Guilford Receives $2.5 Million Milestone Payment for
2.08.1999, 17:57
GLIADEL(R) Wafer in France Baltimore (PROTEXT) - Guilford Pharmaceuticals Inc. (Nasdaq:GLFD) today announced that it has received a $2.5 millionmilestone payment from Rhone-Poulenc Rorer Pharmaceuticals Inc.(RPR) for regulatory developments relating to GLIADEL(R) Wafer inFrance. GLIADEL(R) Wafer has been approved for use in France as anadjunct to surgery to prolong survival in patients with recurrentglioblastoma multiforme (GBM), one of the most common and rapidlyfatal forms of malignant brain cancer. A positive ruling (avisfavorable) has been obtained from the Commission de laTransparence, clearing the way for sale of GLIADEL(R) Wafer tohospitals in France upon publication of the ruling, which isexpected later this quarter. "We are strongly committed to expanding the market forGLIADEL(R) Wafer and making it available to more patientsworldwide," said Craig R. Smith, M.D., President and ChiefExecutive Officer. "In June, we announced that GLIADEL(R) Waferhad received a favorable opinion for marketing authorization inten European countries. We are pleased to report that Ireland andLuxembourg have now granted marketing authorization for theproduct, and we look forward to receiving notice of additionalEuropean marketing authorizations in the coming months." As the first significant new treatment for brain cancer inover 20 years, GLIADEL(R) Wafer 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) Wafer is a biodegradable polymer wafer that isimplanted in the cavity created when a brain tumor is surgicallyremoved. As the wafer slowly erodes in the brain, it releases thecancer chemotherapeutic drug carmustine (BCNU) directly to thetumor site in high concentrations over an extended period oftime. GLIADEL(R) Wafer offers an important new treatment option forneurosurgeons and complements other standard therapies for braincancer. In a randomized clinical trial, GLIADEL(R) Wafer wasshown to prolong survival in patients with GBM for whom surgicalresection is indicated. In a multicenter study involving 145patients with recurrent GBM, GLIADEL(R) Wafer increased six monthsurvival by more than 50%, from 36% with placebo to 56% withGLIADEL(R) Wafer. In a separate Scandinavian study involving 32patients undergoing surgery at the time of their initialdiagnosis, survival at one year was 63% for GLIADEL(R) Wafercompared to 19% for placebo. 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 Company desires to take advantage of the "safe harbor"provision of the Private Securities Litigation Reform Act of1995. This press release contains forward-looking statements thatinvolve risks and uncertainties. The Company describes certain ofthese risks and uncertainties in its filings with the SEC,including the section entitled "Risk Factors'' contained in theCompany's Registration Statement on Form S-3, filed on July 7,1999. These risk and uncertainties could cause the Company'sactual results and experience to differ materially fromanticipated results and expectations expressed in these forward-looking statements. In particular, the timing of officialpublications of regulatory approval, if any, in France and othercountries cannot be assured. Furthermore, the Company cannot besure that any future sales of GLIADEL(R) Wafer in France will besignificant, that efforts to obtain additional approvals tomarket and sell GLIADEL(R) Wafer in other countries for therecurrent or first surgery indications will be successful andpermit sales at prices acceptable to the Company and RPR, andthat the Company will receive any of the payments from RPRassociated with such regulatory milestones. Internet address: http://www.guilfordpharm.com For Press Releases: http://www.prnewswire.com ots OriginalText Service: Guilford Pharmaceuticals Inc. Internet:http://www.newsaktuell.de Contact: Stacey Jurchison or AngelaRubin, Corporate Communications of Guilford Pharmaceuticals,(USA) 410-631-6300 Company News On-Call:http://www.prnewswire.com/comp/112882.html or Fax, (USA) 800-758-5804, ext. 112882 Web site: http://www.guilfordpharm.com
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