Sandoz to acquire Oriel Therapeutics, gaining rights to portfolio of respiratory products targeting asthma and COPD

4/19/2010, 7:15 AM (Source: GlobeNewswire)

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Novartis International AG / Sandoz to acquire Oriel Therapeutics, gaining rights to portfolio of respiratory products targeting asthma and COPD processed and transmitted by Hugin AS. The issuer is solely responsible for the content of this announcement.


·         Sandoz gains rights to three promising development projects, as well
as to novel FreePath(TM) drug delivery system and Solis(TM) multi-dose dry
powder inhaler

·         Regulatory approvals, if achieved, would broaden access to affordable,
high-quality respiratory medicines and reinforce Sandoz leadership in
differentiated generics


Holzkirchen, Germany, April 19, 2010 - Sandoz has signed a definitive agreement
to acquire Oriel Therapeutics, a privately held US pharmaceuticals company,
gaining exclusive rights to a portfolio of generic drug candidates and related
technologies targeting medicines in the inhalable respiratory drug market. Terms
of the deal were not disclosed.

Oriel focuses on developing respiratory products with known pathways as generic
alternatives to patented drugs for asthma and chronic obstructive pulmonary
disease (COPD).

The acquisition provides Sandoz with three promising development projects
targeting leading medicines in this field.

Regulatory approvals of these medicines, if achieved, would enable Sandoz to
increase access to affordable, high-quality therapeutic alternatives for these
increasingly prevalent diseases. Details of Oriel's development programs,
including anticipated timing of future regulatory submissions, are not disclosed
for competitive reasons.

"Oriel is a strong strategic fit with Sandoz and the acquisition is expected to
support our strategy of increasing the number of differentiated, higher-value
products in our development pipeline," said Jeff George, Division Head Sandoz.
"One of our strategic objectives is to offer fully substitutable generic
versions of key branded medicines, including respiratory medicines. This is a
key area of focus that complements our global leadership position in biosimilars
and complex injectables."

The acquisition of Oriel, which will be integrated as a separate development
unit within Sandoz, also offers Sandoz access to its novel FreePath(TM) drug
delivery technology. This has the potential to address some of the hurdles
facing regulatory approval of generic inhaled medicines in the US. Oriel has
also developed the proprietary Solis(TM) disposable dry powder inhaler based on
the FreePath(TM) delivery technology.

According to industry estimates approximately 50% of the current USD 32 billion
global market segment[1]( )for asthma and COPD medicines is expected to lose
patent protection by the end of 2016.[2] Key patents due to expire over this
period in one or more major countries or regions include
Advair(®)/Seretide(®)[3], Symbicort(®)[4], Singulair(®)[5] and Spiriva(®)[6].(
)The asthma and COPD market segment is projected to grow significantly faster
than the pharmaceutical market, driven by factors including a significant level
of under-diagnosis.

The acquisition will enable Sandoz to leverage both its existing range of
in-market products and its extensive in-house expertise. In 2009, Sandoz
invested more than USD 60 million in a new 10 000 m(2) facility at its global
respiratory Center of Excellence in Rudolstadt, Germany, which has validated
full-scale manufacturing capacities for both DPI and MDI inhalers.

In 2009, Sandoz broadened its existing respiratory portfolio by launching
generic salbutamol in several European countries, as the first EU-wide approved
generic inhalable product under new EU regulatory guidelines. In addition to its
in-house expertise, Sandoz has collaborations with other companies as well as
with Novartis Pharmaceuticals Division, which maximize its access to quality
generic inhalable device mechanisms. Novartis Pharmaceuticals has a
complementary portfolio of high-quality patent-protected respiratory medicines
as well as an extensive development pipeline.

Terms of agreement
Sandoz has reached a definitive agreement to fully acquire Oriel Therapeutics,
with terms of the deal not disclosed. Oriel's owners are eligible for additional
payments, which are contingent upon the achievement of various milestones
related to the technical development of these projects as well as regulatory
approvals and market launches. Oriel's owners would also be eligible for sales
royalties. This transaction is subject to customary closing conditions.

About Oriel
Oriel Therapeutics is a specialty pharmaceutical company developing and
commercializing products to improve respiratory care. Combining an experienced
product development team and a growing portfolio of innovative drug delivery
technologies, Oriel is focused on delivering compelling patient options for the
treatment of asthma and COPD. Oriel's investors include New Leaf Venture
Partners, Thomas, McNerney & Partners, HealthCare Ventures and CHL Medical
Partners.

About Sandoz
Sandoz, a Division of the Novartis group, is a global leader in the field of
generic pharmaceuticals, offering a wide array of high-quality, affordable
products that are no longer protected by patents. Sandoz has a portfolio of
about 1000 compounds and sells its products in more than 130 countries. Key
product groups include antibiotics, treatments for central nervous system
disorders, gastrointestinal medicines, cardiovascular treatments and hormone
therapies. Sandoz develops, produces and markets these medicines along with
pharmaceutical and biotechnological active substances and anti-infectives. In
addition to strong organic growth in recent years, Sandoz has made a series of
acquisitions including Lek (Slovenia), Sabex (Canada), Hexal (Germany) and Eon
Labs (US), and EBEWE Pharma (Austria). In 2009, Sandoz employed around 23,000
people worldwide and achieved net sales of USD 7.5 billion.

Disclaimer
The foregoing release contains forward-looking statements that can be identified
by terminology such as "to acquire," "would," "should", "potential,"
"contingent," "promising," "anticipated," "expected," "strategy," "pipeline,"
"objectives," "will," "estimates," "due," "eligible," or similar expressions, or
by express or implied discussions regarding the potential completion of the
proposed Oxford Therapeutics acquisition, or its potential impact on Novartis
and its Sandoz Division, or regarding the potential submission or approval of
any potential new generic or branded pharmaceutical products, or regarding
potential future sales or earnings of the Novartis Group or its Sandoz or
Pharmaceuticals Divisions. You should not place undue reliance on these
statements. Such forward-looking statements reflect the current views of the
Company 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 proposed Oxford
Therapeutics acquisition will be completed in the expected form or within the
expected time frame or at all. Nor can there be any guarantee that any of the
potential new generic or branded pharmaceutical products described in this
release will be approved for sale in any market. Neither can there be any
guarantee that Novartis or its Sandoz or Pharmaceuticals Divisions, will achieve
any particular future financial results or future growth rates or that Novartis
or Sandoz will be able to realize any potential synergies, strategic benefits or
opportunities as a result of the proposed acquisition. In particular,
management's expectations could be affected by, among other things, unexpected
inabilities to fulfill closing conditions; uncertainties involved in the
development of new generic pharmaceutical products; unexpected regulatory
actions or delays or government regulation generally; unexpected inabilities to
obtain or maintain exclusivity periods for developed products; competition in
general; government, industry and general public pricing pressures; unexpected
patent litigation outcomes; unexpected patent litigation outcomes; litigation;
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.



* * *



For further information

Eric Althoff Chris Lewis
Novartis Media Relations Sandoz Global Communications
+41 61 32 47999 +49 8024 476 2550
eric.althoff@novartis.com chris.lewis@sandoz.com





Novartis Investor Relations

International:
Susanne Schaffert

Pierre-Michel Bringer
North America:
John Gilardi Richard Jarvis

Thomas Hungerbuehler Jill Pozarek

Isabella Zinck Edwin Valeriano

Central phone: +41 61 324 7944

E-mail: investor.relations@novartis.com




References
[1] IMS 2009
[2] Publicly available information including IMS and DataMonitor
[3] Advair(®)/Seretide(®) are registered trademarks of GlaxoSmithKline
[4] Symbicort(®) is a registered trademark of AstraZeneca
[5]Singulair(®) is a registered trademark of Merck
[6] Spiriva(®) is a registered trademark of Boehringer Ingelheim



[HUG#1404981]



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