FDA grants BioSante Orphan Drug designation for Melanoma Cancer Vaccine

BioSante Pharmaceuticals, Inc. today announced the receipt of Orphan Drug designation for its Melanoma Cancer Vaccine in the treatment of stage IIb to IV melanoma, from the FDA’s Office of Orphan Products Development. Melanoma is the most deadly form of skin cancer.

During the quarter, the Company submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for abiraterone acetate administered with prednisone, an investigational drug for the treatment of metastatic, advanced prostate cancer in patients who have received prior chemotherapy containing a taxane. In addition, the Company submitted supplemental Biologics License Applications to the FDA seeking to expand the SIMPONI?® label for the inhibition of structural damage in the treatment of psoriatic arthritis and for REMICADE?® (infliximab) for the treatment of moderately to severely active ulcerative colitis in pediatric patients who have had an inadequate response to conventional therapy.

Also during the quarter, Janssen-Cilag International NV filed marketing authorization applications with the European Medicines Agency (EMA) for abiraterone acetate and for telaprevir, an investigational, oral, direct-acting antiviral for the treatment of chronic genotype 1 hepatitis C virus. The Company also received a positive opinion from the EMA’s Committee for Medicinal Products for Human Use recommending the granting of a marketing authorization for paliperidone palmitate for the treatment of schizophrenia.

In January 2011, the Company submitted a NDA to the FDA for rivaroxaban, an investigational, oral, once-daily anticoagulant for the prevention of stroke and non-CNS systemic embolism in patients with atrial fibrillation. In addition, the Company announced that the European Commission approved INVEGA?® (paliperidone ER), the first antipsychotic schizoaffective treatment in Europe, indicated for treatment of psychotic or manic symptoms.

Worldwide Medical Devices and Diagnostics sales of $24.6 billion for the full-year 2010 represented an increase of 4.4% versus the prior year with an operational increase of 3.4% and a positive impact from currency of 1.0%. Domestic sales increased 3.6%; international sales increased 5.0%, which reflected an operational increase of 3.0% and a positive currency impact of 2.0%.

Primary contributors to operational sales growth included Ethicon’s surgical care products; Ethicon Endo-Surgery’s minimally invasive and advanced sterilization products; DePuy’s orthopaedic joint reconstruction and sports medicine businesses; Biosense Webster’s electrophysiology business; Vistakon’s disposable contact lenses; and Ortho-Clinical Diagnostics’ products. This growth was partially offset by lower sales in the Cordis franchise, reflecting continued market and competitive pressures in the drug-eluting stent market.

During the quarter, the Company submitted a Biologic License Application to the FDA for the Fibrin Pad, a novel product that combines Ethicon’s biomaterials and plasma-derived biologics (Human Fibrinogen and Human Thrombin), to aid in stopping soft tissue bleeding during surgery. In addition, the Company received CE Mark for OneTouch?® Verio?®Pro, a system for self monitoring of blood glucose levels.

SOURCE Johnson & Johnson

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