EX-99.4 5 a04-6885_1ex99d4.htm EX-99.4

Exhibit 99.4

 

 

 

 

SCIENTIFIC DATA PRESENTED AT ASCO ANNUAL MEETING

EVALUATING ERBITUX TM (Cetuximab) IN ADVANCED

NON-SMALL-CELL LUNG CANCER

 

NEW ORLEANS, June 7, 2004 – ImClone Systems Incorporated (Nasdaq: IMCL), Merck KGaA, Darmstadt, Germany (Frankfurt Stock Exchange: MRK), and Bristol-Myers Squibb Company (NYSE: BMY) today announced the results of two clinical studies of ERBITUX™ (Cetuximab) Injection, an IgG1 monoclonal antibody, in combination with standard chemotherapy in the first-line treatment of advanced non-small-cell lung cancer (NSCLC) and as a single agent in the treatment of patients with late-stage recurrent or metastatic NSCLC who have exhausted other treatment options.  These new data were presented at the American Society of Clinical Oncology (ASCO) 40th Annual Meeting.

 

Abstract #7012

A randomized phase II study (EMR-011 or LUCAS) conducted by Merck KGaA examined the addition of ERBITUX to standard chemotherapy with cisplatin and vinorelbine as first-line treatment of Epidermal Growth Factor Receptor (EGFR)-expressing advanced NSCLC compared to treatment with cisplatin and vinorelbine alone.  The primary endpoint was objective response rate.

 

Of 43 patients receiving ERBITUX plus chemotherapy, 35 percent (95% CI: 21-51) experienced a confirmed response (54% including unconfirmed response). Of 43 patients receiving chemotherapy alone, 28 percent (95% CI: 15-44) experienced a confirmed response (33% including unconfirmed response).  Overall rate of disease control, defined as partial response plus stable disease, was 84 percent in the ERBITUX plus chemotherapy group versus 68 percent in the chemotherapy-alone group.

 

Median progression-free survival in the ERBITUX plus chemotherapy group was 4.8 months (95% CI: 3.3-5.8) versus 4.2 months (95% CI: 2.5-5.0) in the chemotherapy-alone group.  Median survival time was 8.3 months (95% CI: 6.1-9.9) in the ERBITUX group and 7 months (95% CI: 5.6-9.5) in the chemotherapy-alone group.

 

Commonly occurring grade 3/4 adverse events in the ERBITUX plus chemotherapy arm compared to the chemotherapy-only arm were leucopenia (50% vs. 37%; grade 4, 10% vs. 10%), asthenia/fatigue (19% vs. 2%), nausea/vomiting (17% vs. 14%), skin reaction (12% vs. 0%), fever/chills (10% vs. 5%), infection (5% vs. 2%) and thrombocytopenia (5% vs. 2%).

 

Abstract #7084

A phase II trial (BMS-012) examined response rates in patients with stage IIIB/IV NSCLC who had recurrent or metastatic disease following one or more prior regimens of chemotherapy, including prior platinum-based chemotherapy.  Patients received standard therapy with ERBITUX until disease progression or the development of unacceptable toxicity.

 

At a planned interim analysis of 33 patients with EGFR-expressing NSCLC enrolled in the trial, 6 percent experienced partial responses, 21 percent had stable disease and 73 percent had progressive disease.

 



 

Forty-nine patients were evaluable for toxicity.  Grade 3/4 adverse events that may have been related to therapy were asthenia/malaise (12.2%), acneform rash (4.1%), infusion reaction (2%) and nausea/vomiting (2%).

 

ERBITUXTM (Cetuximab) Approved Indication

ERBITUX is approved by the FDA for use in combination with irinotecan in the treatment of patients with EGFR-expressing, metastatic colorectal cancer who are refractory to irinotecan-based chemotherapy and for use as a single agent in the treatment of patients with EGFR-expressing, metastatic colorectal cancer who are intolerant to irinotecan-based chemotherapy.  The effectiveness of ERBITUX for the treatment of colorectal cancer is based on objective response rates.  Currently, no data are available that demonstrate an improvement in disease-related symptoms or increased survival with ERBITUX.

 

Outside the U.S., Merck KGaA, Darmstadt, Germany, gained approval for use of ERBITUX in combination with irinotecan in patients with EGFR-expressing metastatic colorectal cancer who have failed prior irinotecan therapy in Switzerland in December 2003, with EU approval expected in June 2004.

 

In May 2004, Merck KGaA also received approval for ERBITUX in Argentina and Mexico for use in combination with irinotecan or as a single agent in patients with EGFR-expressing metastatic colorectal cancer after failure of irinotecan-including cytotoxic therapy.

 

ERBITUX Important Safety Information

Severe infusion reactions, rarely fatal and characterized by rapid onset of airway obstruction (bronchospasm, stridor, hoarseness), urticaria, and hypotension, have occurred (3%) with the administration of ERBITUX.  Most reactions (90%) are associated with the first infusion of ERBITUX despite the use of prophylactic antihistamines.

 

Severe cases of interstitial lung disease (ILD), which was fatal in one case, occurred in less than 0.5% of patients receiving ERBITUX.

 

Dermatologic toxicities, including acneform rash (12% grade 3-4), skin drying and fissuring, and inflammatory or infectious sequelae (e.g. blepharitis, cheilitis, cellulitis, cyst) were reported.  Sun exposure may exacerbate these effects.

 

Other serious adverse events associated with ERBITUX in clinical trials were fever (5%), sepsis (3%), kidney failure (2%), pulmonary embolus (1%), dehydration (5% in patients receiving ERBITUX plus irinotecan, 2% receiving monotherapy) and diarrhea (6% in patients receiving ERBITUX plus irinotecan, 0% with monotherapy).

 

Additional common adverse events seen in patients receiving ERBITUX plus irinotecan (n=354) or ERBITUX monotherapy (n=279) were acneform rash (88%/90%), asthenia/malaise (73%/49%), diarrhea (72%/28%), nausea (55%/29%), abdominal pain (45%/25%), vomiting (41%/25%), fever (34%/33%) and constipation (30%/28%).

 

Full prescribing information is available upon request, or at www.ERBITUX.com.

 

Background Information

ERBITUX binds specifically to epidermal growth factor receptor (EGFR, HER1, c-ErbB-1) on both normal and tumor cells, and competitively inhibits the binding of epidermal growth factor (EGF) and other ligands, such as transforming growth factor-alpha.  The EGFR is constitutively expressed in many

 



 

normal epithelial tissues, including the skin and hair follicle.  Over-expression of EGFR is also detected in many human cancers including those of the colon and rectum.

 

According to the American Cancer Society, more than 173,000 Americans will be diagnosed with lung cancer this year, and more than 160,000 will die from the disease.  Lung cancer is the leading cause of cancer deaths.

 

About ImClone Systems Incorporated

ImClone Systems Incorporated is committed to advancing oncology care by developing and commercializing a portfolio of targeted biologic treatments designed to address the medical needs of patients with a variety of cancers.  The Company’s three programs include growth factor blockers, angiogenesis inhibitors and cancer vaccines.  ImClone Systems’ strategy is to become a fully integrated biopharmaceutical company, taking its development programs from the research stage to the market.  ImClone Systems’ headquarters and research operations are located in New York City, with additional administration and manufacturing facilities in Branchburg, New Jersey.

 

Certain matters discussed in this news release may constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and the Federal securities laws.  Although the company believes that the expectations reflected in such forward-looking statements are based upon reasonable assumptions it can give no assurance that its expectations will be achieved.  Forward-looking information is subject to certain risks, trends and uncertainties that could cause actual results to differ materially from those projected.  Many of these factors are beyond the company’s ability to control or predict.  Important factors that may cause actual results to differ materially and could impact the company and the statements contained in this news release can be found in the company’s filings with the Securities and Exchange Commission including quarterly reports on Form 10-Q, current reports on Form 8-K and annual reports on Form 10-K.  For forward-looking statements in this news release, the company claims the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995.  The company assumes no obligation to update or supplement any forward-looking statements whether as a result of new information, future events or otherwise.

 

About Bristol-Myers Squibb

 

Bristol-Myers Squibb is dedicated to the discovery, development and exhaustive exploration of innovative cancer fighting therapies designed to extend and enhance the lives of patients living with cancer.  More than 40 years ago, Bristol-Myers Squibb built a unified vision for the future of cancer treatment.  With expertise, dedication and resolve, that vision led to the development of a diverse global portfolio of anti-cancer therapies that are an important cornerstone of care today.  Hundreds of scientists at Bristol-Myers Squibb’s Pharmaceutical Research Institute are studying ways to improve current cancer treatments and identify better, more effective medicines for the future.

 

Bristol-Myers Squibb is a global pharmaceutical and related health care products company whose mission is to extend and enhance human life.

 

This press release contains “forward-looking statements” as that term is defined in the Private Securities Litigation Reform Act of 1995 regarding product development.  Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes and results to differ materially from current expectations. No forward-looking statement can be guaranteed.  Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect Bristol-Myers Squibb’s business, particularly those identified in the cautionary factors discussion in Bristol-Myers Squibb’s Annual Report on Form 10-K for the year ended December 31, 2003 and in our

 



 

Quarterly Reports on Form 10-Q.  Bristol-Myers Squibb undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.

 

About Merck KGaA, Darmstadt, Germany

Merck KGaA, Darmstadt, Germany, is a global pharmaceutical and chemical company with sales of EUR 7.2 billion in 2003, a history that began in 1668, and a future shaped by 28,300 employees in 56 countries. Its success is characterized by innovations from entrepreneurial employees. Merck’s operating activities come under the umbrella of Merck KGaA, in which the Merck family holds a 74 percent interest and free shareholders own the remaining 26 percent. The former U.S. subsidiary, Merck & Co., has been completely independent of the Merck Group since 1917.

 

Merck KGaA, Darmstadt, Germany, licensed the right to market ERBITUX outside the U.S. and Canada from ImClone Systems Incorporated of New York in 1998.  In Japan, Merck KGaA has co-exclusive marketing rights with ImClone Systems.

 

# # #

 

Note to editors:

 

Data from BMS-012 (Abstract 7084) were presented Saturday, June 5, 8:00 AM CDT during a general poster session on lung cancer.

 

Data from EMR-011 (Abstract 7012) were presented Monday, June 7, 10:00 AM CDT during an oral presentation session on lung cancer.

 

Media and Investor Contacts:

 

Andrea Rabney
Corporate Communications
ImClone Systems Incorporated
Tel: (646) 638-5058
Andrea.Rabney@imclone.com

 

Tracy Furey
Corporate Affairs
Bristol-Myers Squibb
Tel: (609) 252-3208
Tracy.Furey@bms.com

 

Susan Walser
Investor Relations
Bristol-Myers Squibb
Tel: (212) 546-4631
Susan.walser@bms.com

or

 

 

 

 

David Pitts
Corporate Communications
ImClone Systems Incorporated
Tel: (646) 638-5058
David.Pitts@imclone.com

 

Kathy Baum
Corporate Affairs
Bristol-Myers Squibb
Tel: (609) 252-4227
Kathy.Baum@bms.com

 

John Elicker
Investor Relations
Bristol-Myers Squibb
Tel: (212) 546-3775
john.elicker@bms.com

or

 

 

 

 

Stefania Bethlen
Corporate Communications/IR
ImClone Systems Incorporated
Tel: (646) 638-5058
Stefania.Bethlen@imclone.com

 

Phyllis Carter
Corporate Media Relations
Merck KGaA
Tel.: +49 6151 72 7144
Phyllis.Carter@merck.de