Pharmaceutical innovation appeared to have reached a plateau in 2005, with 30 NASs launched, compared with 31 in 2004 and 30 in 2003, according to IMS LifeCycle New Product Focus' annual review. This seems to be setting the trend for the new century, with no foreseeable return to the mid-40s tally of the 1990s and the mid-50s that typified the 1970s and 80s.
US still dominates first world launches
The US domination of both research and country of first launch continued to grow in 2005, with more than 50% of NASs launched in the US as the first market, compared with 35% in 2004.
NAS by country of first launch
Source: IMS LifeCycle New Product Focus
Japan’s tally of first launch country and country of R&D corporation took an upturn in 2005, however, with five NASs, representing 17% of all launches. In 2004 first NAS launches in Japan represented 12%, up from an all-time low of just 5% in 2003. In the previous decade, Japan dominated first launches with 30-40%, but most of the NASs were either domestic products with no international potential, or took 10 years or more to penetrate the US and European markets. An encouraging feature of the Japanese-developed drugs in the class of 2005 is that almost all have international potential. One of the Japanese first launches was an orphan drug and another was a biotechnology product.
NAS launches by nationality of R&D corporation
Source: IMS LifeCycle New Product Focus
What will China’s role be in the global R&D process?
The remarkable occurrence of two innovative new biotechnology drugs being launched in China in 2004 was not repeated in 2005. No Chinese first launch NASs appeared, despite the promising situation in early 2005 when two registered Chinese drugs appeared to be waiting in the wings.
At the Chatham House conference held in London in March, China’s emerging role and the scope for R&D collaboration were discussed. Speakers identified a more supportive role in the early-stage drug development process than the actual production of innovative NASs for the global pharmaceutical industry in the short term.
There is a wealth of returnee Chinese scientists, and this talent pool, low research costs and the setting up of state-of-the-art research facilities have added to the attractiveness of China as an early-phase R&D contract research provider. According to a number of speakers, China is not yet able to offer the early-phase clinical trial outlets that India is geared up to provide, however. Speakers predicted that utilizing China’s early R&D facilities would help to save time in the early R&D process and substantially reduce costs.
Biotech productivity drops
There were only five biotechnology NASs launched in 2005, representing just 17% of total NASs. This was down on the last two years when eight of the NASs were biotechnology drugs – and way off some of the predictions made a few years ago suggesting that within the next five years 50% of NASs would be biotech products.
Number of NASs by year of launch
Source: IMS LifeCycle New Product Focus
Five of the 30 NASs launched in 2005 had orphan drug designations in the EU, US or Japan according to IMS LifeCycle R&D Focus. Conversely, six had analyst sales predictions of $500 million or greater per annum within the next five years.
Therapeutic growth areas
Systemic anti-infectives and central nervous system drugs each accounted for 17% of the NASs launched in 2005, whilst anticancer drugs accounted for 13%; in 2004 the number of oncology NASs was a massive 32% of the total. The number of anticancer drugs reaching the market in future years is expected to remain high or actually increase, based on the burgeoning R&D anticancer pipeline. According to R&D Focus, in 2005 the number of anticancer drugs in the R&D pipeline increased by 17% over 2004, with a 7% increase in the late-stage pipeline for oncology drugs.
No sign of development time decreasing
Analyzing the time to get the drug on the market, was the class of 2005 NASs slower or faster than the touted average of 8-12 years?
Of the evaluable NASs, only 12% took less than eight years from priority product patent application to first world-wide launch. Forty-four percent of the 2005 NASs conformed to the 8-12 year norm, while another 44% took greater than 12 years to reach the market. Indeed, 28% took longer than 16 years to get to market, according to IMS LifeCycle Patent Focus.
Time from priority product patent application to launch
Source: IMS LifeCycle Patent Focus
Licensing features strongly in the research process, with 67% of the 2005 NASs being subject to at least one licensing deal. More than 45% of these deals were struck at the preclinical stage of development.
Development stage at first licensing
Source: IMS LifeCycle R&D Focus
When one considers all licensing deals, 27% occurred at the preclinical phase and 24% at Phase III. Fifty-five percent of all licensing deals occurred pre-Phase III development according to R&D Focus.
All licensing deals by stage of development
Source: IMS LifeCycle R&D Focus
Were large multinational pharmaceutical companies more successful than small biotechnology or specialist companies with regards to launching NASs? Which companies are producing the 2-3 NASs per year needed to sustain growth going forward?
Novartis was the most successful company with regard to NAS launches in 2005, responsible for three, with Bayer close behind with two launches. Novartis launched Enablex (darifenacin) in the US and Germany in January 2005 for treating over-active bladder (originally licensed from Pfizer), and Prexige (lumiracoxib) in Brazil in August for the treatment of acute osteoarthritis. The third NAS launched by Novartis was Exjade (deferasirox), launched in the US in November for treating chronic iron overload due to blood transfusions. Novartis has been the most consistent producer of NASs over the last decade.
Both Bayer’s launches were licensed in from other companies. Nexavar (sorafenib tosylate), co-developed with Onyx, was launched in the US in December for advanced renal cell carcinoma, while GW Pharmaceuticals’ Sativex (tetrahydrocannabinol + cannabidiol) was launched by Bayer in Canada in July for relieving neuropathic pain associated with multiple sclerosis; cannabidiol is the NAS component of the fixed combination.
While the number of NASs launched decreased again in 2005, there are signs that overall pipeline health is increasing, with a greater number of products in development during the year compared with 2004. Now, manufacturers need to focus on targeting significant unmet medical needs, and running substantial clinical trials that help to demonstrate both the safety and cost-effectiveness of their products to ensure that the much-discussed ‘pipeline drought’ begins to diminish.
This article was written by Irene Buggle, Executive Editor of the IMS LifeCycle publications. For further information on LifeCycle or any of its constituent publications, please e-mail Stephanie Earle or call +44 207 393 5757.