ZIOPHARM and Solasia Pharma Announce License and Collaboration Agreement for Darinaparsin in Asia
NEW YORK & TOKYO—(Business Wire)—ZIOPHARM Oncology, Inc. (Nasdaq: ZIOP), 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 today 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 T-cell 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 U.S. 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 tumors.
About ZIOPHARM Oncology, Inc.:
ZIOPHARM Oncology is a biopharmaceutical company engaged in the development and commercialization of a diverse portfolio of cancer therapeutics. The company is currently focused on several clinical programs.
Palifosfamide (ZymafosTM or ZIO-201) is a novel DNA cross-linker in class with bendamustine, ifosfamide, and cyclophosphamide. ZIOPHARM is currently enrolling patients in a randomized, double-blinded, placebo-controlled Phase III trial with palifosfamide administered intravenously for the treatment of metastatic soft tissue sarcoma in the front-line setting. The company is also currently conducting a Phase I intravenous study of palifosfamide in combination with standard of care addressing small cell lung cancer and an oral form of the drug for treatment of solid tumors is currently in the advanced preclinical stage of development.
Darinaparsin (ZinaparTM or ZIO-101) is a novel mitochondrial-targeted agent (organic arsenic) being developed intravenously for the treatment of relapsed peripheral T-cell lymphoma likely with a two-stage potentially pivotal study expected to begin in late 2011. An oral form is in a Phase I trial in solid tumors.
Indibulin (ZybulinTM or ZIO-301) is a novel, oral tubulin binding agent that is expected to have several potential benefits including oral dosing, application in multi-drug resistant tumors, no neuropathy and minimal overall toxicity. It is currently being studied in Phase I/II in metastatic breast cancer.
ZIOPHARM is also pursuing the development of novel DNA-based therapeutics in the field of cancer pursuant to a partnering arrangement with Intrexon Corporation. The partnership includes two existing clinical-stage product candidates, the first of which is in a Phase Ib study and the second of which is the basis of an Investigational New Drug application that ZIOPHARM expects to submit during the first half of 2011.
ZIOPHARM’s operations are located in Boston, MA with an executive office in New York City. Further information about ZIOPHARM may be found at www.ziopharm.com.
About Solasia Pharma, K.K.:
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. In May 2008, Solasia acquired Asia rights to Sancuso (extended release granisetron transdermal patch) from ProStrakan Group plc. Solasia is conducting Sancuso clinical development in China, and expects to complete studies required for filing a New Drug Application (NDA) in China within 2011. To date, Solasia has raised approximately $16 million in Series A financing.
Forward-Looking Safe Harbor Statement:
This press release contains forward-looking statements for ZIOPHARM Oncology, Inc. that involve risks and uncertainties that could cause ZIOPHARM Oncology’s actual results to differ materially from the anticipated results and expectations expressed in these forward-looking statements. These statements are based on current expectations, forecasts and assumptions that are subject to risks and uncertainties, which could cause actual outcomes and results to differ materially from these statements. Among other things, there can be no assurance that any of ZIOPHARM Oncology’s development efforts relating to its product candidates will be successful, or such product candidates will be successfully commercialized. Other risks that affect forward-looking information contained in this press release include the possibility of being unable to obtain regulatory approval of ZIOPHARM Oncology’s product candidates, the risk that the results of clinical trials may not support ZIOPHARM Oncology’s claims, the risk that pre-clinical or clinical trials may not proceed on schedules that are consistent with ZIOPHARM Oncology’s current expectations or at all, risks related to ZIOPHARM Oncology’s ability to protect its intellectual property and its reliance on third parties to develop its product candidates, risks related to the sufficiency of existing capital reserves to fund continued operations for a particular amount of time and uncertainties regarding ZIOPHARM Oncology’s ability to obtain additional financing to support its operations thereafter, as well as other risks regarding ZIOPHARM Oncology’s that are discussed under the heading “Risk Factors” in ZIOPHARM Oncology’s filings with the United States Securities and Exchange Commission. Forward-looking statements can be identified by the use of words such as “may,” “will,” “intend,” ” should,” “could,” “can,” “would,” “expect,” “believe,” “estimate,” ” predict,” “potential,” “plan,” “is designed to,” “target” and similar expressions. ZIOPHARM Oncology assumes no obligation to update these forward-looking statements, except as required by law.
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ZIOPHARM Oncology, Inc.
Tyler Cook, 617-259-1982
David Pitts, 212-600-1902
Takashi Ono, +81-(0)3-6721-8332
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Source: ZIOPHARM Oncology, Inc.
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