NanoPundit -Where Society, Science and the Law get really, really small.

Tuesday, January 11, 2005

Big Nano News from the FDA

In the biggest nanonews of the year, American Pharmaceutical Partners and American Bioscience report that their New Drug Application for Abraxane has been accepted for filing with standard review by the U.S. Food and Drug Administration (FDA). The FDA has determined that the application is sufficiently complete to permit a substantive review. Abraxane is made up of injectible albumin-bound paclitaxel nanoparticles for the treatment of metastatic breast cancer. Links here, here, here and here.

Even in FDA speak this is by far the biggest news of the year. The market reacted accordingly and
APPX stock jumped approximately 50% on the announcement.

American BioScience, Inc. is a privately held biotechnology company focused on the discovery, development and delivery of next-generation therapeutic moieties including biologically active molecules already existing within the human biological system, for the treatment of life-threatening diseases. American Pharmaceutical Partners, Inc. is a majority owned subsidiary of American BioScience, Inc.American Pharmaceutical Partners, Inc. (APPX) is a specialty pharmaceutical company that fulfills an important need in the medical community as a reliable provider of a broad portfolio of primarily injectable pharmaceutical products, including difficult to manufacture, sterile, urgently needed medical products.

APPX’s business is profitable and growing. For the first six months in 2004, the company reported net sales of $187 million, and net income of $21 million, equal to $0.29 per fully diluted share. The company completed its initial public offering in December 2001 and the overallotment was exercised in full in January 2002, raising approximately $154 million in proceeds and providing the company with a sound financial position. (Source:
http://www.corporate-ir.net/ireye/ir_site.zhtml?ticker=APPX&script=2100 )

UPDATE: Thanks to all who have come through Instapundit, Crain’s Cleveland, Brandmalasia and Motley Fool. I sure appreciate the links, readership and comments. For more go to www.millerbarns.com .

3 Comments:

  • My mom died of metastatic breast cancer two years ago. This post revealed to me that I've been living in fear ever since that the same thing would inevitably happen to me. That fear's not gone, but it's been balanced by a healthy hope. I'll be following this issue. Thanks for reporting on it. Really... thanks.

    By Anonymous Anonymous, at 11:37 AM  

  • Searching for cancer stage treatment and information I found this post. I totally agree with you and think it takes time!

    By Blogger cleric resources, at 1:13 PM  

  • Wow that´s a great blog that you have there, mine is slightly differnent but it basically covers the same topics.

    I have a ovarian cancer site. It pretty much covers Cancer related stuff.

    Check it out, you won´t regret it... Cheers.. Roger From Http://www.havecancer.com

    By Blogger Editor, at 2:17 AM  

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