Peptides for Youth The Proceedings of the 20th American Peptide Symp
The American Peptide Society (APS) provides a forum for advancing and promoting knowledge of the chemistry and biology of peptides. The approximately one thousand members of the Society come from North America and from more than thirty other countries thr
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Roche Research Center; Hoffmann-La Roche Inc. Nutley, New Jersey 07110, USA; 2 Roche Bioscience, Palo Alto, California 94304, USA
Introduction
The peptide market is growing nearly twice as fast as the overall pharmaceutical market due to an increased number of therapeutic targets and improved delivery methodologies. There are 67 therapeutic peptides on the market, 150 in clinical phases, 400 in advance pre-clinical stages. Over 100 pharmaceutical and biotech companies are active in the peptide field. The market size for peptide drugs in 2007 is estimated to be 3.01 billion US$. [1] Important factors and questions need to be considered before starting peptide based projects. They include: is there an unmet medical need, and an opportunity to define clinical differentiation for the indication of interest? What is the market size? What about the competitive landscape in the clinic and in the market? Is the target amenable to alternate approaches, such as small molecules or monoclonal antibodies? What are the de-risking approaches vs. small molecules and monoclonal antibodies? What are the possible delivery methods? Are the starting materials available in the amount needed? What will the cost of goods be? To illustrate these points, Male erectile dysfunction (MED) and obesity indications will be used.
Results and Discussion
Medical need for MED: There are approximately 70 million men in seven major pharmaceutical markets diagnosed with MED, due to aging population, lifestyle and increased prevalence of chronic diseases that predispose men to ED drive increase prevalence. Current oral agents (PDE-5 inhibitors) target peripheral erectogenic mechanisms have 20-30% non responders, and face issues related to headaches, dyspepsia and flushing. A melanocortin (MC-4) receptor agonist may restore the natural function of neuro-hormonal pathways in mediating sexual response and offer a non-PDE-5 choice to effectively and safely restore erectile and sexual function. [2] Medical need for treatment of obesity: in the US there are 42.5 million people estimated to be obese (BMI 30+), and 105.5 million are estimated to be overweight and obese (BMI 25+) which represent 38.7% of the US population. Current approaches for treatment of obesity include dietary, surgical intervention and pharmacotherapy. Pharmacological and genetic evidence suggests that MC-4R is a key regulator of energy homeostasis and feeding behavior regulation, and therefore an MC-4 agonist should be effective as a pharmaceutical anti-obesity agent. [3] Small molecule vs. peptides: Are these targets amenable for small molecules approaches? We developed a strategy for de-risking such projects by using a designed series of peptides, for example: N- and C-terminal truncation, systematic S. Del Valle et al. (eds.), Peptides for Youth: The Proceedings of the 20th American Peptide Symposium, 467 DOI: 10.1007/978-0-387-73657-0_201, © Springer Science+Business Media, LLC 2009
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W. Danho et al.
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