Therapy Analysis - Pharma R&D Annual Review
New active substances - stuck on 25
...it was also a good year for new cancer drugs, with 32% of NAS first launches for cancer therapies. Of these, the multikinase inhibitors lapatinib and nilotinib look potentially the most interesting...One piece of data not skewed in any way by changes in data capture procedures is the number of new active substances reaching the market for the first time during 2007. This was unfortunately down to 25 last year – lower than in both 2006 and 2005, when the figure just scraped above 30. It looks as though the industry will just have to accept that the 25-30 range is the new annual rate of launch, and that the rates of 40-50 seen in the mid-nineties were a blip that is unlikely to be repeated in the short term.
In terms of novelty, it was good year for HIV/AIDS, with the first launches of not one but two new types of antiretrovirals with completely novel mechanisms of action. This marks a potentially huge step forward in an area which previously only had three approved treatment strategies – reverse transcriptase inhibition, protease inhibition and fusion inhibition. Added to the armory is Pfizer’s maraviroc (Celsentri), which binds to the human CCR5 coreceptor and thus prevents the virus gaining entry to the cell. This is the first anti-HIV drug to target a host protein, a strategy which is thought to have the advantage of being harder to develop resistance to, but runs the risks of a higher likelihood of side-effects. It is too early to judge the range of this agent’s effect in the field, but it does represent another useful tool for patients running out of treatment options. It was joined by Merck & Co’s raltegravir (Isentress), which targets the viral integrase, and looks to be a very exciting new agent.
As Table 1 shows, it was also a good year for new cancer drugs, with 32% of NAS first launches for cancer therapies. Of these, the multikinase inhibitors lapatinib and nilotinib look potentially the most interesting, with the latter being Novartis’ follow-up to its blockbuster imatinib mesilate (Glivec). Other anticancer market debutantes include Bristol Myers Squibb’s ixabepilone (Ixempra), Epeius Biotechnologies’ Rexin-G, Wyeth’s temsirolimus (Torisel), PharmaMar’s trabectedin (Yondelis), Peregrine Pharmaceuticals’ Tumour Necrosis Therapy and Merck & Co’s vorinostat (Zolinza).
