The year's new drugs & biologics - 2009

Abstract

This annual article presents new drugs and biologics that were launched or approved for the first time during the previous year. In 2009, 51 new medicines and vaccines reached their first markets. Line extensions (new indications, new formulations and new combinations of previously marketed products) accounted for more than 30% of the new products launched in 2009. In addition to providing an overview of all drugs and biologics launched or approved for the first time ever in the previous year, this article will also review in further depth the first-in-class drugs launched for the first time last year, providing a better understanding of their novel mechanisms of action; an analysis of the discovery and development periods for the year's new products; and a comprehensive overview of drug repositioning as a strategy for extending the life spans of medicines. We also provide a brief glimpse at selected drugs and biologics which could reach their first markets in the foreseeable future.

Advantages and Challenges in Drug Re-Profiling

“…Few examples of repositioned drugs include, Celgene's Thalomid ® , which is repositioned thalidomide, and its derivative Revlimid ® (lenalidomide), are relaunched to the market and signify a combined global revenue stream of more than $2.8 billion for Celgene [1]. Since 2007, 30-40% of drugs or biologics that are introduced to the market in United States were either drugs reprofiled for new indications, reformulations or new amalgamations of existing drugs [2]. Besides this, drug re-profiling has also been performed on a regular basis by some companies such as, Pfizer, Novartis, Eli Lilly, Ore Pharmaceuticals, Biovista, Numedicus, Melior Discovery and SOM Biotech [3].…”

The curious stories of drugs with two lives: a new paradigm in drug development

“…It has been suggested that from 2007 to 2009, about 40% of drugs or related products that were approved or launched for the first time in the United States were either drugs repositioned for new indications, reformulations or new combinations of existing drugs. 16 While this can be seen in one respect as useful reuse of current medications, others have suggested that this practice of so-called 'evergreening' simply represents a method that pharmaceutical companies can use to prolong the period of patent protection. 17 More recent papers dealing with drug repositioning have set out to investigate a different question, namely -how can companies best identify potential targets for re-positioning?…”

Synthetic approaches to the 2009 new drugs

“…9 The marketing of this drug was started in June 2009 by Cephalon, who discovered and developed the drug. In comparison to modafinil, armodafinil has a long half-life due to its slower metabolism and excretion, resulting in greater exposure of the drug and consequently a longer duration of action.…”

“…[2][3][4][5][6][7][8] Given that drugs tend to have structural homology across similar biological targets, it is widely believed that the knowledge of new chemical entities and their syntheses will greatly facilitate drug design. In 2009, 51 new products including new chemical entities, biological drugs, and diagnostic agents reached the market, 9 the largest number in the last decade. Twelve additional products were approved for the first time in 2009; however, they were not launched before year's end and thus the syntheses of those drugs will be covered in 2010s review.…”