Download neobiocon and abraxis bioscience launch abraxane in the uae for

News Release
NEOBIOCON AND ABRAXIS BIOSCIENCE LAUNCH
ABRAXANE IN THE UAE FOR TREATMENT OF BREAST
CANCER
Abu Dhabi, UAE, and LOS ANGELES, California, (Oct 9, 2008) – NeoBiocon, a recently
established biotechnology company and Abraxis BioScience, Inc. (NASDAQ:ABII), a fully
integrated biotechnology company, today announced the launch of ABRAXANE® (paclitaxel
protein-bound particles for injectable suspension) (albumin-bound) in the UAE for the
treatment of breast cancer after failure of combination therapy for metastatic disease or
relapse within six months of adjuvant chemotherapy.
NeoBiocon is a joint venture between Dr. B.R. Shetty, Managing Director & CEO of Abu
Dhabi based company Neopharma and Ms. Kiran Mazumdar-Shaw, Chairman & Managing
Director of India’s Biocon Ltd.
ABRAXANE is currently available in the UAE as a single-use 100 mg vial (as a lyophilized
powder, to be reconstituted for intravenous administration).
The Phase III clinical trial in the U.S. demonstrated that ABRAXANE nearly doubled the
response rate, significantly prolonged time to progression, and significantly improved overall
survival in the second-line setting versus solvent-based Taxol® in the approved indication.
In the U.S. pivotal head-to-head trial, the overall response rate of ABRAXANE was 33% vs.
19% compared to Taxol (P = .001), and ABRAXANE achieved a 25% percent improvement in
time to tumor progression (23.0 weeks vs. 16.9 weeks; hazard ratio = 0.75; P = .006) when
compared to Taxol. Furthermore, patients receiving ABRAXANE in the second-line setting
had a significantly prolonged survival by an additional 27% compared to solvent-based Taxol
(56.4 weeks vs. 46.7 weeks; P = 0.24). The tolerability with ABRAXANE and Taxol was
comparable, despite the 50% greater dose of paclitaxel administered as ABRAXANE.
"The launch of ABRAXANE in the UAE represents a major strategic step in our plan to provide
safer and more effective cancer treatments on a global scale,” said Patrick Soon-Shiong,
M.D., Chairman and Chief Executive Officer of Abraxis BioScience. “In addition to the UAE,
our marketing agreement with Biocon covers more than ten countries, and we are working
closely with national authorities throughout the region to receive regulatory approvals and
commence marketing activities as soon as practicable.”
Dr. B.R. Shetty, MD and CEO, NMC group remarked, "It gives us immense pleasure to
introduce world-class pharmaceutical biotech products, to the United Arab Emirates.” He
Abraxis BioScience and NeoBiocon Announce ABRAXANE Launch in the UAE
Page 2
added, "NeoBiocon is committed to developing a range of products for debilitating disease
segments and will offer products that cater to lifestyle disorders and oncology."
“This launch provides breakthrough therapeutics to cancer patients in the UAE,” said Kiran
Mazumdar-Shaw, Chairman & Managing Director of Biocon. “ABRAXANE is a significant
advance in taxane therapy for the treatment of breast cancer. This unique product eliminates
the need for chemical solvents and allows for higher doses of paclitaxel without compromising
safety and tolerability.”
Rakesh Bamzai, President- Marketing at Biocon, said, “The launch of ABRAXANE reiterates
our belief in strategic licensing partnerships to advance therapeutics in the UAE, and we take
great pride in providing oncologists in the UAE with the latest treatment in breast cancer.”
Neil Desai, Ph.D., Vice President of Research and Development at Abraxis BioScience, said,
“ABRAXANE is the first nanotechnology based anti-cancer drug that is administered as
albumin-bound particles of approximately 130 nanometers and takes advantage of albumin, a
natural protein that acts as the body's key transporter of nutrients and other water-insoluble
molecules and accumulates in tumor tissues. The drug has demonstrated superiority in
progression free survival over both Taxol® Injection and Taxotere® Injection in recent
randomized clinical trials. The initial clinical trials for ABRAXANE were conducted in India and
we are very satisfied to be able to bring this drug to the UAE patients through our partner
NeoBiocon.”
Sumit Bhanot, Head-Operations and Marketing at NeoBiocon, said, “Cancer rates in the UAE
are lower than those seen in Western countries, but are rising with increasing life expectancy
and changing lifestyles. The breast is the second most common site of cancer in women after
the cervix uteri.”
In August 2007, Abraxis established a licensing agreement with Biocon for the
commercialization of ABRAXANE in India. Under the terms of the agreement, Biocon has the
right to market ABRAXANE in India, Pakistan, Bangladesh, Sri Lanka, the United Arab
Emirates, Saudi Arabia, Kuwait and certain other South Asian and Persian Gulf countries.
Subsequently, Abraxis received approval in October 2007 from India’s Drug Control General
to market ABRAXANE in India.
ABRAXANE is approved for marketing in 35 countries. Abraxis has several pending patent
applications in India relating to ABRAXANE. In the Asia-Pacific region, ABRAXANE is
approved for marketing in China and Korea in addition to India. ABRAXANE is under
regulatory review for the treatment of breast cancer by the Therapeutic Goods Administration
(TGA) in Australia, the Federal Authority for Healthcare and Social Development Regulation in
Russia, and the Ministry of Health, Labour and Welfare in Japan.
About ABRAXANE®
ABRAXANE® is a solvent-free chemotherapy treatment option for metastatic breast cancer.
Developed using Abraxis BioScience's proprietary nabTM technology platform, ABRAXANE is
a protein-bound chemotherapy agent, which combines paclitaxel with albumin, a naturallyoccurring human protein, to deliver the drug and eliminate the need for solvents in the
administration process. Because solvents are eliminated, ABRAXANE allows for the delivery
of a 49% higher dose compared to solvent-based paclitaxel (Taxol®) without compromising
safety and tolerability. ABRAXANE is administered in 30 minutes (as compared to three
hours for solvent-based paclitaxel).
Abraxis BioScience and NeoBiocon Announce ABRAXANE Launch in the UAE
Page 3
ABRAXANE is currently in various stages of investigation for the treatment of the following
cancers: first-line metastatic breast, non-small cell lung, malignant melanoma, pancreatic, and
gastric. The most serious adverse events associated with ABRAXANE in the randomized
metastatic breast cancer study for which FDA 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. For the full
prescribing information for ABRAXANE, including Boxed Warning, please visit
www.abraxane.com.
ABRAXANE was developed by Abraxis BioScience and is marketed in the United States
under a co-promotion agreement between Abraxis and AstraZeneca.
About NeoBiocon
NeoBiocon, established at Dubai Biotechnology and Research Park (Dubiotech) in Dubai, is a
JV company between Dr. B.R. Shetty, Managing Director & CEO of Neopharma and India’s
Biocon Ltd, that provides affordable life saving drugs to the people of the UAE. NeoBiocon's
platform emerges from a symbiotic partnership between the two companies. Biocon's
knowledge base and cutting-edge technology and Neopharma's manufacturing prowess and
local expertise will complement each other.
NeoBiocon is a pioneering initiative that heralds the region's first foray to develop and market
life saving biopharmaceutical niche products in key therapeutic areas such as oncology,
diabetes, auto-immune disorders, cardiology, anti-obesity drugs and new generation
immunosuppressant drugs.
NeoBiocon will take initiatives to educate people on the debilitating effects of lifestyle diseases
by rolling out educational campaigns through physician workshops. There will be a dual
approach of local development coupled with educational programs/workshops that will benefit
the local population. Besides the UAE, the office will represent the company in Saudi Arabia,
Kuwait, Bahrain, Qatar and Oman.
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 nabTM platform. The first FDA approved product to use this nabTM
platform, ABRAXANE, was launched in 2005 for the treatment of metastatic breast cancer.
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 launch of
ABRAXANE in India. Because these forward-looking statements involve risks and uncertainties, there
Abraxis BioScience and NeoBiocon Announce ABRAXANE Launch in the UAE
Page 4
are important factors that could cause actual results to differ materially from those in the forwardlooking 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 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.
Taxol® is a registered trademark of Bristol-Myers Squibb Company.
Taxotere® is a registered trademark of Sanofi-Aventis.
###
NeoBiocon Contact:
Sumit Bhanot
Head – Operations and Marketing
P.O. Box 7200, Abu Dhabi
971.2.6332255
Abraxis BioScience Contacts:
Investors and Media Inquiries:
Daniel Saks
Vice President, Investor Relations and Corporate Communications
310.405.7417
Pondel Wilkinson, Inc.
Rob Whetstone
310.279.5963
Press Release - 2
Biocon is the 7th largest biotech employer in the world:
Med Ad News
Bangalore, September 22, 2008: Biocon, India’s pioneering biotechnology enterprise,
announced today that the company has been ranked as the 7th largest employer
amongst the top global biotechnology companies, according to a report released by Med
Ad News. The report takes into consideration drug based firms, as these companies
provide the best numbers to track the progress of the sector. Companies have been
ranked by number of employees and Biocon Limited is the only Asian company to
feature at Number 7.
BIO 2008, held in San Diego recently, stated that the global biotechnology industry will
be a $100 billion annual business by 2010. The actual revenue has reached $85 billion
in 2007. There are close to 5000 biotech companies across the globe. The top 25
biotech companies represent 62 percent of all biotech sales and probably over 90
percent of income.
Reacting to the listing, Ms. Kiran Mazumdar-Shaw, Chairman and Managing Director,
Biocon Limited said, “It is a matter of immense pride for Biocon to be ranked amongst
the top global league of Biotech companies. This is a validation of our consistent effort at
attaining global leadership and also highlights the true potential of this sector in a
country like India. This industry will be a key driver in India’s progress towards economic
development.”
Leading Biotech Companies 2007 - By Number of Employees
Rank 2007
1
Company
Amgen Inc
Employees in 2007
17,500
Employees in 2006
20,100
2
UCB SA
12,102
8,477
3
Genetech Inc.
11,174
10,533
4
Genzyme Corp.
10,000
9,000
5
CSL Ltd.
8,423
7,575
6
Biogen Idec Inc.
4,300
3,750
7
Biocon Ltd.
3,000
2,543
8
Gilead Sciences Inc.
2,979
2,515
9
Cephalon Inc.
2,796
2,895
10
Amylin Pharmaceuticals Inc.
1,990
1,550
Source: Med Ad News, 2008
About Biocon Limited:
Biocon Limited is India’s pioneer biotechnology enterprise established in 1978. Biocon
and its two subsidiaries, Syngene and Clinigene form a fully integrated biotechnology
enterprise, with specialized focus on biopharmaceuticals, contract research and clinical
research. Strategic international acquisitions, such as acquiring a majority in the German
pharmaceutical company, AxiCorp, have given Biocon wider global access and greater
market penetration. Many of our products have USFDA and EMEA acceptance.
Biocon’s proprietary technologies have been used effectively in diabetology, oncology,
cardiology, nephrology and other therapeutic treatments. The company’s robust drug
discovery pipeline offers novel therapies on a platform of affordable innovation. Biocon
launched the world's first recombinant human insulin, INSUGEN® in November 2004
using Pichia expression and India's first indigenously produced monoclonal antibody
BIOMAb-EGFR™ in September 2006. Visit us at www.biocon.com
Biocon Limited Contact:
Paula Sengupta
20th K.M - Hosur Road,
Electronic City P.O.,
Bangalore 560 100
Tel: +91 80 2808 2808
Fax: +91 80 2852 3423
Email: [email protected]
Sonia Sharma/ Guna Shekhar
Tel: +91 80 40429000
Email : [email protected]
[email protected]
Press Release - 3
Biocon Limited presents human clinical data on IN-105 (oral
insulin) at the EASD meeting in Rome.
The results indicate that IN-105 is safe and well tolerated by Type 2 diabetic patients and
is able to significantly drop 2-hour post prandial glucose in a dose-related manner.
Bangalore, India September 08, 2008: Biocon Limited, India’s premier biotechnology
company, announced the results of an ascending dose study with their oral insulin drug (IN-105)
at the European Association for the Study of Diabetes (EASD) meeting in Rome on September
8, 2008. The study involved dosing Type 2 diabetes subjects with single doses of 0 mg
(placebo), 10 mg, 15 mg, 20 mg and 30 mg tablets of IN-105 in 5 separate periods before a
mixed 600 kcal breakfast. The outcome measurements were the safety and tolerability of IN105, as well as the pharmacokinetics and pharmacodynamics of IN-105. The results showed
that IN-105 was safe and well tolerated by patients.
Absorption of IN-105 was proportional to the dose administered; a serum average Cmax of 350
milliunits /litre was reached at 30 minutes post dosing at the highest dose of 30 mg. The
resulting glucose drops showed linearity with respect to the dose. The 2 hour postprandial
glucose rise over baseline for the 10, 15, 20 and 30 mg doses were 15.3, 24.1, 31.3 and 49.5
mg/dL lower than the corresponding rise for placebo. There were no symptomatic
hypoglycemic events observed at any of the doses. Due to the rapid pharamacokinetics of the
drug, there were transient values of hypoglycemia seen soon after the administration of the
drug; however these values did not result in any symptoms due to the rapid alleviation of
glucose levels due to the meal that followed the drug. C-peptide values were also significantly
depressed over all the doses tested, indicating a possibility of beta cell rest in patients dosed
with IN-105. Longer term, 6 month, studies are being planned in Type 2 diabetic subjects to
understand the impact of chronic dosing of IN-105 on postprandial glucose control and glycated
haemoglobin.
“The present study shows that IN105 delivers physiologically active insulin orally in
concentrations sufficient to decrease post-meal hyperglycemia and to decrease the burden of
the meal on endogenous insulin secretion. These data support the feasibility of providing insulin
orally to treat postprandial hyperglycemia in diabetic patients” affirmed Dr Harold E Lebovitz,
M.D, FACE, Professor Of Medicine ,Endocrinology and Diabetes State University of New York
Health Science Center at Brooklyn
“The data presented here show that insulin can be reliably delivered in individuals with type 2
diabetes via the oral route. Further the administered insulin improved control post meal plasma
glucose without causing symptomatic hypoglycemia. Such data support the feasibility of oral
insulin delivery as a therapeutic option” said Prof Alan D. Cherrington, Ph.D. Professor of
Molecular Physiology & Biophysics, Professor of Medicine, Vanderbilt University.
About IN-105
IN-105 is a novel analog of insulin, proprietary to Biocon. The product has special properties
that make it feasible for delivery in tablet form stable at room temperature. The advantages of
tablet delivery go beyond the obvious. Besides being a needle-free insulin, this method of
delivery allows IN-105 to be delivered into the body in a physiological manner that mimics the
way that the pancreas release insulin into the circulation (i.e. into the portal vein). This contrasts
with all the other known methods of delivery, including inhaled insulin, which brings in insulin
from the periphery into the circulation.
About Biocon Limited
Biocon Limited is India’s pioneer biotechnology enterprise established in 1978. Biocon
and its two subsidiaries, Syngene and Clinigene form a fully integrated biotechnology
enterprise, with specialized focus on biopharmaceuticals, contract research and clinical
research. Strategic international acquisitions, such as acquiring a majority in the
German pharmaceutical company, AxiCorp, have given Biocon wider global access and
greater market penetration. Many of our products have USFDA and EMEA acceptance.
Biocon’s proprietary technologies have been used effectively in diabetology, oncology,
cardiology, nephrology and other therapeutic treatments. The company’s robust drug
discovery pipeline offers novel therapies on a platform of affordable innovation. Biocon
launched the world's first recombinant human insulin, INSUGEN® in November 2004
using Pichia expression and India's first indigenously produced monoclonal antibody
BIOMAb-EGFR™ in September 2006. Visit the company at www.biocon.com.
Disclaimer
This press release includes forward-looking statements based on our current expectations and
projections about future events. Such statements involve known and unknown risks,
uncertainties and other factors that may cause actual results to differ materially. Such factors
include, but are not limited to, our ability to attract and retain highly skilled professionals, time
and cost overruns on research and development, regulatory developments, our ability to
manage our international operations, reduced demand for technology in our key focus areas,
our ability to successfully manage strategic investments, withdrawal of governmental fiscal
incentives, political instability and regional conflicts, unauthorized use of our intellectual property
and general economic conditions affecting our industry, our ability to successfully implement our
research strategy, the market acceptance of and demand for our products, our growth and
expansion. Any statements in the form of expectations or projections are merely estimates and
the actual results could be materially different in the future. We may, from time to time, make
additional written and oral forward-looking statements, including statements contained in the
company's filings with the Securities and Exchange Board and our reports to shareholders. The
company does not undertake to update any forward-looking statements that may be made from
time to time by or on behalf of the company.
For further information please contact:
Biocon Limited Contact:
Dr. Harish V Iyer
General Manager – R&D
Mob: +919845048327
[email protected] Ms Paula Sengupta Head Corporate Communications [email protected] Phone: +91 80 28082222