Alcon gains exclusive ex-US rights for ocriplasmin, potential first pharmacological treatment for symptomatic vitreomacular adhesion
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Novartis International AG /
Alcon gains exclusive ex-US rights for ocriplasmin, potential first
pharmacological treatment for symptomatic vitreomacular adhesion
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The issuer is solely responsible for the content of this announcement.
* Symptomatic vitreomacular adhesion (VMA) is a progressive, debilitating eye
disease, there is currently no pharmacological treatment available
* Phase III clinical data( )demonstrate resolution of symptomatic VMA
following a single administration of ocriplasmin[1]
* More than 300,000 patients[2] in Europe alone could potentially benefit from
this new therapy
* Alcon to make upfront payment to ThromboGenics, additional payments based on
milestones and royalties on future sales
Basel, March 16, 2012 - Alcon, the global leader in eye care and a division of
Novartis, announced today that it has gained exclusive rights to commercialize
ocriplasmin outside the United States for the treatment of symptomatic
vitreomacular adhesion (VMA). If approved, it will be the first pharmacological
treatment for patients with symptomatic VMA, including macular hole. Symptomatic
VMA is a progressive, debilitating eye disease that may lead to visual
distortion, loss in visual acuity and central blindness[3].
Alcon is licensing ocriplasmin from ThromboGenics, a bio-pharmaceutical company
based in Belgium. The agreement grants Alcon exclusive commercial rights outside
the United States. Under the terms of the agreement, Alcon will make an upfront
payment of ?75 million (approx. USD 100 million) to ThromboGenics with
additional potential payments based on milestones, as well as royalties on sales
of ocriplasmin, if approved.
"There are thousands of symptomatic vitreomacular adhesion patients who
currently do not have an available treatment option. The clinical results[1] for
ocriplasmin show improved visual function and that earlier intervention may
limit the progression of the disease," said Kevin Buehler, Division Head
Alcon. "Ocriplasmin is a strategic fit for Alcon and is expected to further
enhance our portfolio of innovative treatments for the eye."
Ocriplasmin is currently under review with the European Medicines Agency (EMA)
as the first pharmacological treatment for symptomatic VMA, including macular
hole. The drug was accepted for review by the EMA in October 2011. ThromboGenics
retains the rights to commercialize ocriplasmin in the United States and a
decision on approval is expected from the US Food and Drug Administration (FDA)
in the second half of 2012.
Symptomatic VMA primarily involves the interface between the retina's highly
sensitive macular area, which is responsible for detailed, central vision, and
the posterior vitreous membrane, which separates the clear, jelly-like substance
in the center of the eye, called vitreous, from the retina.
With symptomatic VMA patients, the vitreous adheres in an abnormally strong way
to the retina, which can lead to traction ('pulling') on the retina, causing
symptoms including impaired vision. Further unresolved traction may lead to the
development of macular holes and central blindness[3].
For many symptomatic VMA patients, there is no recommended treatment available.
More than 300,000[2] symptomatic VMA patients in Europe alone could potentially
benefit from this new treatment, if approved. The standard of care for patients
advancing to late stage VMA is surgical vitrectomy.
Ocriplasmin is a recombinant truncated form of human protein (plasmin)
administered through a one-time intra-vitreal injection. Clinical data(1
)demonstrate that ocriplasmin resolves symptomatic vitreomacular adhesion (VMA),
on average within seven days, reducing the number of patients advancing to
surgery.
The ocriplasmin in-licensing agreement confirms Alcon's commitment to bringing
innovative eye care treatments to patients with unmet medical needs. With the
company's extensive commercial capabilities, geographic footprint and strong
relationships with retinal specialists and ophthalmologists around the globe,
Alcon is well positioned to bring this innovative treatment to patients around
the world.
Disclaimer
The foregoing release contains forward-looking statements that can be identified
by terminology such as "to make," "potentially," "will," "potential,"
"expected," "expects," "commitment," or similar expressions, or by express or
implied discussions regarding potential marketing approvals for ocriplasmin and
the timing of any such approvals, or regarding potential future revenues from
ocriplasmin. 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 with ocriplasmin to be materially
different from any future results, performance or achievements expressed or
implied by such statements. There can be no guarantee that ocriplasmin will be
approved for sale in any market, or at any particular time. Neither can there be
any guarantee that ocriplasmin will achieve any particular levels of revenue in
the future. In particular, management's expectations regarding ocriplasmin could
be affected by, among other things, unexpected regulatory actions or delays or
government regulation generally, both with regard to the completion of the
license agreement, and with regard to the approval to market ocriplasmin;
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; government, industry and general public pricing pressures;
unexpected manufacturing issues; competition in general; 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 Alcon
Alcon, the global leader in eye care, provides innovative products that enhance
quality of life by helping people worldwide see better. The three Alcon
businesses - Surgical, Pharmaceutical and Vision Care - offer the widest
spectrum of eye care products in the world. Alcon is the second largest division
of the Novartis Group with pro-forma sales of USD 10 billion in 2011.
Headquartered in Fort Worth, Texas, USA, Alcon has 23,000 employees worldwide,
operations in 75 countries and products available in 180 markets. For more
information, visitwww.alcon.com.
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 and
diagnostic tools, over-the-counter and animal health products. Novartis is the
only global company with leading positions in these areas. In 2011, the Group's
continuing operations achieved net sales of USD 58.6 billion, while
approximately USD 9.6 billion (USD 9.2 billion excluding impairment and
amortization charges) was invested in R&D throughout the Group. Novartis Group
companies employ approximately 124,000 full-time-equivalent associates and
operate in more than 140 countries around the world. For more information,
please visithttp://www.novartis.com.
Novartis is on Twitter. Sign up to follow (at)Novartis at
http://twitter.com/novartis.
References
1. Thrombogenics. MIVI-TRUST Phase III Clincal Data.
2. Alcon internal estimates.
3. Trese M, Kaiser P, Dugel P, Brown D, & Humayun M (2011). Symptomatic
Vitreomacular Adhesion (VMA): Diagnosis, Pathologic Implications, and
Management. Retina Today, July/August (Supplement).
# # #
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Unternehmensinformation / Kurzprofil:
Datum: 16.03.2012 - 07:15 Uhr
Sprache: Deutsch
News-ID 125478
Anzahl Zeichen: 11666
contact information:
Town:
Basel
Kategorie:
Business News
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