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U.S. FDA approves Velcade® + Doxil® combination

Ortho Biotech Products, L.P., today announced the U.S. Food and Drug Administration (FDA) has approved the use of DOXIL® (doxorubicin HCl liposome injection) in combination with VELCADE® (bortezomib) for Injection to treat patients with multiple myeloma who have not previously received VELCADE® and have received at least one prior therapy

21 May 2007 , Bridgewater, NJ : Ortho Biotech Products, L.P., today announced the U.S. Food and Drug Administration (FDA) has approved the use of DOXIL® (doxorubicin HCl liposome injection) in combination with VELCADE® (bortezomib) for Injection to treat patients with multiple myeloma who have not previously received VELCADE® and have received at least one prior therapy.

The approval is based on the results of an international Phase III trial comparing the VELCADE® + DOXIL® combination to VELCADE® alone. The research showed that when used together to treat patients with relapsed/refractory multiple myeloma, the two medications significantly extended the median time to disease progression (TTP) from 6.5 months to 9.3 months (p<0.0001; HR 0.55; 95% CI (0.43, 0.71)) over VELCADE® alone.

"This approval means that the VELCADE® + DOXIL® combination offers an important new option for treating relapsed or refractory multiple myeloma," says Robert Orlowski. M.D., Ph.D., from the University of North Carolina, Lineberger Comprehensive Cancer Center in Chapel Hill, and principal investigator of the trial. "This is particularly significant because we need treatment options that improve the prognosis for patients whose disease has not responded to their first round of therapy."

Multiple myeloma is a cancer of the plasma cell, an important component of the immune system. It is the second most prevalent hematologic (blood-related) cancer, after non-Hodgkin’s lymphoma.1 The American Cancer Society estimates that close to 20,000 new cases of multiple myeloma will be diagnosed in the United States this year.2

"The VELCADE® + DOXIL® combination represents an important new therapeutic option for multiple myeloma, a disease that is incurable and has limited treatments available," adds Kathy Giusti, chief executive officer and founder of the Multiple Myeloma Research Foundation, and a myeloma patient. "The FDA approval of this promising combination signifies a critical milestone in the quest to treat patients with multiple myeloma."

The FDA approved Ortho Biotech's Supplemental New Drug Application (sNDA) for the VELCADE® + DOXIL® combination under the agency's Priority Review program. The approval was based on a pre-planned, interim analysis from the DOXIL®-MMY-3001 study, an international, multi-center, phase III, randomized, open-label study of 646 patients with relapsed or refractory multiple myeloma who had not previously received VELCADE®. For more information about the DOXIL®-MMY-3001 study results, go to: www.orthobiotech.com/releaseDetail.jsp?releaseID=300001

In addition to this new approval, DOXIL® is indicated for the treatment of patients with ovarian cancer whose disease has progressed or recurred after platinum-based chemotherapy. The FDA also has granted accelerated approval for DOXIL® for the treatment of AIDS-related Kaposi's sarcoma in patients with disease that has progressed on prior combination chemotherapy, or in patients who are intolerant to such therapy.

"As a company, we are dedicated to the development of treatments for cancer that will make a significant difference in patients' lives," says Craig Tendler, M.D., vice president, Oncology Clinical Affairs, Ortho Biotech. "This approval is another positive development in our partnership with Millennium, and we are pleased the FDA expedited the process of making the VELCADE® + DOXIL® combination available to patients with previously treated multiple myeloma."

About DOXIL®
DOXIL® is indicated in combination with VELCADE® (bortezomib) for the treatment of patients with multiple myeloma who have not previously received VELCADE® and have received at least one prior therapy, and for the treatment of patients with ovarian cancer whose disease has progressed or recurred after prior platinum based therapy.

IMPORTANT SAFETY INFORMATION
BOXED WARNINGS: Cardiotoxicity, infusion reaction, myelosuppression, liver impairment, substitution

The use of DOXIL® may lead to cardiac toxicity. Myocardial damage may lead to congestive heart failure and may occur as the total cumulative dose of doxorubicin HCl approaches 550mg/m2. Prior use of other anthracyclines or anthracenediones should be included in calculations of total cumulative dose. Cardiac toxicity may also occur at lower cumulative doses (400 mg/m2) in patients with prior mediastinal irradiation or who are receiving concurrent cyclophosphamide therapy.
Acute infusion-related reactions have occurred in up to 10 percent in patients treated with DOXIL®. In most patients, these reactions have resolved within a day once the infusion is terminated and in some patients, with slowing of the infusion rate. Serious and sometimes life-threatening or fatal allergic/anaphylactoid-like infusion reactions have occurred. Medications to treat such reactions, as well as emergency equipment should be available for immediate use. The initial rate of infusion should be 1mg/min to minimize the risk of infusion reactions.
Severe myelosuppression may occur.
DOXIL® dosage should be reduced in patients with impaired hepatic function
Accidental substitution has resulted in severe side effects. Do not substitute for doxorubicin HCl on a mg per mg basis.

Contraindication

DOXIL is contraindicated in nursing mothers.

Additional Safety Information

Cardiac function should be carefully monitored. For patients with a history of cardiovascular disease or if the results of cardiac monitoring indicate possible cardiac injury, the benefit of therapy must be weighed against the risk of myocardial injury.
Myelosuppression may occur; monitor hematologic parameters. Hematologic toxicity may require dose modifications.
Hand-foot syndrome (HFS) may occur; dose modifications may be required.
DOXIL® can cause fetal harm when used during pregnancy.
Recall reaction has occurred with DOXIL® administration after radiotherapy.
DOXIL® may interact with drugs known to interact with the conventional formulation of doxorubicin HCl.

In patients with recurrent ovarian cancer, the Grade 3 / 4 adverse reactions (ARs) reported in ≥ five percent of DOXIL®-treated patients were asthenia (seven percent), nausea (five percent), stomatitis (eight percent), vomiting (eight percent), HFS (24 percent), neutropenia (12 percent), and anemia (six percent). Additional non-hematologic all grade ARs reported in ≥ 20 percent were fever (21 percent), diarrhea (21 percent), anorexia (20 percent), and rash (29 percent).

In patients with relapsed multiple myeloma, the Grade 3 / 4 ARs reported in ≥ five percent of patients receiving DOXIL® in combination with VELCADE® were neutropenia (32 percent), thrombocytopenia (24 percent), anemia (nine percent), fatigue (seven percent), asthenia (six percent), diarrhea (seven percent) peripheral neuropathy (seven percent) and HFS (six percent). Additional all grade ARs reported in ≥ 20 percent were pyrexia (31 percent), nausea (48 percent), vomiting (32 percent), constipation (31 percent), stomatitis (20 percent), and rash (22 percent).

Please see full Prescribing Information www.doxil.com/pdf/DOXIL_PI_Booklet.pdf, including Boxed WARNINGS.

About VELCADE®
VELCADE® is being co-developed by Millennium Pharmaceuticals, Inc., and Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Millennium is responsible for commercialization of VELCADE® in the U.S.; Janssen-Cilag is responsible for commercialization in Europe and the rest of the world. Janssen Pharmaceutical K.K. is responsible for commercialization in Japan. For a limited period of time, Millennium and Ortho Biotech Inc. will co-promote VELCADE® in the U.S. VELCADE® is approved in more than 80 countries worldwide. To access the full U.S. prescribing information for VELCADE®, go to: www.mlnm.com/products/velcade/full_prescrib_velcade.pdf.

About Ortho Biotech Products, L.P.
Ortho Biotech Products, L.P., is a leading biopharmaceutical company devoted to helping improve the lives of patients with cancer and with anemia due to multiple causes, including chronic kidney disease. Since it was founded in 1990, Ortho Biotech and its worldwide affiliates have earned a global reputation for researching, manufacturing and marketing innovative products that enhance patients' health. Located in Bridgewater, NJ, Ortho Biotech also markets treatments for anemia, recurrent ovarian cancer, rejection of transplanted organs and other serious illnesses. For more information, visit www.orthobiotech.com.

1 Multiple Myeloma Research Foundation (MMRF). Multiple Myeloma: Disease Overview, 2005.

2 American Cancer Society. What Are the Key Statistics About Multiple Myeloma?, 2006. Available at: www.cancer.org/docroot/CRI/content/CRI_2_4_1X_What_are_the_key_statistics_for_multiple_myeloma_30.asp?rnav=cri.

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