Health Canada Approves ABRAXANE® Plus Gemcitabine for First-Line Treatment of Patients with Metastatic Pancreatic Cancer High unmet need addressed with first new approved treatment in eighteen years MISSISSAUGA, ON – (August 6, 2014) – Health Canada has approved PrABRAXANE® for Injectable Suspension (paclitaxel powder for injectable suspension) (nanoparticle, albumin-bound [nab®] paclitaxel) for first-line treatment of adult patients with metastatic pancreatic cancer. The approval is welcome news for Canadians who are diagnosed with metastatic pancreatic cancer, and represents the first approved treatment for this disease in nearly two decades. The Health Canada approval was based on the results of MPACT (Metastatic Pancreatic Adenocarcinoma Clinical Trial), an open-label, phase III, randomized, international study which was published in the New England Journal of Medicine in October 2013. The MPACT study involved 861 chemotherapy-naïve patients with metastatic pancreatic cancer from 11 countries, including Canada, and showed a statistically significant improvement in median overall survival with ABRAXANE plus gemcitabine compared to gemcitabine alone (8.5 vs. 6.7 months) (HR 0.72, P<0.0001); a 28% overall reduction in risk of death.1 “This is a cancer where there are few effective treatments and the first-line approval of ABRAXANE in combination with gemcitabine represents an important advance,” said. Dr. Malcolm J. Moore, Program Head, Medical Oncology and Hematology and Director, McCain Centre for Pancreatic Cancer at the Princess Margaret Cancer Centre, University Health Network in Toronto and an investigator in the MPACT trial. “This approval will certainly have an impact on the way physicians manage this disease in the future. Pancreatic cancer is a tough one to deal with; patients are desperate and physicians are on the lookout for new advances. The addition of ABRAXANE to gemcitabine has demonstrated significant benefits in overall survival and this gives our patients hope.” “It`s been quite some time since we’ve seen any type of treatment advance for pancreatic cancer making this news so important for patients. This will give patients the hope that is needed to continue to fight,” said Laurie Ellies, Co-founder, and Acting Executive Director of Pancreatic Cancer Canada. “Over the past decade, there has been a significant improvement in cancer survival rates. Sadly, the same cannot be said about pancreatic cancer. We’re dealing with a deadly disease. For a person diagnosed with metastatic disease it can be a question of weeks. This year alone, we can expect an estimated 4,700 Canadians will be diagnosed with this disease. If anything, this number tells us that we are desperately in need of more research and treatments - patients are counting on it.” ABRAXANE is commercially available in Canada. About Pancreatic Cancer Pancreatic cancer is the fourth-leading cause of cancer-related death in Canada.2 The pancreas is composed of two main cell types: exocrine and endocrine. Adenocarcinoma is a sub-type of exocrine tumors and accounts for about 95% of cancers of the pancreas.3 For all stages of pancreatic cancer combined, the five-year survival rate in Canada is about 8%. For metastatic pancreatic cancer, the five-year survival is approximately 2% in Canada.2 About ABRAXANE® ABRAXANE® is an albumin-bound form of paclitaxel that is manufactured using patented nab® technology. ABRAXANE is formulated with albumin, a human protein, and is free of solvents. The most common adverse reactions (≥ 20%) with a ≥ 5% higher incidence in the ABRAXANE/gemcitabine treatment group are neutropenia, fatigue, peripheral neuropathy, nausea, alopecia, peripheral edema, diarrhea, pyrexia, vomiting, decreased appetite, rash, and dehydration.4 Please refer to the ABRAXANE product monograph for complete safety information. ABRAXANE in combination with gemcitabine for the treatment of metastatic pancreatic cancer is approved in the United States and 30 other countries, including Argentina and Australia as well as countries in Europe. About Celgene Celgene Corporation is an integrated global biopharmaceutical company engaged primarily in the discovery, development and commercialization of novel therapies for the treatment of cancer and inflammatory diseases through gene and protein regulation. For more information, please visit the company's website at www.celgene.com. All trademarks used or mentioned in this release are protected by law. -30- FOR FURTHER INFORMATION, PLEASE CONTACT: Stephanie Convery, Weber Shandwick, (416) 642-7945, [email protected] 1 Von Hoff DD, Ervin T, Arena FP, et al. Increased Survival in Pancreatic Cancer with nab-Paclitaxel plus Gemcitabine. New England Journal of Medicine. 2013; 369(18):1691-703. 2 Canadian Cancer Society, Statistics Canada, Public Health Agency of Canada. Canadian Cancer Statistics 2014. Special topic: Skin cancers. Available at: http://www.cancer.ca/~/media/cancer.ca/CW/publications/Canadian%20Cancer%20Statistics%202014/C anadian-Cancer-Statistics-2014-EN.pdf Accessed August 5, 2014. 3 Canadian Cancer Society. Malignant tumours of the pancreas. Available at: http://www.cancer.ca/en/cancer-information/cancer-type/pancreatic/pathology-and-staging/malignanttumours/?region=on Accessed August 5, 2014. 4 ABRAXANE® Product Monograph. July 15, 2014. Celgene Corporation.