Therapy Analysis - Pharma R&D Annual Review
New active substance launches in 2006 - a new set point?
Table 1 details the new active substances (chemicals and biologicals that have not previously been marketed), which were launched for the first time during 2006. There were 31 - the same as in 2005, just above the level seen during most of the early part of the decade. While some believe that a NAS launch rate of 25 to 30 is inadequate and that the industry should strive to recreate the 40-50 per year seen in the best years of the nineties, there is a growing school of thought that the lower rate is unlikely to improve and is considered acceptable. Are we seeing the annual rate settling at a new, lower 'set-point', with which the industry is comfortable, and that will not hold back pipeline expansion?
..the 2006 list does contain some important and potentially huge-selling drugs..At least the 2006 list does contain some important and potentially huge-selling drugs. One of the highest profile of these is Gardasil (HPV vaccine, CSL), which Merck licensed from the Australian company CSL, for the prevention of cervical cancer caused by human papilloma virus. Following its US launch in July, it has been rolled out rapidly and a number of countries are undertaking mass vaccination programmes for young women. This should be a real money-spinner for Merck, although it must be looking over its shoulder at GSK's competitor vaccine Cervarix, which is awaiting approval in a number of markets and is expected to be launched in the 2nd half of the year.
Merck was also behind another of the year's more interesting introductions, the antidiabetic sitagliptin phosphate (Januvia). It was the first of the dipeptidyl peptidase IV inhibitors to reach the market and remains the sole entrant thus far. Its nearest competitor, Novartis' vildagliptin (Galvus), received an approvable letter in the US, requesting further data on safety and efficacy in patients with renal impairment, while its next nearest rivals, Bristol-Myers Squibb's saxagliptin and Takeda'a alogliptin benzoate, remain in Phase III trials. However, Novartis did achieve success with telbivudine (Tyzeka/Sebivo), its nucleoside analogue for the treatment of hepatitis-B and another potentially big money-spinner.
In the area of unmet clinical need, Genentech's ranibizumab (Lucentis) became the first drug therapy to be approved for wet age-related macular degeneration, currently a 'hot' area in R&D. Another of the eight biologicals among this year's NASs was also a therapeutic breakthrough, albeit for a niche area. Genzyme's enzyme replacement therapy alglucosidase alpha (Myozyme) has been widely launched for sufferers of Pompe's disease.
Another notable new launch is Sanofi-Aventis' rimonabant (Accomplia), the first cannabinoid CB1 antagonist to hit the market. It has been approved for use in obesity in patients with risk factors, although it ran into problems in the other main indication it was under development for, smoking cessation. In the cancer field, two potentially very significant therapies targeting cell signalling, Bristol- Myers Squibb's dasatinib (Sprycel) and Prizer's sunitinib malate (Sutent) were added to the armoury. So 2006 could be viewed as a year of quality, if not quantity.
