Novartis sells US rights to the overactive bladder treatment Enablex®

9/24/2010, 7:15 AM (Source: GlobeNewswire)

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Novartis International AG / Novartis sells US rights to the overactive bladder treatment Enablex® processed and transmitted by Hugin AS. The issuer is solely responsible for the content of this announcement.

* Novartis to receive USD 400 million cash payment from Irish based specialty
pharmaceutical company Warner Chilcott

* Warner Chilcott to assume Enablex marketing, sales and manufacturing for the
US

Basel, September 24, 2010 - Novartis announced today that it has signed an
agreement to sell to Warner Chilcott plc the US rights to market Enablex(®)*
(darifenacin) extended release tablets, a medicine to treat adults with symptoms
of overactive bladder. The agreement will be filed with the US Federal Trade
Commission under the Hart-Scott-Rodino Act and, subject to certain closing
conditions set forth in the agreement, the transaction is expected to close by
the end of October 2010.

Novartis will receive an upfront payment of USD 400 million from Warner
Chilcott, with the potential for additional milestone payments up to USD 20
million. Novartis retains the rights to darifenacin worldwide except in the US.
Warner Chilcott expects to assume manufacturing of Enablex for the US once it is
transferred to Warner Chilcott's manufacturing facility.

In 2005, Novartis signed an agreement with Procter & Gamble Pharmaceuticals
(PGP) to co-promote and co-develop Enablex in the US. In October 2009, Warner
Chilcott acquired PGP from Procter & Gamble Company and became Novartis
collaborator in the agreement. Under the terms of the deal announced today,
Warner Chilcott assumes rights to solely promote and develop Enablex for the US.

Enablex was approved in the US by the US Food and Drug Administration in 2004
for the treatment of overactive bladder and launched in early 2005.

Disclaimer
The foregoing release contains forward-looking statements that can be identified
by terminology such as "to receive," "to sell," "is expected," "will,"
"potential," "expects," or similar expressions, or by express or implied
discussions regarding potential regulatory approvals for the sale of the US
rights to market Enablex, or regarding potential future payments from Warner
Chilcott with respect to Enablex. 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 Enablex to be
materially different from any future results, performance or achievements
expressed or implied by such statements. There can be no guarantee that
regulatory approval will be obtained to close the sale to Warner Chilcott of the
rights to market Enablex in the US. Nor can there be any guarantee that Warner
Chilcott will make any particular payments to Novartis in the future with
respect to Enablex. In particular, management's expectations regarding Enablex
could be affected by, among other things, unexpected regulatory actions or
delays or government regulation generally; competition in general; government,
industry and general public pricing pressures; 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; 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 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,
cost-saving generic pharmaceuticals, preventive vaccines, diagnostic tools and
consumer health products. Novartis is the only company with leading positions in
these areas. In 2009, the Group's continuing operations achieved net sales of
USD 44.3 billion, while approximately USD 7.5 billion was invested in R&D
activities throughout the Group. Headquartered in Basel, Switzerland, Novartis
Group companies employ approximately 100,000 full-time-equivalent associates and
operate in more than 140 countries around the world. For more information,
please visithttp://www.novartis.com.

* The tradename is Enablex(®) in the US, Canada and certain countries in Latin
America and Emselex(®) in the rest of the world.

# # #


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[HUG#1446578]



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Novartis International AG
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Media release (PDF):
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