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Guilford Pharmaceuticals Expands Marketing and Distribution Agreement for GLIADEL(R) Wafer With Link Pharmaceuticals


Posted on: 05/17/2004

Guilford Pharmaceuticals Expands Marketing and Distribution Agreement for GLIADEL(R) Wafer With Link Pharmaceuticals

Guilford Pharmaceuticals Inc. (ticker: GLFD, exchange: NASDAQ) News Release - 5/17/2004
BALTIMORE, May 17 /PRNewswire-FirstCall/ -- Guilford Pharmaceuticals, Inc. (Nasdaq: GLFD) announced today that it has granted exclusive rights to Link Pharmaceuticals Ltd. to market, sell and distribute its proprietary brain cancer therapy, GLIADEL(R) Wafer (polifeprosan 20 with carmustine implant) in Germany, France, Benelux, Austria and Switzerland. These countries are in addition to the existing contract with Link for the United Kingdom. Link will be responsible for obtaining pricing approvals for GLIADEL(R) in each of the countries covered under the agreement. Guilford received $500,000 at signing and may receive additional milestone payments totaling up to $2 million. If GLIADEL(R) is approved for initial surgery in France and Germany, Guilford will receive a $750,000 milestone payment. GLIADEL(R) is currently approved for use in 13 countries outside of the United States and Canada to treat recurrent glioblastoma multiforme, an aggressive form of primary malignant brain cancer.

"Guilford's second agreement with Link expands our network of international partners in major global healthcare markets and is a key component of our ability to increase sales of GLIADEL(R) outside the United States," stated Craig R. Smith, M.D., Chairman, President and Chief Executive Officer of Guilford. "The agreement is particularly important as we continue our discussions with European regulatory authorities to seek an expanded indication for GLIADEL(R) during initial surgery for high grade malignant glioma." In February 2003, Guilford received approval in the United States for expanded use of GLIADEL(R) in newly diagnosed patients with high-grade malignant glioma as an adjunct to surgery and radiation. GLIADEL(R) is also approved in Canada for initial surgery in the treatment of high-grade malignant glioma and for use in recurrent glioblastoma multiforme."

"Acquiring GLIADEL(R) for 7 additional Northern European countries is a major step for Link," said Steve Mountain, CEO and Managing Director, Link Pharmaceuticals. "GLIADEL(R) is a strategic product in our UK portfolio of oncology and palliative therapies and now we are looking forward to Link Europe launching GLIADEL(R) and achieving outstanding success in these important countries."

About GLIADEL(R) Wafer

GLIADEL(R) is the only marketed cancer treatment capable of delivering chemotherapy directly to the site of a brain cancer, bypassing the blood-brain barrier and minimizing drug exposure to other areas of the body. GLIADEL(R) is a small, white to off-white dime-sized wafer comprised of a biodegradable polymer (polifeprosan 20) incorporating 7.7 mg. of carmustine (BCNU), a chemotherapeutic agent usually administered intravenously to treat a malignant glioma. Up to eight GLIADEL(R) Wafers can be implanted in the cavity created when a surgeon removes a brain tumor. There, they slowly dissolve, releasing BCNU directly to the tumor site in high concentrations, while minimizing drug exposure to other areas of the body.

For additional information about GLIADEL(R), please visit www.guilfordpharm.com under Products / Marketed Products / GLIADEL.

Important Information About GLIADEL(R) Wafer

GLIADEL(R) is indicated in newly diagnosed high-grade malignant glioma patients as an adjunct to surgery and radiation. GLIADEL(R) is also indicated in recurrent glioblastoma patients as an adjunct to surgery.

The following four categories of adverse events are possibly related to treatment with GLIADEL(R) during initial resection. Frequencies are listed of events that occurred in a randomized trial of GLIADEL(R) and placebo, respectively: seizure (33.3% vs 37.5%); brain edema (22.5% and 19.2%); healing abnormalities (15.8% vs 11.7%); and intracranial infection (5.0% vs 6.0%). The following three categories of adverse events are possibly related to treatment with GLIADEL(R) for recurrent disease. Frequencies are listed of events that occurred in a randomized trial of GLIADEL(R) and placebo, respectively: post-operative seizure (19% vs 19%); healing abnormalities (14% vs 5%); intracranial hypertension (4% vs 4%) and intracranial infection (4% vs 1%).

Patients undergoing craniotomy for malignant glioma and implantation of GLIADEL(R) should be monitored closely for known complications of craniotomy, including seizures, intracranial infections, abnormal wound healing, and brain edema. Cases of intracerebral mass effect unresponsive to corticosteroids have been described in patients treated with GLIADEL(R), including one case leading to brain herniation. GLIADEL(R) contains carmustine and should not be given to patients who are allergic to carmustine. Carmustine can also cause fetal harm when administered to a pregnant woman. The short and long-term toxicity profiles of GLIADEL(R) when given in conjunction with radiation or chemotherapy have not been fully explored.

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(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, and drugs for treating Parkinson's disease and post-prostatectomy erectile dysfunction.

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-Q filed with the SEC on May 10, 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 Guilford will be able to achieve expanded regulatory approval for GLIADEL(R) in France and Germany or elsewhere in Europe, or that if Guilford is successful in its attempt to expand GLIADEL(R)'s approved uses in Europe that GLIADEL(R) sales in Europe will increase as a result.

Contact: Stacey Jurchison, Director, Corporate Communications -
410.631.5022
Internet Address: http://www.guilfordpharm.com SOURCE Guilford Pharmaceuticals Inc.
CONTACT: Stacey Jurchison, Director, Corporate Communications of Guilford Pharmaceuticals Inc., +1-410-631-5022


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