A randomized, international phase III trial (IMCL-9815), conducted by ImClone
Systems and Merck KGaA, Darmstadt, Germany, which examined the impact of combining ERBITUX with radiation on locoregional control and overall survival in 424 patients with locally or regionally advanced SCCHN.
The program is being supported by ImClone
Systems and implemented by MedNet Solutions, Inc.
NEW YORK -- ImClone
Systems Incorporated (NASDAQ: IMCL) today issued the following statement regarding the approval by Swissmedic, the Swiss agency for therapeutic products, of ERBITUX(R) (Cetuximab), an IgG1 monoclonal antibody, in combination with radiation in the treatment of patients with previously untreated, advanced squamous cell carcinoma of the head and neck:
Systems Incorporated is committed to advancing oncology care by developing a portfolio of targeted biologic treatments, designed to address the medical needs of patients with a variety of cancers.
Systems Incorporated (NASDAQ: IMCL) announced today that its Board of Directors has completed a review of the Company's strategic alternatives and has made the decision to remain independent.
As part of the agreements, ImClone
Systems consented to Merck's sublicense of certain intellectual property rights relating to the development and commercialization of an anti-EGFR antibody to Takeda Pharmaceutical Company.
These antibodies are among several targeted therapies in development at ImClone
Systems that give us a uniquely valuable pipeline within the industry," stated Eric K.
Data were presented this year from ImClone
Systems developed antibodies at all stages of development, ranging from those in the lab to our marketed product, ERBITUX(R)," said Joseph L.
The study is being conducted jointly by Bristol-Myers Squibb, ImClone
Systems and Merck KGaA.
Systems will have exclusive, worldwide rights to develop and commercialize therapeutics against any target it selects.
The deal, announced last Monday, values ImClone
at $70 per share, a premium of 51% to ImClone
's closing price on July 30, the day before Bristol made an offer of $60 a share for the 83% of the company it does not already own.
Under terms of the agreement, UCB and ImClone
Systems will share equally all agreed upon development costs for CDP-791 as well as worldwide profits derived from its commercialization in indications jointly pursued by the parties.