Specialised Therapeutics and Helsinn Group Announce a PBS Listing for ALOXI® (Palonosetron) in Australia

Melbourne, Australia and Lugano, Switzerland 1st November 2010: A world leading anti-nausea/anti-vomiting drug for cancer patients undergoing chemotherapy will be available in Australia on the Pharmaceutical Benefits Scheme (PBS) from November 1st 2010.

Aloxi_^® (palonosetron hydrochloride) is a new therapy to prevent acute and delayed nausea and vomiting which can occur in cancer patients undergoing chemotherapy_¹.

The drug is licensed in Australia by Specialised Therapeutics Australia Pty Ltd (STA) following an agreement with Swiss Pharmaceutical Company, The Helsinn Group.

This agreement grants STA the exclusive license and distribution rights for Aloxi_^® in Australia and New Zealand.

Specialised Therapeutics Australia chief executive officer Mr Carlo Montagner said thousands of Australian cancer patients would now benefit from Aloxi_^® and its listing on the PBS.

“Aloxi_^® is a leading antiemetic. Many of the international medical community regards this as the first choice anti-nausea drug for cancer patients following treatment,” he said.

“This PBS listing ensures Australian cancer patients affordable access to this leading treatment.”

“It enables a better quality of life for cancer patients and adds to our portfolio of leading oncology medications.”

Mr Montagner said Aloxi® was highly regarded by the world’s cancer organisations. It is the only drug of its class specifically recommended by the European Society of Medical Oncology (ESMO), and the Multinational Association of Supportive Care in Cancer (MASCC), for moderately emetogenic chemotherapy_³.

Aloxi® is a second generation 5-HT₃ receptor antagonist, which is differentiated to older 5-HT₃antagonists by its higher receptor binding affinity and longer duration of its activity_^1,2.

A single intravenous dose of Aloxi_^® is given on the day of chemotherapy, and has been shown to be effective for up to five days_¹.

Aloxi® has been available in the USA since 2003, and is indicated in Australia for the management of nausea and vomiting associated with cytotoxic chemotherapy.

Today the product is approved in 63 countries, with annual sales last year of over 400 million US dollars.

Mr Montagner added: “The Helsinn Group has done a first class job of developing Aloxi_^®.

Helsinn Group chief executive officer Dr Riccardo Braglia said he looked forward to co-operating with STA on the Australian launch.

“We are delighted to sign this new agreement with STA and look forward to initiating a successful co-operation for Aloxi® in Australia,” he said.

“STA has demonstrated a commitment to grow products in the specialist oncology market, while the patients and the medical community in Australia will enjoy the benefits of an innovative antiemetic like Aloxi_^®.”

Aloxi_^® is PBS approved for the management of nausea and vomiting associated with cytotoxic chemotherapy being used to treat malignancy which occurs within 48 hours of chemotherapy administration.

For further information please contact:
Emma Power at Monsoon Communications on 03 9620 3333 or 0419 149 525.

About ALOXI_^®

Palonosetron (palonosetron hydrochloride) is a second generation 5-HT₃Receptor Antagonist, developed for the prevention of chemotherapy-induced nausea and vomiting (CINV) in patients with cancer, with a long half-life of 40 hours and at least 30 times higher receptor binding affinity than currently available compounds. Palonosetron demonstrates, in clinical trials and clinical practice, a unique long-lasting action in the prevention of CINV. The product has shown to be effective in preventing both acute and delayed CINV in patients receiving moderately emetogenic chemotherapy (MEC). A single intravenous dose of palonosetron provides better protection from CINV than first-generation 5-HT₃receptor antagonists throughout a 5-day post-chemotherapy period. Palonosetron is contraindicated in patients known to have hypersensitivity to the drug or any of its components. The most commonly reported adverse reactions in CINV trials with palonosetron were headache (9 percent) and constipation (5 percent), and they were similar to the comparators. Palonosetron has been developed by the Helsinn Group in Switzerland and today it is marketed as Aloxi_^®, Onicit_^®, and Paloxi_^® in more than 60 countries world-wide. Palonosetron, marketed as Aloxi_^®, is the leading brand in the USA within the CINV Day of Chemo segment, and it is steadily growing in the European markets. In Australia, Aloxi_^® is PBS listed for the management of nausea and vomiting associated with cytotoxic chemotherapy being used to treat malignancy which occurs within 48 hours of chemotherapy administration. For more information about palonosetron, please visit the website: www.aloxi.com

About Specialised Therapeutics Australia Pty Ltd

Specialised Therapeutics Australia Pty Ltd (STA) was established to identify, develop and commercialise innovative anti-cancer and other specialised therapies for the Australasian market. Currently STA markets two world leading cancer and cancer supportive care therapies, ABRAXANE and ALOXI (palonosetron) respectively. Based in Melbourne, Australia, the privately held company is currently developing several more important therapeutic agents for release in Australia and New Zealand.
http://www.specialisedtherapeutics.com.au.

About Helsinn Group

Helsinn is a privately owned pharmaceutical group with headquarters in Lugano, Switzerland, and subsidiaries in Ireland and USA. Helsinn’s business model is focused on the licensing of pharmaceuticals and medical devices in therapeutic niche areas. The Group in-licenses early to late stage new chemical entities, completes their development from the performance of pre-clinical/clinical studies and Chemistry, Manufacturing and Control (CMC), development to the filing for and attainment of their market approval worldwide. Helsinn’s products are sold directly through the Group’s subsidiaries or out-licensed to its network of local marketing and commercial partners, selected for their deep in-market knowledge and know-how, and assisted and supported with a full range of product and scientific management services, including commercial, regulatory, financial, legal and medical marketing advice. The active pharmaceutical ingredients and the finished dosage forms are manufactured at Helsinn’s cGMP facilities in Switzerland and Ireland, and supplied worldwide to its customers. Helsinn is the worldwide licensor of palonosetron, a second generation 5-HT₃ receptor antagonist, for the prevention of chemotherapy-induced nausea and vomiting (CINV) in patients with cancer and of post-operative nausea and vomiting (PONV), and of the original nimesulide, a non-steroidal anti-inflammatory drug (NSAID) distributed in more than 50 countries worldwide.

Helsinn, with a workforce of around 450 employees in Switzerland, Ireland and USA, reported a 2009 turnover of over CHF 305.6 million, covering 85 countries worldwide, with over 20% of this turnover invested in R&D.
For more information about Helsinn Group, please visit the website: www.helsinn.com

• Leading anti-nausea/anti-vomiting drug available November 1st
• PBS listed for Australian cancer patients

References:
1.   Aloxi product Information
2.   Wong E, et al Br J Pharmacol 1995; 114: 851-859.
3.   www.mascc.org

Celgene Acquires Abraxis BioScience and Leading Anti-Cancer Drug Abraxane

In Australia and New Zealand, Celgene assumes partnership role with Specialised Therapeutics Australia (STA)
STA to continue as the exclusive distributor of Abraxane in Australia and New Zealand

Melbourne 20 October 2010: Celgene Corporation (NASDAQ: CELG) today announced it has completed its acquisition of Abraxis BioScience, Inc. The transaction adds Abraxane_^®(nanoparticle albumin-bound paclitaxel) to the company’s existing portfolio of leading cancer products and offers another significant scientific platform that may drive future development.

World leading breast cancer drug Abraxanewill continue to be marketed and supplied in Australia and New Zealand by Specialised Therapeutics Australia (STA), despite the acquisition of STA’s American partner company, Abraxis Bioscience.

STA, which had in-licensed Abraxane from Abraxis Bioscience, said the acquisition would not affect its core business.

Chief executive officer Mr Carlo Montagner said all sales, marketing and medical affairs involving Abraxane in Australia and New Zealand would continue to be managed from STA’s Melbourne office.

He said “it is ‘business as usual’ and we look forward to working with our colleagues at Celgene, and will continue to provide Abraxane throughout Australia.”

Celgene will assume responsibility for ongoing global clinical development of Abraxane into new indications.

“Celgene is an ideal partner to further expand the future indications of Abraxane, in order to improve the lives of patients worldwide,” Mr Montagner said.

Celgene Asia Pacific Vice President, George Varkanis said “by bringing together the tremendous potential of Abraxis with the experience and success of Celgene, we are building a global leader in oncology. We look forward to working with STA to further develop Abraxane in Australia and New Zealand”.

Abraxane is currently approved and reimbursed via the Pharmaceutical Benefits Scheme (PBS) in Australia for patients with metastatic breast cancer after failure of prior therapy.

In patients with metastatic breast cancer, Abraxane has been shown to prolong patient survival times with overall fewer side effects compared to solvent-based paclitaxel.^_1-2

About Specialised Therapeutics Australia, Pty Ltd

http://www.specialisedtherapeutics.com.au.

About ABRAXANE

ABRAXANE is a solvent-free, nanoparticle chemotherapy treatment option for metastatic breast cancer._¹

In Australia, ABRAXANE is currently listed on the PBS for the treatment of metastatic breast cancer after failure of prior therapy.

ABRAXANE is approved for metastatic breast cancer in over 40 countries including the U.S., Canada, European Union, Japan and China, and more than 100,000 cancer patients have received ABRAXANE therapy in the past five years.

In Australia, ABRAXANE has also been granted orphan drug designation by the Therapeutic Goods Administration for the treatment of pancreatic cancer. Orphan drug status is granted to drugs used to treat relatively rare diseases such as pancreatic cancer and may allow for priority evaluation by the TGA.

Additionally, ABRAXANE is currently under Phase III investigation for the treatment of the following cancers: non-small cell lung, malignant melanoma, and metastatic pancreatic.

Developed using Abraxis BioScience’s proprietary nab^(TM) technology platform, ABRAXANE is a nanoparticle protein-bound chemotherapy agent. ABRAXANE combines paclitaxel with albumin, a naturally-occurring human protein, to deliver the drug and eliminate the need for solvents in the administration process. Nanoparticle technology allows ABRAXANE to deliver a 49% higher dose compared to regular solvent-based paclitaxel without compromising safety and tolerability._^1-2

In a randomised Phase III study of metastatic breast cancer patients, ABRAXANE demonstrated nearly double the overall tumour response rate compared to solvent-based paclitaxel. _^1-2

Anthracycline pre-treated patients lived significantly longer._³

The tolerability with ABRAXANE and solvent-based paclitaxel was comparable, despite the 49% greater dose of paclitaxel administered as ABRAXANE._^1-2

Neutropenia was lower with ABRAXANE compared to solvent-based paclitaxel, although there was an increase in incidence of grade 3 peripheral neuropathy with ABRAXANE.

However the median time to improvement, from grade 3 peripheral neuropathy to grade 2 or lower, was 22 days. No adverse events were reported that were not already known for paclitaxel._^1-2

Contraindications and side effects¹:

Like all medications, ABRAXANE may cause side effects.

ABRAXANE should not be used in patients who have baseline neutrophil counts of <1.5 x 10⁹/L.

In patients who have exhibited hypersensitivity reactions to paclitaxel or albumin, patients should not be treated with ABRAXANE. ABRAXANE is contraindicated during pregnancy and lactation.

About Celgene

Celgene Corporation, headquartered in Summit, New Jersey, is an integrated biopharmaceutical company engaged primarily in the discovery, development and commercialisation of novel therapies for the treatment of cancer and immune/inflammatory related diseases. For more information, please visit the Celgene website at www.celgene.com

References:

1. Abraxane Product Information

2. Gradishar WJ et al. J Clinical Oncology 2005;23:7794-7803

3. Vukelja SJ et al. ASCO 2008, Abstract 1082

Abraxis Bioscience and Specialised Therapeutics Announce Approval to Market ABRAXANE® for Metastatic Breast Cancer in New Zealand

Los Angeles, Calif. and Melbourne Australia – July, 2010 – Abraxis BioScience, Inc. (NASDAQ:ABII), a fully integrated, global biotechnology company, and Specialised Therapeutics Ltd. today announced that MEDSAFE, the New Zealand Medicines and Medical Devices Safety Authority, has approved for marketing ABRAXANE® (nanoparticle albumin-bound paclitaxel) for the treatment of metastatic breast cancer after failure of anthracycline therapy.

Abraxis BioScience granted exclusive marketing rights to Specialised Therapeutics for ABRAXANE in New Zealand. Specialised Therapeutics will commence distribution when reimbursement of Abraxane is approved through the New Zealand pharmaceutical reimbursement authority, Pharmac. ABRAXANE is currently fully reimbursed for “Metastatic breast cancer after failure of prior therapy” in Australia under the Pharmaceutical Benefits Scheme.

“In the U.S. and Australia ABRAXANE has rapidly become the taxane treatment of choice in its approved indication,” said Patrick Soon-Shiong, M.D., Executive Chairman of Abraxis BioScience. “We are pleased to provide this new treatment option for women in New Zealand with metastatic breast cancer.”

“Abraxane offers a safer and more efficacious taxane therapy for New Zealand women with metastatic breast cancer. Discussions with Pharmac will commence shortly and we hope to make Abraxane available as soon as an agreement with Pharmac is reached” said Carlo Montagner, CEO of Specialised Therapeutics.

With the approval in New Zealand, ABRAXANE is now approved in 41 countries.
-END-

About ABRAXANE
ABRAXANE is a solvent-free chemotherapy treatment option for metastatic breast cancer which was developed using Abraxis BioScience’s proprietary nab® technology platform. This protein-bound chemotherapy agent combines paclitaxel with albumin, a naturally-occurring human protein. By wrapping the albumin around the active drug, ABRAXANE can be administered to patients at higher doses, delivering higher concentrations of paclitaxel to the tumor site than solvent-based paclitaxel. ABRAXANE is currently in various stages of investigation for the treatment of the following cancers: expanded applications for metastatic breast, non-small cell lung, malignant melanoma, pancreatic and gastric.

The U.S. Food and Drug Administration approved ABRAXANE for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) in January 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. For the full prescribing information for ABRAXANE please visit http://www.abraxane.com.

About nab_^®-Driven Chemotherapy
Abraxis BioScience has developed a proprietary nanoparticle albumin-bound (nab) technology which leverages albumin nanoparticles for the active and targeted delivery of chemotherapeutics to the tumor. This nab-driven chemotherapy provides a new paradigm for penetrating the blood-stroma barrier to reach the tumor cell. The proposed mechanism of delivery of this nab-driven chemotherapy is thought to be by targeting a previously unrecognized tumor-activated, albumin-specific biologic pathway with a nanoshell of the human blood protein albumin. This nano-shuttle system is believed to activate an albumin-specific (Gp60) receptor-mediated transcytosis path through the cell wall of proliferating tumor cells, using caveolin-1 activated caveolar transport. Once in the stromal micro-environment, the albumin-bound drug may be preferentially localized by a second albumin-specific binding protein, SPARC, a protein secreted into the stroma by tumor cells. The resulting collapse of stroma surrounding the tumor cell may thus enhance the delivery of the nab-chemotherapeutic to the intracellular core of the tumor cell itself.

IMPORTANT SAFETY INFORMATION
The use of ABRAXANE has not been studied in patients with hepatic or renal dysfunction. In the randomized controlled trial, patients were excluded for baseline serum bilirubin >1.5 mg/dL or baseline serum creatinine >2 mg/dL.

ABRAXANE can cause fetal harm when administered to a pregnant woman. Women of childbearing potential should be advised to avoid becoming pregnant while receiving treatment with ABRAXANE.

Men should be advised to not father a child while receiving treatment with ABRAXANE. It is recommended that nursing be discontinued when receiving ABRAXANE therapy. ABRAXANE contains albumin (human), a derivative of human blood.

Caution should be exercised when administering ABRAXANE concomitantly with known substrates or inhibitors of CYP2C8 and CYP3A4.

ABRAXANE therapy should not be administered to patients with metastatic breast cancer who have baseline neutrophil counts of less than 1,500 cells/mm3. It is recommended that frequent peripheral blood cell counts be performed on all patients receiving ABRAXANE. Patients should not be retreated with subsequent cycles of ABRAXANE until neutrophils recover to a level >1,500 cells/mm3 and platelets recover to a level >100,000 cells/mm3 In the case of severe neutropenia (<500 cells/mm3 for 7 days or more) during a course of ABRAXANE therapy, a dose reduction for subsequent courses is recommended.
Sensory neuropathy occurs frequently with ABRAXANE.

If grade 3 sensory neuropathy develops, treatment should be withheld until resolution to grade 1 or 2 followed by a dose reduction for all subsequent courses of ABRAXANE. Severe cardiovascular events possibly related to single-agent ABRAXANE occurred in approximately 3% of patients in the randomized trial. These events included chest pain, cardiac arrest, supraventricular tachycardia, edema, thrombosis, pulmonary thromboembolism, pulmonary embolism, and hypertension.

In the randomized metastatic breast cancer study, the most important adverse events included alopecia (90%), neutropenia (all cases 80%; severe 9%), sensory neuropathy (any symptoms 71%; severe 10%), asthenia (any 47%; severe 8%), myalgia/arthralgia (any 44%; severe 8%), anemia (all 33%; severe 1%), infections (24%), nausea (any 30%; severe 3%), vomiting (any 18%; severe 4%), diarrhea (any 27%; severe <1%), and mucositis (any 7%; severe <1%).

Other adverse reactions have included ocular/visual disturbances (any 13%; severe 1%), fluid retention (any 10%; severe 0%), hepatic dysfunction (elevations in bilirubin 7%, alkaline phosphatase 36%, AST [SGOT] 39%), renal dysfunction (any 11%; severe 1%), thrombocytopenia (any 2%; severe <1%), hypersensitivity reactions (any 4%; severe 0%), cardiovascular reactions (severe 3%), and injection site reactions (<1%). During postmarketing surveillance, rare occurrences of severe hypersensitivity reactions have been reported with ABRAXANE.

About Specialised Therapeutics, Pty Ltd
Specialised Therapeutics Australia Pty Ltd (STA) was established to identify, develop and commercialise innovative anti-cancer and other specialised therapies for the Australasian market. Currently STA markets two world leading cancer therapies, ABRAXANE and ALOXI (palonosetron). Based in Melbourne, Australia, the privately held company is currently developing several more important therapeutic agents for release in Australia and New Zealand.

About Abraxis BioScience, Inc.
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 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 metastatic breast cancer and is now approved in 41 countries. The company continues to expand the nab® platform through a robust clinical program and deep product pipeline. Abraxis trades on the NASDAQ Global Market under the symbol ABII. For more information about the company and its products, please visit http://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 clinical development plan, and the timing and scope of clinical studies and trials, for ABRAXANE and the global commercialization of 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, without limitation, the fact that results from pre-clinical studies may not be predictive of results to be obtained in other pre-clinical studies or future clinical trials; delays in commencement and completion of clinical studies or trials, including slower than anticipated patient enrollment and adverse events occurring during the clinical trials; decisions by regulatory authorities regarding whether and when to approve ABRAXANE for various indications as well as their decisions regarding labeling and other matters that could affect the availability or commercial potential of; 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; research and development associated with the nab® technology platform; 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, 2009 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 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.

Contacts:

Investor and Media Inquiries
Pondel Wilkinson Inc.
Rob Whetstone
310.279.5963

Specialised Therapeutics Australia, Pty Ltd
Carlo Montagner
Chief Executive Officer
03 9854 6207

Monsoon Communications
Level 1 350 Collins Street
Melbourne VIC 3000
Ph: 03 9620 3333
www.monsoon.com.au

PBS Change for Leading Breast Cancer Drug ABRAXANE®

More Australian women to potentially have access to leading breast cancer drug

Melbourne, 7 June 2010: Melbourne pharmaceutical company Specialised Therapeutics Australia (STA) wishes to announce a change in the Pharmaceutical Benefits Scheme (PBS) listing for its lead product ABRAXANE_^® (nanoparticle albumin-bound paclitaxel).

From 1 July, Abraxane will be available via PBS Authority to patients with ‘Metastatic breast cancer after failure of prior therapy.’

STA chief executive officer Mr Carlo Montagner said the change would enable more Australian women to access the drug, which is now regarded as a leading treatment for this disease, prolonging survival rates, with overall fewer adverse reactions and greater patient convenience. _^1,2

“We are extremely pleased the Pharmaceutical Benefits Advisory Committee has made this change to the PBS listing of ABRAXANE” he said.

“It paves the way for a greater number of patients to be treated with this therapy. Until now, only those patients with metastatic breast cancer who had received prior treatment including an anthracycline were eligible for PBS reimbursement.

“Now patients who have received prior treatment for their metastatic breast cancer, with or without an anthracycline, will be eligible.”

ABRAXANE is the first solvent-free taxane available as a treatment option to cancer patients. Because it is solvent free, it eliminates the risk of solvent-related hypersensitivity reactions and potentially fatal anaphylaxis seen with solvent-based paclitaxel. _^1-3

It is approved for metastatic breast cancer in over 35 countries including the U.S., Canada, European Union and China. More than 60,000 cancer patients have received ABRAXANE therapy in the past five years.

Ends.

About ABRAXANE

In Australia as of 1 July 2010, ABRAXANE will be approved and reimbursed by the Pharmaceutical Benefits Scheme (PBS) for the treatment of metastatic breast cancer after failure of prior therapy.

ABRAXANE has also been granted orphan drug designation by the Therapeutic Goods Administration for the treatment of pancreatic cancer. Orphan drug status is granted to drugs used to treat relatively rare diseases such as pancreatic cancer and may allow for priority evaluation by the TGA.

Developed using Abraxis BioScience’s proprietary nab(TM) technology platform, ABRAXANE is a nanoparticle protein-bound chemotherapy agent. ABRAXANE combines paclitaxel with albumin, a naturally-occurring human protein, to deliver the drug and eliminate the need for solvents in the administration process. Nanoparticle technology allows ABRAXANE to deliver a 49% higher dose compared to regular solvent-based paclitaxel without compromising safety and tolerability. _^1,2

In a randomised Phase III study of metastatic breast cancer patients, ABRAXANE demonstrated nearly double the overall tumour response rate compared to solvent-based paclitaxel _^1,2. Anthracycline pre-treated patients lived significantly longer ._⁴

The tolerability with ABRAXANE and solvent-based paclitaxel was comparable, despite the 49% greater dose of paclitaxel administered as ABRAXANE_^1-2. Neutropenia was lower with ABRAXANE compared to solvent-based paclitaxel, although there was an increase in incidence of grade 3 peripheral neuropathy with ABRAXANE. However the median time to improvement, from grade 3 peripheral neuropathy to grade 2 or lower, was 22 days. No adverse events were reported that were not already known for paclitaxel._^1-2

For further information, physicians should consult the Abraxane Product Information available on www.specialisedtherapeutics.com.au

About Specialised Therapeutics Australia Pty Ltd

Specialised Therapeutics Australia Pty Ltd (STA) was established to identify, develop and commercialise innovative anti-cancer and other specialised therapies for the Australasian market. ABRAXANE is the first of such therapies. Based in Melbourne, Australia, the privately held company is currently developing several more important therapeutic agents for release in Australia and New Zealand.

References:
1. Abraxane Product Information
2. Gradishar WJ et al. J Clinical Oncology 2005;23:7794-7803
3. Irizarry LD et al. Community Oncology 2009;6(3): 132-134
4. Vukelja SJ et al. ASCO 2008, Abstract 1082

Study Shows Leading Breast Cancer Drug ABRAXANE® Increases Survival Time for Advanced Pancreatic Cancer

Patients Receiving 125mg/m² ABRAXANE in Combination with Gemcitabine Demonstrated:

Median Survival of 12.2 Months
50 per cent Response Rate
68 per cent Disease Control
Decrease in CA19-9 Tumour Biomarker in 100 Percent of Patients Treated

MELBOURNE, May, 2010: An international study of world-leading breast cancer drug ABRAXANE ^®(nanoparticle albumin-bound paclitaxel) has shown promising results for patients with advanced pancreatic cancer when used in combination with Gemcitabine.

Abraxis BioScience, Inc. (NASDAQ:ABII) announced findings from the phase I/II study, which showed patients’ overall survival time almost doubled, and levels of a major tumour marker were decreased by more than 20 per cent in all trial patients.

Specialised Therapeutics Australia Chief Executive Officer Mr Carlo Montagner, said: “As we advance our pivotal Phase III registration trials of ABRAXANE in pancreatic cancer and melanoma, we look forward to potentially bringing a new treatment option to patients with these difficult to treat cancers. While approval may be several years away, we are extremely encouraged by these results.”

The study showed that in 44 patients treated at the recommended dose of 125 mg/m² nab-paclitaxel plus gemcitabine (1000 mg/m²), the median overall survival (OS) time was 12.2 months, a doubling of survival compared to the historical control of gemcitabine administered alone.

This combination of nab-paclitaxel and gemcitabine also resulted in a confirmed overall response rate in 50 percent of patients treated, and a disease control rate (CR, PR and stable disease for 16 weeks or longer according to RECIST criteria) of 68 percent.

In the overall study (n=67), three patients achieved a complete response.

The findings were included in a keynote address by Daniel Von Hoff, M.D., “Epithelium and Stroma: Double Trouble,” during the “Progress in Pancreatic Cancer” session on April 18 at the 101st Annual Meeting of the American Association for Cancer Research (AACR) being held in Washington, D.C.

“The results of this study demonstrate that the combination of nab-paclitaxel and gemcitabine at the recommended dose of 125 mg/m²nab-paclitaxel has substantial antitumour activity,” Mr Von Hoff said.

“ One hundred percent of the patients in the 125 mg/m²nab-paclitaxel arm (n=44) tested for the serum carbohydrate antigen CA 19-9 demonstrated a greater than 20 percent decrease in levels of the tumour marker, a degree of decrease which has been shown to be correlated with improved overall survival.^1-3”

The biomarker CA19-9 is a tumour-associated antigen that has been shown to be highly specific and sensitive for pancreatic cancer; approximately three-quarters of all pancreatic cancer patients have elevated baseline serum CA19-9 level at baseline.⁴

Of the 54 patients in the trial interrogated for CA 19-9, 69 percent had a greater than 70 percent decrease in levels of the biomarker, which correlated to a median overall survival of 15.6 months in this subset.

The updated survival data follow interim data from the Phase I/II pancreatic clinical trial presented at the 45^th Annual Meeting of the American Society of Clinical Oncology. The combination of nab-paclitaxel (125mg/m²) and gemcitabine (1000 mg/m²) is now the treatment arm of a randomized Phase 3 clinical trial that is currently enrolling patients.

Pancreatic cancer is particularly difficult to treat because many patients are diagnosed after their disease has progressed. More than 2000 cases of pancreatic cancer are diagnosed in Australia every year ⁵; fewer than five per cent of patients survive longer than five years ⁵.

About ABRAXANE

In Australia, ABRAXANE is currently approved and reimbursed by the Pharmaceutical Benefits Scheme (PBS) for the treatment of metastatic breast cancer after failure of prior therapy which includes an anthracycline.

ABRAXANE is approved for metastatic breast cancer in over 35 countries including the U.S., Canada, European Union and China, and more than 60,000 cancer patients have received ABRAXANE therapy in the past five years.

Additionally, ABRAXANE is currently under global Phase III investigation including Australia for the treatment of the following cancers: non-small cell lung (NSCLC), malignant melanoma, and metastatic pancreatic. It was recently announced that the global Phase III NSCLC trial achieved its primary endpoint and the results will be presented at the American Society of Clinical Oncology meeting in Chicago on June 7.

ABRAXANE is a solvent-free, nanoparticle chemotherapy treatment option for metastatic breast cancer⁶. Developed using Abraxis BioScience’s proprietary nab^(TM) technology platform, ABRAXANE is a nanoparticle protein-bound chemotherapy agent. ABRAXANE combines paclitaxel with albumin, a naturally-occurring human protein, to deliver the drug and eliminate the need for solvents in the administration process. Nanoparticle technology allows ABRAXANE to deliver a 49% higher dose compared to regular solvent-based paclitaxel without compromising safety and tolerability ^6,7.

In a randomised Phase III study of metastatic breast cancer patients, ABRAXANE demonstrated nearly double the overall tumour response rate compared to solvent-based paclitaxel ⁷. Anthracycline pre-treated patients lived significantly longer ⁷.

The tolerability with ABRAXANE and solvent-based paclitaxel was comparable, despite the 49% greater dose of paclitaxel administered as ABRAXANE. Neutropenia was lower with ABRAXANE compared to solvent-based paclitaxel, although there was an increase in incidence of grade 3 peripheral neuropathy with ABRAXANE. However the median time to improvement, from grade 3 peripheral neuropathy to grade 2 or lower, was 22 days. No adverse events were reported that were not already known for paclitaxel.

Contraindications and side effects⁶:

Like all medications, ABRAXANE may cause side effects.

ABRAXANE should not be used in patients who have baseline neutrophil counts of <1.5 x 10⁹/L.

In patients who have exhibited hypersensitivity reactions to paclitaxel or albumin, patients should not be treated with ABRAXANE. ABRAXANE is contraindicated during pregnancy and lactation.

Most common side effects (≥1/10) caused by ABRAXANE include; neutropenia, anemia, leucopenia, thrombocytopenia, lymphophenia, anorexia, peripheral neuropathy, hypoaesthesia, paraethesia, nausea, diarrhoea, vomiting, constipation, stomatitis, alopecia, rash, arthralgia, myalgia, fatigue, asthenia, pyrexia.

For further information regarding ABRAXANE and potential side effects, physicians should review the ABRAXANE Product Information and patients should consult their oncologist or the ABRAXANE Consumer Medicine Information available on www.specialisedtherapeutics.com.au.

About Specialised Therapeutics Australia Pty Ltd

Specialised Therapeutics Australia Pty Ltd (STA) was established to identify, develop and commercialise innovative anti-cancer and other specialised therapies for the Australasian market. ABRAXANE is the first of such therapies. Based in Melbourne, Australia, the privately held company is currently developing several more important therapeutic agents for release in Australia and New Zealand.

________________________________

A.H. Ko, J. Hwang, A.P. Venook, J.L. Abbruzzese, E.K. Bergsland and M.A. Tempero. Serum CA19-9 response as a surrogate for clinical outcome in patients receiving fixed-dose rate gemcitabine for advanced pancreatic cancer. British Journal of Cancer. July 5, 2005, Volume 93, 195 – 199.
A.H. Ko, E. Dito, B. Schillinger, A.P. Venook, E.K. Bergsland and M.A. Tempero. Phase II Study of Fixed Dose Rate Gemcitabine With Cisplatin for Metastatic Adenocarcinoma of the Pancreas. Journal of Clinical Oncology. January 20, 2006, Volume 24, Issue 3, 379-385.
N.R. Maisey, A.R. Norman, A. Hill, A. Massey, J. Oates and D. Cunningham. CA19-9 as a prognostic factor in inoperable pancreatic cancer: the implication for clinical trials. British Journal of Cancer. September 20, 2005, Volume 93, 740 – 743.
C.Yeo, M. Tempero, and R. Abrams R. Pancreas cancer: clinical management. In Gastrointestinal Oncology: Principles and Practices. J. Tepper (ed), 2002. Philadelphia: Lippincott Williams and Wilkins
AIHW (Australian Institute of Health and Welfare) & AACR (Australasian Association of Cancer Registries) 2008. Cancer in Australia: an overview, 2008. Cancer series no. 46. Cat. no. CAN 42. Canberra: AIHW.
ABRAXANE Product Information
Gradishar WJ et al. J Clinical Oncology 2005; 23:7794-7803

For more information please contact Emma Power at Monsoon Communications on 0419 149 525 or (03) 9620 3333.

ABRAXANE® in Focus at International Conference

CANCER DRUG ABRAXANE^® IN FOCUS AT INTERNATIONAL CONFERENCE
Delegates to hear trial results for future possible ABRAXANE indications including lung cancer and melanoma

Melbourne: 27 May 2010: World leading advanced breast cancer drug ABRAXANE^® (nanoparticle albumin-bound paclitaxel) will be in focus at a leading international medical conference in Chicago next week.

Specialised Therapeutics Australia Pty Ltd (STA), which markets the drug in Australia, says its lead product will be showcased in 31 abstracts at the American Society of Clinical Oncology (ASCO) Conference, which begins in Chicago on June 4.

All presentations will highlight interim or final results for trials with ABRAXANE in several types of cancers, including breast, non-small cell lung, melanoma, ovarian, head and neck, pancreatic and bladder cancer.

Specialised Therapeutics Australia chief executive officer Mr Carlo Montagner said while the drug was currently only approved for metastatic breast cancer, trials around the world into the use of ABRAXANE in other cancer types were “extremely encouraging”.

He indicated Specialised Therapeutics Australia will submit the new data, when available, to the Therapeutic Goods Administration for approval of ABRAXANE in other cancers.

Among ASCO presenters will be world renowned cancer authority Dr Mark Socinski, from the University of North Carolina Lineberger Comprehensive Cancer Centre.

Dr Socinski will present the tumour response rates for the pivotal Phase 3 registration trial of ABRAXANE on 1052 lung cancer patients globally.

The major global study, which included Australian patients, trialled ABRAXANE in combination with Carboplatin, compared with solvent-based paclitaxel and Carboplatin, as a first line therapy in advanced non-small cell lung cancer.

Mr Montagner said he expected strong international interest in this presentation and other ABRAXANE abstracts, with the world’s first nanoparticle drug approved in over 36 countries.

He said that most recently, delegates at the American Association for Cancer Research in Washington were told the drug may have further potential in patients with triple-negative breast cancers when used in combination with Bevacizumab¹.

nab-paclitaxel plus bevacizumab was shown to inhibit tumour growth by 100%, and reduced the incidence of lymph node and lung metastases by 50% and 87% respectively.

Mr Montagner added: “As these pivotal clinical trials around the world advance, we look forward to potentially bringing a new treatment option to patients with these difficult to treat cancers. It may be several years before we have approval for these new indications, however we are extremely encouraged by these results and look forward to presenting them to global medical experts at the ASCO conference.”

Ends.

About Specialised Therapeutics Australia Pty Ltd

Specialised Therapeutics Australia Pty Ltd (STA) was established to identify, develop and commercialise innovative anti-cancer and other specialised therapies for the Australasian market. ABRAXANE is the first of such therapies. Based in Melbourne, Australia, the privately held company is currently developing several more important therapeutic agents for release in Australia and New Zealand.

About ABRAXANE

Additionally, ABRAXANE is currently under Phase III investigation for the treatment of the following cancers: non-small cell lung, malignant melanoma, and metastatic pancreatic.

ABRAXANE is a solvent-free, nanoparticle chemotherapy treatment option for metastatic breast cancer². Developed using Abraxis BioScience’s proprietary nab^(TM) technology platform, ABRAXANE is a nanoparticle protein-bound chemotherapy agent. ABRAXANE combines paclitaxel with albumin, a naturally-occurring human protein, to deliver the drug and eliminate the need for solvents in the administration process. Nanoparticle technology allows ABRAXANE to deliver a 49% higher dose compared to regular solvent-based paclitaxel without compromising safety and tolerability ^2,3.

In a randomised Phase III study of metastatic breast cancer patients, ABRAXANE demonstrated nearly double the overall tumour response rate compared to solvent-based paclitaxel ^2,3. Anthracycline pre-treated patients lived significantly longer ⁴.

The tolerability with ABRAXANE and solvent-based paclitaxel was comparable, despite the 49% greater dose of paclitaxel administered as ABRAXANE^2,3. Neutropenia was lower with ABRAXANE compared to solvent-based paclitaxel, although there was an increase in incidence of grade 3 peripheral neuropathy with ABRAXANE. However the median time to improvement, from grade 3 peripheral neuropathy to grade 2 or lower, was 22 days. No adverse events were reported that were not already known for paclitaxel^2,3.

FOR MORE INFORMATION PLEASE CONTACT EMMA POWER AT MONSOON COMMUNICATIONS ON (03) 9620 3333 OR 0419 149 525.

References:

1 .Ran S et al. Abstract AACR 2010: 3852,

2. Abraxane Product Information

3. Gradishar WJ et al. J Clinical Oncology 2005; 23:7794-7803

4. Vukelja SJ et al. Abstract ASCO 2008;26:1082

ABRAXANE® Meets Primary Endpoint in Phase 3 Trial for Advanced Non-Small Cell Lung Cancer

ABRAXANE^®(nanoparticle albumin-bound paclitaxel), Carboplatin Combination Demonstrated Superiority to Taxol plus Carboplatin in 1st Line Non-Small Cell Lung Cancer

LOS ANGELES and MELBOURNE – March 18, 2010: An international lung cancer trial has shown positive results in those patients treated with the leading breast cancer drug ABRAXANE in combination with carboplatin.

Biopharmaceutical companies Abraxis Bioscience Inc (NASDAQ: ABII) and Specialised Therapeutics Australia Pty Ltd (STA) announced that the extensive trial, conducted at 102 sites globally, including Australia, which enrolled 1052 patients suffering advanced non-small cell lung cancer (NSCLC), met its primary efficacy endpoint as assessed by an independent radiologist review.

Researchers found those patients treated with ABRAXANE and carboplatin combination demonstrated a significant improvement in overall tumour response rate compared with patients treated with a standard chemotherapy combination containing TAXOL and carboplatin.

The Phase 3 trial was led by principal investigator Mark Socinski, M.D., at the University of North Carolina Lineberger Comprehensive Cancer Center, and is recognised as one of the largest NSCLC clinical studies to be conducted.

“This is exciting news for lung cancer patients and has important implications not only in late stage cancer but also in earlier stages of the disease,” Socinkski said.

Professor Michael Boyer of Royal Prince Alfred Hospital, Sydney, was the Australian lead investigator.

The data will be submitted for consideration as a late breaking presentation at the upcoming American Society of Clinical Oncology (ASCO) meeting to be held in June in Chicago.

CEO and founder of Specialised Therapeutics Australia Mr Carlo Montagner said this was positive news for the many Australians who continue to be affected by this disease.

“We are extremely pleased with the results from this Phase 3 study, which included several Australian treatment sites, showing the superiority of ABRAXANE over a commonly used drug combination in Australia,” he said.

“Subject to further data analysis, we anticipate filing to the TGA in 2011 for what will be the second indication for ABRAXANE in Australia.”

NSCLC is the most common form of lung cancer, accounting for approximately 85% of all lung cancer cases.

National lung cancer statistics indicate it is the fourth most commonly diagnosed cancer in Australia, with over 8000 new cases annually. ¹

Study Design

Patients in the study were randomised to two treatment arms: patients in Arm A received ABRAXANE 100 mg/m² weekly plus carboplatin AUC 6 on Day 1 of a three-week treatment cycle; patients in Arm B received Taxol 200 mg/m² every 3 weeks plus carboplatin AUC 6 on Day 1 of a three-week treatment cycle. The primary study endpoint was independently-assessed tumour response rate, as defined by Response Evaluation Criteria in Solid Tumours (RECIST) criteria. Secondary study endpoints included: safety and tolerability; disease control rate and duration of response; progression-free survival (PFS); patient survival. Assessments of ABRAXANE efficacy correlated with specific tumour biomarkers, including secreted protein acidic and rich in cysteine (SPARC).

About ABRAXANE

In Australia, ABRAXANE is currently approved and listed on the PBS for the treatment of metastatic breast cancer after failure of prior therapy, which includes an anthracycline.

Additionally, ABRAXANE is currently under Phase 3 investigation for the treatment of the following cancers: non-small cell lung, malignant melanoma, and metastatic pancreatic.

ABRAXANE is a solvent-free, nanoparticle chemotherapy treatment option for metastatic breast cancer¹. Developed using Abraxis BioScience’s proprietary nab^TM technology platform, ABRAXANE is a nanoparticle protein-bound chemotherapy agent. ABRAXANE combines paclitaxel with albumin, a naturally-occurring human protein, to deliver the drug and eliminate the need for solvents in the administration process. Nanoparticle technology allows ABRAXANE to deliver a 49% higher dose compared to regular solvent-based paclitaxel without compromising safety and tolerability^2,3.

In a randomised Phase 3 study of metastatic breast cancer patients, ABRAXANE demonstrated nearly double the overall tumour response rate compared to solvent-based paclitaxel³. Anthracycline pre-treated patients lived significantly longer³.

Contraindications and side effects²:

Like all medications, ABRAXANE may cause side effects.

ABRAXANE should not be used in patients who have baseline neutrophil counts of <1.5 x 10⁹/L.

In patients who have exhibited hypersensitivity reactions to paclitaxel or albumin, patients should not be treated with ABRAXANE. ABRAXANE is contraindicated during pregnancy and lactation.

About Specialised Therapeutics, Pty Ltd

Specialised Therapeutics Australia Pty Ltd (STA) was established to identify, develop and commercialise innovative anti-cancer and other specialised therapies for the Australasian market. ABRAXANE is the first of such therapies. Based in Melbourne, Australia, the privately held company is currently developing several more important therapeutic agents for release in Australia and New Zealand.

References:

AIHW (Australian Institute of Health and Welfare) Incidence and prevalence of chronic diseases 2006
ABRAXANE^® Product Information
Gradishar WJ et al. J Clinical Oncology 2005;23:7794-7803

Contact:

Emma Power
Monsoon Communications
(03) 9620 3333
0419 149 525

Today Tonight Channel 7: March 2010

The following story appeared on Channel 7’s current affairs program Today Tonight in March 2010. Click to view.

ABRAXANE® Granted Orphan Drug Status for Pancreatic Cancer by Therapeutic Goods Administration

Leading Breast Cancer Drug To Be Investigated In Pancreatic Cancer, Melanoma

Melbourne, February 2010: A leading Australian breast cancer drug, ABRAXANE^® (nanoparticle albumin-bound paclitaxel), has been granted orphan drug status by the Therapeutic Goods Administration (TGA) for pancreatic cancer.

The drug has been available in Australia since last February from Melbourne based pharmaceutical company Specialised Therapeutics Australia Pty Ltd, primarily for patients with metastatic breast cancer ¹.

From May 2009, it has been listed on the Pharmaceutical Benefits Scheme (PBS) for metastatic breast cancer after failure of prior therapy which includes an anthracycline.

ABRAXANE is now regarded as a leading treatment for this disease, prolonging survival rates, with fewer reactions and greater patient convenience as compared to solvent-based paclitaxel in the phase III registration trial^1-2.

Orphan drug status is granted to drugs used to treat relatively rare diseases such as pancreatic cancer and may allow for priority evaluation by the TGA.

Specialised Therapeutics’ Chief Executive Officer, Mr Carlo Montagner, said this was an important step in bringing new treatment options for pancreatic cancer patients, with Phase II data presented at the 2009 American Society of Clinical Oncology annual meeting indicating ABRAXANE is active in pancreatic cancer ³.

“As we advance our pivotal Phase III clinical trials of ABRAXANE in lung, pancreatic cancer and melanoma, we look forward to the potential of bringing a new treatment option to patients with these difficult to treat cancers,” Mr Montagner said.

“If the Phase III studies meet their efficacy targets, we expect ABRAXANE to be approved and generally available for lung, pancreatic and melanoma cancers in the next few years.

“People currently undergoing treatment for these diseases should direct any questions about the ongoing trials to their physicians.”

ABRAXANE is the first solvent-free taxane available as a treatment option to cancer patients. Because ABRAXANE is solvent free, it eliminates the risk of solvent-related hypersensitivity reactions and potentially fatal anaphylaxis ^1,2,4-.

It is also the first nanoparticle drug to be approved by the Therapeutic Goods Administration.

A Phase III trial of ABRAXANE has begun in pancreatic cancer patients at 21 sites around the country, with hospitals now recruiting trial participants.

This international study will evaluate whether ABRAXANE plus gemcitabine has greater activity versus gemcitabine alone as a first line therapy for advanced metastatic pancreatic cancer.

Pancreatic cancer and metastatic melanoma can be particularly hard to treat cancers. More than 2000 cases of pancreatic cancer are diagnosed in Australia every year⁵; fewer than five per cent of patients survive longer than five years ⁵.

Melanoma is an aggressive form of skin cancer that strikes approximately 12,000 Australians every year ⁵.

Metastatic melanoma is the leading cause of skin cancer death. A Phase III trial of ABRAXANE versus a standard drug regimen in first line metastatic melanoma has also begun in Australia, with results expected in the next two years.

The Non-Small Cell Lung Cancer Phase III registration trial was completed in 2009 and the results will be presented later this year.

For further information please contact Emma Power at Monsoon Communications on 03 9620 3333 or 0419 149 525.

About ABRAXANE

In Australia, ABRAXANE is currently approved and listed on the PBS for the treatment of metastatic breast cancer after failure of prior therapy, which includes an anthracycline.

Additionally, ABRAXANE is currently under Phase III investigation for the treatment of the following cancers: non-small cell lung, malignant melanoma, and metastatic pancreatic.

In a randomised Phase III study of metastatic breast cancer patients, ABRAXANE demonstrated nearly double the overall tumour response rate compared to solvent-based paclitaxel². Anthracycline pre-treated patients lived significantly longer⁶.

Contraindications and side effects¹:

Like all medications, ABRAXANE may cause side effects.

ABRAXANE should not be used in patients who have baseline neutrophil counts of <1.5 x 10⁹/L.

In patients who have exhibited hypersensitivity reactions to paclitaxel or albumin, patients should not be treated with ABRAXANE. ABRAXANE is contraindicated during pregnancy and lactation.

About Specialised Therapeutics, Pty Ltd

Specialised Therapeutics Australia Pty Ltd (STA) was established to identify, develop and commercialise innovative anti-cancer and other specialised therapies for the Australasian market. ABRAXANE is the first of such therapies. Based in Melbourne, Australia, the privately held company is currently developing several more important therapeutic agents for release in Australia and New Zealand.

References:

ABRAXANE Product Information
Gradishar WJ et al. J Clinical Oncology 2005;23:7794-7803
Von Hoff D et al. ASCO 2009; Abstract 4525
Irizarry LD et al. Community Oncology 2009; 6(3):132-134
AIHW (Australian Institute of Health and Welfare) & AACR (Australasian Association of Cancer Registries) 2008. Cancer in Australia: an overview, 2008. Cancer series no. 46. Cat. no. CAN 42. Canberra: AIHW.
Vukelja SJ et al. ASCO 2008; Abstract 1082

Specialised Therapeutics and Helsinn Group Announce a PBS Listing for ALOXI® (Palonosetron) in Australia

About ALOXI®

About Specialised Therapeutics Australia Pty Ltd

About Helsinn Group

Celgene Acquires Abraxis BioScience and Leading Anti-Cancer Drug Abraxane

Abraxis Bioscience and Specialised Therapeutics Announce Approval to Market ABRAXANE® for Metastatic Breast Cancer in New Zealand

PBS Change for Leading Breast Cancer Drug ABRAXANE®

Study Shows Leading Breast Cancer Drug ABRAXANE® Increases Survival Time for Advanced Pancreatic Cancer

ABRAXANE® in Focus at International Conference

ABRAXANE® Meets Primary Endpoint in Phase 3 Trial for Advanced Non-Small Cell Lung Cancer

Today Tonight Channel 7: March 2010

ABRAXANE® Granted Orphan Drug Status for Pancreatic Cancer by Therapeutic Goods Administration

About ALOXI_^®