Intas Biopharmaceuticals
Encyclopedia
Intas Biopharmaceuticals Ltd. is an Indian biotechnology
company
headquartered in Ahmedabad, India. Located in the Moraiya,Ahmedabad,it is one of the leading biosimilar
product manufacturer in Asia.
As an independent biopharmaceutical
company of the Intas Group, the company has fully integrated biopharmaceutical operations with R&D facility and an EU-GMP certified bio-pharmaceutical manufacturing facility.
Intas Biopharma is also actively pursuing the Contract Research and Manufacturing Services(CRAMS) line of business. To expand its CRAMS business, Intas Biopharmaceuticals Ltd., in June 2008, acquired a US biotechnology corporation, Biologics Process Development Incorporated (BPD), based in Poway, California.
The biotechnology division was demerged as an independent company Intas Biopharmaceutcials Ltd. in Sep 2006. The ownership of the new company remained with the Chudgar family.
Kotak Private Equity Group invested USD 10 Million equity in the company in late 2007. Till that time company had invested $25 Million in its facility.
The company faced EU-GMP (Good Manufacturing Practice
) audit in Dec 2006, in order to seek approval of clinical trial of its biosimilar Filgrastim
in Europe and was certified as EU-GMP compliant in April 2007, becoming the first company in India to receive such certification for biologics facility.
Apart from EU-GMP certification, the company also has approvals from MCC South Africa
, Gulf Cooperation Council(GCC), Syria
, Yemen
, Belarus
and several other national health authorities for its manufacturing facility and products.
)/ GCSF, in July 2004.
Erythropoietin
injection, under the brand name of Erykine, for anemia due to critical illness like chemotherapy, was introduced in Aug 2005 and Interferon
α2b, under the brand name of Intalfa, was launched in April 2007.
Intas Biopharma also considers itself the first company in the world, after the innovator Amgen, to introduce a PEGylated version of GCSF (PEG-GCSF), under the brand name of Neupeg. Neupeg was launched in Aug 2007. The PEG (polyethylene glycol
) form has a much longer half-life, reducing the necessity of daily injections.
Intas Biopharma plans to invest about US$ 30 million to set up a new drug manufacturing facility dedicated for large-scale manufacturing of Monoclonal antibodies
based products. The commercial production at the proposed facility is likely to commence by year 2011. For set up of this plant Intas Biopharma signed a Memorandum of Understanding (MoU) with the Government of Gujarat for availing special incentives for the project.
Kwizda, Austria and Intas Biopharmaceuticals Ltd. jointly completed phase I clinical trial study of Neukine, biosimilar form of recombinant GCSF in April 2008, paving way towards start of Phase III Clinical trials in Europe.The study was a single-dose, randomised, double blind, two-way crossover trial and used an active control. With this study, Intas Biopharmaceuticals became first Indian company to enter the regulated biotherapeutic market.
Intas Biopharmaceuticals Ltd signed an agreement with Canadian drug major Apotex
Inc, in May 2008, to co-develop and market the low-cost version of a biotech cancer medicine filgrastim (G-CSF) in North America and Europe.
Apotex and Intas Biopharma in Jan 2009 extended their agreement to develop a biosimilar version of pegfilgrastim. This collaboration gives Apotex the rights to market the product manufactured by Intas Biopharmaceuticals in North America, Europe and selected other countries.
Biologics Process Development Inc., based in Poway, California
, is a 100% subsidiary of Intas Biopharmaceuticals Limited, offering research services in the area of Molecular Biology. The biotechnology corporation offers range of R&D services including Express optimization, cell culture, bacterial fermentation, early-stage consulting services.
Celestial Biologicals Limited, focuses on marketing and distribution of plasma-derived products. The company is engaged in marketing of plasma proteins – Albumin, Globucel and Immunoglobulins (IVIG) in the Indian market. Celestial Biologicals is the only player in India, which sources plasma from various blood banks in within India. The company planning to create South Asia’s largest plasma fractionation facility.
Biotechnology
Biotechnology is a field of applied biology that involves the use of living organisms and bioprocesses in engineering, technology, medicine and other fields requiring bioproducts. Biotechnology also utilizes these products for manufacturing purpose...
company
Corporation
A corporation is created under the laws of a state as a separate legal entity that has privileges and liabilities that are distinct from those of its members. There are many different forms of corporations, most of which are used to conduct business. Early corporations were established by charter...
headquartered in Ahmedabad, India. Located in the Moraiya,Ahmedabad,it is one of the leading biosimilar
Biosimilar
Biosimilars or follow-on biologics are terms used to describe officially-approved subsequent versions of innovator biopharmaceutical products made by a different sponsor following patent and exclusivity expiry on the innovator product. Biosimilars are also referred to as subsequent entry biologics ...
product manufacturer in Asia.
As an independent biopharmaceutical
Biopharmaceutical
Biopharmaceuticals are medical drugs produced using biotechnology. They include proteins , nucleic acids and living microorganisms like virus and bacteria where the virulence of viruses and bacteria is reduced by the process of attenuation, they can be used for therapeutic or in vivo diagnostic...
company of the Intas Group, the company has fully integrated biopharmaceutical operations with R&D facility and an EU-GMP certified bio-pharmaceutical manufacturing facility.
Intas Biopharma is also actively pursuing the Contract Research and Manufacturing Services(CRAMS) line of business. To expand its CRAMS business, Intas Biopharmaceuticals Ltd., in June 2008, acquired a US biotechnology corporation, Biologics Process Development Incorporated (BPD), based in Poway, California.
History
Intas Biopharmaceuticals Limited was set up in year 2000, as an independent biotechnology division of Intas Pharmaceuticals Ltd., a mid-sized generic formulation manufacturer located in Ahmedabad, India.Kotak Private Equity Group invested USD 10 Million equity in the company in late 2007. Till that time company had invested $25 Million in its facility.
The company faced EU-GMP (Good Manufacturing Practice
Good Manufacturing Practice
"Good manufacturing practice" or "GMP" are practices and the systems required to be adapted in pharmaceutical manufacturing, quality control, quality system covering the manufacture and testing of pharmaceuticals or drugs including active pharmaceutical ingredients, diagnostics, foods,...
) audit in Dec 2006, in order to seek approval of clinical trial of its biosimilar Filgrastim
Filgrastim
Filgrastim is a granulocyte colony-stimulating factor analog used to stimulate the proliferation and differentiation of granulocytes. It is produced by recombinant DNA technology. The gene for human granulocyte colony-stimulating factor is inserted into the genetic material of Escherichia coli. ...
in Europe and was certified as EU-GMP compliant in April 2007, becoming the first company in India to receive such certification for biologics facility.
Apart from EU-GMP certification, the company also has approvals from MCC South Africa
South Africa
The Republic of South Africa is a country in southern Africa. Located at the southern tip of Africa, it is divided into nine provinces, with of coastline on the Atlantic and Indian oceans...
, Gulf Cooperation Council(GCC), Syria
Syria
Syria , officially the Syrian Arab Republic , is a country in Western Asia, bordering Lebanon and the Mediterranean Sea to the West, Turkey to the north, Iraq to the east, Jordan to the south, and Israel to the southwest....
, Yemen
Yemen
The Republic of Yemen , commonly known as Yemen , is a country located in the Middle East, occupying the southwestern to southern end of the Arabian Peninsula. It is bordered by Saudi Arabia to the north, the Red Sea to the west, and Oman to the east....
, Belarus
Belarus
Belarus , officially the Republic of Belarus, is a landlocked country in Eastern Europe, bordered clockwise by Russia to the northeast, Ukraine to the south, Poland to the west, and Lithuania and Latvia to the northwest. Its capital is Minsk; other major cities include Brest, Grodno , Gomel ,...
and several other national health authorities for its manufacturing facility and products.
Products
Intas Biopharma has focused on biosimilars and has generic versions of 3 of the top 10 blockbuster drugs in its product basket. It launched its first product, Neukine injection (FilgrastimFilgrastim
Filgrastim is a granulocyte colony-stimulating factor analog used to stimulate the proliferation and differentiation of granulocytes. It is produced by recombinant DNA technology. The gene for human granulocyte colony-stimulating factor is inserted into the genetic material of Escherichia coli. ...
)/ GCSF, in July 2004.
Erythropoietin
Erythropoietin
Erythropoietin, or its alternatives erythropoetin or erthropoyetin or EPO, is a glycoprotein hormone that controls erythropoiesis, or red blood cell production...
injection, under the brand name of Erykine, for anemia due to critical illness like chemotherapy, was introduced in Aug 2005 and Interferon
Interferon
Interferons are proteins made and released by host cells in response to the presence of pathogens—such as viruses, bacteria, or parasites—or tumor cells. They allow communication between cells to trigger the protective defenses of the immune system that eradicate pathogens or tumors.IFNs belong to...
α2b, under the brand name of Intalfa, was launched in April 2007.
Intas Biopharma also considers itself the first company in the world, after the innovator Amgen, to introduce a PEGylated version of GCSF (PEG-GCSF), under the brand name of Neupeg. Neupeg was launched in Aug 2007. The PEG (polyethylene glycol
Polyethylene glycol
Polyethylene glycol is a polyether compound with many applications from industrial manufacturing to medicine. It has also been known as polyethylene oxide or polyoxyethylene , depending on its molecular weight, and under the tradename Carbowax.-Available forms:PEG, PEO, or POE refers to an...
) form has a much longer half-life, reducing the necessity of daily injections.
Intas Biopharma plans to invest about US$ 30 million to set up a new drug manufacturing facility dedicated for large-scale manufacturing of Monoclonal antibodies
Monoclonal antibodies
Monoclonal antibodies are monospecific antibodies that are the same because they are made by identical immune cells that are all clones of a unique parent cell....
based products. The commercial production at the proposed facility is likely to commence by year 2011. For set up of this plant Intas Biopharma signed a Memorandum of Understanding (MoU) with the Government of Gujarat for availing special incentives for the project.
Collaborations & Partnerships
The company has entered into several supply and marketing agreements with several companies in regulated and semi-regulated markets of Europe, Asia-Pacific, Middle East, Russia & CIS, South and Central America and Africa.Kwizda, Austria and Intas Biopharmaceuticals Ltd. jointly completed phase I clinical trial study of Neukine, biosimilar form of recombinant GCSF in April 2008, paving way towards start of Phase III Clinical trials in Europe.The study was a single-dose, randomised, double blind, two-way crossover trial and used an active control. With this study, Intas Biopharmaceuticals became first Indian company to enter the regulated biotherapeutic market.
Intas Biopharmaceuticals Ltd signed an agreement with Canadian drug major Apotex
Apotex
Apotex is a Canadian pharmaceutical corporation. Founded in 1974, the company is the largest producer of generic drugs in Canada, with sales exceeding one billion dollars a year...
Inc, in May 2008, to co-develop and market the low-cost version of a biotech cancer medicine filgrastim (G-CSF) in North America and Europe.
Apotex and Intas Biopharma in Jan 2009 extended their agreement to develop a biosimilar version of pegfilgrastim. This collaboration gives Apotex the rights to market the product manufactured by Intas Biopharmaceuticals in North America, Europe and selected other countries.
Subsidiaries
Indus Biotherapeutics Limited is a dedicated biopharmaceutical Contract Research Organization. This company solely concentrates on research and development of novel targets as well as bio-generics. Indus offers services in the areas of process and product development, analytical method development, bio-chemical immunological analysis, process validation, scale-up and technology transfer to manufacturing scale.Biologics Process Development Inc., based in Poway, California
California
California is a state located on the West Coast of the United States. It is by far the most populous U.S. state, and the third-largest by land area...
, is a 100% subsidiary of Intas Biopharmaceuticals Limited, offering research services in the area of Molecular Biology. The biotechnology corporation offers range of R&D services including Express optimization, cell culture, bacterial fermentation, early-stage consulting services.
Celestial Biologicals Limited, focuses on marketing and distribution of plasma-derived products. The company is engaged in marketing of plasma proteins – Albumin, Globucel and Immunoglobulins (IVIG) in the Indian market. Celestial Biologicals is the only player in India, which sources plasma from various blood banks in within India. The company planning to create South Asia’s largest plasma fractionation facility.
External links
- Intas Biopharmaceuticals Ltd: Official website
- Indus Biotherapeutics Ltd.
- Biologics Process Development Inc.
- Intas Pharmaceuticals Ltd.
- Profile at Contract Service Directory, Contract Pharma USA
- Kotak Private Equity Group
- Government of Gujarat
News Articles
- http://www.prurgent.com/2009-02-25/pressrelease31470.htm Intas Biopharma to market PEMETREXED in India : February 2009
- http://www.intasbiopharma.co.in/index.php?act=PressDetailed&id=93 Apotex and Intas Biopharmaceuticals extend their collaborative development of biosimilars to include Peg filgrastim : January 2009
- http://www.intasbiopharma.co.in/index.php?act=PressDetailed&id=79 Intas Biopharma to Market Lung Cancer Drug GEFITINIB in India : May 2008
- http://www.pressemeldinger.no/read.asp?RecNo=48943 Biosimilar G-CSF: Cooperation on Three Continents : April 2008
- http://www.expresspharmaonline.com/20080615/gogujarat06.shtml Paragon of success : June 2008
- http://www.intasbiopharma.co.in/index.php?act=PressDetailed&id=82 Intas Biopharma launches new Sales Divisions in India : March 2008