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- ImClone und Bristol-Myers Squibb wollen weitere Zulassung für Erbitux
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ImClone Systems and Bristol-Myers Squibb Establish Plan with FDA for the Regulatory Filing of ERBITUX-TM- -Cetuximab- in Head and Neck Cancer
ImClone Systems and Bristol-Myers Squibb Establish Plan with FDA for the Regulatory Filing of ERBITUX-TM- -Cetuximab- in Head and Neck Cancer
BW5974 JUL 20,2004 13:23 PACIFIC 16:23 EASTERN
( BW)(NY-IMCLONE-SYSTEMS)(IMCL) ImClone Systems and Bristol-MyersSquibb Establish Plan with FDA for the Regulatory Filing ofERBITUX-TM- -Cetuximab- in Head and Neck Cancer
Business Editors/Health/Medical Writers
NEW YORK & PRINCETON, N.J.--(BUSINESS WIRE)--July 20, 2004--
The Companies Expect to File sBLA in the Second Quarter of 2005
ImClone Systems Incorporated (NASDAQ: IMCL) and Bristol-MyersSquibb Company (NYSE: BMY) announced today that the companies haveestablished a plan with the U.S. Food and Drug Administration (FDA)for the filing of a supplemental Biologics License Application (sBLA)to seek approval for use of ERBITUX(TM) (Cetuximab) Injection, an IgG1monoclonal antibody, as a single agent and in combination withradiation in Squamous Cell Carcinoma of the Head and Neck (SCCHN).Based on the outcome of discussions with the FDA, the Companies intendto submit an sBLA in the second quarter of 2005 and will requestpriority review at the time of filing. The FDA has provided writtennotification that the following clinical trials could form the basisof an sBLA together with other supportive data:
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A randomized, international phase III trial (IMCL-9815) conducted by ImClone Systems and Merck KGaA presented at the American Society of Clinical Oncology (ASCO) annual meeting in June examining the impact of combining ERBITUX with radiation on locoregional control and overall survival in 424 patients with locally advanced SCCHN, and
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A multicenter phase II trial (EMR-016) conducted by Merck KGaA presented at the ASCO annual meeting in June evaluating the response rate of ERBITUX as a single agent in 103 patients with advanced recurrent and/or metastatic SCCHN not suitable for further local therapy and who have failed platinum-based chemotherapy.
" Patients with this disease have been without any significantadvancements in approved treatments for over a decade," stated DanielS. Lynch, Chief Executive Officer of ImClone Systems. " We were pleasedto be able to present clinical trial data in head and neck cancer atthis year´s ASCO annual meeting, including the late-breaking Phase IIIstudy IMCL-9815. We look forward to working diligently with ourpartners to assemble and analyze all the data from the studies thatwill comprise this submission."
" Delivering to patients novel approaches to the treatment ofcancer is part of Bristol-Myers Squibb´s legacy and aligns with ourcomprehensive strategy to focus on areas of significant medical need,in this case the treatment of head and neck cancer," said Andrew G.Bodnar, M.D., Senior Vice President Strategy and Medical & ExternalAffairs, Bristol-Myers Squibb. " We will continue to work with ourpartners to conduct a thorough clinical development program to explorethe use of ERBITUX in various tumor types."
About Head and Neck Cancer
According to the American Cancer Society, approximately 40,000Americans will be diagnosed with oral, head and neck cancer this year,including cancers of the tongue, mouth, pharynx, and larynx. More than11,000 will die from the disease in 2004.
About ERBITUX(TM) (Cetuximab)
ERBITUX is approved by the FDA for use in combination withirinotecan in the treatment of patients with EGFR-expressing,metastatic colorectal cancer who are refractory to irinotecan-basedchemotherapy and for use as a single agent in the treatment ofpatients with EGFR-expressing, metastatic colorectal cancer who areintolerant to irinotecan-based chemotherapy. The effectiveness ofERBITUX for the treatment of colorectal cancer is based on objectiveresponse rates. Currently, no data are available that demonstrate animprovement in disease-related symptoms or increased survival withERBITUX.
ERBITUX binds specifically to epidermal growth factor receptor(EGFR, HER1, c-ErbB-1) on both normal and tumor cells, andcompetitively inhibits the binding of epidermal growth factor (EGF)and other ligands, such as transforming growth factor-alpha. The EGFRis constitutively expressed in many normal epithelial tissues,including the skin and hair follicle. Over-expression of EGFR is alsodetected in many human cancers including those of the colon andrectum.
ERBITUX Important Safety Information
Severe infusion reactions, rarely fatal and characterized by rapidonset of airway obstruction (bronchospasm, stridor, hoarseness),urticaria, and hypotension, have occurred in approximately 3% ofpatients with the administration of ERBITUX (Cetuximab). Mostreactions (90%) were associated with the first infusion of ERBITUX.Caution must be exercised with every ERBITUX infusion as there werepatients who experienced their first severe infusion reaction duringlater infusions.
Severe cases of interstitial lung disease (ILD), which was fatalin one case, occurred in less than 0.5% of patients receiving ERBITUX.
Dermatologic toxicities, including acneform rash (11% grade 3/4),skin drying and fissuring, inflammatory or infectious sequelae (e.g.blepharitis, cheilitis, cellulitis, cyst) and paronychial inflammation(0.4% grade 3) were reported. Sun exposure may exacerbate theseeffects.
Other serious adverse events associated with ERBITUX in clinicaltrials were fever (5%), sepsis (3%), kidney failure (2%), pulmonaryembolus (1%), dehydration (5% in patients receiving ERBITUX plusirinotecan, 2% receiving monotherapy) and diarrhea (6% in patientsreceiving ERBITUX plus irinotecan, 0.2% with monotherapy).
Additional common adverse events seen in patients receivingERBITUX plus irinotecan (n=354) or ERBITUX monotherapy (n=420) wereacneform rash (88%/90%), asthenia/malaise (73%/48%), diarrhea(72%/25%), nausea (55%/29%), abdominal pain (45%/26%), vomiting(41%/25%), fever (34%/27%), constipation (30%/26%) and headache(14%/26%).
Full prescribing information is available upon request, or atwww.ERBITUX.com.
About ImClone Systems Incorporated
ImClone Systems Incorporated is committed to advancing oncologycare by developing and commercializing a portfolio of targetedbiologic treatments designed to address the medical needs of patientswith a variety of cancers. The Company´s three programs include growthfactor blockers, angiogenesis inhibitors and cancer vaccines. ImCloneSystems´ strategy is to become a fully integrated biopharmaceuticalcompany, taking its development programs from the research stage tothe market. ImClone Systems´ headquarters and research operations arelocated in New York City, with additional administration andmanufacturing facilities in Branchburg, New Jersey.
Certain matters discussed in this news release may constituteforward-looking statements within the meaning of the PrivateSecurities Litigation Reform Act of 1995 and the Federal securitieslaws. Although the company believes that the expectations reflected insuch forward-looking statements are based upon reasonable assumptionsit can give no assurance that its expectations will be achieved.Forward-looking information is subject to certain risks, trends anduncertainties that could cause actual results to differ materiallyfrom those projected. Many of these factors are beyond the company´sability to control or predict. Specifically there can be no guaranteethat the sBLA referenced above will be filed, or if filed, will befiled within the timeframe discussed above or that it will be approvedby the FDA. Important factors that may cause actual results to differmaterially and could impact the company and the statements containedin this news release can be found in the company´s filings with theSecurities and Exchange Commission including quarterly reports on Form10-Q, current reports on Form 8-K and annual reports on Form 10-K. Forforward-looking statements in this news release, the company claimsthe protection of the safe harbor for forward-looking statementscontained in the Private Securities Litigation Reform Act of 1995. Thecompany assumes no obligation to update or supplement anyforward-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, developmentand exhaustive exploration of innovative cancer fighting therapiesdesigned to extend and enhance the lives of patients living withcancer. More than 40 years ago, Bristol-Myers Squibb built a unifiedvision for the future of cancer treatment. With expertise, dedicationand resolve, that vision led to the development of a diverse globalportfolio of anti-cancer therapies that are an important cornerstoneof care today. Hundreds of scientists at Bristol-Myers Squibb´sPharmaceutical Research Institute are studying ways to improve currentcancer treatments and identify better, more effective medicines forthe future.
Bristol-Myers Squibb is a global pharmaceutical and related healthcare products company whose mission is to extend and enhance humanlife.
This press release contains " forward-looking statements" as thatterm is defined in the Private Securities Litigation Reform Act of1995. Such forward-looking statements are based on currentexpectations and involve inherent risks and uncertainties, includingfactors that could delay, divert or change any of them, and couldcause actual outcomes and results to differ materially from currentexpectations. No forward-looking statement can be guaranteed.Specifically there can be no guarantee that the sBLA referenced abovewill be filed, or if filed, will be filed within the timeframediscussed above or that it will be approved by the FDA.Forward-looking statements in this press release should be evaluatedtogether with the many uncertainties that affect Bristol-MyersSquibb´s business, particularly those identified in the cautionaryfactors discussion in Bristol-Myers Squibb´s Annual Report on Form10-K for the year ended December 31, 2003 and in our Quarterly Reportson Form 10-Q. Bristol-Myers Squibb undertakes no obligation topublicly update any forward-looking statement, whether as a result ofnew information, future events or otherwise.
--30--ML/ny* CONTACT: Media and Investor Contacts: ImClone Systems Incorporated Andrea Rabney, 646-638-5058 andrea.rabney@imclone.com or David Pitts, 646-638-5058 david.pitts@imclone.com or Investor Relations: Stefania Bethlen, 646-638-5058 stefania.bethlen@imclone.com or Bristol-Myers Squibb Tracy Furey, 609-252-3208 tracy.furey@bms.com or Kathy Baum, 609-252-4227 kathy.baum@bms.com or Investor Relations: Bristol-Myers Squibb Susan Walser, 212-546-4631 susan.walser@bms.com or John Elicker, 212-546-3775 john.elicker@bms.com KEYWORD: NEW YORK NEW JERSEY INDUSTRY KEYWORD: MANUFACTURING PHARMACEUTICAL MEDICALBIOTECHNOLOGY SOURCE: ImClone Systems Incorporated
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