Galen Acquires DaunoXome® (daunorubicin citrate liposome injection) for Advanced HIV-associated Kaposi's Sarcoma
SOUDERTON, Pa., Feb. 23, 2012 /PRNewswire/ -- Galen, a Northern Ireland Pharmaceutical company, has acquired the chemotherapy agent, DaunoXome® (daunorubicin citrate liposome injection) from Gilead Sciences, Inc. Galen US, Inc., a wholly owned subsidiary of Galen Ltd., will market DaunoXome® in the United States.
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DaunoXome® is an anthracycline chemotherapy agent that was first approved in the United States in 1996. It is indicated as a first-line cytotoxic therapy for advanced HIV-associated Kaposi's sarcoma (KS)(1) and has been shown to be as effective as a triple chemotherapy regimen in this disease.(2) KS is a type of cancer that affects both the skin and organs inside the body, such as the lungs, liver, and digestive tract in patients living with active HIV.(3,4)
"HIV-associated KS is an AIDS-defining illness, which has considerable impact on patient prognosis. For some HIV patients with advanced or poorly controlled KS, chemotherapy may be required alongside highly active antiretroviral therapy, to effectively target the cancer. DaunoXome® provides a much needed option for physicians needing to treat advanced HIV-associated KS patients with such chemotherapy regimens," says Dr. Anil Tulpule, Associate Professor of Medicine at the Norris Cancer Center, Los Angeles, California.
Galen is dedicated to supporting the development and provision of innovative medicines in an effort to improve health worldwide. Speaking about the acquisition of DaunoXome®, President of Galen, Mark Scrutton, commented: "We are delighted that we are now able to supply DaunoXome® in the United States for the treatment of patients with this devastating disease. DaunoXome® marks our first step into the oncology arena and this exciting, new acquisition provides us with the opportunity to offer more widely a much-needed therapy for patients with advanced HIV-associated KS."
For healthcare professionals who require further information about the product, including reimbursement, a dedicated helpline is available at 1-855-DAUNOXOME (1-855-328-669663). It is the healthcare professional's sole responsibility to determine and submit appropriate codes, charges, and modifiers for services rendered. Coverage, coding and reimbursement guidelines will vary according to individual insurance plans. Healthcare professionals should contact insurers to verify correct coding procedures prior to submitting claims related to DaunoXome®. In all cases, healthcare professionals will need to follow local payer policies for billing and reimbursement.
DaunoXome® will be made available through wholesalers in the United States.
DaunoXome® is not recommended in patients with less than advanced HIV-related KS.(1) DaunoXome® has a similar safety profile to other anthracycline chemotherapy agents.(5) For further information please click here to refer to the full DaunoXome® Package Insert or visit www.DaunoXome.com.
DaunoXome® is a prescription drug. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088 (1-800-332-1088). If you have a medical information inquiry or wish to report a side effect relating to DaunoXome® to the company, call 1-855-DAUNOXOME (1-855-328-669663).
IMPORTANT SAFETY INFORMATION
BOXED WARNINGS
- Cardiac function should be monitored regularly in patients receiving DaunoXome® (daunorubicin citrate liposome injection) because of the potential risk for cardiac toxicity and congestive heart failure. Cardiac monitoring is advised especially in those patients who have received prior anthracyclines or who have pre-existing cardiac disease or who have had prior radiotherapy encompassing the heart.
- Severe myelosuppression may occur.
- DaunoXome® should be administered only under the supervision of a physician who is experienced in the use of cancer chemotherapeutic agents.
- Dosage should be reduced in patients with impaired hepatic function.
- A triad of back pain, flushing, and chest tightness has been reported in 13.8% of the patients (16/116) treated with DaunoXome® in the Phase III clinical trial, and in 2.7% of treatment cycles (27/994). This triad generally occurs during the first five minutes of the infusion, subsides with interruption of the infusion, and generally does not recur if the infusion is then resumed at a slower rate.
Contraindications
- Therapy with DaunoXome® is contraindicated in patients who have experienced a serious hypersensitivity reaction to previous doses of DaunoXome® or to any of its constituents.
Additional Safety Information
- The primary toxicity of DaunoXome® is myelosuppression. Careful hematologic monitoring is required and since patients with HIV infection are immunocompromised, patients must be observed closely for evidence of intercurrent or opportunistic infections.
- Special attention must be given to the potential cardiac toxicity of DaunoXome®. Patients who have received prior therapy with anthracyclines (doxorubicin > 300mg/m2 or equivalent), have pre-existing cardiac disease, or have received previous radiotherapy encompassing the heart may be less "cardiac" tolerant to treatment with DaunoXome®. Monitoring of LVEF at cumulative DaunoXome® doses should occur prior to therapy and every 160mg/m2 of DaunoXome®.
- Daunorubicin has been associated with local tissue necrosis at the site of drug extravasation. Although no such local tissue necrosis has been observed with DaunoXome®, care should be taken to ensure that there is no extravasation of drug when DaunoXome® is administered.
- The safety and effectiveness of DaunoXome® in pediatric and elderly patients have not been established.
- Safety has not been established in patients with pre-existing hepatic or renal dysfunction. Based on experience with conventional daunorubicin hydrochloride, it is recommended that the dosage of DaunoXome® should be reduced in patients with impaired hepatic or renal function; refer to the full Package Insert for details.
- Pregnancy Category D: DaunoXome® can cause fetal harm when administered to a pregnant woman.
- If DaunoXome® is used during pregnancy, or if the patient becomes pregnant while being treated with DaunoXome®, the patient must be warned of the potential hazard to the fetus. Patients should be advised to avoid becoming pregnant while being treated with DaunoXome®.
Indication
- DaunoXome® is indicated as a first line cytotoxic therapy for advanced HIV-associated Kaposi's sarcoma. DaunoXome® is not recommended in patients with less than advanced HIV-related KS.
About DaunoXome®:
DaunoXome® (daunorubicin citrate liposome injection) works by attacking cancer cells and interfering with DNA production, which stops cancer cells from multiplying.(6) DaunoXome® has a different delivery system compared with conventional anthracyclines; it has a type of coating and particle size, which enables it to effectively target malignant tumors.(1,7,8)
For further information please click here to refer to the full DaunoXome® Package Insert or visit www.DaunoXome.com.
About Galen:
Galen is a privately owned, global pharmaceutical company headquartered in Northern Ireland, UK. Galen's products are now available in 16 countries and the company is working to expand its global reach with the formation of international strategic partnerships. A substantial drug discovery operation is underway, focusing on products for the treatment of cancer.
References
- DaunoXome® (daunorubicin citrate liposome injection) US Package Insert. Revised December 2011.
- Gill PS et al. Randomized Phase III trial of liposomal daunorubicin versus doxorubicin, bleomycin, and vincristine in AIDS-related Kaposi's sarcoma. Journal of Clinical Oncology 1996; 14 (8): 2353-2364.
- National AIDS Education and Training Centers National Resource Center. http://www.aids-ed.org/aidsetc?page=cg-620_kaposi_sarcoma. Accessed February 2012.
- American Cancer Society. What is Kaposi Sarcoma? http://www.cancer.org/Cancer/KaposiSarcoma/DetailedGuide/kaposi-sarcoma-what-is-kaposi-sarcoma. Accessed February 2012.
- Data on file 3, Galen Ltd.
- Brunton LL, Chabner BA, Knollmann BC, editors. Goodman & Gilman's The Pharmacological Basis of Therapeutics, 12th edition. New York, Chicago, San Francisco, McGraw-Hill. 2011: 1671.
- Forssen EA et al. Fluorescence Imaging Studies for the Disposition of Daunorubicin Liposomes (DaunoXome) within Tumor Tissue. Cancer Res 1996;56:2066-2075.
- Forssen EA. The design and development of DaunoXome for solid tumor targeting in vivo. Advanced Drug Delivery Reviews 1997; 24: 133-150.
For further information please contact:
Galen US media relations:
Meredith Butler
Golin Harris
T:919 381 6936
E: mbutler@golinharris.com
Galen UK media relations:
Nicola Kent or Annabel Lee
Packer Forbes Communications
T: +44 20 7036 8550
E: galen-pr@packerforbes.com
SOURCE Galen Ltd.
