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Pharmaceuticals delivers strong underlying growth in first quarter of
2009 as Novartis continues to rejuvenate product portfolio |
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Corporate news announcement processed and transmitted by Hugin AS.
The issuer is solely responsible for the content of this
announcement.
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* Group's strong operational performance led by Pharmaceuticals net
sales growth of 12% in local currencies on rapid expansion of
recently launched products
* R&D progress led by first approvals of anti-cancer medicine
Afinitor and Ixiaro, a vaccine against Japanese encephalitis; key
development projects advancing well
* Q1 2009 reported results include significant negative currency
impact:
* Net sales of USD 9.7 billion (-2%, but +8% in local
currencies, or lc) driven by underlying Pharmaceuticals
expansion; Sandoz up 4% lc on sustained growth in many regions
* Operating income of USD 2.3 billion down 6%, but rises 7%
excluding adverse currencies (-11 percentage points) and
exceptional items in both periods
* Net income of USD 2.0 billion falls 14%, includes effects in
2009 first quarter of lower average net liquidity and Alcon
financing costs
* Basic EPS of USD 0.87 in first quarter of 2009 vs. USD 1.02 in
2008 period
* Novartis expects strong operational performance in 2009, but a
continuation of recent currency rates could more than offset
underlying profit improvements
Key figures - Continuing operations
First quarter
Q1 2009 Q1 2008 % change
% of % of
USD m net sales USD m net sales USD lc
Net sales 9 709 9 909 -2 8
Operating income 2 347 24.2 2 488 25.1 -6
Net income 1 975 20.3 2 308 23.3 -14
Basic earnings per
share USD 0.87 USD 1.02 -15
Basel, April 23, 2009 - Commenting on the results, Dr. Daniel
Vasella, Chairman and CEO of Novartis, said: "New products fueled
ongoing momentum in Pharmaceuticals in the first quarter of 2009, and
the fundamentals of the business remain positive. R&D projects are
progressing well, and I am pleased with the first approvals of
Afinitor, offering hope to advanced kidney cancer patients, and the
Ixiaro vaccine against Japanese encephalitis. The uncertain economy
and currency market volatility create an opportunity to continue to
enhance productivity and manage costs. Our aim in 2009 remains to
again deliver record underlying net sales and earnings excluding
currency effects."
OVERVIEW
Pharmaceuticals led the Group's healthcare portfolio in the first
quarter of 2009, with the division's net sales up 12% in local
currencies. Sustained expansion of recently launched products
rejuvenated the Pharmaceuticals portfolio and led to market share
gains in 11 of the top 15 countries. The benefits of R&D investments
were reaffirmed with the first regulatory approval of the anti-cancer
medicine Afinitor in the US as well as the US and European approvals
of the new Ixiaro vaccine against Japanese encephalitis. Good
progress was achieved in a number of the Group's development
projects.
The solid underlying performance was offset in reported results by
the effect of a stronger US dollar (the Group's reporting currency),
with net sales reduced by 10 percentage points and operating income
by 11 percentage points, and was also impacted by weaker performances
in OTC and Animal Health, due to the global economic crisis.
As a result, net sales rose 8% in local currencies in the first
quarter, but fell 2% in US dollars to USD 9.7 billion. Higher sales
volumes provided eight percentage points of growth over the 2008
quarter, but this could not overcome the 10 percentage points lost to
negative currency movements. Net price changes and acquisitions had
no impact.
Operating income fell 6% to USD 2.3 billion, which included currency
losses along with sustained Pharmaceuticals investments, reduced
contributions from Sandoz and higher one-time gains in 2008. However,
operating income rose 7% when adjusted for currencies, exceptional
items and the amortization of intangible assets in both periods.
Net income declined 14% to USD 2.0 billion, also hurt by currencies.
A drop in average net liquidity and financing costs for the 25% Alcon
stake, which was acquired in 2008, further reduced non-operating
income in the 2009 quarter. Basic earnings per share (EPS) were USD
0.87 in the 2009 first quarter compared to USD 1.02 in the 2008
period.
Targeting sustainable growth in a challenging environment
Novartis continues its focus in 2009 on driving sustainable growth
from its broad healthcare portfolio in a challenging environment, one
in which the demand for medicines continues to rise.
Following a consistent strategy paired with disciplined execution,
Novartis is committed to selectively strengthen its businesses, step
up investments in innovation and expand in high-growth markets while
improving organizational efficiency. These are particularly important
to ensure Novartis, which also benefits from its sound financial
position, emerges stronger and more competitive when economic
conditions start to improve.
Novartis believes it has an excellent portfolio to address the
fast-changing and complex needs of patients and societies worldwide.
The Group is building on leadership, expertise and synergies in
innovative medicines as well as high-quality cost-effective generic
drugs, preventive vaccines and diagnostics, and consumer health
products.
In Pharmaceuticals, recently launched products are increasingly
driving growth, providing USD 0.9 billion of net sales in the first
quarter in 2009 and representing 14% of net sales compared to 8% in
the 2008 quarter. Major R&D investments are being made to accelerate
the highly rated pipeline, spurred on by the first worldwide approval
of Afinitor in the US. More than 130 regulatory submissions are
planned for the US, Europe and Japan between 2009 and 2011, while
decisions are pending for 2008 submissions that included QAB149
(COPD) and Ilaris (formerly ACZ885, Muckle-Wells Syndrome).
Vaccines and Diagnostics has built a platform for growth while
advancing a pipeline led by the 2009 approvals of Ixiaro in the US
and Europe and progress in the two late-stage meningitis vaccines.
Menveo (serogroups A,C,W,Y) is awaiting first regulatory decisions in
the US and Europe after submissions in 2008 for initial use in people
from ages 11 to 55, while the MenB vaccine in late-stage trials has
the potential to be the first of its kind.
Major initiatives are also underway to return Sandoz, the world's
second-largest generics company, to higher growth rates and
profitability. Key to this is resolving challenges in the US while
accelerating the solid growth seen in the rest of the world. New
global and US leadership teams are aiming to increase the
contribution of new product launches and address all FDA concerns
about a US manufacturing site that is being remediated. Globally,
Sandoz is expanding in emerging markets and accelerating development
of higher-value generics.
Consumer Health is maximizing the value of trusted brands and seeking
to achieve above-market growth. While CIBA Vision expands with new
product launches, OTC and Animal Health are addressing difficult
consumer trends amid recessions in some regions, particularly the US,
through renewed efforts on innovation and marketing excellence.
Expansion in targeted high-growth markets continues with a long-term
perspective. Net sales in the top six emerging markets rose 23% lc to
USD 846 million in the 2009 first quarter, with only limited signs to
date of an adverse impact from global economic conditions.
Novartis is also integrating the drive for greater productivity and
increased efficiency into the Group's operations, improving
efficiency and speed while freeing up resources to focus on customers
and growth initiatives. Forward, the Group-wide project launched in
late 2007, is ahead of schedule, delivering USD 329 million of
incremental savings in the 2009 first quarter. The program is set to
exceed the 2009 cost savings goal of USD 1.3 billion, and the 2010
savings goal of USD 1.6 billion (compared to 2007).
Group outlook
(Barring any unforeseen events)
Novartis expects continued strong underlying momentum, with Group net
sales growing in 2009 at a mid-single-digit rate and Pharmaceuticals
net sales growing at a mid- to high-single-digit rate, both in local
currencies. Improvements in underlying operating and net income to
record levels in 2009, however, could very well be more than offset
in reported results by currency-related losses if recent exchange
rates continue during the year.
BUSINESS REVIEW
First quarter
Net sales
Q1 2009 Q1 2008 % change
USD m USD m USD lc
Pharmaceuticals 6 433 6 264 3 12
Vaccines and Diagnostics 247 280 -12 -2
Sandoz 1 726 1 906 -9 4
Consumer Health continuing operations 1 303 1 459 -11 1
Net sales from continuing operations 9 709 9 909 -2 8
Pharmaceuticals: USD 6.4 billion (+3%, +12% lc)
Providing 66% of the Group's net sales, Pharmaceuticals achieved 12%
growth in local currencies thanks to double-digit growth in all
regions and recently launched products nearly doubling their
contribution from the year-ago quarter. The US (USD 2.2 billion,
+13%) reaffirmed the return to growth seen in 2008. Japan (USD 724
million, +14% lc) was among the leading regions and benefited from
the approval and launch of four new medicines (Co-Diovan, Lucentis,
Xolair and Tasigna) in the 2009 quarter. Launches also underpinned
Europe (USD 2.3 billion, +11% lc). The six emerging markets of
Brazil, China, India, Russia, South Korea and Turkey (USD 550
million, +20% lc) grew strongly.
Thanks to ongoing geographic rollout and improving reimbursement
levels, recently launched products - led by Lucentis, Exelon Patch,
Exforge, Exjade, Reclast/Aclasta, Tekturna/Rasilez and Tasigna -
delivered USD 872 million of sales in the 2009 quarter, up 94% lc
over the 2008 quarter. These products provided eight percentage
points of the 12% lc sales growth in the 2009 first quarter while
also representing 14% of the division's net sales compared to 8% in
the 2008 period.
All therapeutic franchises grew in local currencies. Oncology (USD
2.0 billion, +13% lc) ranked as the largest, led by Gleevec/Glivec
(USD 894 million, +13% lc), Femara (USD 286 million, +15% lc) and
Zometa (USD 342 million, +10% lc). Cardiovascular (USD 1.7 billion,
+14% lc) strategic portfolio gains came from the new high blood
pressure medicines Exforge (USD 136 million) and Tekturna/Rasilez
(USD 52 million) as well as ongoing global expansion of Diovan (USD
1.4 billion, +7% lc), particularly outside the US.
Vaccines and Diagnostics: USD 247 million (-12%, -2% lc)
The modest decline in local currencies mainly reflected lower sales
of TBE (tick-borne encephalitis) vaccines due to the weather-related
late start of the European vaccination season in 2009. Seasonal
influenza vaccine sales resumed in the Southern Hemisphere.
Sandoz: USD 1.7 billion (-9%, +4% lc)
All regions outside the US showed solid growth in local currencies,
particularly Central and Eastern Europe (+18% lc) and Asia-Pacific
(+28% lc). Germany (+2% lc) gained market share and improved its
leadership position. The US fell 3%, a smaller decline than in recent
quarters, and largely a consequence of lost sales from approved
products that have been blocked for distribution since 2008 as part
of an FDA review of a US manufacturing site as well as price erosion.
Consumer Health: USD 1.3 billion (-11%, +1% lc)
CIBA Vision rose on the momentum of new contact lens products and
market segment gains. OTC sales were lower due to decelerating growth
in some emerging markets and reduced demand for branded OTC products
in the US, while Animal Health sales were down slightly on a slowdown
in the companion animal business.
Operating income
Q1 2009 Q1 2008 Change
% of % of
net net
USD m sales USD m sales %
Pharmaceuticals 2 062 32.1 2 096 33.5 -2
Vaccines and Diagnostics -67 -53
Sandoz 291 16.9 345 18.1 -16
Consumer Health continuing operations 235 18.0 262 18.0 -10
Corporate Income & Expense, net -174 -162
Operating income
from continuing operations 2 347 24.2 2 488 25.1 -6
Pharmaceuticals: USD 2.1 billion (-2%)
Strong business expansion and increased productivity provided
underlying operating income growth of 11%, which was roughly in line
with the 12% lc net sales expansion. These operating income gains
were more than offset by the adverse impact of currencies (-10
percentage points) and higher exceptional items in the 2008 quarter
(-3 percentage points). As a result, reported operating income in US
dollars fell 2% and the operating margin declined to 32.1% of net
sales from 33.5% in the 2008 quarter. Other revenues fell 0.9
percentage points, mainly from the end of Betaseron® royalty receipts
in late 2008, while Cost of Goods Sold rose 0.8 percentage points on
higher royalty payments made for some products. However, Marketing &
Sales costs fell 0.9 percentage points as productivity gains more
than offset sustained strong investments in new product launches
around the world. R&D investments were unchanged at 20.9% of net
sales.
Vaccines and Diagnostics: USD -67 million
Major investments were made in the competitive vaccines development
pipeline, while the year-ago quarter included an exceptional
settlement gain of USD 49 million. Adjusted operating income,
excluding exceptional items and the amortization of intangible assets
in both periods, was USD 11 million in the 2009 first quarter
compared to an adjusted operating loss of USD 20 million in the
year-ago quarter.
Sandoz: USD 291 million (-16%)
Reduced contributions from the US and negative currency movements of
about 12 percentage points more than outweighed productivity gains
and growth in key markets. Cost of Goods Sold rose 3.3 percentage
points as a percent of net sales compared to the 2008 quarter on
changes to product mix largely due to the lack of US product
launches, while Marketing & Sales and R&D supported geographic
expansion and product development, particularly in difficult-to-make
generics such as biosimilars.
Consumer Health: USD 235 million (-10%)
Reported results were significantly hurt by unfavorable currency
movements, with growth of 9% excluding currency changes. Consumer
Health achieved productivity gains, particularly at CIBA Vision, and
a higher gross margin, thus enabling higher R&D investments for new
products.
Corporate Income & Expense, net
Among reasons for higher net corporate expenses in the 2009 quarter
were increases in pension expenses and additional product liability
costs.
FINANCIAL REVIEW
First quarter
Q1 2009 Q1 2008 Change
USD m USD m USD m %
Operating income from continuing
operations 2 347 2 488 -141 -6
Income from associated companies 83 137 -54 -39
Financial income -48 148 -196 -132
Interest expense -86 -57 -29 51
Taxes -321 -408 87 -21
Net income from continuing operations 1 975 2 308 -333 -14
Net income from
discontinued Consumer Health operations 15 -15
Total net income 1 975 2 323 -348 -15
Income from associated companies
The 25% Alcon stake provided net income of USD 12 million in the 2009
quarter, as the anticipated share of Alcon's net income and a
positive adjustment from reported results in 2008 more than offset
amortization charges. However, reduced income from Roche was largely
due to a negative adjustment of USD 40 million from Roche's reported
2008 results that were below expectations. Overall, income from
associated companies fell to USD 83 million in the 2009 quarter from
USD 137 million the 2008 period.
Financial result, net
Average net liquidity in the 2009 first quarter fell to net debt of
USD 1.8 billion from net liquidity of USD 6.4 billion in 2008,
reflecting the mid-2008 purchase of the Alcon stake. Currency losses
and reduced financial income, which was due to less liquidity as a
result of the Alcon acquisition, contributed to the fall of USD 196
million in financial income. Interest expense rose to USD 86 million,
reflecting an additional expense of USD 50 million in the 2009 first
quarter due to the US dollar bond issued in early 2009 and the Swiss
franc bonds issued in mid-2008.
Taxes
The tax rate (taxes as a percentage of pre-tax income) fell to 14.0%
from 15.0% in the first quarter of 2008, and in line with the 14.1%
tax rate for the full year in 2008.
Net income from continuing operations
Lower contributions from the operating businesses and reduced
non-operating income in the 2009 quarter were among factors for the
14% decline in net income from continuing operations to USD 2.0
billion from USD 2.3 billion in the year-ago period.
Basic earnings per share
Basic earnings per share (EPS) from continuing operations were USD
0.87 per share in 2009, down from USD 1.02 in the 2008 period, in
line with the decline in net income.
Balance sheet
Total assets fell slightly to USD 78.0 billion at the end of the 2009
first quarter from USD 78.3 billion at the end of 2008, mainly from a
decrease of USD 1.9 billion in non-current assets to USD 55.5 billion
due to the stronger US dollar.
The Group's equity declined by USD 4.2 billion to USD 46.2 billion at
the end of the 2009 first quarter from USD 50.4 billion at the end of
2008. Recognized income and expenses were down to USD 0.2 billion as
net income of USD 2.0 billion for the 2009 quarter was more than
offset by USD 0.7 billion in actuarial losses on pension plans, USD
1.4 billion in currency translation losses, and USD 0.1 billion of
negative fair value adjustments on financial instruments and other
factors. A net total of USD 0.2 billion in treasury shares were
repurchased in the first quarter of 2009, but no transactions have
taken place on the second trading line since this program was
suspended in April 2008 following the announcement of the Alcon
transaction. The dividend payment distributed in the first quarter of
2009 amounted to USD 3.9 billion, an 18% increase in US dollars from
the 2008 dividend payment of USD 3.3 billion.
The Group's debt/equity ratio increased to 0.25:1 at the end of the
first quarter from 0.15:1 at the end of 2008, reflecting the
financing program started in the first quarter with the successful
issuance of a USD 5 billion bond (two tranches) in the US. At the end
of the 2009 first quarter, financial debt of USD 11.5 billion
consisted of USD 4.5 billion in current and USD 7.0 billion in
non-current liabilities.
Credit agencies reduced their ratings for Novartis in April 2008,
citing expected financing requirements for Alcon while supporting the
transaction's strategic intentions. Moody's rated the Group as Aa2
for long-term maturities and P-1 for short-term maturities and
Standard & Poor's had a rating of AA- and A-1+, for long-term and
short-term maturities, respectively. Fitch had a long-term rating of
AA and a short-term rating of F1+. These agencies maintained a
"stable" outlook.
Cash flow
Cash flow from continuing operating activities rose 16% to USD 2.0
billion in the first quarter, driven by the underlying business
expansion as well as lower tax payments in the 2009 quarter compared
to the prior-year period. Operating cash flow in the 2008 first
quarter also included restructuring payments for the Forward
initiative.
A substantial amount of the proceeds from the USD 5 billion bond were
reinvested into marketable securities in the first quarter of 2009,
resulting in the swing in cash flow related to investing activites to
an outflow of USD 2.8 billion from an inflow of USD 3.4 billion in
the 2008 quarter. Cash inflows from financing activities were a net
USD 0.5 billion as the USD 5 billion of proceeds from the bond was
offset by the dividend payment of USD 3.9 billion and other items
totaling USD 0.6 billion.
Overall liquidity increased to USD 7.8 billion at the end of the 2009
first quarter from USD 6.1 billion at the end of 2008. Taking into
account the debt raised in 2009, net debt increased to USD 3.6
billion at the end of the first quarter from net debt of USD 1.2
billion at the end of 2008 and net liquidity of USD 4.4 billion at
the end of the 2008 first quarter.
PHARMACEUTICALS PRODUCT REVIEW
Note: Net sales growth data refer to 2009 performance in local
currencies.
Diovan (USD 1.4 billion, +7% lc), the world's top-selling branded
medicine for high blood pressure, achieved 10% lc growth in key
regions outside the US that represented nearly 60% of total sales.
Japan delivered dynamic growth for the Diovan franchise ahead of the
March 2009 introduction of Co-Dio, a single-pill combination with a
diuretic that gained approval in January. In the US, Diovan rose 3%
as growth was hampered by inventory reductions among some
wholesalers, but maintained its leading 40% share of the angiotensin
receptor blockers (ARB) segment.
Gleevec/Glivec (USD 894 million, +13% lc), a targeted therapy for
certain forms of chronic myeloid leukemia (CML) and gastrointestinal
stromal tumors (GIST), was a top driver of incremental sales growth
in the first quarter based on leadership positions in treating these
cancers. Gleevec was approved as the first post-surgery (adjuvant
setting) therapy for GIST in the US (December 2008) and in
Switzerland (February 2009), and also recommended for approval in
Europe (March 2009). Data on these benefits in adjuvant GIST patients
were published in "The Lancet" medical journal.
Zometa (USD 342 million, +10% lc), an intravenous bisphosphonate
therapy for patients with cancer that has spread to the bones, has
seen renewed expansion from improved compliance for existing
indications as well as landmark data presented in 2008 showing a
significant anticancer benefit. In February 2009, "The New England
Journal of Medicine" published these data showing Zometa reduces the
risk of cancer recurrence or death in premenopausal women with
hormone-sensitive, early-stage breast cancer. More studies are
underway to review other potential anticancer benefits of Zometa.
Femara (USD 286 million, +15% lc), an oral therapy for women with
hormone-sensitive breast cancer, maintained strong growth leading to
sustained market segment gains in the US, Europe and Japan. The entry
of generic competition in some markets in 2008, including some
European countries, has had a modest impact on global growth.
Sandostatin (USD 258 million, +6% lc), for acromegaly and
neuroendocrine tumors of the gastrointestinal tract and pancreas,
benefited from an increasing use of Sandostatin LAR, the
once-monthly version that accounts for over 85% of net sales. New
data from a Phase III study presented in January showed patients with
metastatic neuroendocrine tumors of the midgut who received
Sandostatin LAR had significantly increased time to tumor progression
compared with those given a placebo.
Lucentis (USD 229 million, +43% lc), a biotechnology eye therapy
approved in more than 80 countries, has become a leader in its
segment as the only treatment proven to maintain and improve vision
in patients with "wet" age-related macular degeneration, a leading
cause of blindness in people over age 50. Broad sales expansion has
been seen in Europe since the first launch in early 2007, while
Lucentis was approved and launched in Japan in the 2009 first
quarter. Enrollment has been completed for a Phase III trial in
diabetic macular edema (DME) and a regulatory submission in Europe is
still expected for 2010. Genentech holds the US rights to this
medicine.
Exelon/Exelon Patch (USD 203 million, +21% lc), a therapy for mild to
moderate forms of Alzheimer's disease dementia and also dementia
linked with Parkinson's disease, has benefited from the late 2007
launch of Exelon Patch, a novel skin patch, that has led to
significant market segment gains in the US and other countries.
Exforge (USD 136 million, +114% lc), a single-pill high blood
pressure medicine with the angiotensin receptor blocker Diovan
(valsartan) and calcium channel blocker amlodipine, continues to grow
rapidly due to data underscoring its differentiated efficacy profile.
Exjade (USD 122 million, +24% lc), approved in over 90 countries as
the only once-daily oral therapy for transfusional iron overload,
received the first major approval for a new dose of 40 mg/kg in
Switzerland, providing a new dose for high-risk patients needing more
intensive iron chelation.
Reclast/Aclasta (USD 85 million, +128% lc), the first once-yearly
infusion therapy for different kinds of osteoporosis, has shown
dynamic growth thanks to increasing access to patient infusion
centers and improving reimbursement levels. More than 5,700 infusion
centers have been established in the US, more than double from early
2008. Known as Aclasta in Europe and Reclast in the US, this medicine
has 100% reimbursement on US Medicare formularies and full
reimbursement status in France, Germany and the UK.
Lotrel (USD 83 million, -13% lc, only US), a single-pill combination
for high blood pressure, provides sales from higher doses with market
exclusivity. Sales of lower doses fell after an "at risk" generics
launch in 2007 despite a US patent still valid until 2017.
Myfortic (USD 73 million, +30% lc), a therapy for kidney transplant
patients, has seen rapid growth thanks to its novel enteric-coated
formulation of mycophenolic acid.
Xolair (USD 61 million, +77% lc, only Novartis sales), a
biotechnology drug for moderate to severe allergic asthma, was
approved and launched in Japan during the 2009 first quarter. It now
has approvals in more than 60 countries worldwide. The Xolair Liquid
formulation to ease administration was approved in Europe in
February. In December 2008, Xolair was submitted for US and EU
approval for use in children age 6 to less than 12 years old.
Novartis co-promotes Xolair with Genentech in the US and shares a
portion of operating income. Genentech's Xolair US sales were USD 133
million in the first quarter of 2009.
Tekturna/Rasilez (USD 52 million, +97% lc), the first new type of
high blood pressure medicine in more than a decade, has grown
steadily in a competitive market, particularly in Europe, based on
data affirming its ability to reduce blood pressure for over 24 hours
and the potential to protect the heart and kidney, which is being
studied in the ASPIRE HIGHER outcomes program. Rasilez HCT, a
single-pill combination with a diuretic, is being launched in Europe
after approval in January 2009. This combination is already available
in the US as Tekturna HCT. Other single-pill combinations are in
development, while a combination with Diovan was submitted for US
approval at the end of 2008.
Tasigna (USD 35 million), a new second-line therapy for patients with
a form of chronic myeloid leukemia (CML) resistant or intolerant to
prior therapy, including Gleevec/Glivec, was approved and launched in
Japan while growing in key markets. Tasigna shows the potential to
become a leading therapy for newly diagnosed CML patients, with
results expected in 2010 from a Phase III trial comparing it with
Gleevec/Glivec. Submissions for third-line use of Tasigna in GIST
patients are now planned by the end of 2009.
Galvus/Eucreas (USD 26 million), two new oral treatments for type 2
diabetes, have performed well in many European and Latin American
markets after receiving approvals in early 2008 and late 2007,
respectively. Galvus is the market leader in some Latin American
countries due to its strong efficacy profile. Eucreas is a
single-pill combination of Galvus with the oral anti-diabetes
medicine metformin. Galvus has now been launched in over 30
countries, while Eucreas is now available in nearly 20 countries.
Extavia, for patients with some forms of multiple sclerosis (MS),
has been launched in eight countries, including Germany and France,
since the start of 2009 as part of the European rollout. Extavia is
the same medicine as Betaferon®/ Betaseron®, which is marketed by
Bayer Schering and was the first beta interferon therapy for MS.
Novartis gained rights to its own branded version in agreements with
Bayer Schering reached after Novartis fully acquired Chiron. Novartis
plans to launch Extavia in the US in 2009.
R&D UPDATE
Pharmaceuticals
Afinitor (everolimus, RAD001), an oral inhibitor of the mTOR pathway,
received its initial US approval in March as the first therapy for
patients with advanced renal cell carcinoma (kidney cancer) after
failure of treatment with sunitinib or sorafenib. It has also been
submitted in Europe, Switzerland and Japan for this indication.
Afinitor is being studied in many cancer types, with Phase III
studies underway in neuroendocrine tumors (NET) and plans to initiate
Phase III trials in breast and gastric cancer, tuberous sclerosis
complex (TSC), hepatocellular carcinoma (HCC) and lymphoma.
Submissions for Afinitor in advanced secretory carcinoid tumors, a
form of NET, are also planned for 2009. Data from an early clinical
study presented in January showed positive results in patients with
advanced gastric cancer after failure of one or more prior
treatments.
QAB149 (indacaterol), a bronchodilator for chronic obstructive
pulmonary disease (an incurable condition with damaged lungs, usually
from smoking), was accepted for US and European review after
submissions in late 2008. Data from Phase III trials showed QAB149
has a fast onset of action and is more effective than standard
bronchodilators over 24 hours with a good safety profile, even at
doses higher than required for therapeutic effect. Further data from
the Phase III program, which was finished in 2008, are planned to be
made public at the American Thoracic Society meeting in May.
Ilaris (canakinumab, formerly ACZ885), a human antibody targeting
IL-1 beta, has accelerated review status in a number of countries for
its first submission for use in treating a group of rare
auto-inflammatory diseases called Cryopyrin-Associated Periodic
Syndromes (CAPS), which includes Muckle-Wells Syndrome. Submissions
in the US, Switzerland and Europe were made already in December 2008
after data from two studies showed adults and children given Ilaris
achieved rapid and long-lasting clinical remission. Priority review
status has been granted in the US and Switzerland. Studies are
underway in other areas, including gout, Systemic Juvenile Idiopathic
Arthritis (SJIA) and type 2 diabetes.
FTY720 (fingolimod), a novel oral development therapy for multiple
sclerosis, is on track for first submissions by the end of 2009.
Initial results of the Phase III placebo-controlled FREEDOMS trials
also are planned by year-end, while the FREEDOMS II trial is fully
recruited. Data from TRANSFORMS, a one-year Phase III trial against
beta interferon beta-1a (Avonex®), will be presented at the American
Academy for Neurology meeting in April. Initial study results were
made public in December 2008, showing the superior efficacy of FTY720
against Avonex® and a safety profile in line with previous
experience.
SOM230 (pasireotide) is a somatostatin analogue in development for
Cushing's disease, acromegaly and carcinoid syndrome after resistance
or intolerance to Sandostatin. Data from Phase II clinical studies
show significant hormone reductions in Cushing's disease and
acromegaly patients, and achievement of partial or complete symptom
control in patients with refractory/resistant carcinoid syndrome. A
pivotal Phase II registration study in Cushing's disease has
completed enrollment. Phase III studies are currently underway in
acromegaly and carcinoid syndrome refractory/resistant to
Sandostatin.
LBH589 (panobinostat), a novel, highly potent and multi-targeted
pan-deacetylase inhibitor, is currently enrolling patients in a
pivotal third-line trial for Hodgkin's lymphoma, which has been
prioritized as the lead indication. As a result, regulatory
submissions for cutaneous T-Cell lymphoma will not be pursued at this
time.
PRT128 (elinogrel), an anti-clotting development compound, for which
Novartis acquired rights in February from Portola Pharmaceuticals,
has potential advantages over existing treatments due to its
intravenous and oral dosage forms as well as an instant onset of
action that is quickly reversible. Phase III trials are planned to
begin in 2010. A Phase II study by Portola is underway in patients
undergoing non-urgent surgery to repair a damaged blood vessel or to
unblock a coronary artery (percutaneous coronary intervention).
Further studies are planned in patients with acute coronary syndrome
and other cardiovascular conditions.
Vaccines and Diagnostics
Ixiaro received approvals in the US in March and in Europe in April
as a new vaccine to protect against Japanese encephalitis, a viral
infection that results in up to 15,000 deaths annually and a
potential threat for travelers to Asia as well as people living in
the region. Developed in a strategic alliance with Intercell AG,
Ixiaro won approval based on clinical data showing it was a
well-tolerated, effective and convenient vaccine.
Disclaimer
This release contains certain forward-looking statements relating to
the Group's business, which can be identified by terminology such as
"expects," "momentum," "could," "strategy," "aim," "could,"
"targeting," "committed," "believes," "pipeline,' "planned,"
"awaiting," "potential," "aiming," "long-term prospective,"
"schedule," "set," "goal," "outlook," "recommended for approval",
"risk," "on track," "expected," "plans," "accelerated review,"
"priority review," "will," or similar expressions, or by express or
implied discussions regarding potential new products, potential new
indications for existing products, or regarding potential future
revenues from any such products, or potential future sales or
earnings of the Novartis Group or any of its divisions or business
units; or by discussions of strategy, plans, expectations or
intentions. You should not place undue reliance on these statements.
Such forward-looking statements reflect the current views of the
Group 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 any new products will be approved for sale in any
market, or that any new indications will be approved for existing
products in any market, or that such products will achieve any
particular revenue levels. Nor can there be any guarantee that the
Novartis Group, or any of its divisions or business units, will
achieve any particular financial results. In particular, management's
expectations could be affected by, among other things, the uncertain
outcome and progress of the ongoing global financial and economic
crisis, including uncertainties regarding future global exchange
rates and uncertainties regarding future demand for our products;
uncertainties involved in the development of new pharmaceutical
products; unexpected clinical trial results, including additional
analysis of existing clinical data or unexpected new clinical data;
unexpected regulatory actions or delays or government regulation
generally; the Group's ability to obtain or maintain patent or other
proprietary intellectual property protection; uncertainties regarding
actual or potential legal proceedings, including, among others,
product liability litigation, litigation regarding sales and
marketing practices, government investigations and intellectual
property disputes; competition in general; government, industry, and
general public pricing and other political pressures; the impact that
the foregoing factors could have on the values attributed to the
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 described
herein as anticipated, believed, estimated or expected. Novartis is
providing the information in these materials as of this date and does
not undertake any obligation to update any forward-looking statements
as a result of new information, future events or otherwise.
About Novartis
Novartis AG 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 2008, the
Group's continuing operations achieved net sales of USD 41.5 billion
and net income of USD 8.2 billion. Approximately USD 7.2 billion was
invested in R&D activities throughout the Group. Headquartered in
Basel, Switzerland, Novartis Group companies employ approximately
98,000 full-time-equivalent associates and operate in more than 140
countries around the world. For more information, please visit
http://www.novartis.com.
Important dates
July 16, 2009 Second quarter and first half 2009 results
October 22, 2009 Third quarter and first nine months 2009 results
January 2010 Fourth quarter and full-year 2009 results
Please find full media release in English attached and on the
following link:
http://hugin.info/134323/R/1307495/301013.pdf
Further language versions are available through the following links:
German version is available through the following link:
http://hugin.info/134323/R/1307487/301012.pdf
French version is available through the following link:
http://hugin.info/134323/R/1307488/301011.pdf
--- End of Message ---
Novartis International AG
Posfach Basel
WKN: 904278; ISIN:
CH0012005267; Index: SLCI, SMI, SPI, SLIFE;
Listed: Main Market in SIX Swiss Exchange, ZLS in BX Berne eXchange;
Copyright © Hugin AS 2009. All rights reserved.
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