Celgene Corporation
Oct 16, 2013
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ABRAXANE® Phase III Study of Patients with Metastatic Pancreatic Cancer Published in New England Journal of Medicine

BOUDRY, Switzerland--(BUSINESS WIRE)--Oct. 16, 2013-- Celgene International Sàrl, a wholly-owned subsidiary of Celgene Corporation (NASDAQ:CELG), today announced the results of the MPACT (Metastatic Pancreatic Adenocarcinoma Clinical Trial) phase III clinical trial of ABRAXANE® (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) in combination with gemcitabine were published online in the October 16th edition of the New England Journal of Medicine.

The MPACT study, chaired by lead author and study principal investigator, Dr. Daniel D. Von Hoff, Chief Scientific Officer for Scottsdale Healthcare’s Virginia G. Piper Cancer Center Clinical Trials and Physician-In-Chief for the Translational Genomics Research Institute (TGen), is a Celgene-sponsored, open-label, randomized, study of 861 previously untreated patients with metastatic pancreatic cancer at 151 community and academic centers from 11 countries in North America, Eastern and Western Europe and Australia. The article, titled “Increased Survival in Pancreatic Cancer with nab-Paclitaxel plus Gemcitabine,” is available online at http://www.nejm.org/doi/full/10.1056/NEJMoa1304369 for the citation Von Hoff DD, Ervin T, Arena FP, et al. Increased survival in pancreatic cancer with nab-paclitaxel plus gemcitabine. N Engl J Med 2013. DOI: 10.1056/NEJMoa1304369.

“The peer-reviewed publication of the MPACT results in the New England Journal of Medicine further validates the importance of this treatment regimen,” said Markus Renschler, M.D., Corporate Vice President, Global Head of Hematology and Oncology Medical Affairs at Celgene Corporation. “These results led to the U.S. Food and Drug Administration’s approval of ABRAXANE for the first-line treatment of patients with metastatic adenocarcinoma of the pancreas, in combination with gemcitabine.”

About the MPACT Study

In the MPACT (Metastatic Pancreatic Adenocarcinoma Clinical Trial) study, a Celgene-sponsored, open-label, randomized, international study, a total of 861 patients were randomized 1:1 (431 patients to the ABRAXANE/gemcitabine group and 430 patients to the gemcitabine group). Patients randomized to ABRAXANE/gemcitabine received ABRAXANE as an intravenous infusion over 30-40 minutes at a dose of 125 mg/m2 followed by gemcitabine as an intravenous infusion over 30-40 minutes at a dose of 1000 mg/m2 given on Days 1, 8 and 15 of each 28-day cycle. In the comparator treatment group, gemcitabine monotherapy was administered at a dose of 1000 mg/m2 given weekly for 7 weeks followed by a 1-week rest period in Cycle 1 and in Cycle 2 and onwards was administered on Days 1, 8 and 15 of a 28 day cycle. The primary endpoint for the study was overall survival. Secondary endpoints were progression-free survival and overall response rate determined by independent radiological review. Other endpoints included progression-free survival and overall response rate as determined by the investigator, and the safety and tolerability of the combination in this patient population.

About Pancreatic Cancer

Pancreatic cancer is the fourth-leading cause of cancer-related deaths in the United States and Europe. There are two main types of pancreatic cancer tumors: exocrine and neuroendocrine. Adenocarcinoma is a sub-type of exocrine tumors and accounts for about 95% of cancers of the pancreas. More than half of patients with pancreatic cancer are diagnosed after their cancer has already spread. The average life expectancy after diagnosis with metastatic disease is only three months.

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 has been globally approved in more than forty countries for the treatment of metastatic breast cancer (MBC).

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

In September 2013, the FDA approved ABRAXANE as first–line treatment of patients with metastatic adenocarcinoma of the pancreas, in combination with gemcitabine.

Important Safety Information about ABRAXANE

WARNING - NEUTROPENIA

CONTRAINDICATIONS

Neutrophil Counts

Hypersensitivity

WARNINGS AND PRECAUTIONS

Hematologic Effects

Nervous System

Sepsis

Pneumonitis

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 Cancer (NSCLC) Study

Pancreatic Adenocarcinoma Study

Postmarketing 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 at http://abraxane.com/downloads/Abraxane_PrescribingInformation.pdf

About Celgene

Celgene International Sàrl, located in Boudry, Switzerland, is a wholly-owned subsidiary and international headquarters of Celgene Corporation. 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. For more information, please visit 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. Celgene Corporation undertakes 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 Celgene Corporation’s Annual Report on Form 10-K and its other reports filed with the Securities and Exchange Commission.

Source: Celgene International Sàrl

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