ImClone's Delay May Boost Rivals In Cancer Battle
In a high-stakes race to bring a new type of cancer drug to market, two companies have gained important ground after the leading company, ImClone Systems Inc., failed to clear regulatory hurdles.</br></br>To get to the market quickly, ImClone tried a high-risk strategy to seek regulatory approval with one small, unusually designed clinical trial. But the Food and Drug Administration in December refused to review its application. The resulting mess -- a rash of shareholder lawsuits, embarrassing publicity, and investigations by Congress and regulators -- has been a nightmare for ImClone and its officers and directors.</br></br>But ImClone's stumble may have created an unexpected opportunity for AstraZeneca PLC and OSI Pharmaceuticals Inc. in the multibillion-dollar market for this new class of cancer drugs. AstraZeneca may now lead the pack: On the very day ImClone announced the FDA's decision, Dec. 28, AstraZeneca said it had completed its application with the agency for its drug.</br></br>"Whoever is on the market first will dominate for a long period of time," says oncologist Eric Rowinsky, director of clinical research at the Institute for Drug Development in San Antonio, where he has run clinical trials on five rival drugs to ImClone's drug, Erbitux.</br></br>Eagerly anticipated by oncologists and patients, ImClone's treatment was expected to be the first of a new class of drugs that tries to stop cancer from spreading by interfering with the chemical signals -- most notably the activation of substances on the outside of cells called epidermal growth factor receptors -- that seem to tell cells to proliferate. Most solid-tumor cancers -- colorectal, lung, pancreatic, and head-and-neck -- appear to grow using the chemical signaling the medicines aim to block. Although each of the new drugs might be approved initially for different types of tumors, they are expected to compete because oncologists routinely use drugs on many types of cancers besides the approved ones.