By Jim Shrine
AnorMED Inc. reported positive Phase II results from its lanthanum-based drug for treating high blood phosphate levels in patients with chronic kidney failure, which its partner is taking into Phase III trials.
The drug, Lambda (lanthanum phosphate) already is in a Phase III trial in Europe, in which all 600 patients have been enrolled. Shire Pharmaceuticals Group plc, of Andover, U.K., has worldwide rights and is in charge of development.
"This is further proof of our ability to have new products progress through clinical trials, in this case with a partner," said Geoffrey Henson, AnorMED's executive vice president and chief operating officer. "'We've been able to produce a product that has been effective in clinical trials so far and will provide us an income, which will not completely match our burn rate, but will allow us to continue to develop research and development capabilities over the next several years."
Lambda was partnered with Shire when AnorMed, of Vancouver, British Columbia, still was the biomedical research group at Johnson Matthey plc, a London-based precious-metals company. The collaboration came when the drug still was in the research stage, leading to a deal that entitles AnorMED only to mid-single digit royalties on sales.
The Phase II trial involved 145 kidney dialysis patients separated into one of four drug groups or placebo. There were statistically significant reductions in phosphate levels in those taking the three highest doses.
At the end of six weeks, serum phosphate was reduced by 0.95 milligrams per deciliter in the 1,350-milligram dose, and 1.13 milligram per deciliter in the highest dose, 2,250 milligrams. That compares to a phosphate increase of 0.75 milligrams per deciliter in the placebo group.
Most kidney dialysis patients use a phosphate binder to remove excess phosphate, since the kidney can't perform that function.
Henson said Lambda is a much more efficient binder of phosphate than calcium, in part because it is not as soluble. Lambda is designed to be taken with food, so it combines with dietary phosphate to form an insoluble phosphate salt, which is then passed through the system.
AnorMED officials spun their group out of Johnson Matthey in 1996, when the parent company was changing its focus to concentrate on its metals business. AnorMED, which now applies its expertise in metals to drug development, went public in Canada in March through an offering that grossed $21.5 million ($C31.48 million). (See BioWorld Today, March 17, 1999, p. 1.)
Another AnorMED product, DMP-444, is in Phase III trials. It, too, was partnered in a royalty-only collaboration before AnorMED spun out. That product, a radiopharmaceutical agent in Phase III for detecting pulmonary emboli, or blood clots in the lung, is partnered with DuPont Pharmaceutical Co., of Wilmington, Del.
But AnorMED was able to craft a more lucrative deal with its platinum-based drug, ZD0473, which is designed to overcome resistance to platinum-based cancer drugs. It is expected to move into Phase II later this year. The company has a deal for that drug worth up to $33 million, along with double-digit royalties, with AstraZeneca plc, of London.
Henson said the strategy at AnorMED now is to take drugs into Phase II before partnering so it will have more leverage in partnerships. The company has an unpartnered HIV drug in Phase Ia/IIb and one for rheumatoid arthritis that has completed Phase I.