Celgene Corporation
May 23, 2013
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Celgene Announces U.S. FDA Grants Priority Review for ABRAXANE® sNDA in Advanced Pancreatic Cancer

European Medicines Agency Accepts Regulatory Submission of Type II Variation for ABRAXANE for the Treatment of Advanced Pancreatic Cancer

BOUDRY, Switzerland--(BUSINESS WIRE)--May. 23, 2013-- Celgene International Sàrl, a subsidiary of Celgene Corporation (Celgene) (NASDAQ: CELG) today announced that the U.S. Food and Drug Administration (FDA) has assigned a Priority Review designation to the supplemental New Drug Application (sNDA) for the use of ABRAXANE® (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) in combination with gemcitabine for the first–line treatment of patients with advanced pancreatic cancer.

The FDA grants Priority Review to medicines that, if approved, have the potential to offer significant improvement compared to marketed products or provide a treatment where no adequate therapy exists. The goal for completing a Priority Review is six months. The Prescription Drug User Fee Act (PDUFA) date for the sNDA for ABRAXANE is set for September 21, 2013.

In April 2013, the European Medicines Agency (EMA) has also accepted for review a Type II Variation to the current Marketing Authorization Application (MAA) for ABRAXANE, in combination with gemcitabine, for the first–line treatment of patients with advanced pancreatic cancer. Celgene plans to submit dossiers for registration in other countries/regions during 2013.

Both applications included data from an open-label, phase III, randomized, international study, Metastatic Pancreatic Adenocarcinoma Clinical Trial (MPACT) involving 861 patients with metastatic pancreatic cancer. Results from this study were recently presented at the American Society of Clinical Oncology’s (ASCO) 2013 Gastrointestinal Cancers Symposium in January.

Celgene is preparing a development plan for a phase III, international, multicenter, randomized controlled trial evaluating the activity of ABRAXANE plus gemcitabine in the adjuvant pancreatic cancer setting.

ABRAXANE is not currently approved for the treatment of advanced pancreatic cancer.

About Pancreatic Cancer

Pancreatic cancer is the eighth leading cause of cancer-related death worldwide and the fourth leading cause of cancer-related death in the US. The pancreas is composed of two main cell types: exocrine and endocrine. Exocrine tumors are by far the most common type of pancreatic cancer, with adenocarcinoma accounting for about 95 percent of cancers of the pancreas. For all stages of pancreatic cancer combined, the 5-year overall survival rate is about 6 percent, which is the lowest 5-year overall survival rate of any cancer in the US. In Europe, the reported survival rate is less than 10 percent survival at five years.

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.

In the United States, ABRAXANE was first approved in January 2005 for the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated. ABRAXANE is also approved in Canada, India, European Union/European Economic Area (EU/EEA), South Korea, China, Australia, Bhutan, United Arab Emirates, Nepal, New Zealand, Japan, Russia, Sri Lanka, and Argentina for the treatment of metastatic breast cancer.

In October 2012, ABRAXANE was approved by the FDA for the first-line treatment of locally advanced or metastatic non-small cell lung cancer, in combination with carboplatin, in patients who are not candidates for curative surgery or radiation therapy. ABRAXANE is also approved in Japan and Argentina for the treatment of non-small cell lung cancer and is approved in Japan for the treatment of gastric cancer.

ABRAXANE is currently in various stages of investigation for the potential treatment of the following cancers: melanoma, bladder, ovarian, and expanded applications for breast, lung, and pancreatic cancer.

U.S. Regulatory Information for ABRAXANE

ABRAXANE® for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension)(albumin-bound) is indicated for the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated.

ABRAXANE is indicated for the first-line treatment of locally advanced or metastatic non-small cell lung cancer, in combination with carboplatin, in patients who are not candidates for curative surgery or radiation therapy.

Important Safety Information

WARNING - NEUTROPENIA

CONTRAINDICATIONS

Neutrophil Counts

Hypersensitivity

WARNINGS AND PRECAUTIONS

Hematologic Effects

Nervous System

Hypersensitivity

Hepatic Impairment

Albumin (Human)

Use in Pregnancy: Pregnancy Category D

Use in Men

ADVERSE REACTIONS

Randomized Metastatic Breast Cancer (MBC) Study

Non-Small Cell Lung (NSCLC) Cancer Study

Post-marketing Experience with ABRAXANE and Other Paclitaxel Formulations

DRUG INTERACTIONS

USE IN SPECIFIC POPULATIONS

Nursing Mothers

Pediatric

Geriatric

Renal Impairment

DOSAGE AND ADMINISTRATION

Please see full Prescribing Information, including Boxed WARNING, CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS, and ADVERSE REACTIONS, please visit http://www.abraxane.com/docs/Abraxane_PrescribingInformation.pdf

About Celgene

Celgene Corporation, headquartered in Summit, New Jersey, is an integrated global pharmaceutical company engaged primarily in the discovery, development and commercialization of innovative therapies for the treatment of cancer and inflammatory diseases through gene and protein regulation.

Celgene International Sárl, located in Boudry, Switzerland, is a wholly owned subsidiary and international headquarters of Celgene Corporation. For more information, please visit the Company's website at www.celgene.com.

Forward-Looking Statements

This press release contains forward-looking statements, which are generally statements that are not historical facts. Forward-looking statements can be identified by the words "expects," "anticipates," "believes," "intends," "estimates," "plans," "will," “outlook” and similar expressions. Forward-looking statements are based on management’s current plans, estimates, assumptions and projections, and speak only as of the date they are made. We undertake no obligation to update any forward-looking statement in light of new information or future events, except as otherwise required by law. Forward-looking statements involve inherent risks and uncertainties, most of which are difficult to predict and are generally beyond our control. Actual results or outcomes may differ materially from those implied by the forward-looking statements as a result of the impact of a number of factors, many of which are discussed in more detail in our Annual Report on Form 10-K and our other reports filed with the Securities and Exchange Commission.

Source: Celgene Corporation

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