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TAXOTERE® RECEIVES U.S. FDA APPROVAL FOR USE IN ADVANCED STOMACH CANCER

Pressmeddelande   •   Mar 24, 2006 09:00 CET

TAXOTERE®-based regimen demonstrates a 23% reduction in the risk of mortality
in patients with advanced stomach cancer

Paris, France – March 23, 2006 – Sanofi-aventis announced today that following a priority review of
the supplemental new drug application (sNDA), the U.S. Food and Drug Administration (FDA) has
approved TAXOTERE® (docetaxel) Injection Concentrate in combination with cisplatin and
5-fluorouracil for the treatment of patients with advanced stomach (gastric) cancer, including cancer of
the gastro esophageal (GE) junction, who have not received prior chemotherapy for advanced disease.

This is the first FDA approval of an advanced stomach cancer treatment demonstrating a survival
advantage in more than a decade, thereby offering physicians and their patients an important new
option for treating this devastating disease.

This additional new drug application is also currently under
review by the Committee for Medicinal Products for Human Use (CHMP) of the European Agency for
the Evaluation of Medicinal Products (EMEA).

The FDA based its decision on results from the Tax 325 study, the largest international phase III
clinical trial in previously untreated advanced stomach cancer involving 445 patients. Patients treated
with the TAXOTERE®-based chemotherapy regimen (TAXOTERE® plus cisplatin and 5-fluorouracil,
TCF) experienced a significant 23 percent reduction in the risk of death compared to patients who
received a current standard treatment of cisplatin and 5-fluorouracil (CF), (median follow-up:
23 months).

The median overall survival was significantly longer with the TAXOTERE®-containing
regimen (9.2 vs 8.6 months, p=less than 0.02) with a hazard ratio of 1.29 (95% CI: 1.04-1.61). Time to disease
progression was nearly two months longer in the TAXOTERE®-containing arm (5.6 vs 3.7 months,
p=0.0004), hazard ratio 1.47 (CF/TCF 95% CI/ 1.19 -1.83).

“For many years, patients with gastric cancer had limited options for the treatment of their disease,”
said Jaffer A. Ajani, MD, Professor, GI Medical Oncology, The University of Texas M. D. Anderson
Cancer Center, Houston, Texas, Principal Investigator of the TAX 325 study
“With the approval of
this TAXOTERE®-based regimen in this cancer, a new standard of treatment is now available for
advanced gastric cancer patients”.

About the TAX 325 Study
Locally advanced or metastatic stomach cancer has a poor prognosis with a low long-term survival of
only 11.5 percent. This study was undertaken to evaluate the benefits of adding TAXOTERE® to a
standard chemotherapy regimen. The primary study endpoint was time to tumour progression (TTP),
which was significantly improved with TAXOTERE® based therapy (5.6 months) compared to
standard treatment (3.7 months) with a 32 percent reduction in the risk of progression (log-rank test
p=0.0004). The main secondary endpoint was to detect a statistically significant increase in overall
survival. Other secondary objectives included response rate, time to treatment failure, duration of
response, safety profiles, quality of life and disease related symptoms.

In total, 81.4 percent of the patients experienced at least one Grade 3-4 (severe) side effect with the
TAXOTERE®- based regimen versus 75.4 percent in the control arm with neurtropenia being the most
common Grade 3-4 side effect in the TAXOTERE®- based regimen. The most common (all grade)
side effects associated with the TAXOTERE®- based regimen were anemia, neutropenia, diarrhea, and
nausea. The most common (all grade) side effects associated with the cisplatin and 5- fluorouracil arm
were anemia, neutropenia, nausea and vomiting. Primary prophylactic use of growth factor support
(granulocyte-colony stimulating factor, G-CSF) was not allowed per the study protocol. G-CSF is a
bone marrow growth factor that may be administered to reduce febrile neutropenia in patients
receiving myelosuppressive chemotherapy. In the TAXOTERE® arm, febrile neutropenia and/or
neutropenic infection occurred in 12 percent of patients receiving secondary prophylactic G-CSF
compared to 28 percent who did not, which represents a 57 percent reduction.

These results were last presented at the American Society of Clinical Oncology (ASCO) annual
meeting in 2005.
With this new indication, TAXOTERE® is now approved for six indications in the United States, and
eight in Europe, in four different tumor types:

In Breast Cancer:
· In the United States and in Europe TAXOTERE®, is approved for the treatment of patients
with locally advanced or metastatic breast cancer after failure of prior chemotherapy,
· TAXOTERE® is also approved in Europe in combination with doxorubicin for patients who
have received prior cytotoxic therapy for this condition and in combination with capecitabine
after failure of cytotoxic therapy which would have included anthracycline,
· In Europe, TAXOTERE® is approved in combination with trastuzumab for the treatment of
patients with metastatic breast cancer- over expressing Her2 receptor.
· TAXOTERE® is approved in the U.S. and in Europe in combination with doxorubicin and
cyclophosphamide (TAC regimen) for the treatment of patients with operable, node-positive
breast cancer.
In Non-Small Cell Lung Cancer (NSCLC):
· In the U.S. and in Europe, TAXOTERE®, in combination with cisplatin, is approved for the
treatment of patients with unresectable, locally advanced or metastatic non-small cell lung
cancer (NSCLC) who have not received prior chemotherapy for this condition,
· In the U.S., TAXOTERE® is also approved, as a single agent, for the treatment of patients with
locally advanced or metastatic NSCLC after failure of prior platinum-based chemotherapy.
In Prostate cancer:
· TAXOTERE® is approved for use in combination with prednisone for the treatment of patients
with androgen-independent (hormone-refractory) metastatic prostate cancer in the U.S. and in
Europe

“Stomach cancer claims the lives of more than 700,000 people worldwide each year,” said Donna
Vining, President, Gastro Esophageal Cancer Foundation, www.gecancer.org
The approval of
Taxotere® for use in advanced stomach cancer contributes to the on-going efforts by the medical
community to find treatment options that may improve outcomes for those suffering from this
devastating disease.”

About Stomach Cancer
Stomach cancer is the 4th most common type of cancer worldwide with more than 934,000 new
patients every year. It is also the second most common cause of cancer death worldwide; with more
than 700,000 deaths annually. There were about 22,800 new cases of stomach cancer in the
United States in 2005. In Europe, this number is over 143,000 patients. At diagnosis, most patients
with stomach cancer have advanced disease with an expected two-year survival of only 11.5 percent.

About sanofi-aventis
Sanofi-aventis is the world’s 3rd largest pharmaceutical company, ranking number 1 in Europe.
Backed by a world-class R&D organization, sanofi-aventis is developing leading positions in seven
major therapeutic areas: cardiovascular, thrombosis, oncology, metabolic disorders, central nervous
system, internal medicine, and vaccines. Sanofi-aventis is listed in Paris (EURONEXT : SAN) and in
New York (NYSE : SNY)

Contact : Anne Bancillon : +33 (0)6 86 31 03 89

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