today announced that it has acquired from AnorMED Inc. the worldwide exclusive rights, excluding Japan, to develop, manufacture and commercialize AMD473, a platinum-based anti-cancer agent. AMD473 has been administered to more than 500 cancer patients in phase I and phase II clinical trials, demonstrating anti-cancer activity in a wide range of tumors and a manageable safety profile. NeoRx expects to initiate clinical studies of AMD473 in one or more cancer indications in the second half of this year.
"The acquisition of AMD473 fits our strategic focus on broadening our drug development pipeline with a compound that has already proven effective in early stage trials," said Jack L. Bowman, Chairman and CEO of NeoRx. "Furthermore, we believe that the AMD473 development program is highly complementary to our STR(TM) program and we have the clinical staff and financial resources to move forward with AMD473 clinical development, while conducting our phase III trial with STR. We are also very satisfied with this transaction's terms, which allow us to reserve our financial resources for product development. All-in-all, we believe that the acquisition of AMD473 will prove to be beneficial for our Company and our shareholders."
Under the terms of the agreement, NeoRx paid AnorMED a one-time upfront milestone payment of $1 million in NeoRx common stock and $1 million in cash. The agreement also provides for additional milestone payments to AnorMED of up to $13 million, payable in cash or a combination of cash and NeoRx common stock. Upon regulatory approval, AnorMED would receive royalty payments of up to 15% on product sales.
Under the agreement, NeoRx has acquired an exclusive license, under a portfolio of issued patents and patent applications, to develop, manufacture and commercialize AMD473. The patent portfolio relates to composition of matter, formulations and methods of use of AMD473 and related analogs and compounds, and includes issued patents and patent applications in all major countries. The agreement also transfers to NeoRx certain know-how pertaining to AMD473, including clinical and manufacturing data, regulatory submissions, and related information. Also under the agreement, AnorMED will transfer to NeoRx an inventory of finished AMD473 suitable for use in clinical studies.
Philip S. Schein, MD, Chairman of NeoRx's Scientific Advisory Board, said, "In clinical studies to date, AMD473 appears to have a broader spectrum of activity than currently available platinum-based drugs, and also shows anti-tumor activity in some platinum-resistant tumors in laboratory studies. Clinical studies also have indicated that AMD473 has an acceptable safety profile, and reduced toxicity to the kidney and peripheral nervous system associated with the widely used platinum drug cisplatin. AMD473 also is noteworthy for its potential, based on preclinical data, to address the growing need for oral chemotherapeutics for out-patient treatment."
In phase I clinical studies of AMD473 as a single agent and in combination with other cancer therapeutics, anti-tumor activity was observed in a broad range of cancers. In phase II monotherapy studies of AMD473, objective responses were observed in hormone-resistant prostate cancer, and in second-line ovarian, breast, and lung cancers, including platinum-resistant and platinum-sensitive cancers. Existing platinum agents such as cisplatin and oxaliplatin exhibit nephrotoxicity and/or neurotoxicity. No clinically significant nephrotoxicity or neurotoxicity has been observed with AMD473 to date. Moreover, AMD473 has shown oral bioavailability and anti-tumor activity with oral administration in preclinical studies, and has the potential to be the first platinum agent with both intravenous and oral formulations.
Platinum-based cancer drugs have gained broad use since their introduction nearly 20 years ago. The platinum drugs cisplatin, carboplatin and oxaliplatin are widely used in combination therapies for numerous tumor types. The worldwide market for platinum-based cancer drugs is estimated to be over $1 billion. However, available platinum drugs have undesirable side effects and toxicities, which limit their use. There also remain a number of cancer indications that are not well treated with existing platinum agents, and all currently approved platinum agents are administered intravenously. There is a need to expand the spectrum of activities of platinum anti-tumor agents to other cancer types. An orally administered platinum agent also could be of significant benefit in the chemotherapeutic setting.