CHAPTER 7 – FDA DRUG APPROVALS, 2000-2010 Introduction€¦ · CHAPTER 7 – FDA DRUG APPROVALS, 2000-2010 Introduction This chapter reviews drug delivery enabled/enhanced product
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Parameters of Development - Drug Delivery Enabled/Enhanced Products (DDEP 1996-2010) – A Review (Chapter 7)
DDEP 1996-2010, Parameters of Development - Drug Delivery Enhanced/Enabled Pharmaceuticals, v. 2014
This chapter reviews drug delivery enabled/enhanced product approvals by the FDA over the
period 2000-2010. This is a simple analysis that provides some insight into the performance of the
industry in terms of approved products. Unlike new pharmaceutical active products the barriers to
new drug delivery enabled/enhanced products is much less impacted by safety concerns. The
challenges in developing and gaining approval for DDEP are primarily related to identifying
commercially and therapeutically meaningful product opportunities and then shepherding the
products through the clinical development and regulatory approval process.
A detailed definition of a DDEP is provided below. In summary, a DDEP is a pharmaceutical
product that incorporates a drug delivery or formulation technology to alter the absorption,
distribution, metabolism and/or excretion of pharmaceutical active with the intent of enabling
and/or enhancing its therapeutic benefit. This definition excludes products that depend on
technologies that are widely available and are considered simple toolbox formulation
technologies. An example of a simple toolbox technology would be enteric coating as used to
prevent stomach acid degradation of a pharmaceutical active.
Defining DDEP
This report uses the acronym DDEP for drug delivery enabled/enhanced product. We define a DDEP as a pharmaceutical product used for the treatment of humans that incorporates a drug delivery technology to alter the absorption, distribution, metabolism and/or excretion of a pharmaceutical active with the intention of enabling and/or enhancing its therapeutic benefits. DDEP are restricted to products that utilize non-‐toolbox formulation technologies. By non-‐toolbox we refer to drug delivery and formulation technologies that are proprietary, if not patented, and are not generally accessible to all companies. Examples of these non-‐toolbox technologies are PEGylation, Oral Dissolution Technologies (ODT) and Transdermal Patches, all of which in the period covered by this report are available from multiple sources but generally require certain proprietary materials or know-‐how. One technology not included in our definition of DDEP is enteric coating as used to avoid gastric degradation. Accordingly, products such as proton pump inhibitors are excluded from this analysis. The purpose of defining a DDEP in this manner is to provide a reasonable break between drug delivery and simple formulation impacted pharmaceutical products. This is a sliding definition. What was considered a breakthrough drug delivery technology when first introduced is often considered a toolbox or formulation technology a decade or two later.
Parameters of Development - Drug Delivery Enabled/Enhanced Products (DDEP 1996-2010) – A Review (Chapter 7)
DDEP 1996-2010, Parameters of Development - Drug Delivery Enhanced/Enabled Pharmaceuticals, v. 2014
It is possible to further analyze the DDEP approvals in terms of a number of product specific
parameters. These parameters are presented in Table 7-1 with a short description.
Table 7-1: Analysis Parameters, DDEP Approvals
Parameter Description 1. Company Type Big Pharma, Specialty or Drug Delivery 2. Company Leaders Leading Companies with Approved DDEP 3. Indication DDEP by Therapeutic Indication 4. Route DDEP by Delivery Route 5. Technology Suppliers DDEP by Technology Providers
DDEP Approvals by Company Type
It’s worth considering who is responsible for the 235 DDEP approved over the past 11 years. We
define the ‘responsible’ company as that organization primarily responsible for the financing and
execution of product development and approval. This means a product such as Exubera is
considered a Pfizer product because Pfizer was a very early product partner and provided the
largest proportion of financial and clinical development resources to bring Exubera through
development and approval. This is not to minimize the considerable Nektar contribution but
without Pfizer there would not have been a product.
In a similar fashion a Big Pharma or Specialty Pharma company that commissioned a DDEP from a
Drug Delivery company (DDCo) was credited with the approval of this product. An example might
be GSK working with Flamel for a sustained release formulation of Coreg. There are examples of
DDCo, for example DepoMed, that developed their products through to NDA filing or approval
before licensing the DDEP to a partner. These products are credited to the DDCo.
Confusion may arise with respect to the definition of Big Pharma, Specialty Pharma and Drug
Delivery companies. Big Pharma, including Big Bio, are considered in the context of 2010 to have
had annual sales in excess of $7 billion. Specialty Pharma have reported sales less than $7 billion
and a marketing and sales operation. Drug Delivery includes companies without a sales and
marketing resource. In many cases these DDCo provide the technology and resources for a Big
Pharma or Specialty Pharma company to develop their own DDEP. The assignments were
considered at the time a DDEP was filed with the FDA. Often a Specialty Pharma or Drug Delivery
Parameters of Development - Drug Delivery Enabled/Enhanced Products (DDEP 1996-2010) – A Review (Chapter 7)
DDEP 1996-2010, Parameters of Development - Drug Delivery Enhanced/Enabled Pharmaceuticals, v. 2014