Tweet
This stock will be a winner. Abraxane will be approved within the next four months.It is enveloping an existing BMY chemotherapy treatment using nanotechnology.
Here are some stats:
Briefly, here are a few of the advantages of American Pharmaceutical Partners' Abraxane over Bristol-Myers Squibb's Taxol, a 2 billion dollar per year drug:
-- TWICE the response rate of Taxol!
-- Significantly longer time to tumor progression
-- 30-minute infusion time vs. 3 hours for Taxol
-- Reconstituted with saline
-- Uses standard IV tubing
-- No steroid pre-treatment required (which must start 12-16 hours before Taxol administration)
-- No solvents or detergents required, as in Taxol; therefore no hypersensitivity resulting from same.
-- Less myelosuppression than Taxol, despite 50% MORE cancer-fighting paclitaxel delivered in Abraxane dose.
-- No septic deaths
-- More manageable and reversible peripheral neuropathy than Taxol.
-- Ability to drive a higher concentration of drug into the tumor.
-- Has demonstrated significant efficacy in Taxol and Taxotere-resistant breast cancer patients.
-- Can be used in dose-densing therapy, whereas Taxol and Taxotere cannot.
* Fast Track FDA Designation + 505(b)(2) regulatory pathway = Quick FDA approval of Abraxane -- probably by end of 3rd quarter 2004. NDA has been submitted.
* VERY HIGH short position (approx. 53% of float)--source of the frivolous lawsuits--just beginning to be covered, and the "naked short amnesty" theoretically ends in April 2004.
* Lawsuit allegations refuted by detailed peer-reviewed Phase III results presented at recent San Antonio Breast Cancer Symposium.
* Currently produces over 130 generic injectable products (primarily oncology, anti-infective and critical-care markets), with over 360 dosage forms.
* Has at least 20 ANDAs currently pending approval at FDA, with more than 50 generic products in various stages of development.
* Has the only commercial scale, protein-engineered nanoparticle manufacturing capability in the United States. http://biz.yahoo.com/prnews/031118/latu078_1.html
* Nanoparticle albumin-bound (nab) drug delivery technology lends itself to numerous other anti-cancer compounds, as well as having other potential therapeutic areas of application, some of which have already been presented at various scientific conferences.
* Company has initiated clinical trials with Abraxane on patients with advanced non-small-cell lung cancer and on patients with metastatic melanoma.
* Has approx. 58 million in cash and NO DEBT.
* In alliance with Australia's Alchemia to develop and market synthetic heparin. The heparin family of anticoagulants had 2002 sales exceeding $3 billion.
WSTrader2
Here are some stats:
Briefly, here are a few of the advantages of American Pharmaceutical Partners' Abraxane over Bristol-Myers Squibb's Taxol, a 2 billion dollar per year drug:
-- TWICE the response rate of Taxol!
-- Significantly longer time to tumor progression
-- 30-minute infusion time vs. 3 hours for Taxol
-- Reconstituted with saline
-- Uses standard IV tubing
-- No steroid pre-treatment required (which must start 12-16 hours before Taxol administration)
-- No solvents or detergents required, as in Taxol; therefore no hypersensitivity resulting from same.
-- Less myelosuppression than Taxol, despite 50% MORE cancer-fighting paclitaxel delivered in Abraxane dose.
-- No septic deaths
-- More manageable and reversible peripheral neuropathy than Taxol.
-- Ability to drive a higher concentration of drug into the tumor.
-- Has demonstrated significant efficacy in Taxol and Taxotere-resistant breast cancer patients.
-- Can be used in dose-densing therapy, whereas Taxol and Taxotere cannot.
* Fast Track FDA Designation + 505(b)(2) regulatory pathway = Quick FDA approval of Abraxane -- probably by end of 3rd quarter 2004. NDA has been submitted.
* VERY HIGH short position (approx. 53% of float)--source of the frivolous lawsuits--just beginning to be covered, and the "naked short amnesty" theoretically ends in April 2004.
* Lawsuit allegations refuted by detailed peer-reviewed Phase III results presented at recent San Antonio Breast Cancer Symposium.
* Currently produces over 130 generic injectable products (primarily oncology, anti-infective and critical-care markets), with over 360 dosage forms.
* Has at least 20 ANDAs currently pending approval at FDA, with more than 50 generic products in various stages of development.
* Has the only commercial scale, protein-engineered nanoparticle manufacturing capability in the United States. http://biz.yahoo.com/prnews/031118/latu078_1.html
* Nanoparticle albumin-bound (nab) drug delivery technology lends itself to numerous other anti-cancer compounds, as well as having other potential therapeutic areas of application, some of which have already been presented at various scientific conferences.
* Company has initiated clinical trials with Abraxane on patients with advanced non-small-cell lung cancer and on patients with metastatic melanoma.
* Has approx. 58 million in cash and NO DEBT.
* In alliance with Australia's Alchemia to develop and market synthetic heparin. The heparin family of anticoagulants had 2002 sales exceeding $3 billion.
WSTrader2