By Brady Huggett
AnorMED Inc. reported positive results from its Phase III trial of Foznol to treat hyperphosphataemia and can now look ahead to possible dual-continent royalty payments from its partner, Shire Pharmaceuticals Inc.
Data on Foznol (lanthanum carbonate), presented at the 2001 World Congress of Nephrology in San Francisco, showed Foznol was able to maintain and control blood phosphate levels in patients ¿ 59 percent of patients treated with Foznol achieved serum phosphate control vs. 23 percent of patients who received placebo (p=0.001).
The data are just one part of the complete Phase III program under way now in the United States ¿ the details of which are not clear due to Andover, UK-based Shire¿s cloaking ¿ and a program abroad as well.
¿[Shire] has completed an 800-patient Phase III study in Europe and filed that in March with one [reference member state of the European Union]; we don¿t know which one,¿ said William Adams, AnorMED¿s chief financial officer. ¿Our guidance from Shire is an expected approval in the first half of next year.¿ And although there are other fragments to the Foznol program in the United States, Adams said ¿the total Phase III protocol has not been disclosed.¿
The relationship between Shire and AnorMED began when AnorMED was still a part of Johnson Matthey plc, of London. The original deal between the two was signed in 1991, and simply was a research collaboration at the time. Work continued after AnorMED was spun out of Johnson Matthey in 1996, and then as it went public in Canada in March 1999, raising about C$30.5 million (US$20.1 million). Roughly 10 years later, it appears the research collaboration has born a viable moneymaking product. Adams explained how Foznol is designed to provide therapeutic benefits for chronic renal failure patients.
¿[Foznol] is taken with every meal, with food,¿ Adams said. ¿Phosphate is a ubiquitous part of food. Foznol binds phosphate in the gut before it can be absorbed and it is then passed out in the feces.¿
AnorMED estimated the market to be in the range of $400 million to $600 million, and AnorMED would receive mid-single-digit royalties in both Europe and the United States on Foznol sales. However, Foznol, if approved, would have competition. The market contains calcium-based or aluminum-based therapies, as well as Genzyme Corp.¿s Renagel. Foznol is devoid of calcium and aluminum, so it does not pose the threat of elevated calcium levels in the blood or the danger of dialysis dementia, which is associated with aluminum products. And although calcium and aluminum therapies are cheap, Renagel is not, Adams said, which may provide a way to pilfer a section of the market.
¿It¿s certainly a competitive marketplace,¿ Adams said. ¿There is the opportunity for [Foznol to price under Renagel], but that is up to Shire.¿
AnorMED suffered a setback last month when AstraZeneca plc, of London, said it would re-evaluate the design of a Phase III trial for ZD0473, AnorMED¿s partnered anticancer agent. The news dropped AnorMED¿s stock by C$5.90, or about 55 percent, closing that day at C$4.85. (See BioWorld Today, Sept. 4, 2001.)
That product is still AnorMED¿s flagship product, Adams said, but the company has AMD 3100, a blocker of CXCR4 chemokine receptor, in Phase I trials. It also is working on oral chemokine receptors, and AnorMED expects to move a compound into the clinic to treat cancer or inflammation sometime next year.
AnorMED is sound financially. Adams pointed to a cash position of C$85 million, and said the company is burning through about C$1.5 million a month currently, providing the company with about four years of money. But perhaps most important is the 10-year path AnorMED has blazed since it signed with Shire in 1991.
¿I think this demonstrates that AnorMED can develop a product that can move along successfully in the clinic,¿ he said. ¿The royalty rate that we will receive will contribute to our bottom line ¿ it won¿t make us profitable ¿ but it will be nice to be earning royalty income.¿
AnorMED¿s stock (TSE:AOM) rose C28 cents Tuesday to close at C$3.27.