Celgene Corporation
Oct 25, 2012
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ABRAXANE® Demonstrates Significant Improvement in Progression-Free Survival Compared to Standard Chemotherapy in Advanced Melanoma Patients

Society for Melanoma Research Abstracts Published Online in Organization’s Journal

BOUDRY, Switzerland--(BUSINESS WIRE)--Oct. 25, 2012-- Celgene International Sàrl, a subsidiary of Celgene Corporation (NASDAQ: CELG) today announced that abstracts for the upcoming Society for Melanoma Research meeting have been published online in the organization’s official journal at http://onlinelibrary.wiley.com/doi/10.1111/pcmr.12023/abstract. The publication includes an abstract reviewing results from a phase III metastatic melanoma study with ABRAXANE® (paclitaxel protein-bound particles for injectable suspension) (albumin-bound).

In the randomized, open-label, international study (CA033), ABRAXANE showed a statistically significant improvement in progression-free survival (PFS) in chemotherapy-naïve patients with metastatic melanoma compared to patients receiving dacarbazine chemotherapy (4.8 vs. 2.5 months, respectively (HR:0.792; 95.1% CI: 0.631, 0.992; P=0.044)). An interim analysis of overall survival, the secondary endpoint, shows a trend in favor of the ABRAXANE arm compared to treatment with dacarbazine (12.8 and 10.7 months, respectively (HR:0.831; 99.9% CI: 0.578, 1.196; P=0.094)).

“Metastatic melanoma presents significant treatment challenges due in part to limited therapies, low survival rates at diagnosis and no advances in chemotherapy in thirty-seven years,” said Dr. Evan M. Hersh, lead principal investigator and Professor of Medicine at the University of Arizona College of Medicine and Arizona Cancer Center, Tucson, AZ. “Despite advances with targeted treatment and immunotherapies, there is still a need for new agents including chemotherapy treatments for patients with metastatic melanoma.”

The safety profile of ABRAXANE observed in the CA033 study is comparable with other ABRAXANE pivotal clinical trials. The most common grade ≥3 treatment-related adverse events reported in ≥10% patients were neuropathy (ABRAXANE: 25% vs. dacarbazine: 0%), neutropenia (ABRAXANE: 20% vs. dacarbazine: 10%). The median time to neuropathy improvement with ABRAXANE was 28 days.

These results will be presented at the Society for Melanoma Research 2012 Congress on Sunday, November 11th, in Hollywood, CA.

Future regulatory and clinical strategies are being reviewed in light of these results.

These results are from an investigational study. ABRAXANE is not approved for the treatment of metastatic melanoma.

About the Study

CA033 is a phase III randomized, open-label, international study that evaluated the safety and efficacy of ABRAXANE versus standard chemotherapy, dacarbazine in chemotherapy-naïve patients with stage IV metastatic melanoma. The majority of the patients were males (66%), had an ECOG status of 0 (71%), and had very advanced metastatic disease (M1c stage: 65%). Dacarbazine is the only chemotherapy approved since 1975 by the U.S. Food and Drug Administration for metastatic melanoma.

In the CA033 study, 529 chemotherapy-naïve patients were randomized to receive either ABRAXANE (150mg/m2 weekly for 3 out of 4 weeks) (n=264) or standard chemotherapy, dacarbazine (1000 mg/m2 every three weeks) (n=265). The primary endpoint was progression-free survival (PFS) based on blinded assessment of CT scans obtained every 8 weeks, evaluated per RECIST. The secondary endpoint was OS and other endpoints included objective response rate (ORR), disease control rate (DCR), and safety/tolerability.

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 available in Europe, Canada, Russia, Australia, New Zealand, India, South Korea, Bhutan, Nepal, United Arab Emirates and China for the treatment of metastatic breast cancer.

In October 2012, ABRAXANE was approved by the U.S. Food and Drug Administration 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.

For the full prescribing information for ABRAXANE please visit http://www.abraxane.com.

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

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.

About Melanoma

Melanoma is a form of skin cancer characterized by the uncontrolled growth of pigment-producing cells (melanocytes) located in the skin. When melanoma is diagnosed early, it is generally a curable disease. However, when it spreads to other parts of the body, it is the deadliest and most aggressive form of skin cancer. A person with metastatic melanoma typically has on average a short life expectancy that is measured in months. According to the World Health Organization, approximately 132,000 new cases of melanoma are diagnosed each year globally. The incidence of melanoma has increased ten-fold over the past 50 years, and has steadily increased since the 1970s. The American Cancer Society estimates there will be more than 76,000 new cases of melanoma and nearly 9,200 melanoma deaths this year in the United States.

About Celgene International Sàrl

Celgene International Sàrl, located in Boudry, in the Canton of Neuchâtel, 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 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.



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