By Matthew Willett
AstraZeneca plc initiated a Phase III trial of ZD0473, a novel platinum-based anticancer agent designed by AnorMED Inc., triggering a $4 million milestone for AnorMED related to their development and commercialization agreement.
The drug candidate, designed to combat platinum-based therapy resistance, also is in Phase I and Phase II trials in a variety of indications, including non-small-cell lung cancer, small-cell lung cancer, mesothelioma, hormone-resistant prostate cancer, cervical, ovarian, breast and bladder cancers.
Vancouver, British Columbia-based AnorMED officials said in a teleconference call Thursday that the move is an achievement for the company above and beyond its agreement with AstraZeneca, of London.
"Clearly, this announcement represents the achievement of another significant milestone for AnorMED," Michael Abrams, AnorMED's CEO, said. "AstraZeneca's decision, in conjunction with Shire's recent filing for Foznol, pushed AnorMED's profile alongside those North American biotechs with late-stage products with potential for revenue and a strong pipeline."
AnorMED's Foznol (also called Lambda) is partnered with Shire Pharmaceuticals Group plc, of Andover, UK. Shire filed for European marketing approval for Foznol (lanthanum carbonate) in March. Foznol is designed to manage phosphate levels in chronic renal failure patients.
The $4 million milestone payment brings the total revenues for AnorMED from the AstraZeneca deal to $10 million. AstraZeneca paid AnorMED an up-front licensing fee of $6 million when the companies entered the deal, valued at up to $33 million, in 1998.
The deal also includes a royalty schedule for AnorMED that increases with increased sales of a commercialized product.
The Phase III trial, Abrams said, will be a multicenter, parallel-group, open-label, randomized study evaluating the drug's safety and efficacy compared to L-doxorubicin in patients with ovarian cancer who have failed previous platinum-based therapy.
"AstraZeneca decided to move this to Phase III based on promising early results showing ZD0437 is active in ovarian cancer that relapsed after initial therapy," Abrams said. "AstraZeneca's discussions with advisory boards supported going into randomized trials and further discussion with agencies in Europe and with the U.S. FDA supported starting a Phase III study in refractory ovarian cancer."
Though the compound's regulatory approval schedule depends on completion of the Phase III trial, Abrams said his company hopes to see a regulatory filing within two or three years.
AnorMED also is pursuing research on a chemokine receptor antagonist for AIDS, inflammation or cancer and metallo-inhibitors for cancer or parasitic diseases.
AnorMED also has partnerships with DuPont Pharmaceuticals, of Wilmington, Del., for the diagnostic imaging agent RP-517 and a preclinical cancer imaging agent.
Abrams said data from a Phase II trial of ZD0473 will be presented at the American Society of Clinical Oncology meeting in San Francisco in May. AnorMED's stock (TSE:AOM) closed Thursday at C$17.50, up C95 cents. n