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Biotech / Medical | MGI Pharma MOGN New patents, anti cancer

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To: Icebrg who wrote (1520)	9/20/2004 1:59:54 PM
From: Icebrg	of 1824

MGI Pharma "outperform" [The guys at Robert Baird have a habit of saying the same thing over and over again. That there has been a increase in the clinical risk after MOGN's sweep through the biotech sector seems more or less self-evident. But maybe the note itself contains more meat]. Monday, September 20, 2004 9:39:57 AM ET Robert W. Baird NEW YORK, September 20 (newratings.com) - Analysts at Robert W Baird reiterate their "outperform" rating on MGI Pharma (MOGN.NAS). The target price is set to $35. In a research note published this morning, the analysts mention that MGI Pharma’s product pipeline has expanded substantially, following the company's recent acquisitions. The company is expected to have five separate compounds in pivotal trials by mid-2005, the analysts add. The acquisitions have, however, also raised the clinical risk associated with MGI Pharma, Robert W Baird says.

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To: Icebrg who wrote (1525)	9/22/2004 7:15:52 AM
From: Icebrg	of 1824

MGI PHARMA and SuperGen Announce Closing of Stock Purchase Agreement and Effectiveness of License Agreement Wednesday September 22, 7:00 am ET MINNEAPOLIS, and DUBLIN, Calif., Sept. 22 /PRNewswire-FirstCall/ -- MGI PHARMA, INC. (Nasdaq: MOGN - News), and SuperGen, Inc. (Nasdaq: SUPG - News), today announced the closing of the stock purchase agreement pursuant to which MGI PHARMA purchased $40 million of SuperGen common stock at $10 per share and the granting to MGI PHARMA of exclusive worldwide rights to the development, manufacture, commercialization and distribution of SuperGen's Dacogen (TM) (decitabine) pursuant to a license agreement. This transaction, which the companies first announced on September 1, 2004, was subject to certain closing conditions, including clearance under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended. About Dacogen Dacogen is an investigational drug. It has not yet been approved for marketing in the U.S. or by other regulatory agencies in their respective countries. The safety and efficacy of Dacogen has not yet been established in any patient population. In clinical trials, Dacogen has been shown to have a broad spectrum of activity in several hematological malignancies as well as solid tumors. Dacogen belongs to a class of drugs called hypomethylating agents, with a unique mechanism of action. Methylation is a process in which methyl (CH3) groups are added to DNA to inactivate or "silence" genes.

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To: Icebrg who wrote (1530)	9/27/2004 3:39:43 PM
From: tom pope	of 1824

From Briefing. It's all I could find, no other fuller article 12:50 ET MGI Pharma updates Y04 outlook; guides for Y05 (MOGN) 28.00 -0.67: -- Update -- Co reaffirms Y04 Aloxi injection sales of $140-150 mln; reaffirms license revs of approx $3 mln. Co sees total sales in the range of $170-180 mln, Reuters consensus is $188 mln. Co reaffirms outlook of cost of product sales as approx 31% of sales revs. Co now sees R&D expense of approx $40 mln (excluding an estimate of one-time in-process R&D and nonrecurring transaction expense of $96 mln), on 7/14 expected R&D expense to be approx $24 mln, inclusive of milestones associated with current product candidates. Sees a loss before income and taxes of $85 mln. For Y05 co expects revs of approx $280 mln, Reuters consensus is $291.5 mln.

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To: Icebrg who wrote (1527)	10/2/2004 6:45:12 AM
From: Icebrg	of 1824

Aesgen - From 8-K filed yesterday. Item 2.01 Completion of Acquisition or Disposition of Assets On September 28, 2004, MGIP Acquisition Corp., a Delaware corporation and a wholly owned subsidiary of MGI PHARMA, INC. (the “Company”), merged with and into Aesgen, Inc., a Delaware corporation (“Aesgen”), with Aesgen surviving as a wholly owned subsidiary of the Company, pursuant to an Agreement and Plan of Merger and Reorganization by and among the Company, Aesgen, MGIP Acquisition Corp. and the equityholders’ representative listed therein, dated as of August 30, 2004. A copy of the Agreement and Plan of Merger and Reorganization is attached to this report as an exhibit. Aesgen is a company focused on treating the side effects associated with cancer treatments. Through the merger, the Company acquired all of the ownership interests in Aesgen from its securityholders. The Company paid $32 million at the closing as merger consideration to Aesgen’s former securityholders. The Company is also obligated to pay $33 Million to Aesgen’s former securityholders upon FDA approval of Aesgen’s lead product currently known as Saforis (TM), and an additional $25 million in the event that net sales of Aesgen products containing L-Glutamine, including Saforis, exceed $50 million in the second year after commercial launch of Saforis. After aggregate net sales of Saforis exceed $50 million, the Company will also be obligated to pay Aesgen’s former securityholders a 5% royalty on net sales of Saforis through the end of the ten-year period commencing upon commercial launch of Saforis. There are no material relationships between Aesgen’s securityholders and the Company or any of its affiliates, or any director or officer of the Company, or any associate of any such director or officer, other than in respect of the above described merger. Furthermore, there are no material relationships between the sources of the funds used by the Company in the merger and the Company or any of its affiliates.

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To: Icebrg who wrote (1523)	10/7/2004 3:06:53 AM
From: Icebrg	of 1824

Cell Cycle Effects and Induction of Premitotic Apoptosis by Irofulven in Synchronized Cancer Cells. Cancer Biol Ther. 2004 11 9; 3(11): Woynarowski JM, Woynarowska BA, Trevino AV, Salinas R, Herman TS, Waters SJ, Macdonald JR Unlike postmitotic cell death, direct premitotic apoptosis diminishes the risk of clonal selection and allows for the elimination of slowly growing cancer cells. This study characterized the ability to induce premitotic apoptosis by irofulven (hydroxymethylacylfulvene), a novel alkylating drug which targets cellular DNA and proteins. Irofulven effects were examined in HeLa-derived BH2 cancer cells with conditional overexpression of antiapoptotic Bcl-2. Cells were synchronized in either early S or in G(1). Following 12 h exposure to irofulven, cells that were originally in early S accumulated in late S or remained in early S phase (at 0.5 and 2.5 M drug, respectively). Drug treatment of cells in the G(1) cohort prevented their entry into the S phase. Significant apoptosis was detected based on the appearance of sub-G(1) particles and cells with DNA strand breaks in both G(1) and S cohorts. Apoptotic cells were mostly recruited from the G(1)/S border ("G(1)" cohort) and from the S phase ("early S" cohort). All the cell cycle and apoptotic effects were only marginally affected by Bcl-2 overexpression. Similar results were obtained with irofulven-treated synchronized cultures of leukemic CEM cells. Collectively, these observations indicate that irofulven-treated cells become committed to death early. Neither active DNA replication nor traverse through mitosis are necessary for irofulven-induced cell death. The ability to promote direct premitotic apoptosis is likely to play a role in the consistently potent apoptotic effects of irofulven and its ability to cause tumor regression in vivo.

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To: Icebrg who wrote (1533)	10/11/2004 3:20:43 AM
From: Icebrg	of 1824

MethylGene Initiates MG98 Phase II Trial In Metastatic Renal Cell Cancer Wednesday October 6, 9:01 am ET MONTREAL, QUEBEC--(CCNMatthews - Oct. 6, 2004) - MG98 / interferon alpha combination investigated as potential first-line therapy MethylGene Inc. (TSX:MYG - News), a biopharmaceutical company, today announced that it has initiated a randomized, two-step Phase II clinical trial with MG98 in combination with interferon alpha for the treatment of metastatic renal cell cancer. "Metastatic renal cell cancer is a disease with a very high mortality rate and limited treatment options," said Donald F. Corcoran, President and CEO of MethylGene. "We are hopeful, based on our experience with MG98 as a monotherapy in metastatic renal cell cancer supported by pre-clinical data, that the combination of MG98 with interferon will improve the outcome of patients suffering from this aggressive cancer." The first step of this trial will involve approximately 30-50 metastatic renal cell cancer patients who have not previously received chemotherapeutic treatment. Patients will be randomly assigned to two dosing schedules which will combine MG98 with interferon alpha. In one schedule, MG98 will be given continuously for seven days, followed by seven days off. In the second schedule, MG98 will be given intermittently as a two-hour infusion, two days per week for three weeks, followed by one week of rest. In both schedules, interferon alpha will be given subcutaneously three times per week. This first step of the trial will evaluate the safety, tolerability, pharmacokinetics, optimal dosing regimen and activity of MG98 combined with interferon alpha. The second step of the trial will enroll approximately 200 patients at up to 35 sites in North America and Europe. Patients will be randomized to treatment with either a combination of MG98 and interferon alpha or interferon alpha alone. The MG98 dosing schedule for the second step will be selected based on the best results obtained in step one. The primary endpoint of this trial will be median progression-free survival. Secondary endpoints will be tolerability of the combination therapy, one year survival, tumour response and overall survival. An independent safety monitoring board will be established to review data during the second step of the trial and make recommendations about continued recruitment of patients. Full enrollment of this trial is expected to take between 30 and 36 months. About MG98 MG98 is a second-generation antisense oligonucleotide inhibiting the production of the enzyme DNA methyltransferase1 (DNMT1) by targeting its mRNA. If DNMT1 is overexpressed, it may hypermethylate and silence tumour suppressor genes possibly leading to or advancing cancer. Preventing DNMT1 production may allow silenced tumour suppressor genes to be re-activated. In renal cell cancer, it is known that at least six different tumour suppressor genes are methylated or silenced. In addition, interferon appears to have a number of key genes which can be methylated within its biological pathway. In collaboration with the Cleveland Clinic, MethylGene has demonstrated that when renal cancer cell lines resistant to interferon alpha were pre-treated with MG98, they became more sensitive to the induction of cell death by interferon alpha. Those preclinical results, combined with the clinical trial experience with MG98, form the basis for the Phase II combination trial in metastatic renal cell cancer. About Renal Cell Cancer Renal cell cancer (also called cancer of the kidney or renal adenocarcinoma) is a disease in which cancer (malignant) cells are found in certain regions of the kidney. Standard treatments of metastatic renal cell carcinoma are limited to high-dose interleukin-2 and interferon alpha with response rates varying between 10-15%. Metastatic renal cell cancer is a disease with a very high mortality rate (82% at two years and 91% by the fifth year after diagnosis in advanced disease). The incidence of renal cell cancer in the United States is 31,900 new cases per year, resulting in 11,900 deaths annually. Since the mid 1970's, kidney cancer has increased at a rate of approximately 2.5% per year in the U.S. In Canada, the incidence is 4,100 new cases per year, resulting in 1,450 deaths annually. The prevalence of the disease is approximately 200,000 patients in the United States. About MethylGene MethylGene is a biopharmaceutical company focused on the discovery, development and commercialization of novel therapeutics in cancer and infectious disease. Two cancer product candidates, MG98, partnered with MGI Pharma in North America and MGCD0103, partnered with Taiho Pharmaceutical for certain Asian countries, are currently in clinical trials. MG98 entered a randomized two-step Phase II combination trial with interferon alpha in metastatic renal cell cancer. MGCD0103 is currently in two Phase I dose-escalation monotherapy trials against solid tumours. In collaboration with Merck, MethylGene is developing small molecule beta-lactamase inhibitors to overcome antibiotic resistance. MethylGene has a portfolio of preclinical programs including inhibitors of kinases and histone deacetylases (HDACs) for both oncology and non-oncology indications. We expect to exploit our HDAC inhibitors in neurodegenerative diseases with EnVivo Pharmaceuticals. Please visit our website at www.methylgene.com.

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To: Icebrg who wrote (1534)	10/11/2004 3:26:31 AM
From: Icebrg	of 1824

MethylGene/MGI Pharma The status of the cooperation agreement regarding MG98 between the two companies is somewhat diffuse. In the 2004 10K MOGN stated: MG98 and Small Molecule DNA Methyltransferase Inhibitor Programs In August 2000, as part of our strategy to expand our portfolio of marketed and development stage anti-cancer products, we entered into an exclusive license, research and development agreement with MethylGene Inc. for North America rights to its proprietary anti-cancer product candidate MG98 and its DNA methyltransferase small molecule inhibitor program. Included within our license rights is a United States patent on a method for reversing the tumor-causing state of a cell by administering an agent that corrects an aberrant methylation pattern in the DNA of the cell. MethylGene is a chemistry-driven, rational drug design and development company focused on the inhibition of enzyme targets that are associated with disease. It pursues two approaches to enzyme inhibition: rationally designed mRNA inhibitors that block the production of enzymes and rationally designed small molecule inhibitors that block the activity of enzymes. In a December 2003 amendment to the License Agreement, MethylGene acknowledged full satisfaction of our payment obligations and suspended further payment obligations by us pending a planned June 2004 data review of the small molecule inhibitor program and following completion by MethylGene of a planned clinical trial with MG98. If we resume development, our financial responsibilities under the License Agreement would also resume. This in combination with the absence of MOGN's name on the recent PR appears to indicate that MOGN's interest in the compound is very limited for the time being. On the website MG98 is indicated in the pipeline for the treatment of MDS and AML although the agreement covers all types of cancers. Erik

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From: Icebrg	10/22/2004 1:29:22 AM
	of 1824

MGI Pharma initiated with "neutral weight" - update Thursday, October 21, 2004 4:39:17 AM ET Prudential Financial NEW YORK, October 21 (newratings.com) - Analyst Jason Zhang of Prudential Financial initiates coverage of MGI Pharma Inc (MOGN.NAS) with a "neutral weight" rating. The 12-18 month target price is set to $30. In a research note published yesterday, the analyst mentions that the company is poised to benefit in the forthcoming years from its key product, Aloxi, for the treatment of chemotherapy-induced nausea and vomiting (CINV). MGI Pharma's stock performance is likely to be driven in the near term by Dacogen's regulatory progress, the ongoing clinical trials for the recently acquired products and Aloxi's sales, the analyst says. Prudential Financial believes, however, that the company stock is fairly valued at present.

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