NYBob
15 years ago
Abraxis BioScience Launches ABRAXANE in Germany
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Published: 02/04/09 12:01 AM EST
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Abraxis BioScience, Inc.
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Abraxis BioScience, Inc. (ABII), a fully integrated, global biotechnology company, today announced the launch in Germany of ABRAXANE, 5 mg/ml powder for suspension for infusion (paclitaxel).
"ABRAXANE is an ideal treatment for breast cancer patients because of its superior clinical benefits and improved tolerability profile compared to solvent-based paclitaxel,” said Prof. Dr. med. Gunter von Minckwitz, Managing Director, German Breast Group Forschungs GmbH, Neu-Isenburg, Germany. “Additionally, ABRAXANE does not require premedication and can be administered in 30 minutes versus over 3 hours for solvent-based paclitaxel chemotherapy. ABRAXANE should therefore be considered as a new and attractive option for oncologists treating metastatic breast cancer in patients who have failed first-line therapy in Germany.”
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.
ABRAXANE is a unique formulation of paclitaxel with a mean particle size of approximately 130 nanometers, that uses the natural properties of a human protein, albumin, to deliver the drug more effectively to tumors. By wrapping the albumin around the active drug, ABRAXANE can be administered to patients at higher doses, resulting in higher concentrations of the drug at the tumor site and higher efficacy compared to solvent-based paclitaxel. Clinical trials have demonstrated that the tumor response rate was nearly double for patients who received ABRAXANE compared to those who received solvent-based paclitaxel. Of great significance, patients treated with ABRAXANE experienced a significant improvement in progression-free survival and prolonged time to tumor progression compared to patients treated with solvent-based paclitaxel (Gradishar 2005).
Toxic solvents, such as Cremophor® EL, involved in the delivery of currently approved paclitaxel on the market may be the cause of the significant treatment-related side effects, including anaphylaxis and allergic reactions. Patients receiving ABRAXANE, a solvent free paclitaxel, do not require premedication before treatment to avoid these reactions related to toxic solvents.
“The launch of ABRAXANE in Germany is a significant step in our goal to provide patients across Europe with a new option for the treatment of metastatic breast cancer,” said Patrick Soon-Shiong, M.D., Chairman and Chief Executive Officer of Abraxis BioScience. “This marks an important milestone in building a truly global presence for Abraxis BioScience as we continue to seek approvals for new indications for ABRAXANE and continue to develop advanced medicines in our pipeline.”
“In Europe, we have assembled a solid group of seasoned marketing, regulatory and product support professionals to market this new treatment for women with metastatic breast cancer,” said Jean-François Gimonet, M.D., Vice President, European Operations of Abraxis BioScience. “The introduction of ABRAXANE in Germany greatly advances our organization across Europe and further advances Abraxis BioScience towards its goal of becoming an industry leader in the European Union.”
ABRAXANE is available through hospitals in Germany. Following the launches in the United Kingdom and Germany, ABRAXANE will be launched in additional nations in Europe on a country by country basis in 2009.
ABRAXANE has now been approved for marketing in 36 countries across Europe, North America, Asia and Australia. In addition to Germany and the United Kingdom, ABRAXANE is commercially available in the United States and Canada and in India in collaboration with Biocon Limited. In 2009, ABRAXANE is anticipated to launch in Australia in collaboration with Specialised Therapeutics Australia Pty Ltd; in the United Arab Emirates with partner Neobiocon; and in Korea with partner Green Cross Corporation. Additionally, marketing approval for ABRAXANE has been received in China with an anticipated launch in 2009. ABRAXANE is currently under active review in Japan and Russia.
ABRAXANE Clinical Trial Results
In the pivotal Phase III clinical trial, ABRAXANE nearly doubled the overall target lesion response rate versus solvent-based paclitaxel (21.5% vs 11.1%, respectively (US PI)). In addition, time to tumor progression versus solvent-based paclitaxel was significantly prolonged in patients receiving ABRAXANE (23.0 vs 16.9 weeks, P=0.006, Gradishar 2005). ABRAXANE was well tolerated compared with solvent-based paclitaxel, despite the 50% greater dose of paclitaxel administered as ABRAXANE. The most serious adverse events associated with ABRAXANE in the randomized metastatic breast cancer study for which the European approval was based included neutropenia, anemia, infections, sensory neuropathy, nausea, vomiting and myalgia/arthralgia. Other common adverse reactions included anemia, asthenia, diarrhea, ocular/visual disturbances, fluid retention, alopecia, hepatic dysfunction, mucositis and renal dysfunction. Neutropenia was lower with ABRAXANE compared to solvent-based paclitaxel. Although there was an increase in incidence of grade 3 peripheral neuropathy, time to improvement was improved compared to that reported for solvent-based paclitaxel. No adverse events were reported that were not already known for paclitaxel. For the full prescribing information for ABRAXANE, including Boxed Warning, please visit www.abraxane.com.
About ABRAXANE
The U.S. Food and Drug Administration (FDA) approved ABRAXANE for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) in 2005 for the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within six months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated.
The European Medicines Agency (EMEA) approved ABRAXANE, 5 mg/ml powder for suspension for infusion (paclitaxel), in 2008 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.
ABRAXANE is a solvent-free chemotherapy treatment option for metastatic breast cancer. Developed using Abraxis BioScience's proprietary nab® technology platform, ABRAXANE is a protein-bound chemotherapy agent, which combines paclitaxel with albumin, a naturally-occurring human protein.
ABRAXANE is currently in various stages of investigation for the treatment of the following cancers: first-line metastatic breast, non-small cell lung, melanoma, pancreatic and ovarian.
For further information about the approval of ABRAXANE in Europe, please visit http://www.emea.europa.eu/humandocs/Humans/EPAR/Abraxane/Abraxane.htm.
About Abraxis BioScience
Abraxis BioScience is a fully integrated global biotechnology company dedicated to the discovery, development and delivery of next-generation therapeutics and core technologies that offer patients safer and more effective treatments for cancer and other critical illnesses. The company's portfolio includes the world's first and only protein-bound chemotherapeutic compound (ABRAXANE), which is based on the company's proprietary tumor targeting technology known as the nab® platform. The first FDA approved product to use this nab® platform, ABRAXANE, was launched in 2005 for the treatment of breast cancer after the failure of prior chemotherapy for metastatic disease. Abraxis BioScience trades on the NASDAQ Global Market under the symbol ABII. For more information about the company and its products, please visit www.abraxisbio.com.
FORWARD-LOOKING STATEMENTS
The statements contained in this press release that are not purely historical are forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements in this press release include statements regarding our expectations, beliefs, hopes, goals, intentions, initiatives or strategies, including statements regarding the launch of ABRAXANE in the European Union. Because these forward-looking statements involve risks and uncertainties, there are important factors that could cause actual results to differ materially from those in the forward-looking statements. These factors include, without limitation, unexpected safety, efficacy or manufacturing issues with respect to ABRAXANE; the need for additional data or clinical studies for ABRAXANE; regulatory developments (domestic or foreign) involving the company’s manufacturing facilities; the market adoption and demand of ABRAXANE, the costs associated with the ongoing launch of ABRAXANE; the impact of pharmaceutical industry regulation; the impact of competitive products and pricing; the availability and pricing of ingredients used in the manufacture of pharmaceutical products; the ability to successfully manufacture products in a time-sensitive and cost effective manner; the acceptance and demand of new pharmaceutical products; and the impact of patents and other proprietary rights held by competitors and other third parties. Additional relevant information concerning risks can be found in the company’s Annual Report on Form 10-K for the year ended December 31, 2007 and in other documents it has filed with the Securities and Exchange Commission.
The information contained in this press release is as of the date of this release. Abraxis BioScience assumes no obligations to update any forward-looking statements contained in this press release as the result of new information or future events or developments.
ABRAXANE is a registered trademark of Abraxis BioScience in the United States, the European Community and various other countries.
nab is a U.S. registered trademark of Abraxis BioScience.
Contacts:
Investor and Media Inquiries
Abraxis BioScience, Inc.
Maili Bergman
Director, Investor Relations & Corporate Communications
310.405.7522
mbergman@abraxisbio.com
or
PondelWilkinson Inc.
Rob Whetstone
310.279.5963
or
Press Contacts Germany
College Hill
Douglas Pretsell, Robert Mayer, Lauren McConville
abraxis@collegehill.com
+49 (0) 89 5700 1806
Press Releases: ABII
Tue, Mar 03, 2009
Abraxis BioScience Reports 2008 Fourth Quarter and Full-Year Financial Results
- Business Wire
Tue, Feb 24, 2009
Abraxis BioScience Announces Date for 2008 Fourth Quarter and Year-End Financial Results and Investor Conference Call
- Business Wire
Wed, Feb 04, 2009
Abraxis BioScience Launches ABRAXANE in Germany
- Business Wire
Wed, Jan 21, 2009
Abraxis BioScience Names Merck Veteran Van der Ploeg to Lead R&D and Drug Development Efforts at Abraxis Health
- Business Wire
Tue, Jan 20, 2009
Abraxis BioScience Announces Plan to Create Abraxis Health, a New Enterprise Focused on Biomarkers and Personalized Medicine
- Business Wire
More Press Releases
NYBob
15 years ago
Abraxis BioScience Announces Plan to Create Abraxis Health, a New Enterprise Focused on Biomarkers and Personalized Medicine
Abraxis BioScience to Continue Core Focus on Global Commercialization of ABRAXANE Oncology Franchise, Robust Phase 3 Clinical Program and Proprietary nab® Technology Platform Abraxis Health to Pioneer New Paradigm in Healthcare Delivery Rooted in Evidence-Based Medicine and Bioinformatics Abraxis BioScience Shareholders to Receive Shares of the Newly Formed Abraxis Health Company in Accordance With Percentage Ownership of Abraxis BioScience as well as Continue to Hold Existing Shares of Abraxis BioScience
Tuesday January 20, 2009, 8:05 am EST
Related:
* Abraxis BioScience, Inc.
LOS ANGELES--(BUSINESS WIRE)--Abraxis BioScience, Inc. (NASDAQ:ABII - News), a fully integrated, global biotechnology company, announced today that the Board of Directors has approved a strategic plan to create Abraxis Health, Inc., an independent, stand-alone company to be spun-off from Abraxis BioScience that will be dedicated to becoming a fully integrated, next-generation, evidence-based, personalized healthcare company.
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“The opportunity that lies in front of Abraxis BioScience is enormous and is a result of the validated science underlying the company’s proprietary nab® technology in the clinical setting,” said Patrick Soon-Shiong, M.D., Chairman and Chief Executive Officer of Abraxis BioScience. “In 2009, we plan to initiate nine pivotal registrational trials in multiple tumor types, including breast cancer, lung, melanoma and pancreatic cancers. In addition, Abraxis has initiated 65 investigator-sponsored Phase 2 studies and 16 Phase 1 studies. Together with the current approval of ABRAXANE in 36 countries and the continuing need to establish infrastructure for the global launch of this compound, the immense and exciting task that lies ahead should be the primary focus of Abraxis BioScience.”
Abraxis BioScience will be solely dedicated to building its ABRAXANE franchise on a global basis, advancing an extensive Phase 3 clinical program, and leveraging its proprietary nab® technology platform. For the nine months ended September 30, 2008, Abraxis reported revenue from sales of ABRAXANE of $245.8 million.
Selected Abraxis BioScience planned advanced clinical trials are summarized in the following table:
Compound Indication Stage of
Clinical Study
ABRAXANE® 1st line breast cancer Phase 3
1st line lung cancer Phase 3
1st line melanoma Phase 3
1st line pancreatic cancer Phase 3
2nd line pancreatic cancer Phase 3
1st line ovarian cancer Phase 3
1st line gastric cancer Phase 2
nab®-docetaxel 2nd line lung cancer Phase 3
1st line prostate cancer Phase 3
1st line breast cancer Phase 2
Abraxis Health – Pioneering Personalized Medicine
Abraxis Health has been created to focus on generating biological systems and advancing personalized medicine through strategic alliances and internal development. The company believes that the era of predictive, personalized evidence-based medicine has emerged. Therefore its strategic focus will be to identify compounds with specific activity linked to specific biological markers related to specific disease states.
“Abraxis Health will become a pioneer in the burgeoning area of personalized medicine, creating a new paradigm in medical care,” stated Dr. Soon-Shiong, who will become Chairman and Chief Executive Officer of the newly established company. “To do this we must evaluate biological systems in personalized medicine and change the way we develop drugs and how we identify the patient for whom we are developing new drugs. We believe that, based on our proof of principle learned from our decade of research with the nab® platform, we must look at patients as biological systems using bioinformatics to identify chemical and biological entities. We envision a day when a tissue sample can be used to develop the molecular profile of disease which will guide a patient’s therapeutic approach, enabling caregivers to deliver the most effective medicine to the right patient at the right time. Unlike Abraxis BioScience, Abraxis Health’s mission is to pursue early stage development of compounds utilizing new technologies with new methodologies. The company’s R&D program will be led by a team of discovery scientists, medicinal chemists and formulation scientists who will devote their efforts to advancing molecules from the lab to the clinic.”
“We believe we are able to use the molecular profile of disease to deliver the right medicine to the right patient at the right time,” continued Dr. Soon-Shiong. “This will require a novel, global healthcare infrastructure with seamless communication among its various components, including: a network of tissue resources; a national tissue repository; next-generation diagnostic and molecular interrogation techniques; validated and quantitative norms to differentiate normal from disease states; a network of clinical sites working in collaboration to identify cohorts of patients with similar abnormal molecular profiles; and iterative clinical testing program to evaluate drugs based on activity against the particular molecular profile; and, a bioinformatic infrastructure integrating all of these elements.”
In connection with the spin-off, Abraxis Health will obtain the assets and liabilities constituting the drug discovery, pilot manufacturing and development operations currently being conducted through Abraxis BioScience. Detailed information about the spin-off will be provided when the company files a Form 10 registration statement with the Securities and Exchange Commission for Abraxis Health, which is expected to be filed in the first quarter of 2009.
The completion of any spin-off transaction will be subject to customary conditions, including filing of required documents with the Securities and Exchange Commission. There can be no assurance that any spin-off transaction will ultimately occur or, if one does occur, its terms or timing.
About Abraxis BioScience
Abraxis BioScience is a fully integrated global biotechnology company dedicated to the discovery, development and delivery of next-generation therapeutics and core technologies that offer patients safer and more effective treatments for cancer and other critical illnesses. The company's portfolio includes the world's first and only protein-bound chemotherapeutic compound (ABRAXANE), which is based on the company's proprietary tumor targeting technology known as the nab® platform. The first FDA approved product to use this nab® platform, ABRAXANE, was launched in 2005 for the 2nd line treatment of metastatic breast cancer following failure of combination chemotherapy for metastatic disease. Abraxis trades on the NASDAQ Global Market under the symbol ABII. For more information about the company and its products, please visit www.abraxisbio.com.
FORWARD-LOOKING STATEMENTS
The statements contained in this press release that are not purely historical are forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements in this press release include statements regarding our expectations, beliefs, hopes, goals, intentions, initiatives or strategies, including statements regarding the spin-off of the drug discovery and development business and the clinical development plan for ABRAXANE. Because these forward-looking statements involve risks and uncertainties, there are important factors that could cause actual results to differ materially from those in the forward-looking statements. These factors include, but are not limited to, risks that the proposed spin-off disrupts current plans and operations and the potential difficulties in employee retention; the inability to recognize the benefits of the spin-off; the difficulties or delays in developing, testing, obtaining regulatory approval of, and producing and marketing of their products; the impact of competitive products and pricing; the availability and pricing of ingredients used in the manufacture of pharmaceutical products; and the ability to successfully manufacture products in a time-sensitive and cost effective manner. Additional relevant information concerning risks can be found in Abraxis BioScience's Form 10-K for the year ended December 31, 2007 and other documents it has filed with the Securities and Exchange Commission.
The information contained in this press release is as of the date of this release. Abraxis assumes no obligations to update any forward-looking statements contained in this press release as the result of new information or future events or developments.
Contact:
Investor and Media Inquiries
Abraxis BioScience, Inc.
Maili Bergman
Director, Investor Relations and Corporate Communications
310-405-7522
or
Pondel Wilkinson Inc.
Rob Whetstone
310-279-5963
gfp927z
16 years ago
Abraxis MF article (9-26-07). Their improved taxane - Abraxane, is taking the world by storm (a nano-particle sized taxane that is bound to albumin). The company is about to split off their profitable generics business. I'd be interested in hearing any opinions on the viability of the patent suit (Elan is suing over the nano-particle technology) -
>>> 4 Platform Drugmakers to Watch
http://www.fool.com/investing/high-growth/2007/09/26/4-platform-drugmakers-to-watch.aspx
Brian Orelli
September 26, 2007
There's something really great about platform drugmakers. The fact that they can effortlessly roll out five or six drugs using the same technology -- extending patents in the process -- just makes me want to smile. Let's take a look at a few of the platform drugmakers that have the possibility of becoming multibaggers if their technologies catch fire.
Smaller is better
Abraxis BioScience (Nasdaq: ABBI) is developing drugs based on its nab (nanoparticle-albumin bound) technology. Essentially, the company takes chemotherapy drugs and surrounds them with albumin protein. Since albumin is used by tumor cells as a way to bring in nutrients, the tumor cells take up the albumin-bound drug more readily than they would a similar drug without albumin. The shell also increases the solubility of the drug, making it easier to deliver it to wherever it's needed in the body.
Abraxane, the company's one marketed drug based on the nab technology, has been competing well against the other taxanes on the market -- Bristol-Myers Squibb's (NYSE: BMY) Taxol and Sanofi-Aventis' (NYSE: SNY) Taxotere -- since it was approved to treat metastatic breast cancer in 2005. Abraxis is running additional clinical trials to get its label expanded to include other types of tumors.
The company is also developing four other chemotherapy drugs based on the nab technology. Two clinical trials for nab-docetaxel have already begun, and clinical studies for nab-rapamycin are expected to begin later this year. The other two molecules are still in pre-clinical trials, but could be in the clinic as early as 2008.
Investors who would like to purchase Abraxis just for its platform technology would be better off waiting until later in the year. The company is set to spin off its generic drug business, so waiting will let you buy into a pure play in platform technology.
Lasting pain relief
Drug-delivery specialist DURECT (Nasdaq: DRRX) has developed a platform that allows for the slow release of drugs over time. The viscous, gel-like substance comes in two forms: the SABER technology for applying directly to a wound during surgery, and the ORADUR technology, which is delivered through a capsule. The latter is being used by King Pharmaceuticals and Pain Therapeutics to develop Remoxy, an abuse-resistant version of oxycodone.
The cool thing about the technology is that it can be formulated to deliver drugs over periods as short as a day or as long as three months. While the company has limited itself to using its technology with pain relief drugs, the technology could be used with other drugs -- antibiotics for instance -- that need to be delivered over long periods of time. Look for DURECT to set up additional partnerships as its technology is proven successful in current late-stage clinical trials.
A molecular machete
The efficacy of a lot of drugs, especially large protein molecules like monoclonal antibodies, is low because they can't get inside the cell to do their job. Halozyme Therapeutics (Nasdaq: HALO) thinks it has discovered a way to provide an opening for the molecules to get inside the cell. The company's Enhanze Technology is essentially a high-dose formula of its Hylenex drug. The drug breaks down the matrix outside the cell, creating channels for the large drug molecules to enter the cell.
Halozyme has run an initial proof of concept clinical trial with a representative large protein molecule, but so far it has only been able to convince Roche to use the technology to further develop drugs. The technology seems a little speculative at this point -- Roche was only willing to pay $20 million up front for the rights -- so this platform is probably the least developed of the bunch.
Two for the price of one
Motley Fool Hidden Gems pick Flamel Technologies (Nasdaq: FLML) has not one but two platforms to develop drugs. Its Medusa technology combines protein drugs into a nanoparticle that breaks down slowly in the patient, thereby releasing the drug slowly over time. Meanwhile, its Micropump technology is designed for extended or delayed release of drugs by coating them in a polymer-coated microparticle that breaks down slowly in the small intestine.
Flamel has developed one extended release drug from its platform, GlaxoSmithKline's (NYSE: GSK) COREG CR, but it has a whole host of drugs in its pipeline that could be partnered out. With a recently disclosed partnership with Wyeth, things may be turning around for Flamel.
I'd classify all of these companies' platforms as still in the developmental stage, since none of them has developed even two drugs using their platforms. They could end up being one-hit wonders, or their platforms could develop multiple drugs over the coming years. Only time will tell which way they'll go, but they're all certainly worth keeping your eye on. <<<
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surf1944
14 years ago
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