First European Product Containing Delta Biotechnology's Recombumin Receives Marketing Approval from the EMEA
First European Product Containing Delta Biotechnology's Recombumin Receives Marketing Approval from the EMEA
NOTTINGHAM, England, May 22, 2006 - Delta Biotechnology Ltd announced today that the European Medicines Agency (EMEA) has granted a Marketing Authorisation for Sanofi Pasteur MSD's M-M-RVAXPRO(tm) childhood vaccine (measles, mumps and rubella virus (live)). The vaccine is manufactured using and containing Recombumin(r); a recombinant human albumin produced by Delta Biotechnology. Recombumin(r) is a biosynthetic, animal-free material for use in vaccine production and biopharmaceutical formulation.
This development results from collaborative efforts between Delta and Sanofi Pasteur MSD and Merck & Co. To define and test the use of recombinant albumin in the measles, mumps and rubella vaccine production process. Recombumin(r) replaces the human serum albumin currently used in Sanofi Pasteur MSD's MMR vaccine. Following this announcement, Recombumin(r) is the only animal-free, commercially available, recombinant human albumin approved by both the EMEA and FDA for use in the manufacture of human therapeutics. It is a structurally identical, yeast-derived alternative to HSA, which has the potential to improve product acceptance by the regulatory authorities.
Recombumin(r) is manufactured at Delta's cGMP-compliant, Health Canada and FDA inspected facility in Nottingham, UK by a team with over 20 years of leadership and expertise in the development of an animal free biomanufacturing process for the commercial production of recombinant human albumin.
"We are very proud to have gained regulatory approval for the use of Recombumin(r) from both the EMEA and FDA", commented Werner Merkle, CEO of Delta Biotechnology. "Recombumin(r) has passed the strictest regulatory standards and we are now looking forward to global rollout of our premier recombinant albumin product".
"Our customers can now reap the proven benefits of using animal component free recombinant human albumin in their vaccine production and drug formulation. Recombumin(r) provides the industry with an animal-free alternative to human serum albumin. We have approximately 30 healthcare companies evaluating its use in their products with several in clinical development in Europe and the US", added Dermot Pearson, Commercial Operations Director of Delta Biotechnology.
See: http://ec.europa.eu/enterprise/pharmaceuticals/register/2006/20060505112 95/dec_11295_en.pdf for a list of approved products manufactured using and containing Recombumin(r).
For a high resolution image of Recombumin(r), please contact Ben Routley at Northbank Communications on: +44 (0) 1260 296 500 or b.routley@northbankcommunications.com
M-M-RVAXPRO(tm) is the Sanofi Pasteur MSD registered trademark for measles, mumps and rubella virus vaccine live.
About Delta Biotechnology:
Delta Biotechnology Ltd develops and manufactures its lead product, Recombumin(r) using highly engineered, proprietary Saccharomyces cerevisiae yeast strains. The Company also undertakes flexible licensing of its yeast based expression system to offer its pharmaceutical, healthcare and biotech partners customised solutions to their recombinant protein needs. Delta's capabilities range from state of the art molecular biology manipulation of yeast, through to fermentation, process development and analytics to commercial-scale manufacture of proteins in a Health Canada and FDA-inspected, cGMP-compliant facility with an 8000L fermentation capacity.
The Company's proprietary yeast based expression technologies and accompanying Intellectual Property portfolio has resulted in animal component free, high-yielding systems for the production of recombinant proteins at an extremely competitive cost of goods. Delta's protein expression abilities include both the production of native or modified polypeptides and the secretion of proteins genetically fused to albumin using albufuse(tm), the proprietary albumin fusion technology. Fusing proteins to albumin has been shown to significantly enhance circulatory half-life.
Established in 1984, Delta is a wholly-owned subsidiary of Sanofi-Aventis SA, operated as a self-contained business unit with both its R&D and manufacturing facilities based in Nottingham, UK.
For more information on Recombumin(r) or Delta Biotechnology, visit
Media enquiries:
At Delta Biotechnology Ltd:
Dermot Pearson, Commercial Operations Director
Tel: + 44 (0) 115 955 3355
dermot.pearson@deltabiotechnology.com dermot.pearson@deltabiotechnology.com>
At Northbank Communications:
Ben Routley, Account Manager
Tel: +44 (0) 1260 296500
b.routley@northbankcommunications.com b.routley@northbankcommunications.com>
Saludos Cordiales
Dr. José Manuel Ferrer Guerra
NOTTINGHAM, England, May 22, 2006 - Delta Biotechnology Ltd announced today that the European Medicines Agency (EMEA) has granted a Marketing Authorisation for Sanofi Pasteur MSD's M-M-RVAXPRO(tm) childhood vaccine (measles, mumps and rubella virus (live)). The vaccine is manufactured using and containing Recombumin(r); a recombinant human albumin produced by Delta Biotechnology. Recombumin(r) is a biosynthetic, animal-free material for use in vaccine production and biopharmaceutical formulation.
This development results from collaborative efforts between Delta and Sanofi Pasteur MSD and Merck & Co. To define and test the use of recombinant albumin in the measles, mumps and rubella vaccine production process. Recombumin(r) replaces the human serum albumin currently used in Sanofi Pasteur MSD's MMR vaccine. Following this announcement, Recombumin(r) is the only animal-free, commercially available, recombinant human albumin approved by both the EMEA and FDA for use in the manufacture of human therapeutics. It is a structurally identical, yeast-derived alternative to HSA, which has the potential to improve product acceptance by the regulatory authorities.
Recombumin(r) is manufactured at Delta's cGMP-compliant, Health Canada and FDA inspected facility in Nottingham, UK by a team with over 20 years of leadership and expertise in the development of an animal free biomanufacturing process for the commercial production of recombinant human albumin.
"We are very proud to have gained regulatory approval for the use of Recombumin(r) from both the EMEA and FDA", commented Werner Merkle, CEO of Delta Biotechnology. "Recombumin(r) has passed the strictest regulatory standards and we are now looking forward to global rollout of our premier recombinant albumin product".
"Our customers can now reap the proven benefits of using animal component free recombinant human albumin in their vaccine production and drug formulation. Recombumin(r) provides the industry with an animal-free alternative to human serum albumin. We have approximately 30 healthcare companies evaluating its use in their products with several in clinical development in Europe and the US", added Dermot Pearson, Commercial Operations Director of Delta Biotechnology.
See: http://ec.europa.eu/enterprise/pharmaceuticals/register/2006/20060505112 95/dec_11295_en.pdf
For a high resolution image of Recombumin(r), please contact Ben Routley at Northbank Communications on: +44 (0) 1260 296 500 or b.routley@northbankcommunications.com
M-M-RVAXPRO(tm) is the Sanofi Pasteur MSD registered trademark for measles, mumps and rubella virus vaccine live.
About Delta Biotechnology:
Delta Biotechnology Ltd develops and manufactures its lead product, Recombumin(r) using highly engineered, proprietary Saccharomyces cerevisiae yeast strains. The Company also undertakes flexible licensing of its yeast based expression system to offer its pharmaceutical, healthcare and biotech partners customised solutions to their recombinant protein needs. Delta's capabilities range from state of the art molecular biology manipulation of yeast, through to fermentation, process development and analytics to commercial-scale manufacture of proteins in a Health Canada and FDA-inspected, cGMP-compliant facility with an 8000L fermentation capacity.
The Company's proprietary yeast based expression technologies and accompanying Intellectual Property portfolio has resulted in animal component free, high-yielding systems for the production of recombinant proteins at an extremely competitive cost of goods. Delta's protein expression abilities include both the production of native or modified polypeptides and the secretion of proteins genetically fused to albumin using albufuse(tm), the proprietary albumin fusion technology. Fusing proteins to albumin has been shown to significantly enhance circulatory half-life.
Established in 1984, Delta is a wholly-owned subsidiary of Sanofi-Aventis SA, operated as a self-contained business unit with both its R&D and manufacturing facilities based in Nottingham, UK.
For more information on Recombumin(r) or Delta Biotechnology, visit
Media enquiries:
At Delta Biotechnology Ltd:
Dermot Pearson, Commercial Operations Director
Tel: + 44 (0) 115 955 3355
dermot.pearson@deltabiotechnology.com dermot.pearson@deltabiotechnology.com>
At Northbank Communications:
Ben Routley, Account Manager
Tel: +44 (0) 1260 296500
b.routley@northbankcommunications.com b.routley@northbankcommunications.com>
Saludos Cordiales
Dr. José Manuel Ferrer Guerra
posted by Klip7 at
11:29 AM
