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-   -   Abraxane - Not great news, but some news... (https://her2support.org/vbulletin/showthread.php?t=17305)

Ron 03-05-2004 09:10 AM

I have been looking for information concerning Abraxane and attempting to find any new information. I found some forward looking information from the parent company; American Pharmaceutical Partners. This at least gives us the same information that APP is giving their investors. The full report is available at www.appdrugs.com. There is also a recording of the teleconference if you are interested.

This information was taken from APP website. I have condensed the Abraxane information for those of us who are anxiously awaiting release information for reasons other than financial. When we cannot find medical information from those not living with cancer that we must look at the money!

I know this is long even after I condensed it. I only wish I owned about a thousand shares.
ron
______________________________________________


Fiscal 2003 Highlights:

* Net income grew 59% to $71.7 million, or $0.99 per diluted share, after incurring ABRAXANETM pre-launch expense of $9.3 million, or $0.08 per diluted share


ABRAXANE-TM Highlights:
* NDA (New Drug Application) for ABRAXANE-TM for metastatic breast cancer expected to be filed next week
* Clinical trials of ABRAXANE-TM initiated for non-small cell lung cancer and metastatic melanoma

Conference call scheduled for 11:30 a.m. EST, Wednesday, February 26, 2004.
"We are extremely pleased with our strong financial performance in 2003, both in terms of top and bottom line growth," said Patrick Soon-Shiong, M.D., chairman, president and chief executive officer of American Pharmaceutical Partners. "2003 was a year in which we established a solid foundation for our future growth. The Phase III study of our first proprietary product, ABRAXANE-TM, has been completed and the anticipated New Drug Application is expected to be filed with the FDA by next week. In anticipation of a 2004 ABRAXANE-TM launch, we formed Abraxis Oncology, recruited a seasoned sales and marketing team and have hired 54 experienced sales representatives to date and have accumulated approximately $28 million of paclitaxel inventory as reflected on our balance sheet. In addition, American BioScience continues to advance the clinical development of ABRAXANE-TM for other cancer indications.

2004 Outlook -- Forward Looking Information
American Pharmaceutical Partners' 2004 outlook is as follows:
• APP currently expects that in 2004, base product sales will grow in excess of 20% over 2003, with the growth substantially driven by anticipated product launches in the third and fourth quarters, including the launch of two products for which the company has obtained tentative approvals, Fluconazole and Carboplatin, pending only expiration of the innovator patents;
•APP is preparing for potential approval of the ABRAXANE-TM NDA and AN ASSUMED EARLY FOURTH-QUARTER PRODUCT LAUNCH.

Conference Call Information and Forward-Looking Statements:
The conference call may be heard by any interested party through a live audio Internet broadcast at www.appdrugs.com and www.fulldisclosure.com. For those unable to listen to the live broadcast, a playback of the webcast will be available at both websites for one year beginning at approximately 3:00 p.m. (EST), February 26, 2004.
About American Pharmaceutical Partners, Inc. (Abbreviated)
APP has acquired the exclusive North American rights to manufacture and market ABRAXANE-TM, a proprietary nanoparticle injectable oncology product that has completed Phase III clinical trials for metastatic breast cancer and for which the FDA has granted "Fast Track" designation. The NDA submission is ongoing. The company believes that it has established the only commercial scale protein-engineered nanoparticle manufacturing capability in the United States. For more information, visit APP's website at www.appdrugs.com.
SOURCE American Pharmaceutical Partners, Inc.




rose 03-05-2004 06:35 PM

I hated to see the part of the early 4th quarter launch. For me, that is probably too late


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