Celgene Corporation
Jun 6, 2012
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Celgene Advances ABRAXANE® (nab-paclitaxel) Development in Difficult-to-Treat Cancers

Phase III randomized clinical study in metastatic pancreatic cancer completed enrollment

sNDA submitted to U.S. FDA in non-small cell lung cancer, PDUFA date Oct. 12, 2012

CALGB 40502 advances understanding of optimal dosing and scheduling of nab-paclitaxel in metastatic breast cancer

BOUDRY, Switzerland--(BUSINESS WIRE)--Jun. 6, 2012-- Celgene International Sàrl, a subsidiary of Celgene Corporation (NASDAQ: CELG) today announced a series of milestones related to the development of ABRAXANE (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) in metastatic pancreatic cancer, advanced non-small cell lung cancer, metastatic breast cancer and metastatic melanoma.

The company completed enrollment in the largest phase III study of metastatic pancreatic cancer to date (NCI clinical trial reference number NCT00844649). In this global study, 861 patients were randomized to receive either nab-paclitaxel plus gemcitabine or gemcitabine alone. Results from the study with a primary endpoint of overall survival are expected during the second half of 2012. The design of the study is based on the promising results of a phase I/II study in 67 patients published in the Journal of Clinical Oncology in December 2011 (Von Hoff et al, 2011 JCO).

In advanced non-small cell lung cancer, additional regulatory submissions were filed in Japan, Australia and New Zealand, which were based on the positive randomized phase III study reported online in the Journal of Clinical Oncology (Socinski et al, 2012 JCO (epub)). In the United States, the Food and Drug Administration (FDA) has set a PDUFA date of Oct. 12, 2012.

At the American Society of Clinical Oncology (ASCO) 2012 annual meeting, results of Cancer and Leukemia Group B (CALGB) study 40502 were presented evaluating bevacizumab in combination with nab-paclitaxel administered weekly at a dose of 150 mg/m2, which is significantly higher than the approved dose intensity*(Abstract #CRA1002). The study reported that bevacizumab plus nab-paclitaxel was not superior to bevacizumab plus paclitaxel and was associated with increased toxicity and earlier treatment discontinuations in patients receiving first-line therapy for metastatic breast cancer (MBC).

The data presented at ASCO does not impact the body of breast cancer data for nab-paclitaxel monotherapy which has demonstrated significantly superior efficacy and an acceptable safety profile compared to paclitaxel in a randomized Phase III clinical study** that was the basis for nab-paclitaxel approvals in more than 40 countries for the treatment of MBC.

Celgene will use the CALGB 40502 efficacy and safety data to inform the next stage of development of nab-paclitaxel across all stages of breast cancer. The company continues to explore how the molecular characteristics of tumors can be utilized to optimize therapy for patients.

The company plans to support studies that will enroll more than 4,000 patients in the potentially curative, neo-adjuvant treatment setting. The company will work with study investigators to incorporate recent U.S. Food and Drug Administration Guidance for Industry on pathological complete response (pCR) as the endpoint in neoadjuvant (preoperative) treatment of breast cancer to support accelerated approval. This process is intended to incorporate therapies into standard treatment for early-stage breast cancer as rapidly as possible to provide greatest benefit to the most patients.

As a result of the recent changes in the treatment landscape of metastatic melanoma, Celgene is incorporating correlative analyses into its ongoing randomized phase III study of nab-paclitaxel (150 mg/m2 weekly) single-agent versus dacarbazine, including BRaF mutational status (NCI clinical trial reference number NCT00864253). This study completed enrollment in the second quarter of 2011.

*The 150 mg/m2 weekly dose is targeted to have 30% higher weekly dose intensity than the approved dose of 260 mg/m2 every 3 weeks.

**J Clin Oncol. 2005;23(31):7794-7803

About the CALGB 40502 Study

CALGB 40502 was a three-arm study of patients with first-line metastatic breast cancer in which patients were randomized to bevacizumab combined with either nab-paclitaxel, ixabepilone, or paclitaxel. The study enrolled 799 of 900 planned patients (Abstract #CRA1002).

ABRAXANE® for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension) 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.

Important Safety Information

WARNING - NEUTROPENIA

CONTRAINDICATIONS

Neutrophil Counts

Hypersensitivity

WARNINGS AND PRECAUTIONS

Hematologic Effects

Nervous System

Hepatic Impairment

Albumin (Human)

Use in Pregnancy: Pregnancy Category D

Use in Men:

ADVERSE REACTIONS - Randomized Metastatic Breast 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 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.

Source: Celgene International Sàrl

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