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."
About Darinaparsin
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.
ZIOP-G
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.
Photos/Multimedia Gallery Available: http://www.businesswire.com/cgi-bin/mmg.cgi?eid=6636485&lang=en
For ZIOPHARM:
ZIOPHARM Oncology, Inc.
Tyler Cook,
617-259-1982
tcook@ziopharm.com
or
Media:
Argot
Partners
David Pitts, 212-600-1902
david@argotpartners.com
or
For
Solasia:
Takashi Ono, +81-(0)3-6721-8332
Vice President
tono@solasia.co.jp
or
Media:
Annes
Associates
Shari Annes, 650-888-0902
sannes@annesassociates.com
Source: ZIOPHARM Oncology, Inc.
News Provided by Acquire Media
