Adjusted EPS excluding selected items:
Q2 2008: euro 1.34, up 3.9% up 20.7% in U.S. dollars(1)
H1 2008: euro 2.77, up 2.6% up 18.1% in U.S. dollars(1)
Multaq(R) submitted in Europe and the United States
PARIS, July 31 /PRNewswire-FirstCall/ -- Sanofi-aventis announces solid
growth in the second quarter.
Solid growth in the second quarter
-- Net sales: euro 6,689m, up 5.2% on a comparable basis (down 3.6% on a
reported basis)
- 4.1% growth for the Pharmaceuticals business
- Good performance from flagship products
- Resilience from the rest of the portfolio: net sales up 0.8%
- Strong growth in Vaccines (up 17.1% on a comparable basis)
- Double-digit growth in emerging markets
-- 11.2% growth in operating income - current(1) excluding currency
effects
- Ongoing cost control measures, and further improvement in the ratio
of selling and general expenses to net sales (26.7% vs. 27.8%)
-- Adjusted net income excluding selected items: euro 1,753m, up 0.7% (up
3.9% per share)
Acquisitions to enlarge our market presence
-- Competing tender offer for Zentiva
-- Agreement to acquire a nutraceuticals/OTC business in Australia
-- Recommended offer by Sanofi Pasteur for Acambis
Research and Development
-- Multaq(R) submitted in Europe and the United States
-- Approval of the Pentacel(R) pediatric vaccine in the United States at
end June
Increase in 2008 Guidance
Barring major adverse events, sanofi-aventis expects 2008 full-year
adjusted EPS excluding selected items(1) to grow around 8%, calculated at
constant 2007 euro/dollar parity (1.371).
Sensitivity to the euro/dollar exchange rate is estimated at 0.5% of
growth for a 1-cent movement in the exchange rate.
2008 second-quarter and first-half net sales
Unless otherwise indicated, all sales growth figures in this press
release are stated on a comparable basis.
Sanofi-aventis generated second-quarter net sales of euro 6,689
million, up 5.2%. Exchange rate movements had an unfavorable effect of 6.5
points, of which nearly 75% was due to the U.S. dollar. Changes in Group
structure had an unfavorable effect of 2.3 points, which includes the end
of commercialization by the Group of Copaxone(R) in the United States and
Canada under the agreements with Teva. On a reported basis, net sales fell
by 3.6%.
First-half net sales rose by 2.9% to euro 13,626 million. Exchange rate
movements had an unfavorable effect of 5.5 points, of which nearly 80% was
due to the U.S. dollar. Changes in Group structure had an unfavorable
effect of 0.9 of a point. Excluding these effects, net sales fell by 3.5%
on a reported basis.
Net sales by business segment - Pharmaceuticals
Second-quarter net sales for the pharmaceuticals business grew 4.1% to
reach euro 6,032 million, supported by the performance of our flagship
products and by the resilience of the rest of our portfolio. Net sales of
the top 15 products were 5.8% higher at euro 4,027 million, while net sales
of the other products in the portfolio rose by 0.8% to euro 2,005 million.
First-half net sales for the pharmaceuticals business were up 2.3% at
euro 12,421 million. Net sales of the top 15 products were up 3.7% at euro
8,349 million. Excluding the impact of the introduction of generics(2) of
Ambien(R) IR in the United States and Eloxatin(R) in Europe, first-half
growth for the top 15 products would have reached 9.6%. The other products
in the portfolio reported modest first-half decrease of 0.5%, to euro 4,072
million.
Change on a Change on a
Q2 2008 comparable H1 2008 comparable
euro million net sales basis net sales basis
Lovenox(R) 637 +4.6% 1,354 +12.9%
Plavix(R) 664 +8.5% 1,326 +13.4%
Lantus(R) 576 +27.2% 1,133 +28.9%
Taxotere(R) 503 +14.1% 987 +13.7%
Eloxatin(R) 326 -5.0% 668 -5.5%
Aprovel(R) 311 +18.7% 600 +14.9%
Copaxone(R) 103 +24.1% 420 +19.7%
Stilnox(R)/Ambien(R)
/Ambien CR(R)/Myslee(R) 191 -22.4% 401 -50.1%
Allegra(R) 171 -5.0% 375 +1.6%
Tritace(R) 137 -17.0% 275 -27.1%
Amaryl(R) 95 -5.0% 187 -2.6%
Xatral(R) 85 +7.6% 168 +6.3%
Depakine(R) 81 +3.8% 163 +7.2%
Actonel(R) 87 +8.7% 162 +3.8%
Nasacort(R) 60 -22.1% 130 -12.8%
TOP 15 4,027 +5.8% 8,349 +3.7%
Rest of the portfolio 2,005 +0.8% 4,072 -0.5%
Total Pharmaceuticals 6,032 +4.1% 12,421 +2.3%
Comments by product
Lovenox(R), the leading low molecular weight heparin on the market,
reported moderate growth in net sales in the second quarter.
In the United States, following a surge in sales in the a first quarter
(due partly to wholesalers buying buffer stocks in response to the
withdrawal of some unfractionated heparins), net sales of Lovenox(R) rose
by a more modest 6.5% in the second quarter to euro 379 million.
In Europe, we were unable to fully meet demand for the product in the
second quarter due to the withdrawal of some batches in which low levels of
impurities were detected. Shipments are expected to return to normal levels
in the third quarter.
The impact of heparin short supply neutralized over H1 2008 period,
Lovenox sales were up 12.9% at euro 1 354 million.
Net sales of Lantus(R), the world's leading insulin brand, rose by
27.2% in the second quarter to euro 576 million. In the United States, the
product reported growth of 26.2% to euro 328 million, boosted by
LantusSoloSTAR(R).
The results of the TULIP study, presented to the American Diabetes
Association (ADA) in June, confirmed the importance of promptly initiating
insulin treatment when patients with type 2 diabetes are unable to achieve
recommended glycemic targets with diet, exercise and oral diabetes
medications alone. In this study, 66% of patients who began treatment with
Lantus(R) achieved A1C of <7%, the ADA's recommended target for glycemic
control, while only 38% of patients from the lifestyle management arm were
able to achieve the recommended target levels.
Taxotere(R) again achieved double-digit growth in the second quarter,
across all three geographical regions. In the United States, net sales were
up 15.7% at euro 177 million, boosted by use of the product in adjuvant
breast cancer treatment. In May, sanofi-aventis and GEICAM (the Spanish
breast cancer research group) announced that a study of women with
high-risk node-negative early stage breast cancer had shown that adjuvant
treatment (post surgery) with Taxotere(R) as part of the TAC regimen
(Taxotere(R), doxorubicin, cyclophosphamide) was associated with a
significant improvement in Disease Free Survival compared to a standard FAC
regimen (5-fluorouracil, doxorubicin, cyclophosphamide).
Also in May, the results from the AVADO study presented to the American
Society of Clinical Oncology (ASCO) showed the benefits of combining
Taxotere(R) and Avastin(R) as a first-line treatment for women with HER2
negative metastatic breast cancer.
Ambien CR(R) posted second-quarter net sales of $153 million in the
United States, compared with $190 million for the second quarter of 2007.
Net sales of Ambien(R) IR, which went off patent in the United States on
April 20, 2007, totaled $34 million, against $90 million for the comparable
period of 2007.
In Japan, sales of Myslee(R), which have been consolidated by
sanofi-aventis since January 1, 2008, amounted to euro 35 million for the
second quarter (up 15.1%) and euro 61 million for the first half (up
12.3%).
In June, results from a new study presented at the SLEEP 2008 Annual
Meeting of the Associated Professional Sleep Societies (APSS) demonstrated
that Ambien CR(R) 12.5mg provided significant improvement in sleep onset,
sleep maintenance and total sleep time over 8 weeks in patients with
comorbid insomnia and major depressive disorder who were administered a
Selective Serotonin Reuptake Inhibitor (SSRI) for depression.
In the United States, sales of Eloxatin(R) - the market-leading
colorectal cancer treatment as adjuvant and in the metastatic phase - rose
by 4.8% to euro 219 million. In Europe, the ongoing introduction of generic
versions of the product again weighed on total net sales, which fell by
5.0% to euro 326 million. In the Other Countries region, the product
recorded strong growth of 29.7%, to euro 48 million.
In May, the United States Food and Drug Administration (FDA) approved a
supplemental new drug application to include six-year overall survival
analysis from the MOSAIC trial in the Eloxatin(R) prescribing information.
The trial results showed that after a median follow-up of six years, Stage
III colon cancer patients treated with FOLFOX4 (Eloxatin(R) + 5-FU/LV) had
a 20% reduction in the risk of dying compared to those treated with
standard chemotherapy alone. The new prescribing information also includes
five-year disease free survival data in Stage III colon cancer patients
treated following surgery to remove the primary tumor.
Net sales of Acomplia(R) reached euro 32 million in the second quarter
and euro 54 million in the first half. During the second quarter,
Acomplia(R) was launched in Brazil and Italy.
Positive results from ARPEGGIO, the first clinical trial on the
administration of rimonabant to patients with type 2 diabetes not
adequately controlled with insulin therapy, were presented to the American
Diabetes Association (ADA) in June.
Xyzal(R), a new prescription oral antihistamine launched by
sanofi-aventis and UCB in the United States at the start of October 2007,
generated net sales of euro 26 million in the second quarter and euro 44
million in the first half.
Worldwide presence of Plavix(R) / Iscover(R)
Change on a Change on a
comparable comparable
euro million Q2 2008 basis H1 2008 basis
Europe 469 +5.9% 930 +5.1%
United States 774 +18.7% 1,552 +30.4%
Other Countries 228 +20.0% 459 +25.8%
TOTAL 1,471 +14.5% 2,941 +20.5%
In the United States, sales of Plavix(R) (consolidated by Bristol Myers
Squibb - BMS) totaled $1,208 million in the second quarter of 2008,
compared with $1,019 million in the second quarter of 2007. Over the first
half of 2008, sales of the product reached $2,350 million, versus $1,809
million in the first half of 2007 when the product was still affected by
the availability of a generic version, mainly at the start of the period.
In Europe, second-quarter net sales of Plavix(R) were up 5.9% at euro
469 million, though sales are still being adversely affected by Germany.
Sanofi-aventis became aware on May 28, 2008, that the German federal
drug agency (BfArM) had reviewed and approved three applications for
marketing approval relating to clopidogrel besylate in Germany, ahead of
the expiry date of the data exclusivity period for clopidogrel in the
European Union (July 15, 2008). The applications relate to a different
pharmaceutical salt of clopidogrel from the one used in Plavix(R), and the
approvals granted cover only some of the indications of Plavix(R).
Sanofi-aventis believes that these applications - which rely on data from
sanofi-aventis and Bristol-Myers Squibb, who developed Plavix(R)/Iscover(R)
(clopidogrel bisulfate) - should not have been accepted by a regulatory
body within the European Union before this date. Starting in May 2008,
sanofi-aventis therefore instigated a number of civil, administrative and
regulatory actions, which initially led to the suspension of the marketing
authorizations pending further review by the BfArM. On July 29, 2008, the
German administrative court in Cologne ordered the immediate enforcement of
two of these marketing authorizations, ending their suspension.
Sanofi-aventis and BMS are appealing.
In the rest of the world, Plavix(R) recorded growth of 20% in the
quarter and 25.8% in the first half, strengthened by its performance in
Japan: second-quarter net sales reached euro 43 million (Q2 2007: euro 12
million), and first-half sales were euro 70 million (H1 2007: euro 16
million).
Worldwide presence of Aprovel(R)/ Avapro(R)/ Karvea(R)
Change on a Change on a
comparable comparable
euro million Q2 2008 basis H1 2008 basis
Europe 255 +10.9% 500 +9.6%
United States 117 +7.3% 236 +7.8%
Other Countries 127 +32.3% 235 +27.7%
TOTAL 499 +14.7% 971 +13.0%
Second-quarter worldwide sales of Aprovel(R)/Avapro(R)/Karvea(R) were
up 14.7% at euro 499 million. Over the first half, sales of the product
were up 13.0% at euro 971 million.
Net sales by business segment - Human Vaccines
Second-quarter consolidated net sales for the Human Vaccines business
rose by 17.1% to euro 657 million.
Net sales of influenza vaccines increased 78.2% in the quarter to euro
155 million, driven by the fulfillment of a new H5N1 vaccine contract with
the U.S. Department of Health and Human Services for $192.5 million
(compared with $113 million in the second quarter of 2007).
Adult booster vaccines also achieved strong growth, of 18.1%, due
primarily to the performance of Adacel(TM) (adult and adolescent tetanus-
diphtheria-pertussis booster), which increased 33.2% in the quarter to euro
59 million.
Net sales of Menactra(R) rose by 1.9% in the second quarter to euro 92
million. Sales were impacted by the timing of public sector orders that are
expected to occur in the third quarter.
Pentacel(R), the first 5-in-1 pediatric combination vaccine to protect
against diphtheria, tetanus, pertussis, polio and haemophilus influenzae
type b, was approved in the United States at the end June and launched at
the start of July. This new vaccine is expected to strengthen Sanofi
Pasteur's position in the pediatric segment of the U.S. market.
First-half consolidated net sales for the Human Vaccines business were
up 10.1% at euro 1,205 million.
Change on a Change on a
Q2 2008 comparable H1 2008 comparable
euro million net sales basis net sales basis
Influenza Vaccines* 155 +78.2% 200 +38.9%
Polio/Pertussis/Hib
Vaccines 187 +5.1% 355 +1.1%
Meningitis/Pneumonia
Vaccines 109 +4.8% 225 +22.3%
Adult Booster Vaccines 98 +18.1% 200 +1.5%
Travel & Other Endemics
Vaccines 78 0.0% 157 +1.3%
Other Vaccines 30 -3.2% 68 +7.9%
TOTAL 657 +17.1% 1,205 +10.1%
*seasonal and pandemic influenza vaccines
Second-quarter sales at Sanofi Pasteur MSD, the joint venture with
Merck & Co in Europe, rose by 39.4% on a reported basis to euro 274
million, boosted by the performance of Gardasil(R), the first vaccine
against papillomavirus infections (which cause cervical cancer). Net sales
of Gardasil(R) were euro 149 million, compared with euro 58 million in the
second quarter of 2007.
First-half sales for Sanofi Pasteur MSD were up 60.1% on a reported
basis at euro 552 million.
In June, Sanofi Pasteur inaugurated a new vaccine production facility
at Val de Reuil, France. This new facility, which cost approximately euro
100 million, uses the very latest technology to produce vaccines to the
highest quality standards. The facility is due to be operational by the end
of 2008 once it is certified by the healthcare authorities, and has been
designed to fill 200 million syringes and vials per year, doubling the
site's existing capacity.
Net sales by geographic region
Change on a Change on a
Q2 2008 comparable H1 2008 comparable
euro million net sales basis net sales basis
Europe 3,045 +1.0% 6,132 +0.1%
United States 1,979 +6.6% 4,149 +1.5%
Other Countries 1,665 +12.0% 3,345 +10.6%
TOTAL 6,689 5.2% 13,626 2.9%
In Europe, after a slight decrease in the first quarter, sales rose by
1.0% in the second quarter, largely because the rate of decline in German
sales slowed. Overall, first-half net sales rose by 0.1%. The impact of
Eloxatin(R) generics pared approximately 1.4% off growth for the period.
In the United States, sales rose by 6.6% in the second quarter, boosted
by dynamic performances from Lantus (up 26.2%), Taxotere (up 15.7%), and
vaccines (up 23.2%). Over the first half, net sales rose by 1.5%. Excluding
the impact of generics of Ambien(R) IR3, first-half sales growth would have
reached 10.7%.
Net sales in the Other Countries region rose by 12.0% in the second
quarter and by 10.6% in the first half.
Adjusted consolidated income statement
Second quarter of 2008
In the second quarter of 2008, sanofi-aventis generated net sales of
euro 6,689 million, down 3.6% on a reported basis (up 5.2% on a comparable
basis).
Gross profit was euro 5,249 million. Other revenues were affected by
the fall in the U.S. dollar, and slipped by 1.7%. The ratio of cost of
sales to net sales was 25.8%, an improvement of 0.7 of a point, reflecting
the favorable effect of the end of commercialization by sanofi-aventis of
Copaxone(R) in North America.
Research and development expenses fell by 0.9%, but rose by 3.4% after
excluding exchange rate effects.
Selling and general expenses fell by 7.4% (or by 1.9% excluding
exchange rate effects) to euro 1,789 million. Our ongoing cost control
measures led to a further marked improvement in the ratio of selling and
general expenses to net sales, from 27.8% for the second quarter of 2007 to
26.7% for the second quarter of 2008.
Other current operating income, net of expenses totaled euro 74
million, against euro 5 million in the comparable period of 2007. The 2008
figure includes the payment by Teva of a fee calculated in proportion to
North American sales of Copaxone(R).
Operating income - current(1) was 3.1% higher at euro 2,402 million.
Excluding the effect of exchange rates, growth would have reached 14.1%.
After stripping out the euro 61 million expense recognized in 2007 (as a
selected item) for the harmonization of the Group's welfare and healthcare
plans for retirees, operating income - current(1) would have risen by
11.2%.
The 2008 second-quarter financial statements include restructuring
costs of euro 179 million (euro 126 million after tax, included in selected
items) relating mainly to the adaptation of industrial facilities in France
and the sales force in Europe.
An impairment loss of euro 69 million (euro 49 million after tax,
included in selected items) was recognized in the period. This reflects the
discontinuation of the collaboration with Taiho on S-1, and the Data and
Safety Monitoring Board (DSMB) recommendation on the TRIST trial evaluating
Trovax(R) in kidney cancer.
Net financial expenses were euro 33 million, compared with euro 39
million in the second quarter of 2007, and include a gain of euro 38
million (euro 27 million after tax, included in selected items) on the sale
of the investment in Millennium. Interest expense on debt was euro 49
million, compared with euro 55 million in the second quarter of 2007.
The effective tax rate was 29.6%, compared with 30.7% for the second
quarter of 2007.
The share of profits from associates was euro 217 million, versus euro
210 million in the second quarter of 2007. The share of after-tax profits
from territories managed by BMS under the Plavix(R) and Avapro(R) alliance
amounted to euro 145 million, compared with euro 136 million in the second
quarter of 2007, with the rate of growth checked by the weaker dollar.
Minority interests came to euro 105 million, compared with euro 99
million in the second quarter of 2007. This line includes the share of
pre-tax profits paid to BMS from territories managed by sanofi-aventis
(euro 101 million, versus euro 93 million in the second quarter of 2007).
Adjusted net income came to euro 1,605 million, down 4.4%, while
adjusted earnings per share (adjusted EPS) was euro 1.23, down 0.8% on the
2007 second-quarter figure (euro 1.24), based on an average number of
shares outstanding of 1,306.5 million for the second quarter of 2008 and of
1,351.9 million for the second quarter of 2007.
Adjusted net income excluding selected items was euro 1,753 million,
0.7% higher than the 2007 second-quarter figure (euro 1,740 million), while
adjusted EPS excluding selected items was euro 1.34, 3.9% up on the 2007
second-quarter figure (euro 1.29).
Expressed in U.S. dollars(1), adjusted net income excluding selected
items was 16.7% up on the second quarter of 2007, and adjusted EPS
excluding selected items was 20.7% up on the second quarter of 2007.
First half of 2008
In the first half of 2008, sanofi-aventis generated net sales of euro
13,626 million, down 3.5% on a reported basis but up 2.9% on a comparable
basis.
Gross profit was euro 10,581 million. Despite a strong first-half
performance by Plavix(R) in the United States (30.4% comparable-basis
growth), royalty income rose by only 4.2% to euro 570 million due to the
sharp fall in the U.S. dollar. The ratio of cost of sales to net sales was
roughly stable at 26.5%, as a better product mix and the end of
commercialization by sanofi-aventis of Copaxone(R) in North American in the
second quarter almost offset the effect of generic competition for
Ambien(R) IR in the United States in the first quarter.
Research and development expenses were virtually unchanged (down 0.1%)
at euro 2,180 million, but rose by 3.7% after excluding the effect of
exchange rates.
Selling and general expenses totaled euro 3,572 million, a reduction of
6.1% (down 1.3% after excluding the effect of exchange rates), and
represented 26.2% of net sales (versus 26.9% in the first half of 2007),
reflecting the impact of our selective cost adaptation policy.
Operating income - current was 2.5% lower at euro 4,924 million, but
5.9% higher after excluding exchange rate effects, and represented 36.1% of
net sales versus 35.8% in the first half of 2007. After stripping out the
euro 61 million expense recognized in 2007 (as a selected item) for the
harmonization of the Group's welfare and healthcare plans for retirees and
excluding exchange rate effect, operating income - current would have risen
by 4.7%.
The 2008 first-half financial statements include restructuring costs of
euro 207 million (euro 146 million after tax) relating to the adaptation of
industrial facilities in France and the sales force in Europe.
The effective tax rate was 29.6%. In 2007, income tax expense included
a net gain of euro 223 million arising from changes in provisions and the
settlement of tax disputes. The 2007 first-half effective tax rate was
30.7%.
The share of profits from associates was euro 451 million, compared
with euro 369 million in the first half of 2007. The share of after-tax
profits from territories managed by BMS under the Plavix(R) and Avapro(R)
alliance amounted to euro 291 million (versus euro 235 million for the
first half of 2007).
Minority interests totaled euro 220 million, compared with euro 211
million for the first half of 2007. This line includes the share of pre-tax
profits paid to BMS from territories managed by sanofi-aventis (euro 212
million, versus euro 200 million in the first half of 2007).
Adjusted net income was down 8.6% at euro 3,468 million.
Adjusted earnings per share (adjusted EPS) was euro 2.64, 6.0% lower
than the 2007 first-half figure (euro 2.81), based on an average number of
shares outstanding of 1,313.7 million for the first half of 2008 and
1,351.5 million for the first half of 2007.
Adjusted net income excluding selected items was euro 3,636 million,
down 0.4% on the 2007 first-half figure (euro 3,649 million), while
adjusted EPS excluding selected items was euro 2.77, 2.6% higher than the
2007 first-half figure (euro 2.70).
Expressed in U.S. dollars(1), adjusted net income excluding selected
items was 14.8% higher than for the first half of 2007, and adjusted EPS
excluding selected items was 18.1% higher than for the first half of 2007.
Consolidated statement of cash flows and balance sheet as of June 30,
2008
Operating cash flow before changes in working capital for the first
half of 2008 was euro 3,932 million, compared with euro 4,209 million for
the first half of 2007.
Working capital needs increased by euro 690 million over the period,
against euro 1,163 million in the first half of 2007.
Investing activities generated a net cash outflow of euro 692 million,
versus euro 584 million in the first half of 2007. The product acquisitions
(euro 104 million) were mainly related to Myslee(R). The sale in May 2008
of the investment in Millennium Pharmaceuticals, Inc. generated a cash
inflow of euro 71 million, net of tax.
After the dividend payout of euro 2,706 million (euro 2,371 million in
the first half of 2007) and the acquisition of treasury shares for euro
1,225 million, net debt increased by euro 1,363 million in the first half
of 2008.
Net debt stood at euro 5,593 million as of June 30, 2008, compared with
euro 4,230 million as of December 31, 2007 and at the same level as of June
30, 2007
Gearing was 13.5% as of June 30, 2008, compared with 9.5% as of
December 31, 2007.
Increase in 2008 Guidance(4)
Barring major adverse events, sanofi-aventis expects 2008 full-year
adjusted EPS excluding selected items to grow around 8%, calculated at
constant 2007 euro/dollar parity (1.371).
Sensitivity to the euro/dollar exchange rate is estimated at 0.5% of
growth for a 1-cent movement in the exchange rate.
Research and Development
The R&D results highlights of the second quarter of 2008 include the
exceptional results of the ATHENA trial, evaluating the efficacy of
Multaq(R) on morbidity/mortality of patients with atrial fibrillation.
Registration dossier was submitted to the healthcare authorities in Europe
and the United States at the end of June, reflecting the commitment and
responsiveness of the teams behind this project.
Our ongoing portfolio rationalization program, designed to target
resources on the most promising projects, led to the discontinuation during
the quarter of some projects judged to have an inadequate risk/benefit
profile.
The main advances in our portfolio during the quarter are described
below:
Cardiovascular/Thrombosis
Multaq(R): The results of the ATHENA morbidity/mortality trial were
presented at the 29th Annual Scientific Sessions of the American Heart
Rhythm Society (HRS) in San Francisco. The results showed that Multaq(R)
significantly reduced the risk of cardiovascular hospitalization or death
by 24% (p = 2.10(-8)) in patients with atrial fibrillation or atrial
flutter, thereby meeting the trial's primary endpoint.
For the first time in twenty years of pharmaceutical research in atrial
fibrillation, a treatment has shown a significant decrease in the risk of
cardiovascular death by 30% (p = 0.03) on top of standard therapy,
including rate control and antithrombotic drugs. Multaq(R) also
significantly decreased the risk of arrhythmic death by 45% (p=0.01). First
cardiovascular hospitalization was reduced by 25% (p = 9.10(-9)) versus the
placebo group.
Registration dossier for Multaq(R) was submitted at the end of June in
Europe and in the United States.
Idrabiotaparinux (biotinylated idraparinux) is a long-acting selective
neutralizable factor Xa coagulation inhibitor, administered by weekly
subcutaneous injection.
The results of the EQUINOX bioequipotency study show that
idrabiotaparinux has a similar pharmacodynamic profile to idraparinux, as
well as an efficacy and safety profile in line with those obtained with
idraparinux in the Van Gogh study (which evaluated idraparinux in the
treatment of deep vein thrombosis). In addition, after 6 months of
treatment, neutralization of the anti-Xa effect of idrabiotaparinux by
avidin is obtained very rapidly with no rebound effect.
Enrolment to two large-scale phase III trials is ongoing. More than
half of the 3,200 patients for the CASSIOPEA pulmonary embolism trial have
been recruited to date. Enrolment of patients to the BOREALIS-AF trial is
on track. This trial is designed to assess the efficacy of biotinylated
idraparinux versus anti-vitamin K in the prevention of stroke and systemic
embolism in patients with atrial fibrillation. Filing for approval in this
indication is scheduled for 2011.
AVE5026 is a powerful anti-coagulant (ultra low weight molecular
heparin) with pharmacodynamic properties that go beyond anti-Xa factor
activity. Because of its subcutaneous mode of administration, it is not
associated with differences in bioavailability.
Enrolment to the 7 trials in the phase III program, which will include
over 10,000 patients, is under way.
Filing for approval in the first set of indications (prevention of
venous thromboembolic events in patients requiring hip or knee replacement,
or undergoing hip fracture surgery or abdominal surgery, or receiving
chemotherapy) is scheduled for 2010, followed by a subsequent filing
(prevention of thromboembolic events in medical patients) in 2011.
NV1FGF is a highly innovative gene therapy approach. Enrolment to the
TAMARIS phase III trial, which will evaluate the product's efficacy in
preventing amputations in patients suffering from critical lower limb
ischemia, has started with 120 active centers. Filing for approval in this
indication is scheduled for 2010.
It has been decided to discontinue the development of ilepatril (AVE
7688) and SL65.0472.
Oncology
Aflibercept (VEGF Trap) is being developed under an alliance with
Regeneron. It has a unique mechanism of action and its properties, when
compared with monoclonal antibodies, give it the potential to be an
anti-angiogenesis agent with a broader spectrum of activity.
Results from a randomized double-blind study involving 215 women with
advanced ovarian cancer treated with a 2 mg/kg or 4 mg/kg dose of
aflibercept every two weeks have been presented to the American Society of
Clinical Oncology (ASCO).
The study showed clear evidence of a response as measured by RECIST
(Response Evaluation Criteria in Solid Tumors) and CA-125. According to the
IRC (Independent Review Committee), RECIST response rates were 4.6% in
patients receiving the 4 mg/kg dose and 0.9% in those receiving the 2 mg/kg
dose. However, the study did not achieve its primary endpoint of
demonstrating that patients in either arm of the study achieved an
IRC-assessed response of at least 5%.
The CA-125 response, an important marker of tumoral activity in ovarian
cancer, was a secondary endpoint of the study. Response rates, defined as
at least a 50% reduction in CA-125 antigen levels, were 11.6% in the
evaluable patients treated with 4 mg/kg and 11.5% in the evaluable patients
treated with 2 mg/kg.
Enrolment to the 4 pivotal phase III studies is on track:
-- the VENICE study is evaluating aflibercept as a first-line treatment
for hormone refractory prostate cancer (in combination with
Taxotere(R)/prednisone), target patient number 1,240;
-- the VELOUR study is evaluating aflibercept as a second-line treatment
for colorectal cancer (in combination with the FOLFIRI regime), target
patient number 1,200;
-- the VITAL study is evaluating aflibercept as a second-line treatment
for non small cell lung cancer (in combination with Taxotere(R)),
target patient number 900;
-- the VANILLA study is evaluating aflibercept as a first-line treatment
for pancreatic cancer (in combination with gemcitabine), target patient
number 630.
In addition, a phase II study of aflibercept as a first-line treatment
for metastatic colorectal cancer is due to begin in the second half of
2008.
Based on the 1,600 patients already treated, the undesirable
side-effects of aflibercept have been consistent with those expected for
this class of anti-angiogenesis agents (hypertension, proteinuria). The
reported incidence of bowel perforations has been low.
AVE8062 (licensed from Ajinomoto) is an agent that induces rapid
destruction of intra-tumoral micro-vessels. Enrolment to a phase III study
evaluating AVE8062 as a second-line treatment for advanced sarcoma has
begun. Filing in this indication is scheduled for 2011.
In July, the Data Safety Monitoring Board (DSMB) for TRIST study of
Trovax(R) (partnership with Oxford Biomedica) in renal cancer has
recommended that patients vaccinations in this study be discontinued.
On July 18, 2008, sanofi-aventis announced the termination of the
agreement with Taiho Pharmaceutical for the development and
commercialization of S-1.
Central Nervous System
Eplivanserin is a compound in a new class, 5HT2-A antagonists, intended
to treat sleep disorders. It improves the quality of sleep by reducing the
number and duration of WASO (Wake time After Sleep Onset) events in
patients with fragmented sleep patterns, with no residual effects reported
to date.
Submissions for the approval of eplivanserin are due to be filed with
the authorities in the fourth quarter of 2008.
Saredutant: Results from the MAGENTA study, evaluating the maintenance
of the effects of saredutant in the treatment of major depressive
disorders, confirmed the product's good long-term safety profile. However,
the MAGENTA study also showed that relapse was not significantly reduced
versus placebo when patients who had responded to saredutant after 3 months
had their treatment extended to 12 months.
Analysis of all other saredutant short term studies revealed a benefit
for patients with major depressive disorders based on the HAM-D scale.
The decision on submitting saredutant for regulatory approval will
depend on the results of two ongoing trials assessing the product in
combination with the selective serotonin reuptake inhibitors (SSRIs)
escitalopram and paroxetine, which are due to be completed in the first
half of 2009.
Teriflunomide is a potential oral treatment for multiple sclerosis,
with a targeted efficacy profile similar to interferons on relapse and
progression of disability, but with a better safety. Enrolment of the 1,080
patient population in the TEMSO phase III placebo-controlled trial
evaluating teriflunomide as monotherapy is now complete.
It has been decided to discontinue the development of amibegron and SSR
149415 (a V1B receptor antagonist).
Metabolism
AVE0010 is a novel injectable anti-diabetic in the GLP-1 receptor
agonist class. Results from the phase IIb study of AVE0010, presented to
the American Diabetes Association (ADA), showed that treatment with AVE0010
was well tolerated and significantly improved glycemic control, compared to
placebo in type 2 diabetes patients who were unable to achieve adequate
control with metformin as monotherapy. The once-daily dose regimen gave a
marked dose-response effect, with a reduction in HbA1c comparable with that
of a twice-daily regimen. Treatment with AVE0010 was also accompanied by
weight loss, a reduction in post-prandial glycemia, and good
gastro-intestinal tolerance.
A large phase III programme involving over 3,000 patients began in the
second quarter. This programme is evaluating a once-daily injection of
AVE0010 on top of the main existing treatments (metformin, sulfonylurea,
insulin, pioglitazone), and also includes a comparison with exenatide and a
monotherapy study. Submission for approval is scheduled for 2010, but this
date may change due to new FDA pre-conditions in this indication. A phase I
study evaluating a prolonged release formulation is under way.
Rimonabant: The development program in type 2 diabetes is ongoing.
Results from ARPEGGIO, the first clinical trial on the administration
of rimonabant to patients with type 2 diabetes not adequately controlled
with insulin therapy, were presented to the American Diabetes Association
(ADA) in June. Rimonabant significantly improved HbA1c by 0.89% from the
baseline value, and by 0.64% over the control group (p<0.0001). Glucose
control was three times more pronounced when rimonabant was added than with
insulin treatment and lifestyle advice alone.
Enrolment of the 17,000 patient population to the CRESCENDO
morbidity-mortality trial is now complete, and the results are expected in
2011.
AVE5530 is a cholesterol absorption inhibitor. Results from phase IIb
trials showed a significant reduction in LDL at different doses, confirming
the potential benefits of this product. Its mode of action, with limited
systemic absorption relative to competing products, gives it a potential to
avoid drug interaction with good tolerance. AVE5530 has the potential to be
used as monotherapy or in combination with statins. A phase III program
comprising four trials has started. Submission for approval is scheduled
for the second half of 2010, both as monotherapy and in fixed combination
with a statin.
About sanofi-aventis
Sanofi-aventis, a leading global pharmaceutical company, discovers,
develops and distributes therapeutic solutions to improve the lives of
everyone. Sanofi-aventis is listed in Paris (EURONEXT: SAN) and in New York
(NYSE: SNY).
Forward-Looking Statements
This press release contains forward-looking statements as defined in
the Private Securities Litigation Reform Act of 1995, as amended.
Forward-looking statements are statements that are not historical facts.
These statements include product development, product potential projections
and estimates and their underlying assumptions, statements regarding plans,
objectives, intentions and expectations with respect to future events,
operations, products and services, and statements regarding future
performance. Forward-looking statements are generally identified by the
words "expects," "anticipates," "believes," "intends," "estimates," "plans"
and similar expressions. Although sanofi-aventis management believes that
the expectations reflected in such forward-looking statements are
reasonable, investors are cautioned that forward-looking information and
statements are subject to various risks and uncertainties, many of which
are difficult to predict and generally beyond the control of
sanofi-aventis, that could cause actual results and developments to differ
materially from those expressed in, or implied or projected by, the
forward-looking information and statements. These risks and uncertainties
include among other things, the uncertainties inherent in research and
development, future clinical data and analysis, including post marketing,
decisions by regulatory authorities, such as the FDA or the EMEA, regarding
whether and when to approve any drug, device or biological application that
may be filed for any such product candidates as well as their decisions
regarding labeling and other matters that could affect the availability or
commercial potential of such products candidates, the absence of guarantee
that the products candidates if approved will be commercially successful,
the future approval and commercial success of therapeutic alternatives as
well as those discussed or identified in the public filings with the SEC
and the AMF made by sanofi-aventis, including those listed under "Risk
Factors" and "Cautionary Statement Regarding Forward-Looking Statements" in
sanofi-aventis' annual report on Form 20-F for the year ended December 31,
2007. Other than as required by applicable law, sanofi-aventis does not
undertake any obligation to update or revise any forward-looking
information or statements.
Contact: Jean-Marc Podvin, jean-marc.podvin@sanofi-aventis.com, Phone:
33 1 53 77 42 23
Recent Events
May 14, 2008 Shareholders' Annual General Meeting:
- Distribution of a net dividend of euro 2.07 per share (up
18.3%)
- Approval of the appointment of thirteen directors on the
expiry of the mandates of existing Board members at the
end of the AGM
Board meeting following the AGM:
- Reappointment of the Chairman of the Board of Directors
for a two-year term
- Authorization for the company to repurchase its own shares
up to a maximum of euro 3bn, valid until the next AGM
May 15, 2008 Announcement that the U.S. Court of Appeals for the Federal
Circuit had affirmed the decision by the U.S. District Court
in the sanofi-aventis Lovenox(R) patent infringement suit
against Amphastar and Teva.
May 15, 2008 Announcement of very positive results from the ATHENA trial,
showing that Multaq(R) significantly reduces the risk of
cardiovascular hospitalization or death by 24% in patients
with atrial fibrillation or atrial flutter.
May 21, 2008 Release of an updated clinical development program for
aflibercept, including results from a Phase II trial in
advanced ovarian cancer.
May 27, 2008 Announcement that in women with high-risk node-negative
early stage breast cancer (GEICAM 9805/Target-0 study),
adjuvant treatment based on Taxotere(R) was associated with
a significant improvement in disease free survival compared
to a standard regimen.
May 28, 2008 Announcement that the FDA had approved a supplemental new
drug application to include six-year overall survival
analysis from the MOSAIC trial in the Eloxatin(R)
prescribing information.
May 28, 2008 Statement by sanofi-aventis on third-party clopidogrel
registration applications in Germany.
June 2, 2008 Announcement by sanofi-aventis and Oxford Biomedica of
encouraging results from phase II trials of Trovax(R) in
metastatic kidney cancer.
June 7, 2008 Release at the ADA of a study demonstrating the efficacy of
Apidra(R) in the treatment of children and adolescents with
type 1 diabetes.
June 7, 2008 Presentation to the ADA of results of a dose research study
on the novel injectable anti-diabetic AVE0010, a GLP-1
receptor agonist.
June 7, 2008 Presentation to the ADA of results from the TULIP study,
confirming the importance of promptly initiating insulin
treatment when patients with type 2 diabetes are unable to
achieve recommended glycemic targets with diet, exercise and
oral diabetes medications alone.
June 10, 2008 Announcement of results from a new study demonstrating that
Ambien CR(R) relieves insomnia and improves next-day
functioning in patients with associated major depressive
disorders.
June 10, 2008 Presentation to the ADA of a 5-year safety study examining
the effect of Lantus(R) on the progression of retinopathy in
patients with type 2 diabetes.
June 10, 2008 Presentation to the ADA of results from ARPEGGIO, the first
clinical trial on the administration of rimonabant to
patients with type 2 diabetes not adequately controlled with
insulin therapy.
June 16, 2008 Announcement of commitment by sanofi-aventis to donate 60
million doses of H5N1 vaccine to the World Health
Organization over 3 years for the establishment of an H5N1
vaccine global stockpile.
June 18, 2008 Announcement by sanofi-aventis of its intention to make a
competing bid of CSK1,050 per share for Zentiva.
June 23, 2008 Announcement that the FDA had approved Pentacel(R), sanofi
pasteur's new pediatric combination vaccine.
June 25, 2008 Inauguration of a state-of-the-art vaccine production
facility in France.
July 11, 2008 Announcement by Oxford Biomedica that the DSMB for the TRIST
study had recommended discontinuing the vaccination of
patients taking part in the study with Trovax(R).
July 11, 2008 Opening of the tender offer for Zentiva.
July 17, 2008 Announcement of the signature of a 3-year collaboration
agreement with the Division of Allergy and Clinical
Immunology of the Johns Hopkins University School of
Medicine, Baltimore, USA.
July 18, 2008 Announcement of the termination of the agreement with Taiho
Pharmaceutical on the development and commercialization of
S-1.
July 21, 2008 Announcement of the signature of an agreement with Primary
Health Care to acquire Symbion Consumer, its Australian
nutraceuticals and OTC business.
July 21, 2008 Two Regimens Including Lantus(R) and Apidra(R) resulted
in Significant Reductions in A1c in Patients with Type 2
Diabetes, Whatever the Algorithm Used
July 22, 2008 Announcement of the approval by European Commission of
Apidra(R) for Treatment of Children & Adolescents with
Diabetes
July 25, 2008 Announcement of a recommended offer for Acambis plc
July 29, 2008 Two decisions of the German administrative court in Cologne
to order immediate enforcement of German marketing
authorizations held by Yes and by a subsidiary of Ratiopharm
for their clopidogrel besylate products
Financial Timetable
October 31,
2008 2008 third-quarter net sales and results
(1) U.S. dollar figures obtained by translating euro-denominated figures
at the average exchange rate for the period (Q2 2008: 1.562, Q2 2007:
1.348; H1 2008: 1.531, H1 2007: 1.329)
(2) Excluding net sales of Ambien(R) IR in the United States in Q1 2007
and Q1 2008, and of Eloxatin(R) in Europe in H1 2007 and H1 2008
(3) Excluding net sales of Ambien(R) IR in the United States in the first
quarter of 2007 and 2008
(4) Compared with adjusted EPS excluding selected items of euro 5.17 for
2007
SOURCE sanofi-aventis
 back to top
Related links:
http://www.sanofi-aventis.us
http://www.sanofi-aventis.com
http://www.prnewswire.com/comp/232375.html/
CONTACT:
Jean-Marc Podvin, of sanofi-aventis,
jean-marc.podvin@sanofi- aventis.com, +33-1-53-77-42-23
|
