Ortho Biotech Files sNDA for DOXIL(R) for the Treatment of Advanced Breast Cancer

Monday, September 8, 2008 General News
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BRIDGEWATER, N.J., Sept. 8 Ortho Biotech Products, L.P.today announced that the Company has submitted a supplemental new drugapplication (sNDA) to the U.S. Food and Drug Administration (FDA) for thecombination of DOXIL(R) (doxorubicin HCl liposome injection) and Taxotere(R)(docetaxel)* for the treatment of women with advanced breast cancer who havereceived prior anthracycline treatment.

The application to the FDA follows the completion of a randomized,parallel-group, open-label, multicenter Phase III clinical trial thatevaluated time to progression (TTP) of the disease with combination vs.monotherapy docetaxel treatment. The study met its protocol-specified primaryendpoint demonstrating that the DOXIL-docetaxel combination had astatistically significant improvement in TTP as compared to docetaxel alone.Secondary endpoints included overall survival, response rates and safety.

"This is an important milestone in the development of DOXIL as we continueto demonstrate efficacy and safety of this agent across multiple tumor types,"said Craig Tendler, M.D., Vice President, Medical Affairs,Oncology/Nephrology, Ortho Biotech Products, L.P. "We look forward toworking with the FDA throughout the regulatory review process to provide thisnew DOXIL treatment option for advanced stage breast cancer patients who haverelapsed after receiving prior anthracycline-containing adjuvant/neoadjuvanttherapy."

The study results have been selected for oral presentation at the upcomingSan Antonio Breast Cancer Symposium (SABCS) in December. According to theNational Cancer Institute, there will be an estimated 184,450 new cases ofbreast cancer and 40,930 deaths from breast cancer in the United States in2008.

About DOXIL(R)

DOXIL is indicated for the treatment of patients with ovarian cancer whosedisease has progressed or recurred after prior platinum based therapy. DOXILin combination with VELCADE(R) (bortezomib) is indicated for the treatment ofpatients with multiple myeloma who have not previously received VELCADE andhave received at least one prior therapy. DOXIL is also indicated for thetreatment of AIDS-related Kaposi's sarcoma in patients after failure of priorsystemic chemotherapy or intolerance to such therapy.

IMPORTANT SAFETY INFORMATION

BOXED WARNINGS

Cardiotoxicity, infusion reaction, myelosuppression, liver impairment,substitution

-- The use of DOXIL may lead to cardiac toxicity. Myocardial damage maylead to congestive heart failure and may occur as the total cumulative dose ofdoxorubicin HCl approaches 550 mg/m2

-- Prior use of other anthracyclines or anthracenediones should beincluded in calculations of total cumulative dose

-- Cardiac toxicity may also occur at lower cumulative doses (400mg/m2) in patients with prior mediastinal irradiation or who are receivingconcurrent cyclophosphamide therapy

-- Acute infusion-related reactions including, but not limited to,flushing, shortness of breath, facial swelling, headache, chills, back pain,tightness in the chest or throat, and/or hypotension have occurred in up to10% of patients treated with DOXIL. In most patients, these reactions haveresolved within several hours to a day once the infusion is terminated. Insome patients, reactions resolved with slowing of the infusion rate

-- Serious and sometimes life-threatening or fatalallergic/anaphylactoid-like infusion reactions have occurred. Medications totreat such reactions, as well as emergency equipment, should be available forimmediate use

-- The initial rate of infusion should be 1 mg/min to minimize the riskof infusion reactions

-- Severe myelosuppression may occur

-- DOXIL dosage should be reduced in patients with impaired hepaticfunction

-- Accidental substitution has resulted in severe side effects. Do notsubstitute for do


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