Celgene Corporation
Nov 22, 2013
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Celgene Receives Positive CHMP Opinion for ABRAXANE® in Combination with Gemcitabine as Treatment for Patients with Metastatic Pancreatic Cancer

BOUDRY, Switzerland--()--Celgene International Sàrl, a wholly-owned subsidiary of Celgene Corporation (NASDAQ: CELG), today announced that the European Medicines Agency’s (EMA): Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion 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.

“The positive CHMP opinion on ABRAXANE with gemcitabine for metastatic pancreatic cancer is a significant step toward bringing the first new treatment option in many years to people diagnosed with this deadly disease, which has seen multiple clinical trial failures over the years”



The CHMP reviews applications for all 28 member states in the European Union (EU), as well as Norway and Iceland. The European Commission, which generally follows the recommendation of the CHMP, is expected to make its final decision within two to three months.

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. Pancreatic cancer is currently the fourth most common cause of cancer death in the EU for men and women.1 Death rates from the disease are predicted to rise from 7.85 in 2009 to 8.01 in 2013 per 100,000 among men, and from 5.33 to 5.54 per 100,000 among women in same period.1 In fact, the pancreas is the only major cancer site for which no improvements in mortality rates is predicated for either sex.1 There have been no new treatments approved for pancreatic cancer in nearly seven years.

“The positive CHMP opinion on ABRAXANE with gemcitabine for metastatic pancreatic cancer is a significant step toward bringing the first new treatment option in many years to people diagnosed with this deadly disease, which has seen multiple clinical trial failures over the years,” said Alan Colowick, MD, President of Celgene Europe, the Middle East and Africa (EMEA). “Following a positive decision by the European Commission within the next few months, we hope to begin the important work of helping physicians and patients gain access to ABRAXANE plus gemcitabine, which has demonstrated statistically significant and clinically meaningful improvements in overall survival compared to gemcitabine alone, as reported recently in the New England Journal of Medicine.

The CHMP positive opinion 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 16 October 2013 e-publication. 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, nab-paclitaxel 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.2

Grade 3 and higher adverse events that were reported more often with nab-paclitaxel plus gemcitabine versus gemcitabine alone were neutropenia, leukopenia, fatigue, and peripheral neuropathy.

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 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.

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 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 Based on Approved U.S. Label

WARNING - NEUTROPENIA
-- Do not administer ABRAXANE therapy to patients who have baseline neutrophil counts of less than 1500 cells/mm3. In order to monitor the occurrence of bone marrow suppression, primarily neutropenia, which may be severe and result in infection, it is recommended that frequent peripheral blood cell counts be performed on all patients receiving ABRAXANE
-- Note: An albumin form of paclitaxel may substantially affect a drug’s functional properties relative to those of drug in solution. DO NOT SUBSTITUTE FOR OR WITH OTHER PACLITAXEL FORMULATIONS

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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1 Malvezzi M et al., Annals of Oncology 2013, 1-9

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

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