FDA Approves New Taxotere® (docetaxel) Injection Concentrate Formulation

August 5, 2010

BRIDGEWATER, N.J., Aug. 5 /PRNewswire/ — Sanofi-aventis U.S. announced today that the U.S. Food and Drug Administration (FDA) has approved a new one-vial formulation of its chemotherapeutic agent Taxotere® (docetaxel) Injection Concentrate. The 1-vial Taxotere is anticipated to become available to cancer treatment clinics and hospitals nationwide in the fall in both 80 mg and 20 mg dosages.

Introduced more than 14 years ago, Taxotere is approved by the FDA for use in treating patients at specific stages of 5 types of cancer: metastatic and adjuvant breast cancer, metastatic androgen independent prostate cancer, advanced non-small cell lung cancer, advanced gastric adenocarcinoma and locally advanced squamous cell carcinoma of the head and neck.

“This new formulation underscores the commitment sanofi-aventis has made to Taxotere and to healthcare professionals. We look forward to adding this formulation of Taxotere to the arsenal of oncology products sanofi-aventis offers to the cancer community,” said Paul Hawthorne, Vice President and Head of the Oncology Business Unit at sanofi-aventis U.S.

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.

Previously, Taxotere was available to health care professionals in a two vial formulation – one vial containing docetaxel concentrate and the other with the diluent. The 1-vial Taxotere eliminates the need for the initial dilution step with the diluent. The 1-vial Taxotere, now at 20mg/ml concentration, is ready to be added directly into the infusion solution. The new 1-vial Taxotere is expected to help simplify preparation by eliminating the dilution step.

With 1-vial Taxotere, the pharmaceutical ingredients of Taxotere and the one hour IV infusion administration to the patient remain the same.

Taxotere has been used worldwide to treat more than 1.5 million patients, 100,000 of whom were participants in clinical trials.

Important Safety Information for Taxotere (docetaxel) Injection Concentrate

      -- The incidence of treatment-related mortality associated with
         Taxotere(R) 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/m(2)
      -- Taxotere(R) 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(R) therapy should not be given to patients with neutrophil
         counts of < 1500 cells/mm(3)
           - 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(R)
      -- 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(R) infusion and administration of appropriate therapy
      -- Taxotere(R) 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/mm(3)) occurs in virtually all patients given 60-100 mg/m(2) of Taxotere® and grade 4 neutropenia (<500 cells/mm(3)) occurs in 85% of patients given 100 mg/m(2) and 75% of patients given 60 mg/m(2)
  • 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® 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 greater than or equal to 65 years than in younger patients. Adverse events (all grades) occurring at rates greater than or equal to 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)

About Taxotere

Taxotere is approved for 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

     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)

For more information about Taxotere, including full prescribing information and product boxed WARNING, visit: http://products.sanofi-aventis.us/taxotere/taxotere_1Vial.pdf

Sanofi-aventis Oncology

Formed in March 2010, sanofi-aventis Oncology is targeting cancer on all 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 cancer develops, grows and spreads as well as identifying the right science early in the discovery process, the company employs innovative approaches to bring the right medicines to the right patients.

There are currently more than 10 compounds in development across a broad scientific platform, including cytotoxic, antimitotic, anti-angiogenic agents, antivascular agents, monoclonal antibodies and cancer vaccines, as well as supportive care therapies. Four of these compounds are now being investigated in phase 3 clinical studies aimed at multiple solid and hematologic tumors.

About sanofi-aventis

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

Sanofi-aventis U.S. offers reimbursement support services and patient assistance programs through our PACT+ program to help provide eligible patients in financial need with access to therapies prescribed by their healthcare professionals. For more information, please call 1-800-996-6626.

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.


    Lisa Buffington
    Tel: (908) 981-6569
    E-mail: lisa.buffington@sanofi-aventis.com

SOURCE sanofi-aventis U.S.

Source: newswire

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