Press Releases

BRIDGEWATER, N.J., Dec. 9, 2010 /PRNewswire-FirstCall/ -- Sanofi-aventis (EURONEXT: SAN and NYSE: SNY) announced today that the final survival analysis (10-year follow-up) of the BCIRG001 study that included a Taxotere® (docetaxel) Injection Concentrate chemotherapy treatment regimen in the adjuvant breast cancer setting, as well as data from iniparib (BSI-201) pre-clinical and clinical breast cancer studies will be featured during the 33rd Annual San Antonio Breast Cancer Symposium (SABCS) in San Antonio, Texas from December 8 to 12, 2010.  

During SABCS, the final (10-year follow up) survival analysis of the BCIRG001 study that included sanofi-aventis' chemotherapy drug Taxotere, in combination with doxorubicin and cyclophosphamide, in women with operable node-positive breast cancer will be presented. Also being presented are data from pre-clinical and clinical studies involving the sanofi-aventis investigational compound iniparib (BSI-201), which is being studied in breast cancer.  Iniparib is a novel investigational small molecule with poly (ADP-ribose) polymerase (PARP) inhibitory activity.

Key events at SABCS include:

About Iniparib (BSI 201)

Iniparib (BSI-201), the United States Adopted Name (USAN) for BSI-201, is a novel investigational small molecule with poly (ADP-ribose) polymerase (PARP) inhibitory activity.

BiPar Sciences and sanofi-aventis are pursuing a broad development program with iniparib in breast cancer and multiple trials are planned to start in the next several months.  A Phase 3 trial in mTNBC is ongoing, and multiple new trials are planned to start in the next several months.  New trials include:

• A Phase 2 trial in HER2-/Hormone receptor positive (ER+ and/or PR+) metastatic breast cancer
• A Phase 1b/2 trial in HER2- metastatic breast cancer (combination with taxane chemotherapy)
• A Phase 2 trial in mTNBC testing the Taxotere/Cytoxan chemotherapy combination

Iniparib also in being studied in a Phase 3 trial for patients with squamous non-small cell lung cancer, and in Phase 2 trials for patients with ovarian, uterine and brain cancers.  The regulatory submissions are planned for Q1 2011 in the U.S. and Q2 2011 in the European Union.  

About Taxotere (docetaxel) Injection Concentrate

Introduced more than 14 years ago, Taxotere is approved for use in the following indications:

Breast Cancer:  

• TAXOTERE is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of prior chemotherapy
• TAXOTERE in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with operable node-positive breast cancer

Non-Small Cell Lung Cancer:

• TAXOTERE as a single agent is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of prior platinum-based chemotherapy
• TAXOTERE in combination with cisplatin is indicated for the treatment of patients with unresectable, locally advanced or metastatic non-small cell lung cancer who have not previously received treatment

Prostate Cancer:

• TAXOTERE in combination with prednisone is indicated for the treatment of patients with androgen independent (hormone refractory) metastatic prostate cancer

Gastric Adenocarcinoma:

• TAXOTERE in combination with cisplatin and fluorouracil is indicated for the treatment of patients with advanced gastric adenocarcinoma, including adenocarcinoma of the gastroesophageal junction, who have not received prior treatment

Head and Neck Cancer:  

• TAXOTERE in combination with cisplatin and fluorouracil is indicated for the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck (SCCHN)

Important Safety Information for Taxotere® (docetaxel) Injection Concentrate

WARNING

• The incidence of treatment-related mortality associated with Taxotere® therapy is increased in patients with abnormal liver function, in patients receiving higher doses, and in patients with non-small cell lung carcinoma and a history of prior treatment with platinum-based chemotherapy who receive Taxotere® as a single agent at a dose of 100 mg/m2

• Taxotere® should not be given to patients with bilirubin > upper limit of normal (ULN), or to patients with AST and/or ALT > 1.5 X ULN concomitant with alkaline phosphatase > 2.5 X ULN  
  • Patients with elevations of bilirubin or abnormalities of transaminase concurrent with alkaline phosphatase are at increased risk for the development of grade 4 neutropenia, febrile neutropenia, infections, severe thrombocytopenia, severe stomatitis, severe skin toxicity, and toxic death
  • Patients with isolated elevations of transaminase > 1.5 X ULN also had a higher rate of febrile neutropenia grade 4 but did not have an increased incidence of toxic death
  • Bilirubin, AST or ALT, and alkaline phosphatase values should be obtained prior to each cycle of Taxotere® therapy

• Taxotere® therapy should not be given to patients with neutrophil counts of < 1500 cells/mm3
  • In order to monitor the occurrence of neutropenia, which may be severe and result in infection, frequent blood-cell counts should be performed on all patients receiving Taxotere®

• Severe hypersensitivity reactions characterized by generalized rash/erythema, hypotension and/or bronchospasm, or very rarely fatal anaphylaxis, have been reported in patients who received a 3-day dexamethasone premedication
  • Hypersensitivity reactions require immediate discontinuation of Taxotere® infusion and administration of appropriate therapy

• Taxotere® must not be given to patients who have a history of severe hypersensitivity reactions to Taxotere® or to other drugs formulated with polysorbate 80

• Severe fluid retention occurred in 6.5% (6/92) of patients despite use of a 3-day dexamethasone premedication regimen. It was characterized by one or more of the following events: poorly tolerated peripheral edema, generalized edema, pleural effusion requiring urgent drainage, dyspnea at rest, cardiac tamponade, or pronounced abdominal distention (due to ascites).

• Neutropenia (<2,000 neutrophils/mm3) occurs in virtually all patients given 60-100 mg/m2 of Taxotere® and grade 4 neutropenia (<500 cells/mm3) occurs in 85% of patients given 100 mg/m2 and 75% of patients given 60 mg/m2

• Patients should be premedicated with oral corticosteroids prior to each Taxotere® administration to reduce the incidence and severity of fluid retention. Patients with pre-existing effusions should be closely monitored from the first dose for possible exacerbation of the effusions

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

• Localized erythema of the extremities with edema followed by desquamation has been observed

• In case of severe skin toxicity, an adjustment in dosage is recommended

• Severe neurosensory symptoms (e.g. paresthesia, dysesthesia, pain) were observed in 5.5% (53/965) of metastatic breast cancer patients, and resulted in treatment discontinuation in 6.1%

• When these symptoms occur, dosage must be adjusted; if symptoms persist, treatment should be discontinued

• Severe asthenia was reported in 14.9% (144/965) of metastatic breast cancer patients, but led to treatment discontinuation in only 1.8%

• Symptoms of fatigue and weakness may last a few days up to several weeks and may be associated with deterioration of performance status in patients with progressive disease

• Taxotere® (docetaxel) Injection Concentrate can cause fetal harm when administered to pregnant women.  Women of childbearing potential should be advised to avoid becoming pregnant during therapy with Taxotere

• The most common adverse reactions across all Taxotere indications are infections, neutropenia, anemia, febrile neutropenia, hypersensitivity, thrombocytopenia, neuropathy, dysgeusia, dyspnea, constipation, anorexia, nail disorders, fluid retention, asthenia, pain, nausea, diarrhea, vomiting, mucositis, alopecia, skin reactions and myalgia

• In patients treated with TCF for gastric cancer, the incidence of serious adverse events was higher in patients >/=65 years than in younger patients. Adverse events (all grades) occurring at rates >/=10% higher in elderly patients included lethargy, stomatitis, diarrhea, dizziness, edema, and febrile neutropenia/neutropenic infection

• Taxotere should be administered in a facility equipped to manage possible complications (e.g. anaphylaxis)

For more information about Taxotere, including full prescribing information and product boxed WARNING, visit: http://products.sanofi-aventis.us/taxotere/taxotere.pdf

About sanofi-aventis Oncology

Sanofi-aventis Oncology is targeting cancer on several fronts in an effort to address unmet medical needs for a broad range of patients. Starting with a deep understanding of the mechanisms by which cancers develop, grow and spread, as well as translating this deep scientific understanding early in the drug discovery process, the company employs innovative approaches to bring the right medicines to the right patients. Compounds are now being investigated in Phase III clinical studies aimed at multiple solid and hematologic tumor types.

About sanofi-aventis

Sanofi-aventis U.S. is an affiliate of sanofi-aventis, a leading global pharmaceutical company that discovers, develops and distributes therapeutic solutions to help improve the lives of patients. Sanofi-aventis is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY). For more information, visit www.sanofi-aventis.us or www.sanofi-aventis.com.

About BiPar Sciences

BiPar Sciences is a biopharmaceutical organization dedicated to pioneering novel tumor-selective therapies designed to address urgent unmet needs of cancer patients. Located in South San Francisco, California, BiPar is a wholly owned subsidiary of sanofi-aventis.  For more information, please visit www.biparsciences.com.

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 projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future financial results, events, operations, services, product development and potential, 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 EMA, 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 labelling 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, the Group's ability to benefit from external growth opportunities 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, 2009.  Other than as required by applicable law, sanofi-aventis does not undertake any obligation to update or revise any forward-looking information or statements.

SOURCE sanofi-aventis