The gross majority of all drugs, which reach late stage of development, are someway or another passed on to the large pharmaceutical companies because they hold the capital needed to conduct the expensive clinical trials as well as the regulatory commitment needed to gain an approval. In this issue of our Cancer Highlight", BioSeeker Group analyzes the progress made by the large pharmaceutical companies top oncology drug candidates whom has reached Phase III clinical evaluation. This report provides you with update information on the most recent advances made and the competitive struggle that exists between the large pharmaceutical companies. The information structure in our cancer highlight reports will as well include a general description on drugs and targets and provide an easy reading format to track B2B collaborations and industry academic relationships. Hallmarks of 2004 includes that BAY 43-9006 and CCI-779 were granted Fast Track Designition for treating patients with renal cell carcinoma. Fast Track Designition were also awarded to Xcytrin for treating patients brain metastases. In turn, Orphan Drug Status was granted to BAY 43-9006 for renal cancer, PI-88 for melanoma and Revlimid for myelodysplastic syndromes. Four FDA approvals were also reported during 2004. Avastin as well as Erbitux were both approved as treatment for colorectal cancer whereas Alimta was approved as treatment for mesothelioma. And very recently, Tarceva was approved as monotherapy to treat non-small cell lung cancer. The year 2004 has been a year of competitive challenge for AstraZenacas drug Iresssa and Genetechs drug Tarceva. Both drugs target the human epidermal growth factor receptor 1 and have in near term gained FDA approval as treatments of NSCLC. Iressa in May 2003 and Tarceva in November 2004. Moreover, the marketed drug Iressa already on the market has been added to American Society of Clinical Oncology Clinical Practice guidelines. The fact that Tarceva demonstrate an improved survival benefit in advanced NSCLC patients the competitive situation is presently swinging away from Iressa and in favor for Tarceva. Several drugs that are in Phase III are evaluated for treatment of breast cancer. Even though most candidates have been on the market for some years we do see substantial progress in this field. This indicates that a competitive situation is imminent between Pfizer and AstraZeneca. Two of the drugs, Aromasin and Faslodex both block the effects of the estrogen hormone. Pfizers drug Aromasin has been reported to improve disease-free survival and to be superior to Tamoxifen as a first line hormonal treatment for metastatic breast cancer. A potential threat for Aromasin is AstraZenecas drug Faslodex, which has been shown to be at least as effective as anastrozole and associated with a longer median duration of response. As regard the treatment of colorectal cancer, several drugs are candidates to change the standard therapy. Xeloda is suggested as a replacement of 5-FU/LV in the adjuvant therapy of colon cancer. Edotecarin has been shown to be more potent than SN-38. Preliminary resultsfurther suggest that the combination of PTK787 with FOLFIRI as an option in patients with metastatic colorectal cancer. However, Genentechs drug Avastin is still held in high regard as the drug with the largest single sales potential. Even though FDA issued a warning that Avastin could increase the risk of stroke the prognosis is that Avastin is going to be combined with a wide range of 5FU-based chemotherapies. Based on recent positive interim result, Genentech further plans filing of a sBLA. Drugs that will be of future interest are the niche of overcoming Gleevec resistance. Several research reports have been published in this field during the most recent years and we might expect this field to become a highly competitive area. A drug that in near term has been suggested to overcome Gleevec resistance is Pfizers SU11248. Data implicate that SU11248 can overcome Gleevec resistance in patients with metastatic GIST. Moreover, the addition of SU11248 to AML chemotherapy regimens could result in improved treatment results. Beside above candidates developed by the large pharmaceutical companies, Celgenes thalidomide analogs are under intense investigations as a new agent with antimyeloma activity. During 2004 Celgene received FDA approvable letter for Thalomid sNDA in multiple myeloma. The anticipation of an accelerated approval is the results of a study comparing Thalomid plus dexamethasone to dexamethasone alone in previously untreated multiple myeloma patients. Therapeutic candidates included in this analysis: Alimta, Aromasin, Avastin, Bay 43-9006, BMS-247550, CCI-779, Edotecarin, Erbitux, Faslodex, Gleevec, Herceptin, IMC-BEC2, Iressa, Lapatinib, MelVax, PTK787, Sarasar, SU011248, Tarceva, Thalomid (+thalidomide analogs) Tirapazamine and Xeloda. Table of Contents Download TOC in PDF
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