YM BIOSCIENCES ANNOUNCES FDA LIFTS CLINICAL HOLD ON AEROLEF(R) AND CLEARANCE OF A PHASE II CLINICAL TRIAL
AeroLEF is being developed as a novel and effective approach to themanagement of acute pain by delivering a proprietary formulation of inhaled,nebulized, free-and-liposome-encapsulated fentanyl. The free fentanyl resultsin rapid onset of analgesia while the liposome-encapsulated fentanyl producesthe unique extended duration of pain relief. The FDA cleared a Phase IIprotocol in June 2007 to proceed with AeroLEF's first trial in the US,however, immediately prior to the End-of-Phase II meeting scheduled and heldin January 2008, the FDA imposed a Clinical Hold, now lifted.
YM is also pleased to announce that Dr. Ali Raza has been engaged asPresident of the AeroLEF Division to lead the product's further development.Dr. Raza has held a number of leadership roles in established anddevelopment-stage pharmaceutical companies. He led the global development ofCRESTOR(R) (rosuvastatin), a product approved in more than 60 countries andwhich is competing for market leadership with Lipitor(R). Earlier this year heachieved regulatory clearance for and initiated a major Phase III clinicalprogram for a fentanyl product being developed in more than 50 researchcenters in Europe.
"I am delighted to have joined the AeroLEF team at YM BioSciences and lookforward to moving rapidly to the late-stage, international development of thisunique product," said Dr. Raza.
"We welcome Dr. Raza and have high confidence that his breadth ofexperience in global drug development will significantly reinforce our team'sability to realize the substantial value of AeroLEF's unique approach to thetreatment of pain. The scientific pedigree and unique advantages of thisproduct have been established and safety and efficacy data have been reportedfrom previous clinical trials, including in three poster presentations at theAnnual Meeting of the American Pain Society in May 2008," said David Allan,Chairman and CEO. "We also greatly appreciate the timely review by the FDA toour responses and the constructive approach of the Agency."
About YM BioSciences
YM BioSciences Inc. is an oncology company that identifies, develops andcommercializes differentiated products for patients worldwide. In addition toAeroLEF, the Company's other late-stage product, nimotuzumab, is a humanizedmonoclonal antibody that targets the epidermal growth factor receptor (EGFR).It is approved in several countries for treatment of various types of head andneck cancer.
This press release may contain forward-looking statements, which reflectthe Company's current expectation regarding future events. Theseforward-looking statements involve risks and uncertainties that may causeactual results, events or developments to be materially different from anyfuture results, events or developments expressed or implied by suchforward-looking statements. Such factors include, but are not limited to,changing market conditions, the successful and timely completion of clinicalstudies, the establishment of corporate alliances, the impact of competitiveproducts and pricing, new product development, uncertainties related to theregulatory approval process and other risks detailed from time to time in theCompany's ongoing quarterly and annual reporting. Certain of the assumptionsmade in preparing forward-looking statements include but are not limited tothe following: that nimotuzumab will continue to demonstrate a competitivesafety profile in o
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