NEW JERSEY, February 11, 2002: Messy, yes. But what about the cancer patients?

Drugs that target the epidermal growth factor receptor (EGFR) represent the most promising advances in the treatment of cancer in decades. Not only does the EGFR play a key role in the growth of cancer cells, it is expressed in many different forms of cancer, including tumors of the head, neck, breast, prostate and lung, to name a few. Drugs that target this recptor may have application across many malignancies and many stages of disease.

One such drug -- Erbitux -- developed by ImClone, is a monoclonal antibody that is designed to block the EGFR itself. As such, it was intended to interfere with the receptor, and help prevent further cell growth. Formerly known by the code C-225, Erbitux was scheduled to launch about a year earlier than other targeted therapies in development, including OSI's Tarceva and Astra-Zeneca's Iressa.

Unlike Erbitux, Tarceva and Iressa are small molecule agents that interfere with EGFR signalling from the inside of the cancer cell, at the tyrosine kinase enzyme. Despite their differences, however, all three agents have the potential to revolutionize the treatment of many different forms of cancer. And many cancer patients -- indded the entire oncology community -- have been looking forward to their arrival.

Now, ImClone and its partner, Bristol-Myers Squibb, are enbroiled in a messy legal battle over Erbitux. The short version: ImClone is being investigated by the FDA and the FTC after Erbitux failed to get FDA approval. And Bristol-Myers Squibb, a company that already has a solid reputation in oncology, wants to amend the terms of the $2 billion deal it signed in November to help ImClone launch Erbitux.

Although analysts believe that Erbitux will launch eventually, the legal battle is a huge setback for cancer patients -- who were eagerly awaiting its arrival. And it puts added attention on Astra-Zeneca's Iressa, which, like Erbitux, was on a "fast-track" status from the FDA. Tarceva, from OSI, is still undergoing phase III trials, and will likely launch a good deal later than Iressa.

Interestingly, Astra-Zeneca has decided to launch Iressa alone, while OSI has partnered with Roche and Genentech to launch Tarceva.

We at RxME are hoping that the litigation between ImClone and Bristol-Myers Squibb can be resolved quickly, and that the data for Erbitux will lead to the marketing approval of the drug.

Time is of the essence with any pharmaceutical, and anything that can speed delivery of these new agents will be great news for cancer patients around the world. We look forward to a compassionately swift resolution of the current legal battle.

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