Ziopharm Oncology, Inc. an oncology small molecule and synthetic biology drug development company, and Solasia Pharma K K, a developer of Western oncology pharmaceuticals in-licensed for commercialization in Asian markets, announced that they have entered into a license and collaboration agreement to develop and commercialize Ziopharm’s darinaparsin product (Zinapar or ZIO-101) and related organic arsenic molecules in specified Pan-Asian/Pacific territories.
Under the terms of the agreement, Ziopharm granted Solasia an exclusive license to develop and commercialize darinaparsin in both intravenous and oral forms, and related organic arsenic molecules, in all indications for human use in a pan-Asian/Pacific territory comprised of Japan, China, Hong Kong, Macau, Republic of Korea, Taiwan, Singapore, Australia, New Zealand, Malaysia, Indonesia, Philippines and Thailand.
Ziopharm will receive an up-front payment of $5 million to be used exclusively for further clinical development of darinaparsin outside of the pan-Asian/Pacific territory, and will be entitled to receive additional payments of up to $32.5 million in development-based milestones and up to $53.5 million in sales-based milestones.
Ziopharm will also be entitled to receive double digit royalty payments from Solasia on net sales of licensed products in the applicable territories, once commercialized, and a percentage of any sublicense revenues generated by Solasia. Solasia will be responsible for the development and commercialization of darinaparsin in the pan-Asian/Pacific territory, subject to input from a joint steering committee of the parties intended to align a strategy for worldwide development.
The parties anticipate that Ziopharm will supply drug product for Solasia’s clinical trials at Solasia’s cost and Ziopharm expects to be responsible for the expenses of scale up commercial production worldwide. The parties may also carry out future joint development activities under a cost sharing arrangement.
“This agreement marks an important milestone for our darinaparsin program, as it provides validation for the compound’s clinical potential as well as additional support ahead of moving into the pivotal phase later this year,” said Jonathan Lewis, M.D., Ph.D., chief executive officer and chief medical officer of Ziopharm. “Solasia is a strong partner whose management and advisory team are highly experienced in the development and commercialization of products within these territories.”
“We are very excited to add darinaparsin to our growing pipeline of oncology drugs. Cancer is a leading cause of death in Asia, with hematologic malignancies increasing as a subset of the total cancer incidence rate,” said Steven E. Engen, president & CEO of Solasia. “Darinaparsin is well tolerated and is expected to be less toxic than arsenics commonly used in Japan, China and other territories in Asia and has demonstrated promising efficacy in hematologic cancers, including peripheral T-cell lymphoma (PTCL), a disease nearly twice as prevalent in Asia compared to the West, but for which there are very few treatment options. We look forward to working with Ziopharm in developing this novel drug, and to filling this growing unmet medical need in Asia.”
Darinaparsin is a novel mitochondrial-targeted agent (organic arsenic) being developed for the treatment of various hematologic and solid cancers. In a Phase II study, intravenous darinaparsin demonstrated evidence of clinical activity in lymphoma, in particular peripheral Tcell lymphoma (PTCL). Ziopharm expects to initiate a registration-directed study of darinaparsin in patients with PTCL, likely in the refractory setting, in late 2011.
Darinaparsin was granted orphan drug designation in the US and Europe as a treatment of PTCL and Solasia intends to seek similar status in Japan. ZIOPHARM is also currently studying darinaparsin in combination with CHOP (Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone), the current standard of care for front line PTCL, to confirm the tolerability of the combination for a possible future trial in the front-line setting. An oral form is in a phase I trial in solid tumours.
Ziopharm Oncology is a biopharmaceutical company engaged in the development and commercialization of a diverse portfolio of cancer therapeutics and is currently focused on several clinical programmes.
The company is also pursuing the development of novel DNA-based therapeutics in the field of cancer pursuant to a partnering arrangement with Intrexon Corporation.
Solasia Pharma K.K. (Tokyo, Japan) was formed in November 2006 by MPM Capital and ITOCHU Corporation to address unmet needs for important new Western oncology therapies throughout Asia. The company's mission is to expedite patient access to unique oncology therapies through aggressive development and specialized commercialization throughout Japan, China and other Asian countries.