Pharma R&D Annual Review
New active substances - a weaker year
Outside of the cancer arena, in a striking and concerning trend for 2009, innovation was conspicuous by its absence...Before dissecting the current pipeline in further detail, let's take a moment to look at the successes of the past calendar year. At first glance, this year's table of new active substances (NASs) first launched during 2009 looks fairly impressive, with 36 market entrants, up from 32 in 2008. However, as the list reproduced in Table 1 shows, this figure is skewed by the fact that seven of these new drugs are in fact influenza vaccines - six for swine 'flu and one for avian 'flu. Take these, as well as a Japanese encephalitis virus vaccine and a pneumococcal vaccine out of the picture, and the number of new chemical entities and biological falls to a disappointing 27*, below the decade average of 29. It seems reasonable to exclude 'flu vaccines from the total as they are mostly variations on a theme - and while it is creditable that the industry managed to respond quickly to the threat of a pandemic, questions have been asked in some quarters as to whether the response was disproportionate to the threat; indeed many governments are now seeking to offload supplies of vaccines which they bought in bulk and apparently no longer need. Thus their contribution to the overall number of NAS launches in 2009 could justifiably be viewed as distorting.
As Table 1 shows, not counting the vaccines, a further four biologicals made their debuts on the market, all of them monoclonal antibodies. Two of these were for cancer treatment, Trion Pharma's catumaxomab (Removab) for certain types of pancreatic and stomach cancers, and Genmab's ofatumumab (Arzerra) for chronic lymphocytic leukaemia. It was a better year for cancer generally after an uncharacteristically barren 2008, with a further three new launches bringing the total in this area to five. Of particular interest was Allos Therapeutics' pralatrexate (Folotyn), which became the first drug to be approved for relapsed or refractory T-cell lymphoma, an orphan indication. Also of note was the new renal cell carcinoma treatment from GlaxoSmithKline, pazopanib (Votrient), which targets multiple kinases.
Outside of the cancer arena, in a striking and concerning trend for 2009, innovation was conspicuous by its absence. Diabetes saw a further two market entrants, with Bristol-Myers Squibb's sitagliptin (Onglyza) and Novo Nordisk's liraglutide (Victoza) finally being launched following protracted approval processes, but both drugs will compete with existing therapies which share their mechanisms of action. Diabetes, a very popular R&D area with a growing market, is now beginning to look somewhat crowded.
There was some good news in gout, with the first novel drug for this condition in 40 years hitting the market. Due to its historic and largely apocryphal association with port-quaffing aristocrats, gout is sometimes viewed almost comically, belying the fact that it is a highly painful and debilitating condition. Takeda's febuxostat (Uloric) is a xanthine oxidase inhibitor which treats the hyperuricaemia which causes gout. There are a number of other drugs in the gout pipeline, including Novartis' canakinumab (Ilaris) which is itself another 2009 NAS launch, although for a much more niche indication - cryopyrin-associated periodic syndrome.
Novelty of a sort was also evinced by Johnson & Johnson's dapoxetine (Priligy). Noting that the 5-HT reuptake inhibitor class of antidepressants frequently have the side-effect of inhibiting ejaculation, the company developed dapoxetine with this mechanism explicitly to treat premature ejaculation. It is the first compound to be specifically approved for this indication.
The broad therapeutic area with the most compounds debuting during 2009 was CNS/neurological. Its six launches just pipped the five anticancers. Aside from vaccines, anti-infectives fared unusually well, with three new antibacterials entering the market, although as with the CNS drugs, they tended to be 'me-toos' - variations within established classes rather than scientific breakthroughs. In corporate terms, the aforementioned Johnson & Johnson could be judged to have had the most successful year, originating two NASs and being the launch country licensee for Gruenenthal's dual-action analgesic, tapentadol (Nucynta). GlaxoSmithKline also had three debutants, although two of these were vaccines. Interestingly, the world's biggest pharmaceutical company, Pfizer, was unable to launch a single compound originating from its own pipeline, with its only two successes coming from an acquisition (tebipenem pivoxil coming from Wyeth) and a licence (Bausch & Lomb's besifloxacin hydrochloride (Besivance)). Analysts will undoubtedly be looking for increased productivity from the giant company in coming years as evidence of the success of its merger strategy. As for the most popular market for first launches, the US once again was far ahead of the competition, accounting for almost half of NAS market entrances. In Europe, Germany proved the most popular country for a first appearance.
