilford to re-deploy its current GPI 1485 clinical development
staff to other Guilford programs."
Said Mark Kessel, Chairman of SNDC, "SNDC is providing committed capital and
clinical development expertise to advance these four GPI 1485 indications on an
accelerated path. Our collaboration with Guilford provides our investors with
an opportunity to share in these exciting product development programs."
Dr. Frank Hurley, Chief Scientific Officer of RRD and Chief Scientific Officer
of SNDC, commented, "The GPI 1485 programs are attractive clinical candidates
in areas of significant unmet medical need. Collaborating on these programs
with Guilford will be a unique opportunity to bring an important new medicine
to people who are affected by Parkinson's disease and post- prostatectomy
erectile dysfunction."
About GPI 1485
GPI 1485 is an investigational new drug that belongs to a class of small
molecule compounds called neuroimmunophilin ligands. In preclinical
experiments, neuroimmunophilin ligands have been shown to repair and regenerate
damaged nerves without affecting normal, healthy nerves. Neuroimmunophilin
ligands may have application in the treatment of a broad range of diseases,
including: Parkinson's disease, spinal cord injury, brain trauma, and
peripheral nerve injuries including post-prostatectomy erectile dysfunction.
About Parkinson's Disease
Parkinson's disease is a chronic, progressive degenerative disorder that
involves a specialized region of the brain that controls muscle tone and
coordination and affects over one million people in the United States. Most
patients are affected in mid-life and usually develop hand tremors, muscle
rigidity, and postural instability, among the many manifestations of the
disease. The disease is caused by the degeneration of nerve cells that use
dopamine as a chemical messenger. Treatment currently consists of
administering drugs that increase the amount of dopamine in the affected
regions of the brain or substitute for the lost dopamine. Unfortunately, there
are no current treatments that can reverse, or even slow down, the progressive
degeneration of the affected dopamine nerve cells.
About PPED
The American Cancer Society estimates that approximately 190,000 American men
will be diagnosed with prostate cancer this year. Of these, the cancer will be
localized in 70% of patients, and a significant proportion will undergo
prostatectomy for treatment. Potential complications of surgery include
urinary incontinence and sexual dysfunction. In a retrospective study of
patient outcomes, published in the Journal of the American Medical Association,
the incidence of sexual dysfunction reported at eighteen months following
prostatectomy ranged from 60 percent to 85 percent (JAMA. 2000; 283:354-360).
About Guilford
Guilford Pharmaceuticals Inc. is a pharmaceutical company engaged in the
research, development and commercialization of products that target the
hospital 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). Guilford's product pipeline includes a novel
anesthetic, AQUAVAN(R) Injection. For additional information about GLIADEL(R)
Wafer, please visit http://www.guilfordpharm.com/ under Products / Marketed
Products / GLIADEL; and for AGGRASTAT(R), please see http://www.aggrastat.com/.
About SNDC
SNDC is a privately held biopharmaceutical development company, the purpose of
which is to develop the GPI 1485 programs. On June 17, 2004, a group of
institutional investors, led by Symphony Capital Partners, L.P., invested $43
million to provide development capital to SNDC. Symphony Capital is a New
York-based private equity firm that invests in development stage
biopharmaceutical programs.
Contact:
Guilford: Stacey Jurchison, Director, Corporate Communications -
410-631-5022 http://www.guilfordpharm.com/
SNDC: Mark Kessel, Chairman, 212-632-5400
This press release contains forward-looking statements that involve risks and
uncertainties, including those described in the section entitled "Risk Factors"
contained in Guilford's Quarterly Report on Form 10-Q filed with the SEC on May
10, 2004, that could cause Guilford'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
GPI 1485 will continue to advance through clinical development or receive
regulatory approval for commercialization either in the United States or in
international markets.
DATASOURCE: Guilford Pharmaceuticals Inc.
CONTACT: Stacey Jurchison, Director, Corporate Communications, Guilford
Pharmaceuticals, +1-410-631-5022; or Mark Kessel, Chairman, SNDC,
+1-212-632-5400
Web site: http://www.guilfordpharm.com/
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