|
|
 | | | |
- close
- close
- close
- close
| |||||||||
This excerpt taken from the ABII 8-K filed Nov 5, 2009. Recent Company Highlights
(more)
Abraxis BioScience, Inc. 2009 Third Quarter Financial Results Page 5
This excerpt taken from the ABII 8-K filed Aug 6, 2009. Recent Company Highlights
(more)
Abraxis BioScience, Inc. 2009 Second Quarter Financial Results Page 5
This excerpt taken from the ABII 8-K filed May 7, 2009. Recent Company Highlights
(more)
Abraxis BioScience, Inc. 2009 First Quarter Financial Results Page 4
Additional data presented at the meeting included combination studies of the pipeline drugs ABI-009 (nab-rapamycin) and the vascular disruptive agent ABI-011 (nab-5404). ABI-009 is an inhibitor of the mTOR pathway, which is critical to cell proliferation and tumor growth. ABI-011 is an investigational agent designed to directly disrupt tumor vasculature to compromise tumor growth and progression. This excerpt taken from the ABII 8-K filed Mar 3, 2009. Recent Company Highlights In early October, the National Comprehensive Cancer Network (NCCN) agreed to conduct multiple investigator-initiated studies for ABRAXANE. The NCCN studies will evaluate ABRAXANE in the treatment of breast, non-small cell lung, head and neck, melanoma and ovarian cancers. The clinical research will include investigations of tumor gene expression by microarray and the expression of SPARC (secreted protein acidic and rich in cysteine), a protein that is over expressed and secreted in many cancers. SPARC, a known prognostic factor for poor survival in a number of tumor types, is an albumin binding protein that may mediate an enhanced anti-tumor effect of ABRAXANE via a SPARC-albumin interaction. Also in October, NeoBiocon, a joint venture between Abu Dhabi based Neopharma and India’s Biocon Ltd., launched ABRAXANE in the United Arab Emirates for the treatment of breast cancer after failure of combination therapy for metastatic disease or relapse within six months of adjuvant chemotherapy. In October 2008, the Therapeutic Goods Administration (TGA) in Australia approved ABRAXANE for the treatment of metastatic carcinoma of the breast after failure of anthracycline therapy. ABRAXANE was subsequently launched in Australia through a strategic relationship with Melbourne-based Specialised Therapeutics Australia, Pty Ltd. Results from five company-sponsored studies of ABRAXANE were presented at the 31st Annual San Antonio Breast Cancer Symposium in December. Preliminary results from a single-arm, open-label, Phase II clinical trial evaluating ABRAXANE in combination with gemcitabine and epirubicin for the treatment of patients with locally advanced breast cancer (neoadjuvant treatment) indicated that 18 percent of patients (n=23) given a regimen of ABRAXANE, gemcitabine and epirubicin achieved a complete pathologic response (the disappearance of all target lesions), and 68 percent (n=84) achieved a partial response (a 30
percent or greater decrease in size of target lesions). The company also presented pre-clinical data evaluating the potential antitumor activity of nab®-paclitaxel given in combination with two investigational therapies that utilize the company’s proprietary nanoparticle technology, nab®-rapamycin and nab®-IDN5404. In the first quarter of 2009, Abraxis completed the re-acquisition of the exclusive rights to market ABRAXANE in the United States. Abraxis also initiated the launch of ABRAXANE in the European Union. In the EU, ABRAXANE is indicated for the treatment of metastatic breast cancer in patients who have failed first-line treatment for metastatic disease and for whom standard, anthracycline-containing therapy is not indicated. Initially the company launched ABRAXANE in the U.K. in late 2008 and launched ABRAXANE in Germany in early 2009. This excerpt taken from the ABII 8-K filed Nov 14, 2008. Recent Company Highlights In September, Abraxis signed an agreement with ProMetic Life Sciences, Inc. (TSX: PLI) for the development and commercialization, on a world-wide basis (excluding China and Taiwan), of four biopharmaceutical products targeting underserved medical conditions. The transaction included an initial strategic investment by Abraxis (with rights to make optional investments) as well as access to ProMetic’s proprietary protein technologies. In October, NeoBiocon, a joint venture between Abu Dhabi based Neopharma and India’s Biocon Ltd., launched ABRAXANE in the United Arab Emirates for the treatment of breast cancer after failure of combination therapy for metastatic disease or relapse within six months of adjuvant chemotherapy.
5
Abraxis BioScience, Inc. 2008 Third Quarter Financial Results
Also in October, the Therapeutic Goods Administration (TGA) in Australia approved ABRAXANE for the treatment of metastatic carcinoma of the breast after failure of anthracycline therapy. With this approval, ABRAXANE is now cleared for marketing in 36 countries. Abraxis will market ABRAXANE in Australia through a strategic relationship with Melbourne-based Specialised Therapeutics Australia, Pty Ltd., which is launching ABRAXANE in the fourth quarter of 2008. Abraxis recently added Edward C. Geehr, M.D., to its senior management team. Dr. Geehr joined the company as Executive Vice President of Operations. In this newly created position, Dr. Geehr is responsible for the commercial, manufacturing and marketing operations of Abraxis. He comes to the company with extensive operational knowledge, having held numerous entrepreneurial and executive posts in the healthcare industry. In early October, the National Comprehensive Cancer Network (NCCN), Abraxis and AstraZeneca (NYSE: AZN) entered into a collaboration to conduct multiple investigator-initiated studies for ABRAXANE. The NCCN studies will evaluate ABRAXANE in the treatment of breast, non-small cell lung, head and neck, melanoma and ovarian cancers. The clinical research will include investigations of tumor gene expression by microarray and the expression of SPARC, (secreted protein acidic and rich in cysteine), a protein that is over expressed and secreted in many cancers. SPARC, a known prognostic factor for poor survival in a number of tumor types, is an albumin binding protein that may mediate an enhanced anti-tumor effect of Abraxane via a SPARC- albumin interaction. This excerpt taken from the ABII 8-K filed Aug 13, 2008. RECENT COMPANY HIGHLIGHTS In July, Biocon Limited, a biotechnology company in India, and Abraxis launched ABRAXANE in India for the treatment of breast cancer after failure of combination therapy for metastatic disease or relapse within six months of adjuvant chemotherapy. ABRAXANE is now available in India as a single-use 100 mg vial (as a lyophilized powder, to be reconstituted for intravenous administration). In August 2007, Abraxis established a licensing agreement with Biocon for the commercialization of ABRAXANE in India, Pakistan, Bangladesh, Sri Lanka, the United Arab Emirates, Saudi Arabia, Kuwait and certain other South Asian and Persian Gulf countries. In July, Abraxis also received approval from the China State Food and Drug Administration to market ABRAXANE for the treatment of breast cancer after failure of standard chemotherapy for metastatic disease or relapse within six months of adjuvant chemotherapy. Abraxis has three issued Chinese patents covering ABRAXANE, as well as five additional pending patent applications in China. In April, the Korean FDA granted marketing approval for ABRAXANE for the treatment of breast cancer after failure of standard chemotherapy for metastatic disease. As previously announced, Abraxis granted an exclusive license to Green Cross Corporation for the commercialization of ABRAXANE in Korea. Green Cross currently expects to launch ABRAXANE in Korea in the first quarter of 2009. Also in April, Abraxis completed the acquisition of Shimoda Biotech and Platco Technologies, gaining a pipeline of novel cyclodextrin-based products and next-generation platinum-based oncology compounds. As part of the acquisition, Abraxis also gained a revenue stream from Shimoda’s Dyloject® product (diclofenac sodium solution for injection), an injectable painkiller
5
Abraxis BioScience, Inc. 2008 Second Quarter Financial Results
for the treatment of post-surgical pain. Dyloject® was launched in December 2007 in the United Kingdom by Javelin Pharmaceuticals under an exclusive worldwide license from Shimoda. In May, David O’Toole was appointed Executive Vice President and Chief Financial Officer. Mr. O’Toole comes to Abraxis with 24 years of experience providing financial, consulting and international tax services to global companies, with particular expertise in the life sciences industry. Mr. O’Toole was with Deloitte & Touche LLP for the past 16 years, last serving as Partner—Strategic Client Group, where he was responsible for providing solutions to issues facing the life sciences industry for biotechnology clients, including enterprise cost reduction, commercialization and distribution of drugs, human resources, Sarbanes Oxley compliance and tax compliance and planning. | EXCERPTS ON THIS PAGE:
|
| |||||||
