ImClone Starts Approval Process for New Cancer Drug

As expected, ImClone Systems IMCL has begun the process of seeking regulatory approval for its experimental cancer drug, IMC-C225.

The New York City-based biotech firm said today that it has initiated a "rolling" application with the Food and Drug Administration. The company wants the FDA to approve the use of IMC-C225 to treat patients suffering from advanced colon cancer. ImClone's drug is used in combination with another chemotherapy drug.

In May, ImClone executives said they expected to file for approval by the end of June. The FDA has given IMC-C225 "fast track" status, which means the agency could issue a decision within six months of the application's completion.

A time frame for that decision is hard to pinpoint, however. ImClone's rolling application means the company will submit data and information to the FDA in sections, as they are completed. The full application won't be submitted to the FDA until the end of October at the earliest, according to Harlan Waksal, ImClone's COO. That's when a study looking at IMC-C225 as a single-drug treatment will be completed.

"The [study] and our application will be completed in October and then it takes some time for the FDA to accept it all, so we expect the [six-month] clock to start in November," says Waksal.

If everything goes by the book, ImClone could get an answer from the FDA by next May. Of course, dealings with the FDA are rarely smooth these days because the agency is without a commissioner and approval times are slowing, especially for drugs such as IMC-C225.

IMC-C225 is in a new class of monoclonal antibody drugs that allow doctors to fight cancer in a new way. Simply put, the drug works by blocking the receptor attached to epidermal growth factor, a common cell protein that somehow goes haywire in cancer cells. By targeting cancer cells that "express" for epidermal growth factor, IMC-C225 seems to stop or shrink tumor growth without the nasty, or potentially fatal, side effects of traditional chemotherapy drugs.

These so-called "EGFR blocker" drugs made a huge splash at the American Society of Clinical Oncologists meeting, held last month in San Francisco, and potentially represent a new, multibillion-dollar market for cancer drugs. ImClone's drug is furthest along the development trail, but AstraZenecaAZN and a joint venture of GenentechDNA and OSI Pharmaceuticals OSIP are close behind.

Shares of ImClone rose $2.49, or 5.3%, to $49.87 in Thursday trading. The company has traded as high as $56.30 in the weeks following its strong showing at the ASCO cancer meeting.