A New Assault on Addiction motivated to take it. "If this drug isn't used with a comprehensive treatment program," Medicine: Can a single drug keep alcoholics on the says DuPont Merck president Kurt Landgraf, “the failure rates are very high." And wagon and help junkies through withdrawal? naltrexone poses hazards of its own. The common side effects are minor, ranging from
ZIOPHARM and Solasia Pharma Announce License and Collaboration
Agreement for Darinaparsin in Asia
NEW YORK & TOKYO (March 7, 2011) – 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
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
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.
ZIOPHARM Oncology, Inc.
Takashi Ono, Vice President
WRIGHT-PATT CREDIT UNION INTERNET ACCOUNT ACCESS AGREEMENT, OPTIONAL BILL PAY AGREEMENT AND DISCLOSURE STATEMENT IMPORTANT: THE WRIGHT-PATT CREDIT UNION, INC. (“WPCU”) INTERNET ACCOUNT ACCESS AGREEMENT (“HOME BANKING”), OPTIONAL BILL PAY AGREEMENT AND DISCLOSURE (“AGREEMENT”) IS A LEGALLY BINDING CONTRACT. BY USING THIS ELECTRONIC SERVICE, YOU AGREE TO BE BOUND BY THE TERMS AND CONDI