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 Abraxane will 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

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 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 10/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

 




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.

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.

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 ABRAXANE1-2.  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/mnab-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 45th 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 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.

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 10/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. 

 

________________________________

 

  1. 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.
  2. 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.
  3. 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.
  4. 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
  5. 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.
  6. ABRAXANE Product Information
  7. 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® 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.

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 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 nabTM 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 tolerability2,3.

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.

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

 

Contact:

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

 




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 trial1-2.

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.

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 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 cancer1. Developed using Abraxis BioScience’s proprietary nabTM 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 tolerability1,2.

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

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 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 10/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, 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. Von Hoff D et al. ASCO 2009; Abstract 4525
  4. Irizarry LD et al. Community Oncology 2009; 6(3):132-134
  5. 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.
  6. Vukelja SJ et al. ASCO 2008; Abstract 1082