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Biotech / Medical : MGI Pharma MOGN New patents, anti cancer -- Ignore unavailable to you. Want to Upgrade?

To: Icebrg who wrote (1516)	9/1/2004 6:14:01 AM
From: Icebrg	Read Replies (1) \| Respond to of 1826

MGI PHARMA to Acquire Aesgen -- Saforis For Oral Mucositis Bolsters MGI's Oncology Supportive Care Franchise Wednesday September 1, 6:00 am ET MINNEAPOLIS--(BUSINESS WIRE)--Sept. 1, 2004--MGI PHARMA, INC. (Nasdaq:MOGN - News), an oncology-focused biopharmaceutical company, and Aesgen, Inc., a privately held company focused on treating side effects associated with cancer treatments, today announced that they have signed a definitive merger agreement under which MGI PHARMA will acquire all outstanding equity of Aesgen for $32 million in cash. MGI PHARMA may also be obligated to make performance milestone payments of $33 million upon regulatory approval and $25 million if sales exceed $50 million in the second year following product launch. In addition, MGI PHARMA will pay a 5% royalty on product sales, including sales of Saforis(TM), a product candidate in development for treatment of oral mucositis. This acquisition, which has been approved by the boards of directors of both companies, is subject to approval by the shareholders of Aesgen. MGI PHARMA and Aesgen expect the transaction to close during 2004. Under the agreement, key Aesgen management personnel will assume new roles within the MGI PHARMA organization. "This transaction is an excellent strategic fit for MGI PHARMA that further strengthens our oncology supportive care franchise," said Lonnie Moulder, president and chief executive officer of MGI PHARMA. "With the addition of Saforis, we now have a phase 3 product candidate that may help manage the debilitating side effects of oral mucositis that patients often experience during chemotherapy." Saforis(TM) For Oral Mucositis Saforis is an oral formulation of L-glutamine in a proprietary delivery vehicle designed to increase uptake of glutamine by the oral mucosa. Glutamine is an amino acid essential in the healing and regeneration of mucosal cells. Data from a phase 3 trial of Saforis, conducted in 326 breast cancer patients receiving anthracycline based chemotherapy regimens, was the subject of an oral presentation at ASCO 2004. The primary endpoint of this trial defined as a reduction in clinically significant oral mucositis was met. Data indicated that patients receiving Saforis experienced a 22% risk reduction of clinically significant (WHO greater than or equal to grade 2) oral mucositis compared with placebo. In addition, only 1.2% of Saforis treated patients experienced WHO grade 3 oral mucositis compared to 6.7% of placebo treated patients (p=0.0136). Side effects of Saforis treatment were mild in nature and similar to placebo. A second pivotal, phase 3 trial to support a New Drug Application (NDA) filing with the U.S. Food and Drug Administration (FDA) will be initiated in early 2005. Chemotherapy and radiation-induced oral mucositis are oncology supportive care areas of significant unmet need that can lead to chemotherapy dose reductions and an increased risk of infection. It is estimated that more than 15% of patients receiving chemotherapy experience significant oral mucositis, and more than 90% of patients receiving combination chemotherapy and radiation therapy for head and neck cancer experience significant oral mucositis. There are no FDA approved drugs for the prevention or treatment of oral mucositis. Current options for the treatment of oral mucositis include coating agents, pain palliation, anti-septic and anti-inflammatory agents, none of which have demonstrated effectiveness in patients with solid tumor malignancies. Banc of America acted as exclusive advisor to MGI PHARMA in this transaction. UBS Investment Bank acted as exclusive advisor to Aesgen. Updated Financial Guidance This section provides forward looking information about MGI PHARMA's updated financial outlook for 2004 for our current operations, including the impact of the three agreements announced in news releases issued this morning, September 1, 2004. For the year ending December 31, 2004, we currently expect: * Aloxi® injection sales of $140 to $150 million; * Other product sales of $27 million; * Licensing revenue of $3 million; * Research and development expenses of approximately $29 million that excludes an estimate of one-time in-process research and development and nonrecurring licensing expense of $98 million associated with the three transactions announced today; * SG&A expenses of approximately $73 million; and * Net loss before interest and taxes of approximately $80 million. For the year ended December 31, 2005, we expect total revenues of approximately $280 million and total operating expenses of approximately $205 million, which would result in earnings before interest and taxes of approximately $75 million. We anticipate that the product candidates acquired in the three transactions announced today could add $500 million in additional combined net sales to our total revenue approximately three to four years after their commercial launches. Conference Call And Webcast Details MGI PHARMA will host a conference call today, September 1, 2004 at 9:30 a.m. Eastern Time to discuss the three news releases issued by the Company this morning and the Company's updated financial guidance, and to answer questions from investors and analysts. Lonnie Moulder, president and chief executive officer of MGI PHARMA, will host the call. All interested parties are welcome to access the webcast via the Company's Web site at www.mgipharma.com. This audio webcast will be archived on the Company's Web site for a limited period of time. About Aesgen Aesgen, Inc., is a privately owned specialty pharmaceutical company founded in 1994. Aesgen is focused on developing pharmaceutical products resulting from their cancer research collaborations and on the specialized delivery of peptides, proteins, and small molecules for critical care.

To: Icebrg who wrote (1516)	9/4/2004 6:52:16 AM
From: Icebrg	Respond to of 1826

ZYC101a for treatment of high-grade cervical intraepithelial neoplasia: a randomized controlled trial. Garcia F, Petry KU, Muderspach L, Gold MA, Braly P, Crum CP, Magill M, Silverman M, Urban RG, Hedley ML, Beach KJ. Department of Obstetrics and Gynecology, University of Arizona Health Sciences Center, 1501 North Campbell Avenue, Tucson, AZ 85724, USA. fcisco@email.arizona.edu OBJECTIVE: The objective of this study was to assess the safety and efficacy of a novel therapeutic, ZYC101a, for the treatment of women with histologically confirmed cervical intraepithelial neoplasia (CIN) 2/3. ZYC101a contains plasmid-DNA-encoding fragments derived from the E6 and E7 proteins of human papillomavirus (HPV) 16 and 18, and is formulated within small biodegradable microparticles. METHODS: A multicenter, double-blind, randomized, placebo-controlled trial was conducted in a group of women with biopsy-confirmed CIN 2/3. Subjects were randomized to 3 intramuscular doses of either placebo or ZYC101a (100 or 200 microg). Six months after the first injection, subjects underwent cervical conization. The primary endpoint for this study was histologically confirmed resolution of CIN 2/3. A total of 161 subjects were randomized, dosed, and evaluated for safety. After central pathology review, 127 subjects were evaluable for efficacy. RESULTS: The most common adverse events were related to the injection site, were mild to moderate, and did not worsen at later treatments. The proportion of subjects who resolved was higher in the ZYC101a groups compared to placebo (43% versus 27%), but the difference was not statistically significant (P =.12). In a prospectively defined population of women younger than 25 years (n = 43), resolution was significantly higher in the combined ZYC101a groups compared to placebo (70% versus 23%; P =.007). ZYC101a activity was not restricted to HPV-16-or HPV-18-positive lesions. CONCLUSIONS: ZYC101a was shown to be well tolerated in all patients and to promote the resolution of CIN 2/3 in women younger than 25 years. LEVEL OF EVIDENCE: I [Somewhat mixed results. It will be interesting to see what strategy they choose going forward].

To: Icebrg who wrote (1516)	9/10/2004 5:52:27 PM
From: Icebrg	Read Replies (1) \| Respond to of 1826

Item 2.01 Completion of Acquisition or Disposition of Assets [From today's 8-K]. On September 3, 2004, Zycos Acquisition Corp., a Delaware corporation and a wholly owned subsidiary of MGI PHARMA, INC. (the "Company"), merged with and into Zycos Inc., a Delaware corporation ("Zycos"), with Zycos surviving as a wholly owned subsidiary of the Company, pursuant to an Agreement and Plan of Merger by and among the Company, Zycos, Zycos Acquisition Corp. and the stockholders' representatives listed therein, dated as of August 25, 2004. A copy of the Agreement and Plan of Merger is attached to this report as an exhibit. Zycos is a company focused on the creation and development of oncology and antiviral products. Through the merger, the Company acquired all of the ownership interests in Zycos from its securityholders. The Company paid $50 million in cash at the closing as merger consideration to Zycos's securityholders, subject to a working capital adjustment. There are no material relationships between Zycos'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.