By Karen Pihl-Carey

As promised to investors, Ilex Oncology Inc. and Millennium Pharmaceuticals Inc. submitted a biologics license application (BLA) for Campath to treat advanced B-cell chronic lymphocytic leukemia (CLL) that is refractory to existing therapies.

"It is very good news that they got it in by year-end," said Peter Ginsberg, an analyst with US Bancorp Piper Jaffray Inc. in Minneapolis. "We think that this product will ultimately have sales of $200 million or more, that it will be initially used primarily in late-stage CLL patients, but ultimately also in earlier-stage CLL patients."

Campath has received a fast-track designation, as well as an orphan drug designation, meaning the FDA will make its decision within six months. If all goes well, the drug could be on the market next summer. It would be the first marketed product for both Millennium and Ilex.

"We're very excited about it. We're quite proud about the quality of the BLA. I think we have a real strong filing," said Ilex President and CEO Richard Love. "We also think it is a very important milestone for us. We have told investors we would submit before the end of the year. So it was a pretty feverish December."

In a $30 million deal signed in August, Schering AG, of Berlin, assumed distribution and marketing rights to Campath in the U.S., Europe and everywhere else, besides Japan and East Asia. Ilex and Millennium retained the rights to Campath in Japan and East Asia, but plan to do a separate deal for those areas sometime in 2000, Love said. (See BioWorld Today, Aug. 25, 1999, p. 1.)

Campath, a monoclonal antibody, was developed through a 50-50 joint venture with LeukoSite Inc., of Cambridge, Mass. Millennium, also of Cambridge, acquired LeukoSite in a deal that closed Wednesday.

"We're extremely excited about it because it will be our first therapeutic product on the market," said Sally McCraven, director of corporate communications at Millennium. "The fast-track designation generally means we will have an answer in six months.

"It's a product that I think will help a lot of people who suffer from CLL."

Love agreed, saying, "We're very hopeful that this drug will do a lot for patients who don't have any alternatives."

CLL, the most prevalent form of adult leukemia, is characterized by an accumulation of malignant lymphocytes, a subclass of white blood cells, in the bone marrow and other tissues. It causes bone marrow dysfunction and enlargement of the lymph nodes, liver and spleen. With no current cure, most patients eventually become refractory.

Schering already markets one of the leading drugs for patients with CLL. Fludarabine is a drug given to CLL patients when chemotherapy fails.

"It's an effective drug, but unfortunately patients ultimately develop resistance to it, and at that point, there are no alternatives," Love told BioWorld Today. "At that point, the life expectancy is only six to nine months."

That is where Campath comes in. Researchers have said Campath appears to be effective and safe in the treatment of advanced B-cell CLL. In a 93-patient pivotal trial, Campath treatment produced a 33 percent response rate, and patients have had a median survival time of more than 16 months, Ginsberg said.

Love said the market for Campath in oncology is about $200 million worldwide a year.

"But that $200 million a year is just for oncology," he said. "Campath, because it brings down both B and T lymphocytes, very likely is going to have use outside of oncology in autoimmune diseases. There's some very interesting data now in multiple sclerosis and in the prevention of organ transplant rejections."

Ginsberg said his firm expects Campath to reach the market in the third quarter of 2000, and that projected sales of $200 million do not account for potential applications of the drug in multiple sclerosis and transplants. He expects sales in cancer indications to be about $9 million in 2000, $41 million in 2001, $98 million in 2002 and $154 million in 2003.

Ilex's stock (NASDAQ:ILXO) closed Thursday at $21.06, up $1.93, while Millennium's stock (NASDAQ:MLNM) closed at $119.12, down 56.25 cents.