-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, PpykRyTTE3HMmwzuBx8mZKfjY/KOOnjILPkjIqE2313BSK5Ya4Vw1i2Im8GJE0PN he+J+FoMyBLy1PYKw9ccGg== 0001104659-04-017403.txt : 20040621 0001104659-04-017403.hdr.sgml : 20040621 20040621163023 ACCESSION NUMBER: 0001104659-04-017403 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20040618 ITEM INFORMATION: Other events ITEM INFORMATION: Financial statements and exhibits FILED AS OF DATE: 20040621 FILER: COMPANY DATA: COMPANY CONFORMED NAME: IMCLONE SYSTEMS INC/DE CENTRAL INDEX KEY: 0000765258 STANDARD INDUSTRIAL CLASSIFICATION: BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836] IRS NUMBER: 042834797 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-19612 FILM NUMBER: 04872838 BUSINESS ADDRESS: STREET 1: 180 VARICK ST CITY: NEW YORK STATE: NY ZIP: 10014 BUSINESS PHONE: 2126451405 MAIL ADDRESS: STREET 1: 180 VARICK ST CITY: NEW YORK STATE: NY ZIP: 10014 8-K 1 a04-6885_28k.htm 8-K

 

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 


 

FORM 8-K

 

CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934

 

Date of Report (Date of earliest event reported):  June 18, 2004

 

IMCLONE SYSTEMS INCORPORATED

(Exact name of Registrant as Specified in Charter)

 

Delaware

 

0-19612

 

04-2834797

(State of incorporation or
organization)

 

(Commission File Number)

 

(I.R.S. Employer Identification
No.)

 

180 Varick Street, 6th Floor
New York, New York 10014

(Address of Principal Executive Offices) (Zip Code)

 

(212) 645-1405

(Registrant’s telephone number, including area code)

 

N/A

(Former Name or Former Address, if Changed Since Last Report)

 

 



 

Item 5.                                                         Other Events and Required FD Disclosure

 

On June 18, 2004, ImClone Systems Incorporated (the “Company”) announced that the U.S. Food and Drug Administration has approved the Company’s Chemistry, Manufacturing and Controls supplemental Biologics License Application for licensure of its manufacturing facility (referred to as BB36).

 

The text of this press release, which is attached as Exhibit 99.1, is incorporated by reference herein in its entirety.

 

Item 7.                                                           Financial Statements, Pro Forma Financial Information and Exhibits

 

(c)           Exhibits

 

Exhibit No.

 

Exhibit Title

 

 

 

99.1

 

Press release of ImClone Systems Incorporated dated June 18, 2004.

 

2



 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

 

 

IMCLONE SYSTEMS INCORPORATED

 

 

 

By:

/s/ Clifford R. Saffron

 

 

Name:

Clifford R. Saffron

 

 

Title:

Senior Vice President, Legal and General Counsel

 

 

Date:  June 21, 2004

 

 

3



 

EXHIBIT INDEX

 

Exhibit No.

 

Exhibit Title

 

 

 

99.1

 

Press release of ImClone Systems Incorporated dated June 18, 2004.

 

4


EX-99.1 2 a04-6885_2ex99d1.htm EX-99.1

EXHIBIT 99.1

 

 

ImClone Systems Incorporated

Investors:

 

Media:

Andrea F. Rabney

 

David M. F. Pitts

(646) 638-5058

 

(646) 638-5034

 

IMCLONE SYSTEMS ANNOUNCES FDA APPROVAL OF CMC SUPPLEMENTAL
BLA FOR ITS BB36 MANUFACTURING FACILITY

 

NEW YORK, NY – June 18, 2004 – ImClone Systems Incorporated (NASDAQ: IMCL) announced today that the U.S. Food and Drug Administration (FDA) has approved the Company’s Chemistry, Manufacturing and Controls (CMC) supplemental Biologics License Application (sBLA) for licensure of its manufacturing facility (referred to as BB36). BB36 is a 30,000 liter capacity, single-product manufacturing facility dedicated to the production of ERBITUX™ (Cetuximab). From the beginning of 2002 through the end of 2003, the Company produced approximately 200 kilograms of bulk product which is equivalent to 400,000 doses of ERBITUX. At maximum capacity, BB36 is expected to produce 250 kilograms of bulk product per year.

 

“With today’s licensure of the BB36 manufacturing facility, ImClone Systems is now well positioned to meet the ongoing commercial demand for ERBITUX, as well as supply our clinical development program to explore the drug’s potential in early-stage colon and other cancers,” stated Daniel S. Lynch, Chief Executive Officer of ImClone Systems. “The licensure of BB36 was achieved thanks to the efforts of many people at ImClone Systems and the FDA.”

 

About ERBITUX (Cetuximab)

ERBITUX is a first-of-its-kind antibody approved for use in the United States 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 is based on objective response rates. Currently, no data are available that demonstrate an improvement in disease-related symptoms or increased survival with ERBITUX.

 

ERBITUX, an IGg1 monoclonal antibody, 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.

 

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.

 

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(TM) 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%).

 

Patients should be screened for EGFR expression using immunohistochemistry (IHC) to determine if they are appropriate candidates for treatment with ERBITUX. ERBITUX is also being studied in earlier stages of colorectal cancer, as well as in other types of cancer that express the EGF receptor.

 

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

 

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.

 

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