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Novartis International AG: Novartis announces exclusive agreement to extend leadership in ophthalmology, leveraging novel anti-PGDF therapy Fovista®

Novartis International AG / Novartis announces exclusive agreement to extend
leadership in ophthalmology,leveraging novel anti-PGDF therapy Fovista® .
Processed and transmitted by NASDAQ OMX Corporate Solutions.The issuer is
solely responsible for the content of this announcement.
* Novartis acquires exclusive ex-US rights to Fovista from Ophthotech;
upfront payment of USD 200 million plus potential future recruitment and
other milestone payments; additionally Ophthotech to receive royalties on
ex-US Fovista sales

* Fovista is the most advanced anti-PDGF technology in development, and if
approved, is expected to be first to market in this class of therapies for
wet AMD

* Novartis to commercialize Fovista outside the US as stand-alone treatment
and as a co-formulation with a Novartis proprietary anti-VEGF product

Basel, May 19, 2014
Novartis announced today the signing of a licensing and commercialization
agreement with Ophthotech Corporation (Ophthotech) for the exclusive rights
to market Fovista® (anti-PDGF aptamer) outside the United States. Under the
financial terms of the agreement, Ophthotech will receive an immediate
payment of an upfront fee of USD 200 million plus potential future
recruitment and other milestone payments. In addition, Ophthotech is eligible
to receive royalties on ex-US Fovista®sales. Fovista is being studied in
combination with anti-VEGF agents for patients suffering from wet age-related
macular degeneration (wet AMD). Novartis will also develop a co-formulation
of Fovista with a Novartis proprietary anti-VEGF treatment. Ophthotech will
hold the marketing rights to Fovista in the United States.

"Novartis is committed to addressing key unmet needs in medical retina.
Fovista in combination with currently available anti-VEGF treatments could
further improve outcomes of patients suffering from avoidable vision loss,"
said David Epstein, Division Head, Novartis Pharmaceuticals. "If approved,
Fovista is expected to be the first to market in this class of therapies for
wet AMD confirming our commitment and leadership in the ophthalmology space."

Fovista offers a new mechanism of action to address unmet need to further
improve visual acuity and potentially slow disease progression. In Phase II
clinical studies, combination therapy of Fovista and Lucentis® (ranibizumab)
significantly improved baseline visual acuity in wet AMD patients. No new
safety signals were observed with Fovista / Lucentis adjunctive therapy as
compared to Lucentis monotherapy.

Novartis expects to develop Fovista and the co-formulation in its proprietary,
innovative pre-filled syringe as part of this agreement.

About Novartis in Ophthalmology
Novartis, through its Alcon and Pharmaceuticals Divisions, is the global
leader and partner for physicians in medical retina, and as such, offers the
industry's most comprehensive portfolio of innovative retina products to
support professionals to help achieve the best possible patient outcomes.

Novartis medical retina pipeline includes investigational treatments in
late-stage clinical development such as RTH258 for wet AMD (next generation
anti-VEGF), and LFG316 for the treatment of dry AMD. Novartis holds the
marketing rights for Fovista (anti-PDGF aptamer) outside the United States.
Ophthotech Corporation holds the marketing rights to Fovista in the United

About Lucentis®(ranibizumab)
Lucentis was designed to save sight and has demonstrated transformational
efficacy with individualized dosing in its licensed indications. As an
antibody fragment with a short systemic half-life, Lucentis was specifically
designed, developed, formulated and licensed for ocular conditions, and is
manufactured to the highest standards for intra-ocular use.

Lucentis is licensed in more than 100 countries, for the treatment of wet
age-related macular degeneration (wet AMD), visual impairment due to diabetic
macular edema (DME) and for visual impairment due to macular edema secondary
to retinal vein occlusion (RVO), including both branch- and central-RVO.
Also, Lucentis is licensed in more than 60 countries, not including the US,
for the treatment of patients with visual impairment due to choroidal
neovascularization (CNV) secondary to pathologic myopia (myopic CNV). In most
countries, including those in Europe, Lucentis has an individualized
treatment regimen with the goal of maximizing visual outcomes while
minimizing under- or over-treating patients.

Lucentis has a well-established safety profile supported by 43 sponsored
clinical studies and real-world experience. Its safety profile has been well
established in a clinical development program that enrolled more than 12,500
patients across indications and there is more than 2.4 million
patient-treatment years of exposure since its launch in the United States in

Lucentis was developed by Genentech and Novartis. Genentech has the commercial
rights to Lucentis in the United States. Novartis has exclusive rights in the
rest of the world. Lucentis is a registered trademark of Genentech Inc.

The foregoing release contains forward-looking statements that can be
identified by words such as "to extend," "to receive," "if approved,"
"expected," "to be," "to commercialize," "will," "committed," "could,"
"commitment," "offers," "potentially," "expects," "to develop," "pipeline,"
"investigational," "designed to," "goal," or similar terms, or by express or
implied discussions regarding potential marketing approvals for Fovista,
RTH258, LFG316 or other investigational treatments in the Novartis medical
retina pipeline, potential new indications or labeling for Lucentis or
Lucentis pre-filled syringe, and potential future revenues from such
products. You should not place undue reliance on these statements. Such
forward-looking statements are based on the current beliefs and expectations
of management regarding future events, and are subject to significant known
and unknown risks and uncertainties. Should one or more of these risks or
uncertainties materialize, or should underlying assumptions prove incorrect,
actual results may vary materially from those set forth in the
forward-looking statements. There can be no guarantee that Fovista, RTH258,
LFG316 or any other investigational treatment in the Novartis medical retina
pipeline will be submitted or approved for sale in any market, or at any
particular time. Neither can there be any guarantee that Lucentis or Lucentis
pre-filled syringe will be submitted or approved for any additional
indications or labeling in any market, or at any particular time. Nor can
there be any guarantee that such products will be commercially successful in
the future. In particular, management's expectations regarding such products
could be affected by, among other things, the uncertainties inherent in
research and development, including unexpected clinical trial results and
additional analysis of existing clinical data; unexpected regulatory actions
or delays or government regulation generally; global trends toward health
care cost containment, including ongoing pricing pressures; general economic
and industry conditions; the company's ability to obtain or maintain
proprietary intellectual property protection; unexpected manufacturing
issues, and other risks and factors referred to in Novartis AG's current Form
20-F on file with the US Securities and Exchange Commission. 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

About Novartis
Novartis provides innovative healthcare solutions that address the evolving
needs of patients and societies. Headquartered in Basel, Switzerland,
Novartis offers a diversified portfolio to best meet these needs: innovative
medicines, eye care, cost-saving generic pharmaceuticals, preventive
vaccines, over-the-counter and animal health products. Novartis is the only
global company with leading positions in these areas. In 2013, the Group
achieved net sales of USD 57.9 billion, while R&D throughout the Group
amounted to approximately USD 9.9 billion (USD 9.6 billion excluding
impairment and amortization charges). Novartis Group companies employ
approximately 135,000 full-time-equivalent associates and sell products in
more than 150 countries around the world. For more information, please

Novartis is on Twitter. Sign up to follow @Novartis

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Source: Novartis International AG via Globenewswire


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