Therapy Analysis - Pharma R&D Annual Review
New active substances - a better year
...it was the usually more moribund area of blood/clotting disorders and other cardiovascular drugs which enjoyed the most success through the year, with no fewer than ten market entrants....Of course in some ways, the number of drugs in the pipeline is irrelevant - it's the number that make it to market which is the real benchmark of success. There is some cause for cheer here too, with an increase in the number of New Active Substances reaching the market for the first time in 2008 relative to 2007. [New Active Substances are new chemical or biological entities, as opposed to reformulations of existing drugs]. There were 32 market entrants during the course of 2008, a considerable improvement on the disappointing 25 seen the previous year, and above the average seen through this decade. However, as usual, there are some caveats. Firstly, this is still well below the figures seen during the heady days of the nineties, when there were frequently more than 40 introductions per year. Secondly, it would be hard to identify a drug which looks like it could be a really big superstar seller. Thirdly, it seems quite extraordinary that there was not a single anticancer drug launched during the course of the year. As data later in this article shows, oncology is by far the biggest area for R&D, and an area of high risk but potentially high returns. It is extremely unusual for cancer to remain completely unrepresented in a list of newly-launched drugs covering an entire year. In 2007, it accounted for a third of all first launches!
As Table 1 shows, it was the usually more moribund area of blood/clotting disorders and other cardiovascular drugs which enjoyed the most success through the year, with no fewer than ten market entrants. The new generation of anticoagulant drugs was represented by Shire's rivaroxaban (Xarelto), while Boehringer Ingelheim launched the thrombin inhibitor dabigatran etexilate (Pradaxa), for which it has hopes of blockbuster status. Meanwhile, two products were launched for thrombocytopenic diseases: GlaxoSmithKline's (GSK) eltrombopag olamine (Promacta), an oral thrombopoietin receptor agonist for idiopathic thrombocytopenic purpura, and Amgen's injectable version, romiplostim (Nplate) for the same indication. Shire's icatibant (Firazyr), which it picked up when it acquired Jerini, and Viropharma's Cinryze became the first two therapies to hit the US market for hereditary angioedema. The set of new therapies in this area was topped off by Asahi Kasei Pharma's recombinant human thrombomodulin (Recomodulin) for disseminated intravascular coagulation in sepsis, and ZymoGenetics's recombinant thrombin alfa (Recothrom) for surgical bleeding control. In the wider cardiovascular area, there was a new hypertensive, clevidipine butyrate (Cleviprex), and CV Therapeutics' agent for use in cardiac perfusion, regadenoson (Lexiscan).
The similarly arguably unfashionable alimentary/ gastrointestinal area also had a good year, with another GSK drug, alvipoman (Entereg) for post-operative ileus, UCB's certolizumab pegol (Cimzia) for Crohn's disease, Merck & Co's fosaprepitant meglumine (Emend) for prevention of acute and delayed chemotherapy-induced nausea and vomiting, Il Yang's ilaprazole (Aldenon) for peptic ulcers, and Progenics' methylnaltrexone (Relistor) for opioid-induced constipation being launched.
Away from these two areas, there was little evidence of innovation, with Genzyme's small molecule CXC chemokine receptor 4 antagonist perixafor (Mozobil) being among the more interesting drugs, launched as it was for stem cell mobilisation in patients undergoing autologous transplantation following non-Hodgkin's lymphoma or multiple myeloma. The HIV/AIDS area followed an exciting 2007, which saw two first-in-class launches, with a less than exceptional year: Johnson & Johnson's NNRTI was the only market entrant. The only other two new anti-infectives were a new cephalosporin and a new quinolone, highlighting the need for more innovation in this area.
The biggest area after oncology, CNS, also had a relatively quiet year for launches. Its three new drugs, blonanserin (Lonasen) for schizophrenia, desvenlafaxine succinate (Pristiq) for major depressive disorder and lacosamide (Vimpat) for epilepsy, may have decent market sizes, but none of them are first-in-class. It is also interesting to note that just one unconjugated monoclonal antibody, Johnson & Johnson's ustekinumab (Stelara), was among the six biotech launches of the year. The drug is for mild-to-moderate plaque psoriasis.
Looking at launches by company, it was the aforementioned Johnson & Johnson along with UCB, GSK and Genzyme who enjoyed the most first launches in 2008. The US remains the pre-eminent market, with 15 of the 32 debuts occurring there.
So overall, a somewhat perplexing year in new product introductions, with good news on numbers, but this excitement possibly tempered somewhat by a dearth of novelty, particularly in the hottest areas of drug R&D. So can a more detailed look at the pipeline offer us any encouragement?
