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市場調查報告書
蛋白藥劑的給藥方式發展動向
Evolving Approaches for Protein Drug Delivery
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本報告已在2011年12月21日停止出版。
蛋白藥劑現今仍有與給藥相關的重要問題。如果能改善蛋白藥劑的給藥方式，市場規模將可望更進一步地擴大。製藥企業目前正進行著與新的蛋白藥劑給藥方式相關研究。
專門於醫療產業相關廣泛調查的美國市調公司Decision Resources Inc. （總公司：美國Massachusetts洲），針對蛋白藥劑的給藥系統進行調查分析，並系統整理調查結果後出版報告書"Evolving Approaches for Protein Drug Delivery" 。
本報告書內容包括：蛋白藥劑的藥品開發及研發、研發中的新給藥方法、未來發展前景等。內容綱要摘記如下：
策略分析
介紹
近年來蛋白藥劑給藥畫時代的成果
為改善藥物動態解析的蛋白藥劑調整
添加聚乙烯乙二醇 融合蛋白 替代或消除胺基酸
新的蛋白藥劑開發及研發
- 新添加聚乙烯乙二醇的蛋白藥劑
- Nektar Therapeutics
- Prolong Pharmaceuticals
- 新的融合蛋白
- Human Genome Sciences
- Syntonix Pharmaceuticals
- 新的生物科技蛋白藥劑
經皮系統及皮下植入
- 經皮膚給藥
- Macroflux
- Apogee Technology
- Altea Therapeutics
- 經皮給藥用的縮氨酸伴隨分子
- MicroCHIPS
口服、經口腔給藥
- Unigene
- Emsphere Technologies
- Spherics Pharmaceuticals
- Generex
- DOR BioPharma
經肺及經鼻給藥
- 後期開發中的經肺胰島素產品
- Alkermes/Eli Lilly
- MannKind
- Novo Nordisk
- 新興的經肺及經鼻給藥系統
- Chrysalis Technologies
- Aegis Therapeutics
蛋白藥劑給藥系統的未來發展預測
Abstract
Introduction
Despite their remarkable success, protein drugs continue to suffer from
important drawbacks, especially with respect to their delivery (subcutaneously
or intravenously injected). Improvements in protein drug delivery will
increase patient compliance and expand many drug markets. In addition, some
new formulations may be patentable and can therefore extend a drug' s life
cycle. For these reasons, pharmaceutical and biotechnology companies are
researching and testing new delivery methods for protein drugs.
Get the Answers You Need to Shape Your Strategy
- Although protein-based drugs have had great commercial success, they still
suffer from signifi cant drawbacks, especially in the area of delivery.
What are these drawbacks and what are the barriers for creating better
protein drug delivery methods?
- Many companies see the potential for improving the delivery methods for
protein-based drugs. What companies are at the forefront of these
improvements?
- Researchers are approaching this opportunity from several different
angles. Some companies are looking to modify drugs to improve pharmacokinetics
while other companies are developing whole new technologies. What are the
specifi c programs and development initiatives in place? What is the time line
for the introduction of these improved drugs and/or delivery devices?
Scope
- Milestones: Recent approval of two large-molecule drugs (Fortical
and Exubera) that do not require injection show proof-of-principle that
noninjected protein and peptide drugs can be developed successfully
- Modifi cation and discovery of protein drugs: Pegylation, fusion
proteins, amino acid substitution or omission.
- Discovery and development of novel modifi ed proteins: novel
pegylated protein drugs, novel fusion protein drugs, and novel bioengineered
protein drugs
- Novel delivery methods in development: oral delivery, buccal
delivery, transdermal systems, subcutaneous implants, pulmonary delivery,
intranasal delivery
- Outlook: status of current programs, anticipated product launches,
outlook for protein drug market.
Companies Mentioned in This Spectrum Report
- Aegis Therapeutics
- Aerogen
- Alkermes
- Altea Therapeutics
- Alza
- Amgen
- Amylin Pharmaceuticals
- Apogee Technology
- Aradigm
- Bayer
- Biovitrum
- Chrysalis Technologies
- DOR BioPharma
- Eli Lilly
- Emisphere Technologies
- Enzon
- Generex
- Georgia Tech Research Corporation
- GlaxoSmithKline
- Human Genome Sciences
- Intranasal Therapeutics
- Johnson & Johnson
- Macrofl ux
- MannKind
- MicroCHIPS
- Nautilus Biotech
- Nektar Therapeutics
- Novartis
- Novo Nordisk
- Pfi zer
- Prolong Pharmaceuticals
- Roche
- Sandoz
- Sanofi -Aventis
- Schering-Plough
- Spherics Pharmaceuticals
- Syntonix Pharmaceuticals
- Takeda
- UCB Pharma
- Unigene Laboratories
- Upsher-Smith
- Wyeth Pharmaceuticals
Table of Contents
- Strategic Considerations
- Introduction
- Recent Milestones in Protein Drug Delivery
- Modifi cation of Protein Drugs to Improve Pharmacokinetics
- Pegylation
- Fusion Proteins
- Amino Acid Substitution or Omission
- Discovery and Development of Novel Modifi ed Proteins
- Novel Pegylated Protein Drugs
- Nektar Therapeutics
- Prolong Pharmaceuticals
- Novel Fusion Protein Drugs
- Human Genome Sciences
- Syntonix Pharmaceuticals
- Novel Bioengineered Protein Drugs
- Transdermal Systems and Subcutaneous Implants
- Transdermal Delivery
- Macrofl ux
- Apogee Technology
- Altea Therapeutics
- Peptide Chaperone for Transdermal Delivery
- MicroCHIPS
- Oral and Buccal Delivery
- Unigene
- Emisphere Technologies
- Spherics Pharmaceuticals
- Generex
- DOR BioPharma
- Pulmonary and Intranasal Delivery
- Pulmonary Insulin Products in Late-Stage Development
- Alkermes/Eli Lilly
- MannKind
- Novo Nordisk
- Emerging Pulmonary and Intranasal Drug Delivery Systems
- Chrysalis Technologies
- Aegis Therapeutics
- Outlook for Protein Drug Delivery
Tables:
- 1. Select Marketed Modifi ed Protein Drugs
- 2. Select Novel Modifi ed Protein Drugs in Development
- 3. Novel Transdermal Systems and Subcutaneous Implants
- 4. Novel Oral and Buccal Formulations of Protein and Peptide Drugs
- 5. Novel Pulmonary and Intranasal Formulations of Protein and Peptide Drugs
Figures:
- 1. Anatomy of the Skin
- 2. MicroCHIPS' s Implanted Drug Delivery Device
- 3. Schematic Representation of a Micelle and a Reverse Micelle
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