ImClone Systems Inc. received $60 million from Erbitux partner Bristol-Myers Squibb Co., a payment that marks the one-year anniversary of the signing of their amended agreement.

Bristol-Myers clamored for a new deal following a series of setbacks for Erbitux, and got one. A year ago, the companies revised their September 2001 agreement worth up to $2 billion, calling for $100 million less in milestone payments, but ImClone got an added $200 million up front. (See BioWorld Today, March 7, 2002.)

Originally, the deal called for a $300 million milestone payment when the FDA accepted the biologics license application for Erbitux. The revamped version called for ImClone to get $140 million for signing and stipulated a $60 million cash payment one year later. Also, the $500 million milestone that was to be paid to ImClone after FDA approval was broken into two $250 million payments - one for each of the first two approved indications. ImClone was able to keep its 39 percent royalty rate on future Erbitux sales.

For those in biotechnology sector, New York-based ImClone's travails are well known. Briefly, the recap runs as such: The company developed a much-hyped cancer drug, Erbitux (cetuximab), that caught the attention of most of the oncology world as well as Bristol-Myers. Bristol-Myers signed ImClone to a deal valued at as much as $2 billion for the drug, only to see the FDA soundly reject ImClone's BLA in irinotecan-refractory colorectal cancer in late December 2001. What followed was a sticky mess of federal investigations and allegations that culminated in former CEO Samuel Waksal pleading guilty to six counts that included bank fraud, securities fraud, conspiracy to obstruct justice and perjury. ImClone's stock, once as high as $72, was dragged as low as $6.11.

All of which left the companies to sort out their most difficult task - getting the drug approved. Merck KGaA is developing the product in Europe, and it and ImClone had originally expected swapping data to bolster filing packages. For a while, it appeared ImClone would attempt to bundle Merck's data with its own and refile with the FDA, but in November, ImClone and Bristol-Myers said they had submitted two protocols to the FDA for Erbitux Phase III trials. The agency has not yet responded. (See BioWorld Today, May 17, 2002, and Nov. 4, 2002.)

Erbitux is a monoclonal antibody designed to target and block the epidermal growth factor receptor. The receptor is expressed on the surface of certain cancer cells in multiple tumor types.

ImClone's stock (NASDAQ:IMCL) has regained some weight since the company's initial implosion. It rose $1.31 Thursday, or 8.6 percent, to close at $16.58.

ImClone officials did not return calls seeking comment.

The company has not yet released fourth-quarter and year-end earnings, but as of Sept. 30, it had $293.1 million in cash, cash equivalents and securities for sale. It lost about $42 million in the third quarter.