IHS Global Insight Perspective | |
Significance | The drug research projects discontinued include a potential fibromyalgia and a generalised anxiety disorder therapy. This brings the number of terminated development projects to 15, and in Phase III projects to two since early 2009. |
Implications | The move will be viewed as a setback for the firm, as it indicates the firm is still in the process of evaluating its research and development (R&D) pipeline to reflect its new focus therapy areas. With Pfizer noting no safety concerns for the experimental drugs, the development also begs the question why the firm did not discontinue the projects in September 2008, when it announced a shake up of its R&D outlook. |
Outlook | Pfizer's focus since the acquisition of Wyeth, particularly its interests in R&D, will be closely followed by the industry. Further potential discontinuations are possible as integration with Wyeth's operations ensue. |
Pharma giant Pfizer has announced the termination of two drug research and development (R&D) projects: PD-332334, as a potential treatment for generalised anxiety disorder, and esreboxetine for fibromyalgia. The firm said that the decision was made after a review of the "development and commercial" portfolio in the new Primary Care business unit. Both the drug candidates are currently undergoing Phase III clinical trials. Providing an insight into the rationale to the decision, Pfizer said that the review of its R&D pipeline showed that the two products did not provide any significant benefit over the current standard of care in their respective segments. The company stressed that the products were not terminated due to safety reasons.
Looking ahead, Pfizer noted that the terminated programmes would allow additional resources to be added to other continuing research programmes. Providing an update on the current opportunities of its promising drug candidates, Pfizer said that tanezumab is being researched in areas of pain management other than osteoarthritis. Furthermore, the firm will pursue its new indications research in Lyrica (pregabalin) which is already approved for fibromyalgia, and, interestingly, is being developed as a potential treatment for generalised anxiety disorder.
Pfizer has reiterated its focus areas in the R&D arena, with Alzheimer's disease and thrombosis receiving special mention. Investments by Pfizer into biotechnology and oncology research are also found to have increased, highlighting the firm's interest in specific therapy areas. The table below provides Phase III clinical programmes, indicating the terminated projects in Pfizer portfolio.
Pfizer's Phase III Pipeline, as of September 2008 | ||
Candidate | Indication/Therapeutic Area | Notes |
Thelin | Pulmonary hypertension | Progressed from Phase II |
Apixaban | Venous thromoboembolism | New indication or enhancement |
Apixaban | Atrial fibrillation | New indication or enhancement |
CP-945598 | Obesity | |
Dalbavancin | Skin and skin structure infections | Returned to previous phase of development |
Eraxis/Vfend | Aspergillosis | New indication or enhancement |
Maraviroc | HIV in treatment-naïve patients | New indications or enhancements |
Zithromax/chloroquine | Malaria | |
PD 332334 | Generalised Anxiety Disorder | Terminated in 2009 |
Geodon | Adjunct bipolar depression | New indication or enhancement |
Geodon | Bipolar relapse prevention | New indication or enhancement |
Lyrica | Epilepsy monotherapy | New indication or enhancement |
Lyrica | Generalised Anxiety Disorder | New indication or enhancement |
CP-751871 | Non-small cell lung cancer | |
Axitinib | Renal cell carcinoma | New indication or enhancement |
Axitinib | Pancreatic cancer | Terminated in 2009 |
Sutent | Colorectal cancer | New indications or enhancements |
Sutent | Hepatocellular cancer | New indications or enhancements |
Sutent | Prostrate cancer | New indications or enhancements |
Sutent | Lung cancer | New indications or enhancements |
Sutent | Breast cancer | New indications or enhancements |
Celebrex | Gouty arthritis | New indications or enhancements |
Esreboxetine | Fibromyalgia | Terminated in 2009 |
Lyrica | Post-operative pain | New indications or enhancements |
Source: Pfizer website. | ||
Outlook and Implications
The termination of the two late-stage drugs by Pfizer will be increasingly viewed as another setback for Pfizer. Earlier this year, the firm pulled an axitinib research programme as a potential treatment for pancreatic cancer, and in December last year had to amend the clinical trial design for a glioblastoma multiforme drug in Phase III trials. Both these events, along with the current announcement, depict rising challenges to Pfizer's research programme. It is interesting to note that the firm had announced a wide-ranging restructuring programme for its operations in 2008, which included a shake up of its R&D programme. Following this, the firm discontinued 13 research programmes (in September 2008).
But industry watchers will question the timing of the announcement of the current termination, noting that the pharma major seems to still be evaluating its R&D programme for blockbuster drugs. While projected estimates in media reports suggest that the drugs could have garnered US$1 billion each in peak sales (source: Reuters), it is clear that Pfizer is aiming for much more than that figure, particularly given the firm has indicated there were no safety concerns related to the terminated products. The Phase III table provided above provides some indication of the firm's current strategy, as most of the drugs being researched are either new indications of approved drugs or enhancements. In the case of PD-332334, there is another drug, Lyrica, which is also being researched for the same potential indication. Lyrica is also approved for fibromyalgia which is the indication researched for the terminated esreboxetine. Here it seems the decision to back the approved drug is apparent.
With the acquisition of Wyeth (U.S.) earlier this year, more rationalisation of the R&D portfolio can be expected. It is important to note that Pfizer's latest decisions may not have a big impact on its future financial projections. The receipt of various regulatory approvals for the Wyeth-Pfizer acquisition will kick off a merger and subsequent integration expected later this year.
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- United States: 2 February 2009: Pfizer Halts Axitinib Drug Late-Stage Trial for Pancreatic Cancer
- United States: 27 January 2009: Pfizer Acquires Wyeth in the Industry's Largest-Ever Takeover Deal
- United States: 19 December 2008: Pfizer and Celldex to Amend Phase III Clinical Trial Design for Glioblastoma Multiforme Drug
- United States: 1 October 2008: Pfizer Provides Updates on R&D Pipeline, Discontinues 13 Drugs from Development.