FierceBiotech - The Biotech Industry's Daily Monitor
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A free daily biotech newsletter. In today's issue:
1. Aphton drug offers survival benefit for pancreatic cancer
Aphton released encouraging results from a Phase III European clinical trial of G17DT as monotherapy in patients with pancreatic cancer. The study enrolled 154 treatment-naive patients with advanced pancreatic cancer. All subjects in the study had a life expectancy of at least two months and a Karnofsky index performance status of greater than or equal to 60 percent. Preliminary comparison of survival data was conducted once 101 patients had died. Median survival for patients receiving G17DT was 151 days compared to 83 days for patients in the placebo group. Approximately 22 percent of G17DT patients lived nine months or longer compared with 11 percent taking placebo.
- read this release to learn more
2. Elan floats mixed equity and debt offering
Shares of specialty drug maker Elan rose 3 percent this morning after the company announced plans to sell 35 million shares of newly issued common stock and offer $250 million in guaranteed convertible notes. Proceeds will be used to repay obligations on Liquid Yield Option Notes due December 14. Issuance of the guaranteed convertible notes is contingent on Elan, which currently has 350 million shares outstanding, selling at least 30 million shares of common stock. The convertible note offering is expected to close by November 11 and have a term of five years.
- read this story from Reuters to learn more
3. Avalon signs cancer pact with Medarex
Avalon Pharmaceuticals will collaborate with Medarex to develop antibody products for the treatment of cancer. Terms of agreement call for the two companies to share equally all development costs and jointly commercialize any antibody products identified through the partnership. Avalon has identified several genes using its cytogenetics and gene-expression platforms that the company believes are over-expressed in various cancers. Medarex is expected to produce antibodies to these promising disease targets. Financial terms of the agreement were not disclosed. Avalon is a member of the Fiercest 15, FierceBiotech’s list of the 15 top privately held biotechnology companies for 2003.
- read this release to learn more
4. Celltech licenses Orphan’s Xyrem
Celltech Pharmaceuticals licensed European marketing rights to Orphan Medical’s Xyrem for the treatment of cataplexy and narcolepsy. Terms of the agreement call for Orphan to receive an upfront license fee of $2.5 million and $6 million in product development milestones. The company is also entitled to $7 million of sales-related milestones and royalties in the mid-teens range. Celltech also received the right to license Xyrem for fibromyalgia and other indications. Food and Drug Administration approved Xyrem for the treatment of cataplexy in July 2002 and is currently conducting Phase III studies in narcolepsy and excessive daytime sleepiness. Celltech expects to file for European approval of Xyrem for cataplexy early next year.
- read this release to learn more
5. Blood substitute delayed
Shares of blood products researcher Biopure sunk more than 50 percent after the company announced the Food and Drug Administration had submitted additional questions about its application to sell an artificial blood substitute. While the company doesn’t need to conduct additional studies, submitting answers to the FDA’s question won’t be completed until the end of June. Biopure plans to eliminate 30 percent of its staff in an effort to conserve cash.
- read this story from Reuters to learn more
ALSO NOTED
TODAY'S SPOTLIGHT... The Food and Drug Administration approved the long-acting schizophrenia drug Risperdal Consta. Release
And finally... The European Commission approved Serono’s pre-filled syringe for the infertility treatment Ovitrelle. Release
CHUTES & LADDERS
Drug discovery startup Kalypsys recruited two scientists with big pharma credentials to lead the company’s preclinical research team. Stewart Noble joins Kalypsys as director of chemistry and Tadimeti Rao was named director of pharmacology and preclinical development. Noble comes to the company from Pharmacia where he oversaw programs in arthritis, inflammation, and pain. Rao recently served as senior research fellow at Merck where he focused on immunology, inflammation, neuropsychiatry, and neurodegenerative diseases.
Angiogenesis researcher Genaera appointed two new senior executives to oversee the company's financial and manufacturing operations. John L. Armstrong, Jr. joined the company as executive vice president with responsibility for the company’s manufacturing functions. Prior to joining Genaera, Armstrong served as CEO of UroCor’s Mills Biopharmaceuticals subsidiary. John A. Skolas joined the company as senior vice president, CFO, general counsel and secretary. Prior to joining Genaera, Skolas served as CFO of several biotechnology startups.
CEOs
Former Axya Medical CEO Terrance J. Bieker was named president and CEO of reagent manufacturer BioSource International.
Scientists
Former PAREXEL International executive Warren Stern was named senior vice president, drug development for DOV Pharmaceutical.
Paradigm Genetics CSO and vice president, business development John E. Hamer left the company for a position at merchant bank Burrill & Co.
Former LifeScoreä assistant medical director Kimberly Yeager will oversee the clinical operations at IntraTherapies.
Operations
Victor F.C. Raczkowski joined Cephalon as vice president, worldwide regulatory affairs. Raczkowski comes to the company from the FDA where he was director of the Office of Drug Safety for the Center for Drug Evaluation and Research.
Larry Rosen is leaving Aventis to pursue other opportunities. Julien Verley will takeover the role of senior vice president of corporate finance and treasury.
DS Pharma Services named Samantha Weston senior director, business development. Prior to joining MDS Pharma Services, Weston worked for Intercern Clinical Research Solutions and PPD Development.
Sharan A. Pagano was named vice president, business development & alliances for drug discovery startup Genstruct. Pagano joins Genstruct from Incyte where she served in the company's business development and strategic collaborations department.
Directors
The head of Harvard Medical School’s genetics department, Philip Leder, was elected to the board of Schering-Plough.
Maxygen named James R. Sulat to its board of directors. Sulat is senior executive vice president of printing company Moore Wallace.
EVENTS
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> International Biotech and Lab Automation Europe - Nov 25-26, Olympia, London, UK
International Biotech and Lab Automation Europe combine a conference, education, seminars, poster sessions, networking and partnering opportunities with 2 innovation-packed exhibitions of biotech and lab automation products with over 220 exhibitors. For FREE REGISTRATION visit www.internationalbiotech.com or www.labautomationeurope.com
> Cancer Drug Research & Development - Nov 20-21, San Diego
Four sessions: 1. Growth & apoptosis 2. Angiogenesis 3. Immunity 4. Future Perspectives. Keynote Speaker Tony Hunter, Professor, The Salk Institute Protein phosphorylation and the new age of signal transduction inhibitor drugs. For detailed agenda, go to gtcbio.com/ebrochure/Cancer-p1.pdf
> SPI USA cGMP Training Seminar – Dec 8-9, Washington, DC
Come join us for two days of comprehensive cGMP Training that will keep you up to date with all FDA regulations. Topics covered include: FDA Inspections, Quality Concepts, Documentation, Cleaning, and more. For more information about this seminar and the many other events and opportunities we offer, visit us at www.spi.pt/seminar or call 410-997-5600.
> 55th AIChE Annual Meeting - Nov 16-21, San Francisco
The 55th AIChE Annual Meeting features leading academic and industrial R&D professionals with more than 4,000 papers in 500 sessions. Select from topical conferences in Systems Biology, Bioinformatics and Metabolic Engineering, Discovery, Development and Delivery of Medicines and others. Be there for the launch of AIChE's new Society for Biological Engineering. Click here or call 1.800.242.4363
> BIO VentureForum East – Nov 17-19, Philadelphia
The Biotechnology Industry Organization in collaboration with the Mid-Atlantic Venture Conference presents the industry’s largest East coast venture capital conference. Seventy pre-screened biotech companies seeking seed-, early-, and late-stage funding will present their products and platforms to international investors. Email Steve Suriano for more info. Click here to register!
> Pharma Regulatory & Compliance Congress & Best Practices Forum - Nov 12-14, Washington, DC
Join the nation's pharmaceutical leaders to discuss critical industry topics such as drug pricing, sales and marketing practices, clinical trials, and a proposed Medicare prescription drug benefit. Register or learn more at www.pharmacongress.com or 800-684-4549.
> BIO-Europe 2003: 9th Annual International Partnering Conference - Nov 17-19, Frankfurt, Germany
Europe’s premier Partnering Conference! A forum to promote business development between pharmaceutical, financial and biotechnology companies. For more information and online registration please visit our conference website at www.ebdgroup.com/bioeurope
MARKETPLACE
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> FREE White Paper: Meeting Audit Trail Requirements for 21 CFR 11
This white paper analyzes audit trail requirements under FDA Title 21 CFR Part 11 and discusses the best approach to take and the pitfalls to avoid to comply. White paper is brought to you by Lumigent Technologies. To download, go to: www.lumigent.com/go/fb12
> Perfect for Biotech Biz Dev & Research - BioZak InfoBase CD-ROM
Detailed profiles of 14,500 life science companies and 29,000 industry execs, 60 industry sectors, 10+ search criteria, easy navigation. For more info: click here.
> Georgia – Where Smart People Do Business.
The success of technology companies is the goal of Georgia’s Office of Science and Technology. Looking for a place to collaborate, pursue new business, and network with the best and brightest in the industry? Look no further than Georgia. Visit us at www.smartgeorgia.org
FierceBiotech is the biotech industry's daily monitor.
Editor: Kevin DeGeeter - kevin@fiercebiotech.com
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