Celgene Corporation
Jan 7, 2014
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ABRAXANE® Plus gemcitabine Receives European Marketing Authorization for First-Line Treatment of Patients with Metastatic Pancreatic Cancer

First new treatment to be approved for pancreatic cancer in nearly seven years, highlighting the challenges and unmet needs in treating the disease

BOUDRY, Switzerland--()--Celgene International Sàrl, a wholly-owned subsidiary of Celgene Corporation (NASDAQ: CELG), today announced that the European Commission (EC) has granted approval for ABRAXANE (paclitaxel formulated as albumin bound nanoparticles, or nab-paclitaxel) in combination with gemcitabine for first-line treatment of adult patients with metastatic adenocarcinoma of the pancreas, or metastatic pancreatic cancer.1

“With such low survival rates for this disease, the situation for patients and their families is really very poor. But now, we have been able to show that the addition of nab-paclitaxel to conventional treatment with gemcitabine provides substantial benefits in overall survival, with manageable side effects”



During the last few decades, little progress has been made in improving outcomes for patients diagnosed with pancreatic cancer. According to the European Cancer Observatory, 78,654 people were diagnosed with pancreatic cancer in the EU in 2012, and 77,940 died that same year.2 The mortality of pancreatic cancer is high, making it the fourth deadliest cancer for both men and women.3 Patients diagnosed with metastatic disease have a median life expectancy, after diagnosis, of approximately three to six months.4 There have been no new medications approved for pancreatic cancer in nearly seven years.

“With such low survival rates for this disease, the situation for patients and their families is really very poor. But now, we have been able to show that the addition of nab-paclitaxel to conventional treatment with gemcitabine provides substantial benefits in overall survival, with manageable side effects,” said Josep Tabernero, MD, Head of the Medical Oncology Department at the Vall d'Hebron Institute of Oncology and the Vall d'Hebron University Hospital in Barcelona, Spain, and a primary investigator for the MPACT trial. “My perception is that this approval is going to mandate a change in the way that we treat patients, offering a new option with a good efficacy and safety profile.”

Alan Colowick, MD, President of Celgene Europe, the Middle East and Africa (EMEA), added: “ABRAXANE in combination with gemcitabine is the first treatment in Europe to be approved for pancreatic cancer in nearly seven years. In fact, since 1990, more than 30 Phase III trials have failed to lead to regulatory approval in the European Union for advanced or metastatic pancreatic cancer. Today’s announcement is a significant step forward, but it is by no means the end for Celgene. We remain committed to developing innovative treatments to improve the lives of those with this devastating disease.”

The EC decision was based on the results of the MPACT (Metastatic Pancreatic Adenocarcinoma Clinical Trial), an open-label, Phase III, randomized, international study published in the New England Journal of Medicine in its 31 October 2013 edition. The MPACT study involved 861 chemotherapy-naïve patients with metastatic pancreatic cancer at 151 community and academic centers from 11 countries, including North America, Eastern and Western Europe, and Australia. In the study, ABRAXANE plus gemcitabine demonstrated a statistically significant improvement in median overall survival compared to gemcitabine alone (8.5 vs. 6.7 months) (HR 0.72, P<0.0001); a 28% overall reduction in risk of death.5

Grade 3 and higher adverse events that were reported more often with ABRAXANE plus gemcitabine versus gemcitabine alone were neutropenia, fatigue, and peripheral neuropathy.5

The EC decision follows the positive opinion issued by the Committee for Medicinal Products for Human Use (CHMP) in November 2013.6

ABRAXANE will be launched in the European Union in the coming months according to local requirements.

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 European countries covered by the European Commission, ABRAXANE was approved in January 2008 as monotherapy for the treatment of metastatic breast cancer (MBC) in adult patients who have failed first-line treatment for metastatic disease and for whom standard, anthracycline containing therapy is not indicated.

In the United States, ABRAXANE was first approved in January 2005 by the U.S. Food and Drug Administration (FDA) for the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within six 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 MBC.

In October 2012, ABRAXANE was approved by the FDA for 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 Based on Approved U.S. Label

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 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 Sàrl, located in Boudry, Switzerland, is a wholly owned subsidiary and international headquarters of Celgene Corporation. 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.

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References

1 ABRAXANE Summary of Product Characteristics

2 European Cancer Observatory. Pancreatic cancer. http://eu-cancer.iarc.fr/EUCAN/Cancer.aspx?Cancer=15 Accessed December 2013

3 Malvezzi M et al. Ann Oncol 2013;24:792-800

4 Huggett MT et al. Practitioner. 2011 ; 255(1742): 21–3.

5 Von Hoff DD et al. N Engl J Med 2013;369:1691-1703

6 European Medicines Agency, Committee for Medicinal Products for Human Use (CHMP). Summary of opinion – ABRAXANE (available online at: http://www.ema.europa.eu/docs/en_GB/document_library/Press_release/2013/11/WC500155476.pdf )

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