UNITED
STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
8-K
CURRENT
REPORT
PURSUANT TO SECTION 13 OR 15(d) OF
THE SECURITIES EXCHANGE ACT OF 1934
PURSUANT TO SECTION 13 OR 15(d) OF
THE SECURITIES EXCHANGE ACT OF 1934
Date
of
report (date of earliest event reported): November 3, 2006
ZIOPHARM
Oncology, Inc.
(Exact name of registrant as specified in its charter)
(Exact name of registrant as specified in its charter)
|
Delaware
|
0-32353
|
84-1475642
|
|
(State
or other jurisdiction of incorporation)
|
(Commission
File Number)
|
(IRS
Employer Identification No.)
|
1180
Avenue of the Americas, 19th
Floor
New York, NY 10036
New York, NY 10036
(Address
of principal executive offices) (Zip Code)
(646)
214-0700
(Registrant’s
telephone number, including area code)
_________________________________________
(Former
name or former address, if changed since last report)
Check
the
appropriate box below if the Form 8-K filing is intended to simultaneously
satisfy the filing obligation of the registrant under any of the following
provisions:
o Written
communications pursuant to Rule 425 under the Securities Act (17 CFR
230.425)
o Soliciting
material pursuant to
Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
o Pre-commencement
communications
pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR
240.14d-2(b))
o Pre-commencement
communications
pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR
240.13e-4(c))
Item
1.01. Entry into a Material Definitive Agreement.
Purchase
Agreement.
On
November 3, 2006 (the “Closing Date”), ZIOPHARM Oncology, Inc. (the “Company”)
entered into an Asset Purchase Agreement (the “Purchase Agreement”) with Baxter
Healthcare S.A., Baxter International, Inc. and Baxter Oncology GmbH, which
are
affiliates of Baxter Healthcare Corporation (collectively referred to as
“Baxter”). Pursuant to the Purchase Agreement, the Company acquired certain
assets, including patents, contracts (including all rights and obligations
thereunder), regulatory submissions, inventory and related assets relating
to an
oncology product candidate known as indibulin. Pursuant to the Purchase
Agreement, Baxter also granted the Company an exclusive worldwide, non-royalty
bearing license (including the right to grant sublicenses) to Baxter’s
non-purchased intangible property rights to the extent such rights are required
to use, market, sell, make, offer to sell and manufacture
indibulin.
Indibulin,
which has been designated by the Company as ZIO-301, is a novel anti-cancer
agent that targets mitosis like the taxanes, and is available as both an
oral
and a proprietary nanosuspension intravenous form. The oral form is currently
in
a Phase I trial, with Phase II expected to initiate in the first half of
2007
under an Investigational New Drug Application expected to be filed in the
United
States. The nanosuspension intravenous form is currently in late preclinical
development with a Phase I trial anticipated in 2007. While the development
program for indibulin is evolving, potential application of ZIO-301 is possible
in a wide variety of cancer types. Depending upon the ultimate application,
the
Company believes the worldwide sales potential of ZIO-301 could range from
$500
million to $2 billion at product maturity. However, the Company can provide
no
assurance that it will be able to obtain regulatory approvals for ZIO-301,
that
development efforts relating ZIO-301 will be successful, or that ZIO-301
will be
successfully commercialized.
In
consideration for the assets and license acquired by the Company under the
Purchase Agreement, including Baxter’s inventory of indibulin capsules and
powder, the Company is required to make a $1.225 million up-front cash payment
to Baxter. The Company also agreed to make annual payments to Baxter on the
sixth through twelfth anniversaries of the Closing Date that total $1.5 million
in the aggregate (the “Annual Payments”). As further consideration, the Company
agreed to pay to Baxter up to an aggregate of $6.625 million upon the
achievement of various clinical and regulatory milestones relating to indibulin,
commencing with a $625,000 payment required to be made within 30 days following
the first effectiveness of an investigational new drug application submitted
to
the FDA (or a European equivalent). In addition to milestone payments, the
Company is require to pay Baxter royalties based on net sales of products that
are covered by the purchased patents, the amount of which may be offset by
the
amount of any previously-paid Annual Payments. Royalties will be further reduced
in the event the Company is required to license third party patent rights in
order to make, have made, or sell indibulin without infringing on such
rights.
The
Company will have the right and obligation to file, prosecute and maintain
the
purchased patents in various jurisdictions world-wide. Should the Company
abandon or fail to continue any required patent filing, prosecution or
maintenance obligation, Baxter may elect to assume such obligations, provided
that the patents will remain the sole property of the Company.
Each
party has agreed to indemnify the other for breaches of their respective
representations and warranties and failure to perform their respective
obligations under the Purchase Agreement. In addition, Baxter has agreed to
indemnify the Company for its ownership and operation of the purchased assets
prior to the Closing Date, and the Company has agreed to indemnify Baxter for
its ownership and operation of the purchased assets from and after the Closing
Date. The parties’ indemnification obligations under the Purchase Agreement also
to apply to damages claimed under the License Agreement (as defined below).
License
Agreement.
Also
on
November 3, 2006, the Company entered into a License Agreement (the “License
Agreement”) with Baxter Healthcare S.A. and Baxter International, Inc.
(collectively referred to as the “Licensors”), pursuant to which the Licensors
granted the Company an exclusive, world-wide, royalty bearing license (including
the right to grant sublicenses) under certain patents (the “Licensed Patents”)
to use, market, offer to sell and import indibulin-related nanosuspension (the
“Licensed Product”). The Licensors also granted the Company an exclusive
worldwide, non-royalty bearing license (including the right to grant
sublicenses) to other intangible property rights to the extent such rights
are
required to use, market, sell, make, offer to sell and manufacture Licensed
Products. The License Agreement does not grant to the Company a license to
manufacture the Licensed Product or have the Licensed Product manufactured
by a
third party.
In
consideration for the licenses, the Company has agreed to make a $500,000 cash
payment to the Licensors within 30 days following the first effectiveness of
an
investigational new drug application submitted to the FDA (or a European
equivalent) permitting the Company to initiate human clinical trials of a
Licensed Product in the United States or Europe, whichever occurs first. In
addition, the Company agreed to pay royalties to the Licensors based on net
sales of a License Product, which may be offset by the amount of any Annual
Payments previously made under the Asset Purchase Agreement. The royalty
payments will be further reduced in the event the Company is required to license
third party patent rights in order to use, market, offer to sell or import
a
Licensed Product without infringing on such rights.
The
Licensors will have the right and obligation to file, prosecute and maintain
the
Licensed Patents in various jurisdictions world-wide, and the Company has agreed
to pay half of the estimated costs associated with such obligations on an annual
basis (“the Maintenance Fee”). Should the Licensors abandon or fail to continue
any required Licensed Patent filing, prosecution or maintenance obligation,
the
Company may elect to assume such obligations, provided that the patents will
remain the sole property of the Licensors. In such event, the Company will
be
permitted to deduct 50% of the direct cost associated with assuming such
obligation from its payment of the annual Maintenance Fee.
Either
the Company or the Licensors may terminate the License Agreement in the event
that the other has materially breached its obligations under the License
Agreement and fails to remedy such breach within 60 days following notice by
the
non-breaching party. If such breach is not cured, then the non-breaching party
may terminate the License Agreement at the end of such 60 day period. However,
if the breach is incapable of cure within 60 days but is otherwise capable
of
cure, the terminating party will not be materially prejudiced if the cure is
effected within a reasonable time and the curing party is proceeding to effect
such cure in good faith and with reasonable diligence, the termination shall
not
become effective until the curing party has had a reasonable time to effect
the
cure. In addition, the Company may terminate the License Agreement at any time
upon 60 days prior written notice, at which time all licenses granted under
the
License Agreement will terminate and no further payment obligations of the
Company under the License Agreement will accrue.
Indibulin
is the subject of both issued patents and applications worldwide. Unless
terminated earlier, the licenses granted under the License Agreement expire
upon
the expiration of the last to expire of the Licensed Patents, which for the
currently issued patents, is 2017.
On
November 6, 2006, the Company issued a press release announcing entry into
the
above referenced agreements. Such press release is attached hereto as Exhibit
99.1 and is incorporated herein by reference.
Item
9.01 Financial Statements and Exhibits.
(d) Exhibits.
99.1 Press
Release dated November 6, 2006.
SIGNATURE
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant
has
duly caused this report to be signed on its behalf by the undersigned hereunto
duly authorized.
| Date: November 6, 2006 | ZIOPHARM
Oncology, Inc.: (REGISTRANT)
|
|
| |
|
|
| By: | /s/ Richard E. Bagley | |
|
RICHARD
E. BAGLEY,
President, Chief
Operating
Officer and Chief Financial Officer
|
||
Exhibit
Index
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Exhibit
No.
|
Description
|
|
99.1
|
Press
Release dated November 6, 2006
|
Exhibit
99.1
ZIOPHARM
Acquires Indibulin Oncology Program from Baxter
--Novel
Oral and Nanosuspension Taxane-Related Anti-Cancer Drugs --
--Oral
Form in Phase I with Expected Advantages to Taxanes--
NEW
YORK, NY - November 6, 2006
-
ZIOPHARM Oncology, Inc. (NASDAQ: ZIOP), announced today the signing of a
definitive agreement to acquire indibulin, a novel synthetic anti-cancer
agent
that targets mitosis like the taxanes, from affiliates of Baxter Healthcare
Corporation. Indibulin is available as both an oral and a proprietary
nanosuspension intravenous (IV) form with the oral form in a phase I trial
and
the nanosuspension in late preclinical. Indibulin, now designated as ZIO-301,
may offer efficacy, dosing and toxicity advantages as compared to marketed
taxanes, including paclitaxel (Taxol®),
paclitaxel protein-bound particles for injectable suspension
(Abraxane®),
and
docetaxel (Taxotere®).
Indibulin is the subject of both issued patents and applications
worldwide.
The
Phase
I trial is ongoing at the Netherlands Cancer Institute and University Medical
Center, Utrecht with Prof. Jan Schellens as principal investigator. As part
of
the purchase, the Company has acquired the existing drug supply manufactured
by
Baxter and has assumed all responsibility for the phase I trial. The Company
expects to file an IND in the United States to initiate a phase II study
with
the oral form in the first half of 2007 followed by phase I trials with the
nanosuspension IV formulation.
Taxanes
are administered by intravenous administration (IV) and are among the most
effective clinical chemotherapeutic agents in the world today, with 2005
sales
in excess of $3 billion. Notwithstanding this extensive use, all of the marketed
agents are associated with severe toxicities, primarily neurotoxicity and/or
myelosuppression. The Company believes that indibulin has the potential to
provide important competitive advantages over currently marketed taxanes,
including the availability of both an oral and a proprietary IV nanosuspension,
preclinical evidence of activity against multi-drug and taxane resistant
tumors,
and reduced toxicity.
“Taxanes
are well established as standard of care for treating a great variety of
solid
cancers”, commented Prof. Jan Schellens of the Netherlands Cancer Institute and
the Principal Investigator for the ongoing phase I trial. “Indibulin appears to
have a unique mechanism of action and it is orally bioavailable and so far
lacking neurotoxicity. We look very forward to collaborating with ZIOPHARM
on
this program.”
Terms
of
the acquisition include an upfront cash payment, clinical and regulatory-based
milestone payments, and royalties on net product sales typical of a product
at
this stage of development.
ZIOPHARM
Acquires Phase I Product from Baxter
“We’re
excited about adding a third potential phase II candidate to our portfolio,”
commented Jon Lewis, MD, PhD the Company’s Chief Executive Officer. “This
transaction is synergistic with our ongoing ZIO-101 and ZIO-201 programs.
The
expected near-term availability of an oral version of ZIO-101, our organic
arsenic, along with the possibility of an oral ZIO-201, means we should be
uniquely positioned among our peers with three proprietary oral anti-cancer
agents in clinical trials in 2007, a year that promises to be a very exciting
one for ZIOPHARM.”
About
ZIOPHARM Oncology, Inc.
ZIOPHARM
Oncology, Inc. is a biopharmaceutical company engaged in the development
and
commercialization of a diverse, risk-sensitive portfolio of in-licensed cancer
drugs to address unmet medical needs. The Company applies new insights from
molecular and cancer biology to understand the efficacy and safety limitations
of approved and developmental cancer therapies and identifies proprietary
and
related molecules for better patient treatment. For more information, visit
www.ziopharm.com.
Forward-Looking
Safe Harbor Statement:
This
press release contains forward-looking statements for ZIOPHARM Oncology,
Inc.
that involve risks and uncertainties that could cause the Company'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 the Company'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 the Company's product candidates, the risk that the results of
clinical trials may not support the Company's claims, and risks related to
the
Company's ability to protect its intellectual property and its reliance on
third
parties to develop its product candidates. The Company assumes no obligation
to
update these forward-looking statements, except as required by law.
Contact:
Suzanne
McKenna
ZIOPHARM
Investor Relations
Investors
(646)
214-0703
smckenna@ziopharm.com
Tina
Posterli
Rx
Communications
Media
(917)
322-2565
tposterli@rxir.com