Challenges

The Challenges of the Innovative Drug Industry

Overview

The ability to identify and successfully develop new drugs lies at the heart of the value creation process for the innovative drug industry. IMS Health Inc. (www.imshealth.com) defines the innovative drug industry as the sum of companies seeking to optimize areas of greatest unmet medical need having the potential for high economic output. This industry is estimated to have total worldwide annual sales in excess of $300 billion (US) and is growing at an annual rate of approximately 8%. The industry includes 10 to 15 major pharmaceutical companies with annual research and development budgets in excess of $1 billion (US). The industry includes the major pharmaceutical companies with extensive annual research and development budgets, hundreds of smaller pharmaceutical companies - as well as thousands of biotechnology companies - designing and developing therapeutic drugs.

Challenges We Face

As one of the companies within the innovative drug industry, ConjuChem faces evolving problems and challenges as we move forward:

  • Competition
  • Drug pricing pressures
  • Research and drug development costs
  • Shortened product lifecycles

Most currently marketed drugs are small organic compounds either derived from natural sources or chemically synthesized. The traditional drug discovery process involves screening a large number of small organic compounds to identify one or more candidate compounds appearing to have the properties of a therapeutic drug in the indication for which the drug screens are targeted. Under this model, it is often necessary to screen 10,000 to 100,000 compounds in order to select one lead candidate for full preclinical testing.

Once a lead candidate is selected, it enters the research phase during which it undergoes extensive testing in animals to characterize its biological activity and safety profile further. If it still has an attractive profile at this point, the compound enters a lengthy clinical testing process that, if successful, culminates in a new drug submission with appropriate regulatory authorities in each chosen country. After an intensive review process, authorities either approve or reject an investigational new drug. Historically, only around 10% of compounds entering clinical testing are finally approved.

The traditional discovery phase for the new drug targets can take five years or more to complete, and the preclinical/clinical/regulatory phase requires five to eight additional years for most drugs. The average cost per approved drug is between $800 million and $1.2 billion (US). The process is time consuming, high risk, and capital intensive.

To address these challenges, the pharmaceutical industry has tried to apply new technologies to existing drugs or well-known compounds to create new drugs with improved properties. In this way, they can often resurrect drugs that did not survive the development process due to drawbacks of the original compound.

Another response has been to develop new enabling technologies to create nontraditional drugs, such as antibodies, proteins, and peptides that are functional products of genes.

The ConjuChem Response

At ConjuChem, we create novel peptides with enhanced therapeutic properties and increased duration of activity. Like proteins, most peptides have highly targeted mechanisms of action. As such, the potential for adverse events, negative side effects, or general intolerance is greatly reduced when compared with traditional organic molecule-based drugs. However, peptides have a very short duration of activity (measured in minutes) and are therefore generally unsuitable for development as commercial drugs. By protecting the peptides from peptidase degradation and rapid excretion from the body, our Drug Affinity Complex™ (DAC™) and Preformed Conjugate-Drug Affinity Complex™ (PC-DAC™) technology platforms lengthen their otherwise short duration of activity and produce compounds with powerful medical potential.