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Sandoz to acquire Oriel Therapeutics,
gaining rights to portfolio of respiratory products targeting
asthma and COPD
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.
- Sandoz gains rights to three promising development projects,
as well as to novel FreePath™ drug delivery system and Solis™
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
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™ 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™ disposable dry powder inhaler based on
the FreePath™ 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 m2 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
Novartis Media Relations
+41 61 32 47999
eric.althoff @novartis.com
Chris Lewis
Sandoz Global Communications
+49 8024 476 2550
chris.lewis@sandoz.com
Novartis Investor Relations
International:
Susanne Schaffert
Pierre-Michel Bringer
John Gilardi
Thomas Hungerbuehler
Isabella Zinck
Central phone: +41 61 324 7944
E-mail: investor.relations @novartis.com
North America:
Richard Jarvis
Jill Pozarek
Edwin Valeriano
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
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