GLIADEL(R) Wafer Receives Favorable Opinion for
24.06.1999, 15:06
Marketing Authorization In Ten European Countries / FirstLocalized Treatment for Malignant Glioblastoma Collegeville, Pa. and Baltimore (PROTEXT) - Rhone-PoulencRorer Inc. and Guilford Pharmaceuticals Inc. (Nasdaq: GLFD) todayannounced that GLIADEL(R) 7.7 mg Implant, (polifeprosan 20 withcarmustine), the first commercially available brain cancertreatment to deliver chemotherapy directly to the tumor site, hassuccessfully completed the Mutual Recognition Procedure in tenEuropean countries. This is one of the two European registrationprocedures used to obtain marketing authorization in Europe.Consequently, Germany, Italy, the United Kingdom, Austria,Greece, Ireland, Luxembourg, Portugal, Spain, and the Netherlandsare expected to grant national marketing authorization within thenext six months. "The successful outcome of the European Mutual RecognitionProcedure is the result of excellent teamwork by both RPR andGuilford," 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 forpatients with recurrent glioblastoma multiforme (GBM), once anyrequired pricing and/or labeling approvals are obtained." Once GLIADEL(R) is available for marketing in the ten Europeannations, it will be used as an adjunct to surgery in patientswith recurrent GBM for whom surgical resection is indicated. GBMis one of the most common and rapidly fatal forms of malignantbrain cancer. In this European Mutual Recognition Procedure, France acted asthe Reference Member State. The first marketing authorization ofGLIADEL(R) in Europe was granted in France in December 1998. As the first significant new local treatment for brain cancerin over 20 years, GLIADEL(R) is the only marketed cancertreatment capable of delivering chemotherapy directly to the siteof a brain tumor, minimizing drug exposure to other areas of thebody. GLIADEL(R) is a biodegradable polymer wafer that isimplanted in the cavity created when a brain tumor is surgicallyremoved. As the wafer erodes in the brain, it releases the cancerchemotherapeutic drug, carmustine (BCNU), directly to the tumorsite in high concentrations over an extended period of time. GLIADEL(R) was first approved by the FDA in the fall of 1996for use as an adjunct to surgery to prolong survival in patientswith recurrent GBM for whom surgical resection is indicated. In1996, Guilford and Rhone-Poulenc Rorer (RPR) entered into aworldwide marketing and distribution rights agreement grantingRPR worldwide marketing rights (currently excluding Scandinaviaand Japan), for GLIADEL(R). "We are pleased by RPR's commitment to expand the market forGLIADEL(R), both in Europe and in other international markets,"remarked Craig R. Smith, President and Chief Executive Officer ofGuilford. "Their commitment to the field of oncology is wellestablished, and we are very pleased by their ability to secureregulatory approval for GLIADEL(R) throughout Europe." Marketing authorization is the first of several stepsnecessary to market GLIADEL(R). Additional labeling and pricingapprovals are required before GLIADEL(R) may be launched in mostEuropean and international markets. If RPR obtains these Europeanapprovals for the current labeled indication, Guilford iseligible to receive milestone payments. GLIADEL(R) offers an important treatment option forneurosurgeons and complements other standard therapies for braincancer. In a randomized clinical trial, GLIADEL(R) was shown toprolong survival in patients with GBM for whom surgical resectionis indicated. In this multicenter study involving 145 patientswith recurrent GBM, GLIADEL(R) increased six month survival from36% with placebo to 56% with GLIADEL(R). The spectrum of adverse events observed in patients withrecurrent malignant glioma who received GLIADEL(R) or placebo wasconsistent with that encountered in patients undergoingcraniotomy for malignant gliomas. Clinically relevant sideeffects that were more common with GLIADEL(R) versus placeboincluded healing abnormalities, brain edema, and intracranialinfections. Seizures that occurred in patients receivingGLIADEL(R) had a much earlier onset, although the incidence ofseizures was the same in the placebo and GLIADEL(R) groups. Rhone-Poulenc Rorer is a global pharmaceutical subsidiary ofRhone-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; Euros13.232 billion), Rhone-Poulenc employs 65,000 people in 160countries worldwide. The RPR Internet website is athttp://www.rp-rorer.com. Guilford Pharmaceuticals Inc. is a biopharmaceutical companyengaged in the development of polymer-based therapeutics forcancer, and novel products for the diagnosis and treatment ofneurological diseases, including Parkinson's disease, Alzheimer'sdisease, stroke, severe head trauma, spinal cord injuries,multiple sclerosis and peripheral neuropathies. The GuilfordInternet website is http://www.guilfordpharm.com. ots OriginalText 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 GuilfordPharmaceuticals, 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 Website: http://www.guilfordpharm.com
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