Leveraging follow-on Biologics or Biosimilars.
With $51 billion in worldwide sales, therapeutic proteins represent approximately 64% of all biopharmaceuticals and 8.5% of the $602 billion world pharmaceutical market (2005 data). Currently, biopharmaceuticals are growing at an estimated 20% per year, more than twice the growth rate of the overall pharmaceutical market. Many of the earliest approved protein-based biologics, including some blockbusters with over $1 billion in annual sales, are facing patent expiration, which should open the market to generic competition, commonly referred to follow-on protein products in the United States and biosimilars in Europe.
The traditional approach.
In order to manage the life-cycle of their product franchise, firms that hold the expiring patent have typically modified and/or reformulated their original protein drug, in an effort to improve its pharmacological profile, such as plasma half-life. Competitor firms planning to market an alternative biosimilar have employed a similar strategy. Invariably, the approach implemented by these firms has incorporated the traditional trial and error methods, including site-specific amino acid substitution, conjugation to carrier domains and post-expression chemical conjugation, usually to monomethoxypolyethylene glycol (PEG). While these approaches can be successful, they are time consuming and costly to develop and often are heavily encumbered by existing intellectual property.
Aequus offers a better approach.
Data obtained using our Genetic Polymer™ platform technology suggests that a follow-on protein drug with an improved pharmacological profile can quickly and efficiently be developed. We can collaborate with you to investigate whether we can improve your biosimilar. For further information, please contact us.
