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Novartis gains worldwide rights to elinogrel, a Phase II
anti-clotting compound with potential to reduce risk of heart attack
and stroke |
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Corporate news announcement processed and transmitted by Hugin AS.
The issuer is solely responsible for the content of this
announcement.
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* Exclusive rights licensed from Portola Pharmaceuticals Inc. for
elinogrel (PRT060128), further strengthening Novartis
cardiovascular portfolio
* Elinogrel offers oral and intravenous formulations, has shown a
fast onset of action and could offer physicians a rapid way to
reverse its anti-clotting action if needed
* Novartis has responsibility for Phase III trials, manufacturing
and commercialization, while collaborating with Portola on
ongoing Phase II trials
* Novartis to make USD 75 million upfront payment, Portola eligible
for milestones and royalties on future sales
Basel, February 12, 2009 - Novartis has gained the exclusive
worldwide rights to elinogrel, a promising anti-clotting agent in
Phase II clinical trials that has shown potential to offer clinical
improvements over current anti-clotting medications in helping
patients avoid heart attacks and strokes.
As part of the agreement with the US biotechnology company Portola
Pharmaceuticals, Inc., Novartis will have responsibility for the
Phase III development, manufacturing and commercialization of
elinogrel.
Elinogrel belongs to a class of cardiovascular medicines that seek to
prevent blood platelets circulating in the arterial system from
sticking together and forming potentially dangerous clots. These
clots can limit or stop the flow of blood to the heart or brain,
leading to heart attacks or strokes.
"More than 13 million people die every year from complications
related to blood clots, which underscores the ongoing and significant
unmet need," said Trevor Mundel, MD, Global Head of Development at
Novartis Pharma AG. "Elinogrel is a novel compound with attributes
that have the potential to offer clinical benefits over currently
approved antiplatelet therapies. Elinogrel will further diversify our
cardiovascular pipeline and we hope it will prove to be a strong
addition to our portfolio."
Elinogrel is being developed as oral and intravenous formulations. It
has an instant onset of action that could quickly provide protection
from clotting. Elinogrel's effect is also reversible, which may offer
physicians a way to rapidly reverse its anti-clotting actions when
necessary. Data from Portola's Phase I and Phase IIa trials showed
elinogrel was well tolerated and had predictable, dose-dependent
platelet inhibition[1].
INNOVATE-PCI, an 800-patient Phase IIb clinical trial, was initiated
in December 2008 involving the intravenous and oral forms of
elinogrel to explore the compound's clinical efficacy, biological
activity, tolerability and safety. This trial includes a broad group
of patients undergoing non-urgent surgery to repair a damaged blood
vessel or to unblock a coronary artery (percutaneous coronary
intervention). The trial involves a head-to-head assessment of
elinogrel's intravenous and oral formulations against clopidogrel
(Plavix®), considered the leading antiplatelet agent.
Clinical trials are planned for elinogrel in patients with acute
coronary syndromes and more broadly in patients with a prior heart
attack or stroke, and those with peripheral vascular disease.
Novartis is focused on improving the lives of the hundreds of
millions of people with cardiovascular and metabolic diseases. As a
global leader in cardiovascular and metabolic health for nearly 50
years, Novartis provides innovative therapies and support programs to
treat high blood pressure and diabetes - both major public health
issues. The portfolio includes the world's most-prescribed
angiotensin receptor blocker, the first and only approved direct
renin inhibitor, a single pill combining two leading high blood
pressure medicines, and a novel DPP-4 inhibitor. Novartis is
dedicated to helping physicians and patients through effective
medicines, programs and an ongoing commitment to research.
Terms of the agreement
Novartis will make an upfront payment of USD 75 million to Portola
for the exclusive worldwide rights to elinogrel. Novartis will share
with Portola the costs of the ongoing Phase II trial, but will have
responsibility for Phase III clinical development, manufacturing and
commercialization. Portola will also be eligible for additional
payments based on achieving defined development and commercialization
milestones and is also eligible to receive royalties on future sales.
In addition, Portola has an option to co-promote elinogrel in the US
limited to hospitals and specialty markets and an option to co-fund
Phase III clinical trials and other development activities in return
for additional royalties. This transaction is subject to customary
regulatory approvals.
Disclaimer
The foregoing release contains forward-looking statements that can be
identified by terminology such as "potential," "potentially," "will,"
"seek," "can," "hope," "could," "may," "to explore," "planned,"
"future sales," "dedicated," "commitment," or similar expressions, or
by express or implied discussions regarding potential regulatory
approval for the elinogrel license agreement, potential regulatory
submissions or approvals to market elinogrel, or regarding potential
future revenues from elinogrel. You should not place undue reliance
on these statements. Such forward-looking statements reflect the
current views of management regarding future events, and 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 the agreement between
Portola Pharmaceuticals and Novartis to license elinogrel will be
approved by the necessary regulatory authorities. Neither can there
be any guarantee that elinogrel will be submitted or approved for
sale in any market. Nor can there be any guarantee that elinogrel
will achieve any particular levels of revenue in the future. In
particular, management's expectations regarding elinogrel could be
affected by, among other things, unexpected regulatory actions or
delays or government regulation generally; unexpected clinical trial
results, including unexpected new clinical data and unexpected
additional analysis of existing clinical data; the company's ability
to obtain or maintain patent or other proprietary intellectual
property protection; competition in general; government, industry and
general public pricing pressures; the impact that the foregoing
factors could have on the values attributed to the Novartis Group's
assets and liabilities as recorded in the Group's consolidated
balance sheet, and other risks and factors referred to in Novartis
AG's current Form 20-F on file with the US 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 provides healthcare solutions that address the evolving
needs of patients and societies. Focused solely on healthcare,
Novartis offers a diversified portfolio to best meet these needs:
innovative medicines, preventive vaccines, diagnostic tools,
cost-saving generic pharmaceuticals, and consumer health products.
Novartis is the only company with leading positions in these areas.
In 2008, the Group's continuing operations achieved net sales of USD
41.5 billion and net income of USD 8.2 billion. Approximately USD 7.2
billion was invested in R&D activities throughout the Group.
Headquartered in Basel, Switzerland, Novartis Group companies employ
approximately 96,700 full-time-equivalent associates and operate in
more than 140 countries around the world. For more information,
please visit http://www.novartis.com.
References
[1] Gretler DD, Conley PB, Andre P, Jurek M, Pandey A, Ronanko K,
Leese PT, Hutchaleelaha A, Phillips DR "First in human" experience
with PRT060128, a new direct-acting, reversible, P2Y12 inhibitor for
IV and oral use. J Am Coll Cardiol. 2007;9(Suppl 2):326A.
# # #
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Central media line : +41 61 324
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Novartis Global Media Relations Novartis Pharma Communications
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8425 2456
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e-mail: e-mail:
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--- End of Message ---
Novartis International AG
Posfach Basel
WKN: 904278; ISIN:
CH0012005267; Index: SLCI, SMI, SPI, SLIFE;
Listed: Main Market in SIX Swiss Exchange, ZLS in BX Berne eXchange; Copyright © Hugin AS 2009. All rights reserved.
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