GLIADEL(R) Wafer Receives Favorable Opinion for
Marketing Authorization In Ten European Countries / First Localized Treatment for Malignant Glioblastoma Collegeville, Pa. and Baltimore (PROTEXT)
Rhone-Poulenc Rorer Inc. and Guilford Pharmaceuticals Inc. (Nasdaq: GLFD) today announced that GLIADEL(R) 7.7 mg Implant, (polifeprosan 20 with carmustine), the first commercially available brain cancer treatment to deliver chemotherapy directly to the tumor site, has successfully completed the Mutual Recognition Procedure in ten European countries. This is one of the two European registration procedures used to obtain marketing authorization in Europe. Consequently, Germany, Italy, the United Kingdom, Austria, Greece, Ireland, Luxembourg, Portugal, Spain, and the Netherlands are expected to grant national marketing authorization within the next six months. "The successful outcome of the European Mutual Recognition Procedure is the result of excellent teamwork by both RPR and Guilford," said Max Talbott, RPR Worldwide Vice President, Regulatory Affairs. "We look forward to making GLIADEL(R) available in Europe as an important new treatment option for patients with recurrent glioblastoma multiforme (GBM), once any required pricing and/or labeling approvals are obtained." Once GLIADEL(R) is available for marketing in the ten European nations, it will be used as an adjunct to surgery in patients with recurrent GBM for whom surgical resection is indicated. GBM is one of the most common and rapidly fatal forms of malignant brain cancer. In this European Mutual Recognition Procedure, France acted as the Reference Member State. The first marketing authorization of GLIADEL(R) in Europe was granted in France in December 1998. As the first significant new local treatment for brain cancer in over 20 years, GLIADEL(R) is the only marketed cancer treatment capable of delivering chemotherapy directly to the site of a brain tumor, minimizing drug exposure to other areas of the body. GLIADEL(R) is a biodegradable polymer wafer that is implanted in the cavity created when a brain tumor is surgically removed. As the wafer erodes in the brain, it releases the cancer chemotherapeutic drug, carmustine (BCNU), directly to the tumor site in high concentrations over an extended period of time. GLIADEL(R) was first approved by the FDA in the fall of 1996 for use as an adjunct to surgery to prolong survival in patients with recurrent GBM for whom surgical resection is indicated. In 1996, Guilford and Rhone-Poulenc Rorer (RPR) entered into a worldwide marketing and distribution rights agreement granting RPR worldwide marketing rights (currently excluding Scandinavia and Japan), for GLIADEL(R). "We are pleased by RPR's commitment to expand the market for GLIADEL(R), both in Europe and in other international markets," remarked Craig R. Smith, President and Chief Executive Officer of Guilford. "Their commitment to the field of oncology is well established, and we are very pleased by their ability to secure regulatory approval for GLIADEL(R) throughout Europe." Marketing authorization is the first of several steps necessary to market GLIADEL(R). Additional labeling and pricing approvals are required before GLIADEL(R) may be launched in most European and international markets. If RPR obtains these European approvals for the current labeled indication, Guilford is eligible to receive milestone payments. GLIADEL(R) offers an important treatment option for neurosurgeons and complements other standard therapies for brain cancer. In a randomized clinical trial, GLIADEL(R) was shown to prolong survival in patients with GBM for whom surgical resection is indicated. In this multicenter study involving 145 patients with recurrent GBM, GLIADEL(R) increased six month survival from 36% with placebo to 56% with GLIADEL(R). The spectrum of adverse events observed in patients with recurrent malignant glioma who received GLIADEL(R) or placebo was consistent with that encountered in patients undergoing craniotomy for malignant gliomas. Clinically relevant side effects that were more common with GLIADEL(R) versus placebo included healing abnormalities, brain edema, and intracranial infections. Seizures that occurred in patients receiving GLIADEL(R) had a much earlier onset, although the incidence of seizures was the same in the placebo and GLIADEL(R) groups. Rhone-Poulenc Rorer is a global pharmaceutical subsidiary of Rhone-Poulenc S.A. (NYSE: RP), a leading life sciences company, growing through innovations in human, plant and animal health. With sales in 1998 of FF86.8 billion (US$14.8 billion; Euros 13.232 billion), Rhone-Poulenc employs 65,000 people in 160 countries worldwide. The RPR Internet website is at http://www.rp-rorer.com. 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 and peripheral neuropathies. The Guilford Internet website is http://www.guilfordpharm.com. ots Original Text Service: Guilford Pharmaceuticals Inc. Internet: http://www.newsaktuell.de Contact: Stacey Jurchison, (USA) 410- 631-5022, or Angela Rubin, (USA) 410-631-6449 both of Guilford Pharmaceuticals, or Terri Pedone of Rhone-Poulenc Rorer, (USA) 610-454-8284 Company News On-Call: http://www.prnewswire.com/comp/112882.html or Fax, (USA) 800- 758-5804, ext. 112882 Web site: http://www.rp-rorer.com Web site: http://www.guilfordpharm.com
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