Kaye Scholer Represents Novartis in Agreement with Bayer Schering Pharma
New York - Kaye Scholer represented Novartis in an agreement with Bayer Schering Pharma AG that will provide Novartis the opportunity to introduce its own branded version of interferon beta-1b for patients with the debilitating neurological disease multiple sclerosis (MS). Bayer Schering Pharma will provide regulatory support and supply this medicine to Novartis in return for royalty payments. In addition, Novartis will transfer manufacturing responsibility for interferon beta-1b to Bayer Schering Pharma, which will purchase the related equipment and inventory as well as lease certain buildings at a Novartis site in Emeryville, California.
The Kaye Scholer team included partners Adam Golden and William Wallace.
About Kaye Scholer
Kaye Scholer refers to Kaye Scholer LLP and its affiliates, with offices in New York, Chicago, Frankfurt, London, Los Angeles, Shanghai, Washington, D.C. and West Palm Beach.
Founded in New York City in 1917, Kaye Scholer now includes some 525
attorneys and represents public and private companies, governmental
entities, financial institutions and other organizations in matters
around the world.
The following press release was issued earlier today:
26/03/2007, 2007, 07.15 AM CET
Novartis to launch its own branded version of a leading multiple sclerosis therapy through agreement with Bayer Schering Pharma
- A Novartis-branded version of interferon beta-1b to be launched in first half 2009
- Move strengthens Novartis multiple sclerosis (MS) portfolio ahead of on-track submission in 2009 of once-daily oral therapy FTY720, currently in Phase III trials
- Novartis will transfer manufacturing responsibility for Bayer Schering Pharma's interferon beta-1b (marketed as Betaseron®[1]) to Bayer Schering Pharma
- Bayer Schering Pharma to pay approximately USD 200 million for transfer of production equipment, inventory and leasing of buildings at California site
- Novartis to continue receiving royalties from global sales of Bayer Schering Pharma's Betaseron until October 2008
Basel, March 26, 2007 - Novartis has signed an agreement with Bayer Schering Pharma AG that will provide Novartis the opportunity to introduce in the first half of 2009 its own branded version of interferon beta-1b for patients with the debilitating neurological disease multiple sclerosis (MS).
The planned launch of a Novartis-branded version, which requires
approval from regulatory authorities, will give Novartis an increasing
presence in helping patients with MS ahead of the anticipated
submission in 2009 of its oral once-daily therapy FTY720 (fingolimod),
which is currently in Phase III trials.
Bayer Schering Pharma will support Novartis in the regulatory filing
process of a Novartis-branded version of interferon beta-1b. They will
also assume manufacturing responsibility for its interferon beta 1b
from Novartis and supply Novartis with this product for its own branded
version in return for a double-digit royalty payment. Novartis has the
right to further develop new formulations and presentations of its
branded version of this medicine.
"This agreement gives us an opportunity to strengthen our Neuroscience
portfolio and build our presence in multiple sclerosis while preparing
for the submission of FTY720 as planned for 2009," said Thomas Ebeling,
CEO of Novartis Pharma AG. "As a truly new treatment approach with
once-daily oral dosing, we believe FTY720 can offer significant
therapeutic benefits to MS patients."
Under the terms of the agreement, Novartis will transfer manufacturing
responsibility for interferon beta-1b to Bayer Schering Pharma, which
will purchase the related equipment and lease certain buildings at a
Novartis site in Emeryville, California, for a one-time cash payment of
approximately USD 110 million. Bayer Schering Pharma will also purchase
related interferon beta-1b product inventory for an estimated USD 90
million cash, which is subject to adjustment at closing.
Bayer Schering Pharma will continue to pay Novartis royalties on
worldwide net sales of Betaseron® until October 2008 when the original
regulatory filing, development and supply agreement expires.
Novartis plans to maintain in Emeryville the operations of its Vaccines
and Diagnostics division, including the headquarters for its
diagnostics business, as well as pharmaceutical research conducted by
the Novartis Institutes for Biomedical Research (NIBR).
This agreement with Bayer Schering Pharma is subject to regulatory
approvals, including antitrust review, and is expected to be completed
by the third quarter of 2007.
Multiple sclerosis is estimated to affect more than 2.5 million
patients worldwide and is one of the leading causes of neurological
disability in young adults. This disease typically presents in
relapsing forms involving acute self-limiting attacks of neurological
dysfunction (or relapses), followed by complete or partial restoration
of function.[2]
Betaseron is marketed by Bayer Schering Pharma AG, which Bayer AG
acquired in 2006. In 1993 Bayer Schering Pharma signed an agreement
covering the regulatory filing, development and supply of Betaseron
with Chiron, which Novartis acquired in 2006. Novartis assumed Chiron's
rights to this product, and since then has continued to produce
Betaseron.
Disclaimer
This release contains certain forward-looking statements relating to
the business of Novartis, which can be identified by the use of
forward-looking terminology such as "to launch", "to be launched", "on
track", "will", "to pay", "to continue", "to introduce", "planned",
"anticipated", "to further develop", "believe", "plans", "expected", or
similar expressions, or by express or implied discussions regarding the
potential regulatory approval and completion of the announced agreement
with Bayer Schering, or regarding potential future regulatory
submissions or approvals or regarding potential future revenues from
interferon beta-1b, new formulations or presentations of interferon
beta-1b, or FTY720. Such forward-looking statements reflect the current
views of Novartis regarding future events, and involve known and
unknown risks, uncertainties and other factors that may cause actual
results with interferon beta-1b or FTY720 to be materially different
from any future results, performance or achievements expressed or
implied by such statements. There can be no guarantee that the
announced deal will receive the necessary regulatory approvals, or if
approved, will be completed, or that interferon beta-1b, new
formulations or presentations of interferon beta-1b, or FTY720 will be
submitted for approval or will be approved for sale for any indications
or labeling in any market. Nor can there be any guarantee that
interferon beta-1b, new formulations or presentations of interferon
beta-1b, or FTY720 will achieve any sales or any particular level of
sales. In particular, management's expectations could be affected by,
among other things, unexpected clinical trial results, including
additional analysis of existing clinical data or new clinical data;
unexpected regulatory actions or delays or government regulation
generally; competition in general; government, industry and general
public pricing pressures; Novartis' ability to obtain or maintain
patent or other proprietary intellectual property protection, 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 (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.
References
[1] Marketed as Betaferon® in Europe
[2] Multiple Sclerosis International Federation http://www.msif.org/en/ms_the_disease/index.html
# # #
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