NeoRx Corp., with its skeletal cancer treatment in Phase III trials, has bought AnorMed Inc.'s earlier-stage, platinum-based cancer agent, AMD473, for $2 million up front and as much as $13 million more in milestone payments.
Karen Auditore-Hargreaves, president and chief operating officer of NeoRx, said the company has "been saying for some time we wanted to broaden our pipeline," and the AnorMed compound is one that "doesn't have some of the perceived weaknesses" of NeoRx's lead therapy.
Shares of NeoRx (NASDAQ:NERX) closed Monday at $4.05, down 5 cents.
NeoRx paid $1 million in NeoRx common stock and $1 million in cash for an exclusive license with issued patents and patent applications to develop, manufacture and commercialize AMD473.
Milestone payments of up to $13 million may be made in cash or a combination of cash and NeoRx stock, and AnorMed is in line for royalties of up to 15 percent, if the drug reaches the market.
In March, NeoRx started enrolling its pivotal Phase III trial with Skeletal Targeted Radiotherapy in patients with multiple myeloma. STR delivers high doses of radiation to tumor sites in the skeleton with minimal damage to organs outside the bone, zeroing-in on bone and adjacent marrow with a small-molecule agent known as DOTMP, combined with the radionuclide holmium-166. The treatment is to be used with high-dose chemotherapy and autologous stem cell transplantation.
One of the perceived weaknesses of STR, Auditore-Hargreaves said, is its first, rather small target disease, although NeoRx disagrees with such a view, since "we think it's indicated in any disease where transplant is an option."
Another problem, at least in the view of some, is STR's radioactivity.
"I don't know that it's viewed as a big issue by the informed, but it's certainly viewed as a big issue by the uninformed," she said, adding that many people compare STR to Bexxar (tositumomab, iodine-131) and Zevalin (ibritumomab tiuxetan) - both for non-Hodgkin's lymphoma - and "sales of those agents have been really dismal."
Bexxar and Zevalin (Corixa Corp. and partner GlaxoSmithKline plc, and Biogen Idec Inc., respectively) are prescribed mainly by community oncologists, Auditore-Hargreaves said, and the drugs "cause a fair amount of cytopenia," or reduction of the number of cells circulating in the blood, which is difficult to manage in that setting. STR, on the other hand, is given by transplant physicians. "For them, cytopenia is a way of life," she said. "They induce cytopenia and know how to handle it." Some people, she added, are "just radiophobic."
AMD473 is nonradioactive, and NeoRx got rights to the drug without paying entirely in cash, "which was important to us because we wanted to conserve as much of our cash as we could," she said.
AMD473 has "been in several Phase II studies in several different cancers," Auditore-Hargreaves said. "I expect to do some additional Phase II studies before moving on to Phase III." She declined to be more specific, saying the company wants to "spend some time looking through the data and talking with the FDA" before deciding.
AnorMed, of Vancouver, British Columbia, also is handing over to NeoRx certain know-how pertaining to clinical and manufacturing data, regulatory submissions and related information, along with a batch of finished AMD473 suitable for use in clinical studies.
"I think this could be a transformative event for NeoRx," Auditore-Hargreaves said of the deal. "If it works out as well as we hope it will, it will be the only branded platinum drug that will be available as oral and intravenous [therapy]," she said.
Other cancer drugs in the platinum-based family include cisplatin, which is off patent. Carboplatin will lose patent protection shortly. Oxaliplatin retains its patent coverage but can be administered only intravenously. In Phase III trials is satraplatin, from GPC Biotech AG, of Martinsried, Germany, and Irvine, Calif.-based Spectrum Pharmaceuticals Inc. - but that one is for oral delivery only.
Separately, Seattle-based NeoRx said it has executed an agreement to sell its Pretarget intellectual property to privately held Aletheon Pharmaceuticals Inc., of Seattle. Under the terms, NeoRx could get up to $6.6 million in milestone payments if Aletheon achieves certain development goals, plus royalties. Auditore-Hargreaves described the milestones as "standard vanilla," and they are related to clinical trial success and regulatory submissions.
Pretarget technology is a platform for developing immunotherapeutics that deliver intense doses of cancer-killing agents to tumor cells while sparing healthy tissues, with resulting drugs "rather more similar to a Zevalin or a Bexxar," Auditore-Hargreaves said.
"We worked on it for many years, and discontinued the program in 2002, when we were in a cash crunch. The manufacturing for that kind of agent was very expensive and needs to be made well in advance of Phase III trials. We felt it didn't fit with our manufacturing expertise." STR and AMD473, however, are small molecules "that can be readily made," she said.
NeoRx also said Melinda Kile has resigned as vice president of finance, effective April 16, and will serve as a consultant as a successor is chosen. Michael Jackson has been promoted to chief accounting officer from controller and will be assuming the senior financial responsibilities until a replacement for Kile is announced.