Monday, January 31, 2011

Innovations in Oral Solid Drug Delivery


Innovations in Oral Solid Drug Delivery: Advances in nanotechnology, controlled formulations & peptide delivery

This report concentrates on innovations in oral solid dose delivery systems (OSDDS) with an emphasis on the links between start up companies and academic collaborations. It deals with the impact of the difficult economic climate with the restriction on funding and opportunities for partnering projects.
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Developments are assessed in relation to understanding the dynamics of the market. For instance the report discusses the loss of patent protection for blockbuster drugs peaking between 2007-2012, loss of patent protection for the first-generation of OSDDS in the last few years, the dearth of NCEs coming through the pipeline and puts new developments in the context of a market that is seeing a decline in its value in some therapeutic areas. It identifies the drivers for new OSDDS and the issues surrounding them.
A key theme is the transition of peptides and proteins from intravenous to oral delivery. The report looks at the competitive landscape, making reference to sales and market dynamics. A recurring theme is the reformulation of old generic drugs to get over inadequacies in the original drug for instance: low solubility, bioavailability, short duration of action, high side effect potential, poor stability, poor absorption following oral administration, bitter or unpleasant taste, narrow GI absorption window and inter- and intra-patient variability in absorption.
With a growing geriatric population and with people living longer much of the emphasis is on development of OSDDS drugs to more effectively treat diseases of an aging population such as Alzheimer’s disease, Parkinson’s disease, type 2 diabetes and obesity, osteoporosis, cancer and rheumatoid arthritis, etc. Often these treatments have side effects, problems with dosing and short duration of action or have to be administered by injection which reduces their acceptability.
Key features of this report
  • Analysis of innovative platform technologies, companies and product development pipelines involved in transitioning injectable to oral drug delivery.
  • Review of companies and technologies developing oral formulations of peptides and small proteins, highlighting stage of development, indications and competitive nature of the area.
  • Providing an understanding of the specific problems involved in transitioning intravenous peptides to oral delivery and the mechanisms of crossing the GI mucosa, together with a review of approaches utilized.
  • Analysis of sales data, growth rates, market share, generic entrants, new products for therapeutic areas in which the new products using the new technologies will compete.
  • Assessment of market potential of the new osdds products in relation to the current market and competitors.
Scope of this report
  • Get a comprehensive understanding of the range of new innovative osdds technologies and how they can overcome problems with the original active ingredient.
  • Identify potential novel technologies which might allow you to overcome a problem with your own drug portfolio or which would allow you to extend your products’ franchise in the market place.
  • Allow you to identify potential licensing opportunities or collaborations with innovative technology companies and assess the potential with respect to recent products commercialized.
  • Allows you to identify which companies and which therapeutic areas are successful in gaining backing for their technologies and those that are not.
  • Identify the time scales, hurdles and progress in developing new innovative technologies such as nanotechnologies/nanomedicines, oral peptides and proteins, new prodrugs and assess market factors affecting the developments and their success/failure.
Key Market Issues
  • Asthe population ages and those elderly people live longer there is a greater need for better drugs which treat chronic conditions associated with aging such as Alzheimer’s disease, Parkinson’s disease, osteoporosis, rheumatoid arthritis, osteoarthritis, type 2 diabetes and obesity,cancer, hypertension and heart disease.
  • The specific challenges in providing for mentally ill patients in which compliance is a problem is driving the demand for formulations which get over problems with swallowing difficulties, frequent dosing, variability in oral absorption or bioavailability,unacceptable side effect potential .
  • The low numbers of new chemical entities approved annually (around 30 compared to 40-50 three decades ago), the record number of blockbuster drugs becoming generic up to 2012 and the first-generation delayed-release products losing patent protection is depressing the sales value in certain billion dollar therapy markets.
Key findings from this report
  • The development of oral peptide hormones is a highly competitive area with many companies developing oral versions of the same peptide and these products will have to compete with new developments in inhaled peptides and very long-duration transdermal or sc depot products which are several years ahead of oral formulations.
  • The failure of Exubera (inhaled insulin) has had a knock on effect on the development of new oral insulins with investors seeing oral insulins as being more risk prone and in addition the issues encountered with some oral insulins has meant that some companies are no longer considering this area a key focus.
  • Many dds companies have switched their development focus to new oral GLP-1 analogs for the treatment of type 2 diabetes and obesity in the light of Byetta’s success but these oral products are several years behind the development of new long-acting transdermal, injectable and inhaled GLP-1 analogs .
  • Generic nasal calcitonin products have depressed the value of second-generation nasal preparations which are still patent protected thus this does not bode well for prices achievable for oral salcatonin products which are nearing the market as they have to offer better therapeutic outcomes in order to achieve higher prices and ultimately market share.
Key questions answered
  • What oral peptide products have the greatest growth potential and how far along the development path have they reached?
  • What are the strategies employed by brand leaders to protect their franchise in the $10 billion US antiepileptic market in the face of recent generic competition?
  • How has the failure of Exubera (inhaled insulin) affected the oral insulin developments and oral peptides in general?
  • What are the main diseases and how advanced are the oral peptide and protein formulations?
  • How successful is prodrug technology in terms of drug development and what are the latest developments?
  • What innovative companies and platform technologies are attracting investment and collaboration agreements?

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