Biopharmaceutical Pipeline Includes 749 Projects Targeting Diabetes

A recent report prepared by the Analysis Group sought to describe the current pipeline of biopharmaceuticals under development that could benefit US-based patients within the next 5 to 10 years.

Drawing on data from the Evaluate Pharma database—which curates publicly available information on companies and their products—as well as FDA data, the researchers identified new medicines under development or regulatory review as of August 2016, and found 6300 biopharmaceutical products (unique molecules) in global clinical development or under regulatory review that were a part of over 9500 projects (unique molecule-indication combinations). A range of projects explored novel scientific approaches in clinical development, including gene therapy, cell therapy, DNA and RNA therapy, and conjugated monoclonal antibodies (which use monoclonal antibodies joined to chemotherapy agents or other drugs to target specific cells, such as cancer cells).

While the projects in question address a variety of therapeutic areas, the report shows a robust number of projects targeting the underserved population of diabetes patients—the report found a total of 749 projects and 432 products for the treatment of diabetes or diabetes-related complications:

• 482 preclinical projects

• 97 phase 1 projects

• 125 phase 2 projects

• 42 phase 3 projects

• 3 projects filed with the FDA as of August 2016

Of the diabetes projects identified, 599 have the potential to result in the first products of a unique pharmacological class. A majority of the diabetes-focused projects seeking to be first-in-class are in preclinical research, with 16 projects in phase 3 trials.

The report also identifies 11 projects and 10 unique products intended to treat diabetes or diabetes-related complications that are designated as orphan projects. However, the authors point out that its count of orphan-designated medicines under development may be low, as early-stage projects may not yet have orphan designation.

While the number of projects in the diabetes biopharmaceutical pipeline is promising, the authors remind their audience that, of the investigational compounds that eventually reach clinical trials, only 12% are ultimately approved by the FDA (after 10 to 15 years of testing and an average of $2.6 billion in development costs). Clinical trials have become increasingly complex in recent years, the authors note; compared with the period from 2001 to 2005, the period from 2011 to 2015 saw the mean number of total endpoints in a typical phase 3 trial protocol increase by 86%, and the total number of procedures (such as blood work and exams) conducted during such trials increase by 70%. The authors suggest that such a trend could lead to longer timeframes and increased costs for drug approvals unless efficiency measures can be properly implemented.

The authors conclude that, while it is impossible to accurately predict which projects and products under development will eventually reach patient populations, the current pipeline for biopharmaceuticals, including those intended to address the needs of patients with diabetes, is both extensive and innovative. While the need for continued development of new treatments for US patients remains high, the current pipeline, they say, “is laying the groundwork for tomorrow’s breakthrough therapies for patients with few other therapeutic alternatives.”