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Taxotere(R) (Docetaxel) Receives 2 New European Approvals For Treatment of Breast Cancer

Posted on: Tuesday, 11 January 2005, 03:00 CST

PARIS, Jan. 11 /PRNewswire-FirstCall/ -- Sanofi-aventis announced today that the European Commission has approved 2 new indications for Taxotere(R) (docetaxel) Injection Concentrate for treatment of breast cancer.

The first granted TAXOTERE(R), in combination with doxorubicin and cyclophosphamide, for the adjuvant treatment of patients with operable node- positive breast cancer.

A second granted TAXOTERE(R), in combination with Herceptin(R) (trastuzumab), for the treatment of patients with metastatic breast cancer whose tumors over-express the Her2 gene.

The Commission approval is based on the results of two separate large randomized international trials.

* In adjuvant setting, second interim analysis from the pivotal Breast

Cancer International Research Group (BCIRG) 001/TAX 316(1) trial

demonstrated a better efficacy of TAXOTERE(R) based regimen over the

standard FAC (5-fluoro-uracil, doxorubicin and cyclophosphamide) with a

significant 28 percent reduction in risk of relapse and a 30 percent

reduction in risk of death after 55 months of follow-up.

TAXOTERE(R) is the only drug from its class to demonstrate such survival benefit regardless of woman's hormone receptor status.

"These results bring new hope for all the women with operable node- positive breast cancer. With Taxotere, about 9 women on 10 are alive at 5 years, that is 30 % of additional reduction of the risk of mortality" said Dr Jean-Paul Guastalla (Leon Berard center, Lyon- France) and investigator of the trial.

"The addition of Taxotere to this standard therapeutic strategy would save 18 000 additional lives at 5 years in the world" commented Dr Miguel Martin (Hospital Clinico San Carlos, Madrid- Spain), President of the GEICAM (Grupo Espanol de Investigacion en Cancer de Mama) and member of the BCIRG steering committee.

* For the treatment of metastatic breast cancer that over-expresses Her2

(more aggressive tumors), international randomized clinical trial

M77001(2) demonstrated a better efficacy of TAXOTERE(R)-trastuzumab

combination with significant improvement of overall survival as well as

significant improvement of other efficacy endpoints (objective response

rate, time to progression, median survival).

"It is a true advance for all these patients with a breast cancer that can increase and spread very quickly," said Pr Michel Marty (Institut Gustave Roussy, France), principal investigator of the trial. "These patients concerned by a more aggressive tumor should benefit from this innovative regimen today," he concluded.

Breast Cancer

Breast cancer is the most common cancer among women other than skin cancer. It is the second-leading cause of cancer death in women after lung cancer -- and is the leading cause of cancer death among women ages 40 to 59. More than 1,000,000 new cases of breast cancer are reported worldwide annually and more than 400,000 women die each year from the disease. The risk of a woman developing breast cancer during her lifetime is approximately 11 percent (about one in nine of all women worldwide). In the European Union, 191,000 new cases will be diagnosed, and more than 60,000 European women will die of the disease. In the United States, more than 215,000 American women will be diagnosed with breast cancer this year, and 40,000 will die of the disease.

Her2 is a protein present in some breast cancers. When there are high levels of Her2 the breast cancer is known as over-expressing Her2 or Her2- positive. This affects around one in five women and the cancer can increase and spread very quickly because it encourages the cancer cells to divide and grow.

Earlier diagnosis of breast cancer results in earlier treatment and may offer better chance for cure.

About Taxotere(R)

Docetaxel (TAXOTERE(R)), a drug in the taxoid class of chemotherapeutic agents, inhibits cancer cell division by essentially "freezing" the cell's internal skeleton, which is comprised of microtubules. Microtubules assemble and disassemble during a cell cycle. Docetaxel promotes their assembly and blocks their disassembly, thereby preventing many cancer cells from dividing and resulting in death in some cancer cells.

TAXOTERE(R) is indicated for treatment of metastatic breast cancer, non- small cell lung cancer, and androgen-independent (hormone-refractory) metastatic prostate cancer. TAXOTERE(R) is being studied extensively in clinical trials for safety and efficacy in early-stage breast, Head and Neck and gastric cancers.

In 2003, TAXOTERE(R) generated worldwide sales of over 1.3 billion euro.

Important safety information

WARNING: Taxotere(R) treatment can cause serious, physically limiting, and potentially life-threatening side effects, such as infection, low blood-cell counts, allergic reaction, and retention of excess fluid (edema).

Taxotere(R) should not be given to patients with low white-blood-cell counts, abnormal liver function, or a history of allergic reactions to Taxotere(R) or any of the ingredients in Taxotere(R).

Taxotere(R) should be administered only under the supervision of a qualified physician experienced in the use of anticancer treatments. Appropriate management of complications is possible only when adequate diagnostic and treatment facilities are readily available.

Treatment-related acute myeloid leukemia (AML) has occurred in patients given anthracyclines and/or cyclophosphamide, including use with Taxotere(R) in adjuvant therapy for breast cancer.

Because of the potential risk of fetal harm, pregnant women should not receive Taxotere(R). Women of childbearing potential should avoid becoming pregnant during treatment with Taxotere(R).

For more information about Taxotere(R), visit http://www.taxotere.com/ or see full prescribing information including boxed WARNING. For more information about ongoing clinical trials, please call 1-800-RxTrial or visit http://www.aventisoncology.com/.

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 disease, thrombosis, oncology, diabetes, central nervous system, internal medicine, vaccines.

Forward Looking Statements

This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995. Forward-looking statements are statements that are not historical facts. These statements include financial projections and estimates and their underlying assumptions, statements regarding plans, objectives and expectations with respect to future operations, products and services, and statements regarding future performance. Forward-looking statements are generally identified by the words "expect,""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 those discussed or identified in the public filings with the SEC and the AMF made by sanofi-aventis and Aventis, including those listed under "Forward-Looking Statements" and "Risk Factors" in sanofi-aventis's annual report on Form 20-F for the year ended December 31, 2003 and those listed under "Cautionary Statement Regarding Forward-Looking Statements" and "Risk Factors" in Aventis's annual report on Form 20-F for the year ended December 31, 2003. 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

Vice President, Media Relations

sanofi-Aventis

+331-53-77-4223

Charles F. Rouse III

sanofi-Aventis

908-243-0650

(1) Martin et al. SABCS 2003 (abs # 43, oral presentation)

(2) Marty et al. SABCS 2003 (abs #672, oral presentation)

sanofi-aventis

CONTACT: Jean-Marc Podvin, Vice President, Media Relations,+331-53-77-4223, or Charles F. Rouse III, +1-908-243-0650, both ofsanofi-Aventis

Web site: http://www.taxotere.com/http://www.aventisoncology.com/

Company News On-Call: http://www.prnewswire.com/comp/232375.html

Source: PRNewswire-FirstCall

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