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NOVOSIS |
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1.What is BMP-2 ?
In 1965, Dr. Urist revolutionised the current understanding of fracture healing by hypothesizing the existence of bone morphogenetic proteins (BMPs) allocated onto the extracellular collagenous matrix (Ref.1 and 2). The genetic sequences of BMPs were first identified by Wozney et al. in 1988 (Ref. 3) and since then over 40 BMPs have been discovered. Subsequently, with the advances made in molecular medicine and molecular biology extensive research is ongoing to elucidate the unique role of different molecules and their interactions in the healing cascade. BMPs reside in osteoprogenitors and mesenchymal cells, osteoblasts, bone extracellular matrix and chondrocytes in human body. They activate differentiation of undifferentiated
mesenchymal stem cells into chondrocytes and osteoblasts and osteoprogenitors into osteoblasts. Members of the BMP family are divided into at least four separate subgroups depending on their primary amino acid sequence. Group one consists of BMP-2 BMP-4, and group two includes BMP-5, -6, and -7. The third group includes GDF-5 (or BMP-14), GDF-6 (or BMP-13) and GDF-7 (or BMP-12), and finally group four includes BMP-3 (or osteogenin) and GDF-10 (or BMP-3b) (Ref. 4). All of these BMPs, BMP-2 plays major role in the whole differentiation processes of osteocyte from mesenchymal stem cell. So, BMP-2 is the most potent BMP among BMP-2,3,4,5,7 up to now.
2. Expected Indications
1) Spinal Indications
Disc degeneration
Disc herniation
Thining disc
Marginal hypertrophic change of the vertebral bodies
Spinal stenosis
Spondylolisthesis
2) Bone Fracture Indications
Fracture in Tibia and Femur
Fracture in Radius and Ulnar
3) Other expected indication
Osteoporosis
4) Dental Area
Maxilla
Mandible
3. Strong Points of Daewoong Novosis
1) High purity
The purity of DW rhBMP-2 is over 95% by RP-HPLC analysis.
2) Cost effective
efficient production process enables higher production yield of rhBMP-2.
3) Efficacy
In vivo efficacy tests of DW rhBMP-2 showed the same or better results compared to those of glycosylated BMP-2
which is produced from mammalian cells.
4) Safety
The production process and quality are controlled under the regulations of the pharmaceutical GMP.
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