ABRAXANE® Now Reimbursed in Italy as a First-Line Treatment of Adult Patients with Metastatic Pancreatic Cancer

The Italian Medicines Agency recognises ABRAXANE as first innovative treatment for metastatic pancreatic cancer to be approved in the last 8 years

BOUDRY, Switzerland--()--Celgene International Sàrl, a wholly owned subsidiary of Celgene Corporation (NASDAQ: CELG), today announced that Italian authorities have issued a positive decision for NHS reimbursement of ABRAXANE® (paclitaxel formulated as albumin-bound nanoparticles, or nab-paclitaxel) in combination with gemcitabine, for the first-line treatment of patients with metastatic adenocarcinoma of the pancreas, or pancreatic cancer. For the first time in this disease, the Italian Medicines Agency (AIFA) has recognised the important innovation that ABRAXANE brings as a therapeutic treatment for pancreatic cancer.

The reimbursement decision has been published in the Italian Official Gazette no. 30, dated 6 February 2015, and it follows the December 2013 European Commission (EC) approval of ABRAXANE for this indication. ABRAXANE has been available and reimbursed in Italy for the treatment of metastatic breast cancer since 2011.

During the last few decades, little progress has been made in improving outcomes for patients diagnosed with pancreatic cancer. The mortality of pancreatic cancer is high, making it the fourth deadliest cancer for both men and women.1 Patients diagnosed with metastatic disease have a median life expectancy, after diagnosis, of approximately three to six months. There have been no new medications approved for pancreatic cancer in eight years.

“Since 1990, more than 30 Phase III trials in pancreatic cancer have failed to lead to regulatory approval in the European Union. Today’s announcement that patients in Italy are now able to access ABRAXANE, the first approved medication in eight years for metastatic pancreatic cancer, is a particularly important milestone that reinforces our commitment at Celgene to develop innovative treatments for debilitating diseases,” says Gianni de Crescenzo, Celgene Italy’s Medical Director.

AIFA’s approval of the reimbursement of ABRAXANE comes approximately one year after the European Commission’s approval of ABRAXANE. The EC decision was based on results from the MPACT (Metastatic Pancreatic Adenocarcinoma Clinical Trial) study, published in the October 2013 edition of the New England Journal of Medicine, which demonstrated an increase in median overall survival of 1.8 months with ABRAXANE plus gemcitabine when compared with gemcitabine alone [(8.5 months vs. 6.7 months respectively) (HR 0.72; P<0.001)].2 Grade 3 and higher adverse events that were reported more often with ABRAXANE plus gemcitabine versus gemcitabine alone were neutropenia, fatigue, and peripheral neuropathy.2

Most recently, the Scottish Medicines Consortium granted a positive reimbursement decision in February 2015 for the medicine. Celgene announced the positive CHMP opinion for ABRAXANE in non-small cell lung cancer in January; a European Commission decision is expected in the coming months.

About ABRAXANE® (nab-paclitaxel)

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.

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 6 months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated. In Europe, ABRAXANE was approved in January 2008 as monotherapy for the treatment of metastatic breast cancer in adult patients who have failed first-line treatment for metastatic disease and for whom standard, anthracycline containing therapy is not indicated. ABRAXANE is now approved in more than 50 countries 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 (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, Chile, Ecuador, Guatemala, Hong Kong, Japan, New Zealand and Singapore.

In September 2013, the FDA approved ABRAXANE as first–line treatment of patients with metastatic adenocarcinoma of the pancreas, in combination with gemcitabine. In December 2013, ABRAXANE in combination with gemcitabine was approved for first-line treatment of adult patients with metastatic adenocarcinoma of the pancreas in Europe. ABRAXANE is also approved for the treatment of metastatic pancreatic cancer in more than 40 countries.

Please refer to the Summary of Product Characteristics for full European prescribing information.

About Celgene

Celgene Corporation, headquartered in Summit, New Jersey, is an integrated global biopharmaceutical company engaged primarily in the discovery, development and commercialisation of innovative therapies for the treatment of cancer and inflammatory diseases through gene and protein regulation. For more information, please visit www.celgene.com. You can also follow Celgene on Social Media: @CelgenePinterestLinkedIn and YouTube.

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 Celgene Corporation’s Annual Report on Form 10-K and other reports filed with the Securities and Exchange Commission.

All registered trademarks are owned by Celgene Corporation.

# # #

References

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

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

Contacts

Celgene
Investors:
+41 32 729 8303 ir@celgene.com
or
Media:
+41 32 729 8304 media@celgene.com

Contacts

Celgene
Investors:
+41 32 729 8303 ir@celgene.com
or
Media:
+41 32 729 8304 media@celgene.com