By Karen Pihl-Carey

AnorMED Inc. said its drug candidate for chronic kidney failure entered Phase III trials in the U.S., following positive Phase II results released earlier this year.

Lambda, a lanthanum carbonate-based drug, is designed to treat high blood phosphate levels in patients with chronic kidney failure. It entered Phase III trials in Europe in January.

AnorMED, based in Vancouver, British Columbia, is co-developing Lambda with Andover, UK-based Shire Pharmaceuticals Group plc, which also holds worldwide exclusive marketing rights to the drug. Shire is paying for the development and commercialization of Lambda. It also will pay AnorMED a royalty on sales, if the product receives regulatory approval.

Michael Abrams, president and CEO of AnorMED, said the start of the pivotal trials is significant to AnorMED, bringing the company one step closer to putting a drug on the market.

"It's a positive indication that they [Shire] are pushing the compound forward," he told BioWorld Today.

Shire did not release specific details of either trial.

"They are, for competitive reasons, being very close-mouthed," Abrams said.

Abrams could not say how long the U.S. trial would take nor how many people would be recruited. The trial in Europe completed enrollment of 600 patients in June.

AnorMED, a company spun off in 1996 from Johnson Mathey plc, of London, estimates the worldwide market for phosphate binders for dialysis patients is between $400 million and $600 million. That figure could increase if pre-dialysis patients also see a benefit from the treatment.

Kidney failure leads to hyperphosphatemia, or excess levels of phosphate in the blood, that can result in osteodystrophy. Almost all kidney dialysis patients use a phosphate binder to remove excess phosphate. Lambda is designed to be taken with food so it passes through the digestive tract and is not absorbed into the bloodstream.

"The endpoint [of the Phase III trials] is going to be some specific reduction of phosphate levels in the blood," Abrams said.

AnorMED's Geoffrey Henson, executive vice president and chief operating officer, said in June that Lambda binds phosphate more efficiently than calcium because it is not as soluble.

Shire plans to market Lambda to the 650,000 patients worldwide with end-stage kidney disease using its own sales force. It partnered with AnorMED while the drug was still in the research stages, and is obligated to pay mid- single digit royalties on sales.

In June, Shire released positive Phase II results of Lambda that showed statistically significant reductions in phosphate levels in kidney dialysis patients who took the three highest doses. (See BioWorld Today, June 28, 1999, p. 1.)

AnorMED's stock (TSE:AOM) closed Tuesday at C$6.15, down 5 cents. The company went public in Canada in March through an offering that grossed $21.5 million (C$31.48 million). (See BioWorld Today, March 17, 1999, p. 1.)

Other than Lambda, the company has four other products in the clinic. DMP-444, a radiopharmaceutical imaging agent for detecting deep vein thrombosis, is in a Phase III trial. It is partnered with DuPont Pharmaceutical Co., of Wilmington, Del., in a royalty-only deal for AnorMED.

AnorMED's platinum-based drug, ZD0473, which is designed to overcome resistance to platinum-based cancer drugs, is scheduled to start a Phase II trial before the end of the year. It is partnered in a $33 million deal, which includes double-digit royalties, with AstraZeneca plc, of London.

The company's product for HIV, AMD-3100, is in a Phase Ib/IIa trial. It is designed to inhibit the binding of HIV to the CXCR4 chemokine receptor, preventing the virus from entering the healthy cell.

Atiprimod for rheumatoid arthritis recently completed a Phase I trial at the end of 1997. The company is analyzing the data from that trial before proceeding, Abrams said.