Global Insight Perspective | |
Significance | The lineup in U.S. major Pfizer's Phase III clinical trials looks solid with 25 drugs and an overall 31 programmes advancing to the next stage of development. Pfizer has discontinued development on 13 drugs, however, with one drug, dalbavancin, withdrawn from registration. |
Implications | The R&D focus is now directed to oncology, diabetes, inflammation, pain and neurodegenerative disease areas. However, the cardiovascular sector has taken a back seat, with the firm indicating a case-by-case basis investment. |
Outlook | While not surprising, the shift in therapeutic areas represents a general trend in the industry towards high-value disease areas. Drug collaborations and a potential restriction in terms of R&D spending could be observed in the forthcoming quarters at Pfizer. |
Pfizer's R&D Pipeline
U.S. pharma major Pfizer has outlined the progress of its R&D pipeline in the traditional six-month update, affirming a focus on certain therapeutic areas; namely, oncology, pain, inflammation, diabetes, Alzheimer’s disease and schizophrenia. Main points from the announcement are as follows:
- A total of 114 clinical programmes are in the overall R&D pipeline from clinical trial development to registration.
- There are 25 drugs in Phase III, 38 Phase II and 50 in Phase I clinical trials. Also, 13 projects were discontinued since March 2008 and one drug in registration.
- Fablyn (lasofoxifene), a selective estrogen receptor modulator is the only drug under registration.
- Up to 31 clinical drug programmes have shown a progress to the next stage of development, with 19 going towards Phase III clinical trials.
- There are 16 biotherapeutic drugs in development, reiterating the firm's investments in the biotechnology sector.
- The company aims for 28 new molecular entities or new indications by December 2009 and 15-20 regulatory submissions in the 2010-2012 year period.
- Pfizer has indicated that it will review which compounds need to be discontinued or terminated on a case-by-case basis, the Wall Street Journal reported, quoting Pfizer R&D Chief Martin Mackay. However, the source reveals that Pfizer's intention is to exit the following disease areas: anaemia, atherosclerosis/hyperlidaemia, heart failure, bone health, liver fibrosis, obesity, osteoarthritis and peripheral arterial disease among others. Phase III drugs are not likely to be discontinued, though.
- There will be a higher focus on out-licensing and drug collaborations with other firms, indicating a slight shift from traditional research strategies, a trend expected to be pronounced in the forthcoming years.
The entire document on Pfizer's R&D programmes can be found here.
Pfizer Drugs Discontinued from Development | ||
Compound Name | Therapeutic Area | Phases of Development |
PF-4603629 | cardiovascular, metabolic and endocrine diseases | diabetes (biologic) |
PF-446687 | genitourinary | female sexual health |
PF-3274167 | genitourinary | Incontinence |
PF-3475952 | inflammation | rheumatiod arthritis (biologic) |
PF-755616 | inflammation | rheumatiod arthritis |
PD-325901 | oncology | cancer |
PF-738502 | pain | fibromyalgia |
UK-432097 | allergy/respiratory | chronic obstructive pulmonary disease |
CP-195543 | inflammation | rheumatoid arthritis |
PF-3187207 | opthalmology | glaucoma |
Esreboxetine | pain | pain |
Maraviroc | inflammation | rheumatoid arthritis |
CP-675206 | oncology | melanoma (biologic) |
Source: Pfizer | ||
Outlook and Implications
The Pfizer update does not provide many new surprises, particularly in terms of therapeutic area focuses. The firm had indicated earlier this year that it would be looking to target high-value disease areas such as oncology and neurodegenerative disorders. The first indication of such a move emerged in June 2008 when the firm announced a 400% increase in the oncology R&D budget, preceding the formation of a new oncology unit. There have been other announcements too in the area of stem cell research and the firm's intention to bet on alliances. So far this year, Pfizer has entered into eight research and development deals to help bolster its pipeline. In terms of strategic investments in R&D infrastructure too, there have been some insights. Pfizer increased investments in its Chinese R&D facility to boost its workforce, spun off its research centre in Japan to form ReQualia and set up a research unit in Hungary. Hence the stage is now being set to accelerate the pipeline towards commercialisation and the forecasts of 28 new molecular entities or indications do not seem too optimistic.
However, the reasons behind the firm's decision to review its investments in certain disease areas, albeit on a case-by-case basis, is significant. The fact that bone health features in the therapeutic areas for discontinuation is not surprising, as the firm has terminated four rheumatoid arthritis drugs. However in the case of the cardiovascular sector, the decision is not as clear. Pfizer has been looking to replace its top-seller Lipitor (atorvastatin) as it nears patent expiry, but it is surprising to note that the firm has indicated cardiovascular as one of the disease areas that could receive a chop in the future. While Pfizer has maintained that there are no immediate decisions on the issue, the intent is certainly interesting and any move in that respect will be closely watched by the industry. The drug major's investment in R&D could also face some restrictions as regulatory challenges and pricing and reimbursement pressures could evoke a measured response from all Big Pharma firms.
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