Download biocon and abraxis bioscience launch abraxane in india

Press Release - 1
BIOCON AND ABRAXIS BIOSCIENCE LAUNCH ABRAXANE IN INDIA
FOR TREATMENT OF BREAST CANCER
BANGALORE, India, and LOS ANGELES, California, (July 18, 2008) – Biocon Limited,
India's pioneering 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 India for the
treatment of breast cancer after failure of combination therapy for metastatic disease or
relapse within six months of adjuvant chemotherapy. ABRAXANE is now available in India as
a single-use 100 mg vial (as a lyophilized powder, to be reconstituted for intravenous
administration).
In October 2007, ABRAXANE was approved by the Drug Controller General of India. The
approval was based on the clinical trial data that was the basis of approval in the United
States. 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.
Abraxis BioScience and Biocon Announce ABRAXANE Launch in India
Page 2
"The launch of ABRAXANE in India 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 India, 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.”
“This launch provides breakthrough therapeutics to cancer patients in India,” 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. The launch of ABRAXANE reiterates our belief in strategic licensing
partnerships to advance therapeutics in India, and we take great pride in providing oncologists
in India with the latest treatment in breast cancer.”
Ms. Mazumdar-Shaw noted that ABRAXANE is an important addition to Biocon's
Oncotherapeutics portfolio, which has already seen the successful launch of its proprietary
antibody, BIOMAb EGFR™ for the treatment of head and neck cancers.
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 Indian patients through our partner
Biocon.”
Rakesh Bamzai, President – Marketing, Biocon, said, “Presently, more than 100,000 new
cases of breast cancer occur in Indian women every year. Breast cancer is the second largest
cause of death among women diagnosed with cancer in India. With the launch of ABRAXANE
through Biocon’s innovation led Oncotherapeutics division and the growing need for this drug
in the country, we look forward to attaining market leadership in this segment.”
Abraxis BioScience and Biocon Announce ABRAXANE Launch in India
Page 3
Cancer rates in India are lower than those seen in Western countries, but are rising with
increasing migration of rural population to the cities, increasing life expectancy and changing
lifestyles. The breast is the second most common site of cancer in women after the cervix
uteri. In the metropolitan cities of New Delhi and Mumbai, it is the most common kind of
cancer in women. The annual age-adjusted rate (AAR) varies between the urban and rural
areas. In the urban areas, the AAR is 21.9 to 28.3 per 100,000, whereas in rural areas, it is
8.6 per 100,000.
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 Biocon Announce ABRAXANE Launch in India
Page 4
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 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 BIOMAbEGFR™ in September 2006. Visit the company at www.biocon.com
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
Abraxis BioScience and Biocon Announce ABRAXANE Launch in India
Page 5
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 forwardlooking 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 are important factors that could cause actual
results to differ materially from those in the forward-looking statements. These factors
include, without limitation, unexpected safety, efficacy or manufacturing issues with respect to
ABRAXANE; the need for additional data or clinical studies for ABRAXANE; regulatory
developments (domestic or foreign) involving the company’s manufacturing facilities; the
market adoption and demand of ABRAXANE, the costs associated with the ongoing launch of
ABRAXANE; the impact of pharmaceutical industry regulation; the impact of competitive
products and pricing; the availability and pricing of ingredients used in the manufacture of
pharmaceutical products; the ability to successfully manufacture products in a time-sensitive
and cost effective manner; the acceptance and demand of new pharmaceutical products; and
the impact of patents and other proprietary rights held by competitors and other third parties.
Additional relevant information concerning risks can be found in the company’s Annual Report
on Form 10-K for the year ended December 31, 2007 and in other documents it has filed with
the Securities and Exchange Commission.
The information contained in this press release is as of the date of this release. Abraxis
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.
###
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
Abraxis BioScience and Biocon Announce ABRAXANE Launch in India
Page 6
BioCon Limited Contact:
Paula Sengupta/Gayatri Appaya
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]
[email protected]
Sonia Sharma/ Guna Shekhar
Tel: +91 80 4126 5354
Email : [email protected]
[email protected]
Press Release - 2
BIOCON’S Q1 FY ‘09 IMPACTED BY EXCEPTIONAL FACTORS
Revenues Rs. 277 crores. EBITDA Rs. 70 crores
PAT Rs. 15 crores (MTM provision Rs. 26 crores)
Bangalore, July 17th, 2008
Biocon Limited today announced its financial performance for the three months ended June
30th, 2008.
PERFORMANCE HIGHLIGHTS
•
Sales on a like for like basis (i.e. excluding enzymes) increased by 7%.
•
Pre tax profits at a consolidated level were impacted by exchange losses across the group by
Rs. 6 crores. A Mark to Market provision of Rs. 26 crores added to the impact.
•
Absence of licensing income affected Q1 FY ‘09 profits. Licensing income is event driven
and inherently variable across quarters. Licensing Income accounted for Rs. 17 crores in Q1
FY ’08.
•
Biopharmaceutical business (excluding licensing income) showed 40% increase in PAT (from
Rs. 28 crores in Q-1 FY ’08 to Rs. 39 crores in Q-1 FY ’09) demonstrating strong profit
growth in our core biopharmaceutical business.
•
Branded formulations encompassing Cardio-Diabetes, Nephrology and Oncology delivered
good growth.
•
Syngene had a difficult quarter due to a number of factors. The impact of currency loss
combined with operational delays resulted in a Rs. 6 crores decline in operating profit.
•
Clinigene is now fully operational at its new facility and is on track to deliver 100% growth
this fiscal.
•
Biocon’s balance sheet remains strong. Net cash as on 30 June 2008 was Rs. 74 crores.
•
Clinical development of the Company’s lead programs viz., IN105 (Oral Insulin) and T1h
(Anti CD6 Monoclonal antibody) are progressing well.
•
Biocon filed 23 new patents in Q1 FY ’09 bringing the total tally to 881 filed and 154
granted patents.
•
Biocon has been ranked the 20 leading Biotechnology company in the world and No:1 in
Asia by a reputed US trade journal.
th
th
.
Outlook:
Commenting on the results, Kiran Mazumdar-Shaw, Chairman & Managing Director, Biocon
Limited, said:
“Biocon’s Q1 FY ’09 performance has been unfortunately impacted by Rupee volatility which has
seen us make a Mark to Market provision of Rs. 26 crores. We have consciously been conservative
in making this provision. I believe that our business fundamentals are robust, which is well
demonstrated by the strong profit growth in our core biopharmaceutical business. The absence of
licensing income this quarter has had a disproportionate impact on profitability. However, we are
confident that licensing income will be significant this fiscal. We are particularly encouraged by
the good growth demonstrated by our branded formulations where several brands have attained
®
high rankings in their product segments in India. INSUGEN has now garnered an all India market
share of ~15% in the vial segment.
Syngene has had a particularly difficult quarter. Management is confident of compensating for
this in the quarters ahead especially with the BMS facility becoming fully operational in Q3
FY ’09.
Clinigene is now fully operational at its new facility and is on track to deliver good growth this
fiscal.
We are making excellent progress on the research front with several programs approaching a
licensing phase over the next 2 years, which is expected to provide attractive ROI.
We expect the quarters ahead to compensate for the exchange losses booked this quarter and
end the year with improved profitability.”
CORPORATE DEVELOPMENTS:
Biocon to launch Abraxane on 18th July, 2008
Biocon Limited, India's pioneering biotechnology company, and Abraxis BioScience, Inc.
(NASDAQ:ABII), a fully integrated biotechnology company, announced the launch of ABRAXANE®
(paclitaxel protein-bound particles for injectable suspension) (albumin-bound) in India for the
treatment of breast cancer after failure of combination therapy for metastatic disease or relapse
within six months of adjuvant chemotherapy. ABRAXANE is now available in India as a single-use
100 mg vial (as a lyophilized powder, to be reconstituted for intravenous administration).
ABRAXANE is approved for marketing in 35 countries including USA and Europe.
Biocon to present IN105 data at EASD, 2008
Dr. Harish Iyer, Head of R&D will present the latest data on an ascending dose Phase IIa Clinical
study on Type II Diabetic patients using IN 105 (Oral Insulin) at The European Association for the
Study of Diabetes meeting to be held in Rome between September 8-11th 2008. This is the first
time this data is being presented at a public forum. The data clearly establishes the linear dose
related response of IN105 which paves the way forward for longer term clinical trials. Phase IIb/III
clinical trials are being planned for later in the year.
Biocon is ranked 20th leading Biotechnology Company in the world by Med Ad News
Med Ad News, a leading US Trade publication, ranked Biocon at No. 20 in its 2007 list of Leading
Global Biotechnology Companies, based on revenue and income . The report takes into
consideration drug based firms, as these companies provide the best numbers to track the
progress of the sector. Biocon Limited is the only Asian company to feature in the Top 25.
------------------------------------------------------------------------------------------------------------------------------
Note: The discussions in this release reflect the audited financial performance of Biocon Limited
based on Indian GAAP on a consolidated basis. This considers the financial performance of
Biocon Limited, its wholly owned subsidiaries Syngene International Limited and Clinigene
International Limited and its 51% joint venture Biocon Biopharmaceuticals Private Limited.
----------------------------------------------------------------------------------------------------------------------About Biocon: Established in 1978, Biocon Limited is one of India's premier biotechnology
companies. Biocon and its two subsidiary companies, Syngene International Ltd and Clinigene
International Ltd form a fully integrated biotechnology enterprise, specializing in
biopharmaceuticals, custom research and clinical research. With successful initiatives in clinical
development, bio-processing and global marketing, Biocon delivers products and solutions to
partners and customers across the globe. Many of these products have USFDA and EMEA
acceptance. 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-EGFRTM. Visit us at www.biocon.com
Certain statements in this release concerning our future growth prospects are forward-looking
statements, which are subject to a number of risks, uncertainties and assumptions that could
cause actual results to differ materially from those contemplated in such forward-looking
statements. Important factors that could cause actual results to differ materially from our
expectations include, amongst others general economic and business conditions in India, our
ability to successfully implement our strategy, our research and development efforts, our growth
and expansion plans and technological changes, changes in the value of the Rupee and other
currency changes, changes in the Indian and international interest rates, change in laws and
regulations that apply to the Indian and global biotechnology and pharmaceuticals industries,
increasing competition in and the conditions of the Indian biotechnology and pharmaceuticals
industries, changes in political conditions in India and changes in the foreign exchange control
regulations in India. Neither our company, our directors, nor any of our affiliates have any
obligation to update or otherwise revise any statements reflecting circumstances arising after this
date or to reflect the occurrence of underlying events, even if the underlying assumptions do not
come to fruition.
For further information contact:
BIOCON LIMITED,
20th K.M – Hosur Road,
Electronics City P.O.,
Bangalore – 560 100
Paula Sengupta / Gayatri Appaya
Phone: +91 80 2808 2222
Fax: +91 80 2852 3423
Email: [email protected]
[email protected]
Press Release - 3
Biocon is world’s top 20 biotechnology company : Med Ad News
Bangalore, July 17, 2008: Biocon, India’s pioneering biotechnology enterprise,
announced today that the company has been featured amongst the top 25 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 revenue and by
income and Biocon Limited is the only Asian company to feature in this ranking at
Number 20.
BIO 2008, held in San Diego last month, 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.”
Nineteen of the top 25 companies are based in the U.S., while six companies hail from
Europe to India to Australia.
Leading Biotech Companies 2007 - By Revenue and Income
Company/Country
2007 Revenue
(billions)
%
Growt
h
2007 Income
(billions)
% Growth
1. Amgen (U.S.)
$14.8
+4%
$3.2
+7%
2. Genentech (U.S.)
$11.7
+26%
$2.8
+31%
3. UCB (Belgium)
$5.0
+42%
$.2
(56%)
4. Gilead Sciences (U.S.)
$4.2
+40%
$1.6
>999%
5. Genzyme (U.S.)
$3.8
+20%
$.5
>999%
6. Biogen Idec (U.S.)
$3.2
+18%
$.6
+193%
7. CSL ( Australia)
$2.8
+14%
$.5
+359%
8. Cephalon (U.S.)
$1.8
+1%
($.2)
(>999%)
9. Celgene (U.S.)
$1.4
+56%
$.2
+128%
10.Actelion (Switzerland)
$1.1
+39%
$.1
(49%)
11. Amylin
Pharmaceuticals (U.S.)
$.8
+53%
($.2)
+3%
12. Elan (Ireland)
$.8
+36%
($.4)
(65%)
13. ImClone Systems
(U.S.)
$.6
(13%)
>$.1
(>999%)
14. Millenium
Pharmaceuticals (U.S.)
$.5
+9%
>$.1
NA
15. OSI Pharmaceuticals
(U.S.)
$.3
+41%
$.1
>999%
16. Abraxis Bioscience
(U.S.)
$.3
+84%
(>$.1)
NA
17. Cubist
Pharmaceuticals (U.S.)
$.3
+51%
$.1
>999%
18. Crucell (Netherlands)
$.3
+55%
($.1)
100%
19. Nektar Therapeutics
(U.S.)
$.3
+25%
($.1)
NA
20. Biocon (India)
$.3
+10%
$.1
+25%
21. PDL BioPharma
(USA)
$.3
+4%
-
NA
22. Alkermes (U.S.)
$.2
+44%
-
+125%
23. United Therapeutics
(U.S.)
$.2
+32%
-
(73%)
24. ViroPharma (U.S.)
$.2
+28%
$.1
+42%
25. Vertex
Pharmaceuticals (U.S.)
$.2
(8%)
($.4)
(100%)
Top 25
$52.5
+13%
$8.7
+129%
Source: Med Ad News, June, 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/Gayatri Appaya
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]
[email protected]
Sonia Sharma/ Guna Shekhar
Tel: +91 80 4126 5354
Email : [email protected]
[email protected]
Press Release – 4
Biocon launches ‘ERYPRO Safe™’ and ‘NUFIL Safe™’ Pre-filled
Syringes in collaboration with Safety Syringes Inc., USA
First-of-its-kind New Drug Delivery System introduced in India
Bangalore: June 4, 2008: Biocon Limited, India’s pioneering biotechnology
company has announced the launch of a Safety Device in the form of pre-filled
syringes for two of its life saving products, GCSF (granulocyte-colony stimulating
factor) and EPO (Erythropoietin). This innovative product has been launched in
collaboration with Safety Syringes Inc. and is being introduced for the first time in
India. ERYPRO Safe™ and NUFIL Safe™ will be the first two drugs that will
marketed using this novel device with other injectable products to follow in the future.
Pre-filled syringes are advantageous for self-injecting patients. This allows patients a
high degree of flexibility, independence and simple handling in a home setting.
Biocon’s pre-filled syringe device incorporates features that provide for simple and
safe handing, a discrete appearance of the injector and a retractable needle that
reduces the chances of injuries during injection. The device is tamper proof and
ensures that the syringe is non-reusable thus ensuring safety of the highest order.
Biocon has decided to launch two of its life saving drugs using this novel device viz.
ERYPRO Safe™ and NUFIL Safe™ . These products will be available across the
country at the prices listed in the table below.
ERYPRO Safe™
ERYPRO Safe™
ERYPRO Safe™
ERYPRO Safe™
ERYPRO Safe™
2000IU
3000IU
4000IU
5000IU
10000IU
MRP – 715 (Incl Tax)
MRP - 975 (Incl Tax)
MRP – 1295(Incl Tax)
MRP – 1465 (Incl Tax)
MRP – 2995(Incl Tax)
Ms. Kiran Mazumdar-Shaw, Chairman and Managing Director, Biocon Limited
said, “In line with our philosophy of differentiation, we are pleased to introduce
ERYPRO Safe™ and NUFIL Safe™ as pre-filled syringes with advanced safety
features. Safety Syringes Inc. of USA have developed a novel pre-filled device that
enhances safety and convenience of use. We are delighted to be able to collaborate
with them and introduce this proprietary device to the Indian market for the first time
which will greatly benefit Indian patients.”
Commenting on the launch, Mr. Rakesh Bamzai, President, Marketing, Biocon
Limited said, “Biocon is committed to cater to the needs of patients across
the country and this technology will be advantageous to our patients.
The launch of this new drug delivery system is significant as it allows for
product differentiation in the market. This also means simplified drug
administration and better patient compliance. With this launch, Biocon has
placed great emphasis on the safety of patients and the medical
fraternity involved in the administration of ERYPRO Safe™ and NUFIL
Safe™. We are excited about our collaboration with Safety Syringes Inc. and
will look at making other products available in this format.”
“We are very pleased to add Biocon Limited as our newest valued pharma
partner. The introduction of the ERYPRO Safe™ and NUFIL Safe™– the
UltraSafe Passive® Delivery System – represents a significant advantage for
Biocon over other drug delivery devices for prefilled syringe presentations.”
added Mr. Mark Hassett, Executive Vice President, Safety Syringes Inc.
Biocon Limited will also look at launching this product in other markets in the
coming months.
The pharmaceutical industry has registered an increasing demand in the
market segment of pre-filled syringe systems over the past ten years. These
systems have the endorsement of healthcare professionals worldwide. There
is a growing trend of injectable drugs moving into the pre-fill syringe as a
presentation format. Worldwide, prefilled syringe volumes have reached more
than two billion units. The opportunity for Indian biotech companies in prefilled syringes is immense as India is being viewed as a low-cost, high-quality
manufacturing base. It has the largest number of USFDA approved plants
outside the US.
About Safety Syringes, Inc.
Safety Syringes, Inc., headquartered in Carlsbad, California, develops and
manufactures delivery systems for vaccines, low molecular weight heparins,
epoetins, and other medicines including many of the newer biotechnology
drugs.
Safety Syringes offers proven and preferred drug delivery systems for a full
range of prefilled glass syringe presentations ranging from 0.5mL to 2.25mL
and for use with staked needle, luer lock and luer slip configurations.
The UltraSafe Passive® Delivery System is overwhelmingly chosen by
leading pharmaceutical companies around the world for ease of use and
protection against needle stick injuries.
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
PR contact:
SAFETY SYRINGES, INC.
Mark Hassett
Phone: +760-918-9908
E-Mail: [email protected]
BIOCON LIMITED
Paula Sengupta /Gayatri Appaya
Phone: +91 80 28082222
Email: [email protected]
:[email protected]