Novartis Expands Late-stage Oncology Pipeline With AS1404, a Novel Agent Shown to Break Down Blood Vessels That Support Tumor Growth
- Novartis acquires worldwide rights to AS1404, a small molecule vascular disrupting agent (VDA), from Antisoma
- AS1404 to enter Phase III in 2008 in squamous non-small cell lung cancer after positive Phase II data showed AS1404 extended median survival
- Novartis to make upfront payment of USD 75 million and further payments contingent upon development milestones, approvals and sales
- Transaction complements broad and deep Novartis Oncology
pipeline, now with seven compounds to be in late-stage development
by the end of 2008
BASEL, Switzerland, April 19, 2007 - Novartis has expanded its
late-stage oncology pipeline through an exclusive licensing
agreement with Antisoma plc for the worldwide rights to AS1404, a
small molecule vascular disrupting agent expected to begin Phase
III trials in 2008 in patients with squamous non-small cell lung
cancer.
"This agreement further strengthens our broad and deep oncology
pipeline by adding a novel mechanism to treat solid tumors," said
David Epstein, President and CEO of Novartis Oncology. "As a
potentially first-in-class tumor vascular disrupting agent, AS1404
represents an opportunity to provide physicians and patients with
an innovative new treatment option."
Novartis reached this agreement following the presentation in
November 2006 of positive Phase II results involving patients with
non-small cell lung cancer that showed AS1404 extended median
survival by five months when used in combination with a standard
chemotherapy regimen of paclitaxel and carboplatin over
chemotherapy alone. Recently reported results of a confirmatory
Phase II trial in non-small cell lung cancer showed a response rate
of 50% in AS1404 patients, while another 43% showed disease
stabilization.
AS1404, given as a 20-minute infusion immediately following
chemotherapy, is the first compound in this new class of compounds
called vascular disrupting agents (VDAs) to report positive data
from a randomized Phase II clinical trial.
These compounds selectively disrupt established blood vessels in
solid tumors, which rely on a network to survive and grow. VDA
compounds exert an effect different to angiogenesis inhibitors,
which inhibit the formation of new tumor blood vessels.
The need for new lung cancer treatments is urgent since it is one
of the most common cancers worldwide with low survival rates. About
1.2 million deaths worldwide are linked to lung cancer each year.
Non-small cell lung cancer represents about 80% of all lung cancer
cases. The squamous form is one of three NSCLC types and represents
25% to 40% of cases.
Initial data from other Phase II trials in ovarian and prostate
cancers have shown increased response rates through the addition of
AS1404 to standard chemotherapy. The potential benefits of this
compound in these cancers, as well as other solid tumors, will be
further explored during the development program.
The addition of AS1404 to the Novartis pipeline brings to seven the
number of compounds planned to enter late-stage development by the
end of 2008. In addition to AS1404, other compounds include RAD001
(multiple tumors), SOM230 (Cushing's disease/refractory carcinoid
tumors, acromegaly), LBH589 (chronic myeloid leukemia/cutaneous
T-cell lymphoma), Tasigna (chronic myeloid leukemia), EPO906
(ovarian), and PKC 412 (acute myelogenous leukemia).
AS1404 was discovered by Professors Bruce Baguley and William Denny
and their teams at the Auckland Cancer Society Research Centre,
University of Auckland, New Zealand. Antisoma acquired the rights
to this compound from Cancer Research Ventures Limited (now Cancer
Research Technology) in 2001.
Financial terms of the agreement
Novartis will gain the worldwide commercialization rights for
AS1404 and will assume the management and costs of Phase III
development. An upfront cash payment of USD 75 million will be made
to Antisoma, which can receive additional payments of USD 380
million contingent upon the achievement of development milestones
and approvals in four oncology indications worldwide and one
non-oncology indication. Further potential milestones of up to USD
325 million are contingent on the performance of any future net
sales. Antisoma will also receive sales royalties and has a
co-commercialization option in the United States. An agreement has
also been reached that provides Novartis an option to acquire a
potential back-up compound to AS1404 that is currently in
early-stage development. If this option is exercised, and if this
back-up compound achieves development milestones and regulatory
approval, Antisoma could receive up to an additional USD 110
million.
Disclaimer
The foregoing release contains forward-looking statements that can
be identified by terminology such as "to enter," "to make,"
"contingent," "to be in late-stage development," "pipeline,"
"expected," "potentially," "opportunity," "potential," "planned,"
"will," "could," or similar expressions, or by express or implied
discussions regarding potential commercialization, potential
indications, potential marketing, or future sales of AS1404 or
other pipeline products. Such forward-looking statements involve
known and unknown risks, uncertainties and other factors that may
cause actual results to be materially different from any future
results, performance or achievements expressed or implied by such
statements. There can be no guarantee that AS1404, or any of our
other pipeline products, will be approved for any indications in
any market, or that they will reach any particular sales levels. In
particular, management's expectations regarding these products
could be affected by, among other things, unexpected clinical trial
results, including additional analysis of existing clinical data
and new clinical data; unexpected regulatory actions or delays or
government regulation generally; the company's ability to obtain or
maintain patent or other proprietary intellectual property
protection; competition in general; increased government, industry,
and general public pricing pressures; and other risks and factors
referred to in the Company's current Form 20-F on file with the
U.S. Securities and Exchange Commission. Should one or more of
these risks or uncertainties materialize, or should underlying
assumptions prove incorrect, actual results may vary materially
from those anticipated, believed, estimated or expected. Novartis
is providing the information in this press release as of this date
and does not undertake any obligation to update any forward-looking
statements contained in this press release as a result of new
information, future events or otherwise.
About Novartis
Novartis AG (NYSE: NVS) is a world leader in offering medicines to
protect health, cure disease and improve well-being. Our goal is to
discover, develop and successfully market innovative products to
treat patients, ease suffering and enhance the quality of life. We
are strengthening our medicine-based portfolio, which is focused on
strategic growth platforms in innovation-driven pharmaceuticals,
high-quality and low-cost generics, human vaccines and leading
self-medication OTC brands. Novartis is the only company with
leadership positions in these areas. In 2006, the Group's
businesses achieved net sales of USD 37.0 billion and net income of
USD 7.2 billion. Approximately USD 5.4 billion was invested in
R&D. Headquartered in Basel, Switzerland, Novartis Group
companies employ approximately 101,000 associates and operate in
over 140 countries around the world. For more information, please
visit http://www.novartis.com.
# # #
Novartis Media Relations
John Gilardi
Novartis Global Media Relations
+41 61 324 3018 (direct)
+41 79 596 1408 (main)
john.gilardi@novartis.com
Geoffrey Cook
Novartis Oncology Media Relations
+1 862 778 2675 (direct)
+1 973 652 7927 (mobile)
geoffrey.cook@novartis.com
e-mail: media.relations@novartis.com
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