Washington Editor

Genentech Inc.'s good fortune may have spilled over a bit to help boost the shares of companies it's in business with.

In particular, Protein Design Labs Inc.'s stock (NASDAQ: PDLI) closed Monday at $13.80, up $2.13, or 18.3 percent. Jim Goff, spokesman for the Fremont, Calif.-based company, attributed the increase to its relationship with Genentech, and to its progress with three humanized antibodies in inflammatory bowel disease.

Genentech, of South San Francisco, has options under PDL's patents on six antibodies, and so far it has exercised only one option, for the breast cancer drug Herceptin.

While PDL receives royalties on Herceptin, it may be in line for a royalty on Avastin (bevacizumab, rhuMAb-VEGF), a treatment for metastatic colorectal cancer. Genentech's stock shot up 44.7 percent, or $16.95, Monday when the company said a Phase III study of Avastin plus chemotherapy in previously untreated metastatic colorectal cancer patients met its primary endpoint of improving overall survival.

Under their agreement, PDL also could receive royalties on the allergic asthma drug Xolair and the psoriasis drug Raptiva. An FDA advisory panel recommended approval of Xolair last week, and Genentech filed the biologics license application for Raptiva in December. (See BioWorld Today, May 16, 2003, and Dec. 27, 2002.)

"We have not had specific conversations with Genentech regarding these antibodies, but we would expect that if they are approved and reach the market that they could generate royalties for PDL," Goff told BioWorld Today. "I wouldn't comment on the percentage, but analysts do tend to model those on the 3 percent range."

PDL trials in Crohn's and ulcerative colitis are progressing well.

Apart from its dealings with Genentech, PDL is on the road to progress by way of its own drug programs.

Company officials presented positive data on three products over the weekend at the annual Digestive Disease Week meeting in Orlando, Fla.

The most advanced of the humanized antibodies is Nuvion (visilizumab) for the treatment of ulcerative colitis. PDL hopes to file for regulatory approval in late 2006, if the FDA determines that Phase II data are acceptable, Goff said.

PDL reported positive data from 10 patients with severe ulcerative colitis refractory to steroids who were treated with one daily intravenous injection of Nuvion on two consecutive days. The clinical safety profile was satisfactory, and preliminary efficacy results on eight patients were strong, according to the company.

The company expects to open a second Phase I trial later this year to study lower doses.

PDL also reported that it has started a Phase II trial of daclizumab in patients with moderate to severe ulcerative colitis. That is a randomized, double-blind, placebo-controlled trial of up to 150 patients at 40 sites in Europe and North America. PDL hopes to complete enrollment this year.

In a prepared statement, Steven Benner, senior vice president and chief medical officer at PDL, said findings from the Phase II should be ready during 2004. "We believe it is likely that well-controlled, randomized Phase III trials will be needed to support the registration of daclizumab in this disease setting. Such a trial may take the form of randomization to standard therapy, with and without daclizumab."

In Crohn's disease, PDL said it has started a second Phase II trial in Europe to study a higher dose of HuZAF (anti-gamma interferon antibody). Approximately 120 patients will be randomized into one of two treatment groups or placebo.

Goff said the company plans to present abstracts from both Phase II trials next year at the Digestive Disease Week meeting.

The company may consider partnering any or all of the candidates, particularly in Europe or Japan, and possibly in North America.