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Innovative Drug Discovery in Emerging Markets
THE AUTHOR: Paul Taylor
From: Business Monitor
Definition of innovative drug discovery
A very large proportion of the pharmaceutical industry in emerging markets is engaged predominantly in the manufacture of generic drugs. To achieve differentiation from competitors, many generics manufacturers expend substantial effort on the development of novel formulations providing improved properties such as stability, mode and frequency of delivery, or bioavailability. The work to develop these formulations is commonly described by such companies as innovative research and development (R&D). Undoubtedly that is very often appropriate, as indicated by the large number of patent applications filed to protect the drug formulation intellectual property (IP) generated by this research. However, such work leads not to novel therapies for the treatment of disease, but rather to modified versions of existing medicines containing active pharmaceutical ingredients (APIs) that have already passed regulatory hurdles, and in this regard the level of risk to the financial investment is considerably lower. Consequently, such formulation R&D is in general excluded from the scope of this report, and the bar for inclusion has been set deliberately high. It was determined that at least one of the following criteria should be met:
- Evidence of the invention of novel and innovative chemical or biologic matter intended to treat a disease;
- Isolation of novel natural products (whether single components or as partially purified mixtures) of therapeutic value;
- In-licensing of chemical and biologic entities at a stage when significant uncertainty and risk remain, i.e. prior to proof-of-concept having been achieved;
- Development of novel and innovative combinations of previously known APIs as a single medicine.
Given the decision to exclude companies involved only in formulation work with generic drugs, the last criterion above offers the least sharp differentiation between exclusion and inclusion. As we considered this last criterion to be the weakest indicator of innovative drug discovery, we have chosen to err on the side of exclusion, and thus the report may not be comprehensive in its account of companies developing such combinations. Simply put, to trigger inclusion there needed to be very clear evidence that development of a combination involved a highly significant component of innovation and research into the therapeutic effect of the combination (for example, previously unreported synergism or applicability to a new indication).
Biologics, and especially vaccines, are considerably harder to assess against the above criteria than are small molecules. The exact composition of such entities is often poorly defined in publically disclosed information, and thus judgment of the level of innovation they represent versus similar therapeutics can be challenging. In many cases it is the technological process by which the biologic is produced that represents the key innovative step. Therefore, biologics and vaccines have only been included when there is an abundance of evidence that the company involved has pioneered the fundamental research into such entities or related technologies, or has led the way in developing the clinical application.
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