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Delivering Therapeutic Proteins - An Analysis of the Special Formulations and Delivery Strategies Required for Complex Therapeutic Substances

Posted on: Friday, 3 October 2008, 09:00 CDT

Research and Markets (http://www.researchandmarkets.com/research/91e292/delivering_therape) has announced the addition of the "Delivering Therapeutic Proteins - Drugs, Devices and Delivering Strategies" report to their offering.

While the ability of recombinant protein drugs to treat previously refractory conditions continues to generate excitement and investment, the complex structure of these therapeutic substances require special formulation and delivery strategies, creating special challenges for drug developers and their formulation technology and delivery device partners. The stakes are high. The current list of approved therapeutic proteins will grow at an exponential rate as the convergence of automated drug discovery and biotechnology production methods create new biological drugs for an expanding number of previously intractable ailments. Currently, more than two-thirds of all therapeutic proteins for chronic diseases are sold as combination pen or auto-injector products.

We expect the impressive success of combination drug-device products to continue their dominance on a total market value basis. And while injection will remain the dominant route of administration for protein drugs for the rest of the decade, the recent clinical success of several inhaled protein products will result in escalating interest in inhalation as a protein drug delivery method. Work on stabilized oral formulations is also making progress. In the near term, the cost per dose of recombinant proteins will continue to provide device technologists with enough running room to continue developing rather elegant protein-device combination products.

In recent years, the number of protein-based pharmaceuticals reaching the marketplace has increased exponentially. The clinical application of these drugs is limited by a lack of desirable attributes for adequate absorption or distribution. It therefore becomes critical to formulate these drugs into safe, stable and efficacious delivery systems. Because these drugs face formidable enzymatic and penetration barriers when administered orally, peptide and protein drugs have until recently been marketed almost exclusively for parenteral administration.

A limitation of the parenteral route for delivery of peptides and proteins is the extremely short half-lives of these drugs - in the order of a few minutes. This demands repeated administration, which is inconvenient to the patient. For this reason, non-parenteral routes of administration are being pursued. Another approach is to incorporate controlled release parenteral formulations, where a single injection may release the drug over several weeks or longer.

These combination products, where the drug and device are clinically tested and approved as a single product entity, are becoming one of the fastest new drug categories. Combination drug delivery products are growing at an annual rate of fourteen percent across all technology segments, and will total $38 Billion in 2008. The growth of combination products is having a significant effect on the way drugs and devices are developed. Cooperation between device designers and drug developers is occurring much earlier in the drug development cycle, allowing device designs in many cases to be tailored to the bioavailability targets and pharmacokinetic profiles of specific drug therapies. In the near term, the cost per dose of recombinant proteins will continue to provide device technologists with enough running room to continue developing elegant protein-device combination products.

Key Topics Covered:

- Protein Therapeutics Market Dynamics

- Formulating Protein Drugs for Administration

- Protein Delivery - The State of the Art

- Product Design Factors

- Approved Protein Drugs - Current Strategies and Future Directions

- Protein Drug Therapeutics - Disease Segment Analysis

- Company Profiles, Portfolios & Prospects

For more information visit http://www.researchandmarkets.com/research/91e292/delivering_therape

Source: Business Wire

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