- December 10, 2007
Reference Data
1. MGI PHARMA's Operating Results
(In US$ millions)
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| Year Ended December 31 | Revenues | R&D Expenses | Gain (loss) on Operations |
Net gain (loss) |
|---|---|---|---|---|
| 2004 | 195.7 | 62.6 | (84.7) | (85.7) |
| 2005 | 279.4 | 70.9 | (134.8) | (132.4) |
| 2006 | 342.8 | 100.1 | (31.2) | (40.2) |
| 2007 3Q | 288.8 | 56.9 | 14.5 | 13.7 |
2. MGI PHARMA's Core Products Profile
(1) Aloxi® (injection)
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| Generic name: | palonosetron hydrochloride |
| MOA & characteristics: | Serotonin subtype 3(5-HT3) receptor antagonist |
| Indication: | Chemotherapy-induced nausea and vomiting (CINV) |
| Features: | Only 5HT3 receptor antagonist approved for prevention of both acute and delayed chemotherapy-induced nausea and vomiting |
| US Launch: | 2003 |
| Sales for 2006: | US$251 million |
| New indication: | Post-operative nausea and vomiting (PONV): U.S. NDA filed |
| New formulation: | Oral formulation: U.S. NDA submitted |
(2) Dacogen® (injection)
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| Generic name: | decitabine |
| MOA & characteristics: | Anti-cancer activities through inhibition of DNA methylation |
| Indication: | Myelodysplastic syndrome (MDS) |
| Features: | Broad indication in patients with MDS: all subtypes, de novo and secondary MDS, previously treated and untreated |
| US Launch: | 2006 |
| Sales for 2006: | US$36 million |
| New indication: | Acute myeloid leukemia (AML): Phase Ⅲ |
(3) Gliadel® Wafer
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| Generic name: | polifeprosan 20 with carmustine implant |
| MOA & characteristics: | Localized delivery of carmustine, DNA/RNA alkylating agent |
| Indication: | Newly-diagnosed high-grade malignant glioma patients as an adjunct to surgery and radiation Recurrent glioblastoma patients as an adjunct to surgery |
| Features: | Only FDA approved implant treatment for brain cancer |
| US Launch: | 1996 |
| Sales for 2006: | US$36 million |
3. MGI PHARMA's Pipeline
(1) Submitted
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| Aloxi® | [Additional indication] Post-operative nausea and vomiting (PONV) |
| [New formulation] Oral formulation (Chemotherapy-induced nausea and vomiting (CINV) | |
| Aquavan | Minimal to moderate sedation of patients undergoing brief diagnostic or surgical procedures |
(2)Clinical Development
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| Saforis™ | Oral mucositis | Phase Ⅲ |
| Dacogen® | [Additional indication] Acute myeloid leukemia (AML) | Phase Ⅲ |
| Amolimogene (therapeutic DNA vaccine) |
Cervical dysplasia | Phase Ⅱ / Ⅲ |
| AKR-501 | Idiopathic thrombocytopenic purpura (ITP) | Phase Ⅱ |
| Irofulven | Hormone refractory prostate cancer | Phase Ⅱ |
| ZYC300 (therapeutic DNA vaccine) |
Solid tumors | Phase I / Ⅱ |
4. Eisai's Oncology Portfolio Overview
(1) Products
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| ONTAK® (denileukin diftitox) |
Treatment of patients with persistent or recurrent cutaneous T-cell lymphoma, whose malignant cells express the CD25 component of the Interleukin-2 receptor |
| Targretin® (bexarotene) capsules |
Treatment of cutaneous manifestations of cutaneous t-cell lymphoma in patients who are refractory to at least one prior systemic therapy |
| Targretin® (bexarotene) gel 1%v |
Treatment of cutaneous manifestations of cutaneous t-cell lymphoma in patients who are refractory to at least one prior systemic therapy |
| Panretin® (alitretinoin) gel 0.1% |
Treatment of cutaneous lesions in patients with AIDS-related Kaposi's sarcoma |
| FRAGMIN® (dalteparin sodium injection) |
Extended treatment of symptomatic venous thromboembolism (VTE) (proximal deep vein thrombosis (DVT) and/or pulmonary embolism (PE)) to reduce the recurrence of VTE in patients with cancer |
(2) Pipeline
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| Mode of Action | Target Indication and Phase | Status | |
| E7389 | Microtubule growth suppressor | Breast cancer (3rd line treatment) | Under preparation for submission under Subpart H |
| Breast cancer (2nd & 3rd line treatment) | Phase Ⅲ | ||
| Prostate cancer, Sarcoma | Phase Ⅱ | ||
| NSCLC (combination therapy) | Phase I | ||
| MORAb-003 | Monoclonal antibody | Ovarian cancer | Phase Ⅱ |
| E7820 | Alpha 2 integrin expression inhibitor | Cancer | Phase I / Ⅱ |
| E7070 | Cell cycle GI phase targeting agent | Small cell lung cancer, pancreatic cancer (combination therapy) | Phase I |
| E7080 | VEGF receptor tyrosin kinase inhibitor | Cancer | Phase I |
| E7974 | Hemiasterlin type tubuin polymerization inhibitor | Cancer | Phase I |
| MORAb-009 | Monoclonal antibody | Pancreatic cancer | Phase I |
| E7107 | Splicing factor modulator | Cancer | Phase I |
| E6201 | Multi-kinase inhibitor | Cancer | Preparing for Phase I |