IHS Global Insight Perspective | |
Significance | The main highlights of the update include a high number of discontinued projects, 21 programmes demonstrating advancement into the next phase, and 25 drug candidates in Phase III clinical trials. The firm has indicated it has discontinued one late-stage trial on Sutent for advanced breast cancer. |
Implications | In total, the number of programmes under development has been cut from 114 to 100, a reduction of 12.2%, with the reductions mainly evident in Phase I and II trials. The firm has increased the number of drugs in registration to two. These efforts reflect on Pfizer's therapeutic focus, which was revised last year following a restructuring of business focus. |
Outlook | The updates underscore the strength of Pfizer's R&D pipeline despite the drop in overall projects in a clinical phase of development. The pipeline is expected to be widened once Wyeth is merged into the company. |
Pfizer R&D Pipeline Update
U.S. pharma major Pfizer has provided new updates on the progress of its research and development (R&D) pipeline in the last six months. The firm has reaffirmed its therapeutic area focus in oncology, neurodegenerative, diabetes, and infectious diseases, but there is a clear attempt to narrow down the focus in terms of number of drug candidates. Main highlights from the updates are as follows :
- As of 31 March 2009, Pfizer's pipeline contains a total of 100 drug programmes in clinical phases of development, down 12.28% from the previous year. This includes 40 in Phase I, 33 in Phase II, 25 in Phase III and two in registration. The period also saw the firm receive approval for Fablyn (lasofoxifene) which won approval from European drug regulators on 25 March 2009. The product is yet to receive the greenlight from the U.S. FDA.
- 26 projects have been discontinued in the past six months. This is in stark contrast to 13 programmes which were discontinued in the last update, representing a 100% increase. Interestingly, the firm has provided some insight, noting that 15 of the 26 projects discontinued were "strategic decisions to stop work and reallocate resources". Furthermore, 11 projects were candidate attritions.
- On the positive side, 21 programmes have advanced in the given time period with most—19—in Phase III. These were mainly observed in new indications or enhancements in Sutent, apixaban, Lyrica and Celebrex among others. The firm said it had initiated seven Phase III programmes since the last update including clinical trials for two new molecular entities.
Selected Pfizer Drugs Discontinued from Development | ||
Compound Name | Therapeutic Area (Indication) | Phases of Development |
UK-369003 | Genitourinary (benign prostatic hyperplasia) | Phase II |
CE-224535 | Inflammation (rheumatoid arthritis) | Phase II |
PF-3564746 | Neuroscience (ADHD) | Phase II |
PF-4480682 | Pain (neuropathic pain) | Phase II |
CE-326597 | Cardiovascular and Metabolic Diseases (diabetes mellitus type II) | Phase II |
CP-866087 | Genitourinary (female sexual health) | Phase II |
PD-200390 | Neuroscience (insomnia) | Phase II |
PF-885706 | GI/Hepatology (gastroesophageal reflux disease) | Phase II |
CP-945598 | Cardiovascular and Metabolic Diseases (Obesity) | Phase III |
Esreboxetine | Pain (fibromyalgia) | Phase III |
PD-332334 | Neuroscience (generalised anxiety disorder) | Phase III |
Axitinib | Oncology (pancreatic cancer) | Phase III |
Geodon | Neuroscience (adjunct bipolar depression) | Phase III |
Source: Pfizer | ||
Sutent Clinical Trial
Separately, the firm also announced the discontinuation of one of the late-stage trials relating to oncology drug Sutent (sunitinib) following observations made by the independent data monitoring committee (DMC). The product SUN-1107 was undergoing clinical trials as a treatment for advanced breast cancer. The evaluation involved single agent sunitinib compared to capecitabine for patients with advanced breast cancer after failure in standard treatment. The DMC findings indicate that sunitinib may not be able to demonstrate statistical improvement achieving its primary endpoint of progression-free survival in that study population. Hence, the firm has discontinued the trial but insists three other Phase III trials and two Phase II trials involving the product will continue.
Outlook and Implications
The R&D pipeline update provides insight into the impact Pfizer's overall restructuring initiatives have had on the strategy direction of drug candidates in phases of clinical development. Significantly, the reduction in the number of programmes overall and the number of programmes advanced reflects on the perceived narrowing of focus areas particularly in terms of therapeutic disease areas. Last year, the firm had indicated that it will not seek to explore potential drug candidates in obesity, some cardiovascular disease conditions, and pain management drugs. A glance at some of the drugs discontinued in the mid and late-stage affirm this decision.
There is also a clear reflection of the different business units that the drug candidates are now assigned to. This includes Primary Care, Specialty Care, Global Research and specialised areas such as Biotherapeutics and Bioinnovation Centre and Oncology. In terms of the programmes that have progressed into the next stage of development, a clear strength in new indications and enhancements is visible, particularly in Phase II and III. This suggests that Pfizer is pursuing expansion of successful franchises which have already demonstrated a level of safety in the market place—a key area of concern from a regulatory standpoint in the United States recently.
In terms of new molecular entities progressing, Xiaflex, a biologic aimed as a potential treatment for dupuytren's contracture, tanezumab, also a biologic for osteoarthritis signs and symptoms, and dimebon, for alzheimer's dementia, present the most promising candidates in late-stage development progression. Pfizer will hope to gain regulatory approval for Geodon for bipolar relapse prevention and Selzentry/celsentri for HIV in treatment-naive patients, and also an FDA approval for its Fablyn in osteoporosis which is pending this year.
Meanwhile, the Sutent Phase III trial discontinuation will be viewed as a minor setback, not impacting the overall programme, as the firm is determined to pursue other clinical trials involving the product in advanced breast cancer treatment.
Related Articles
- United States: 1 October 2008: Pfizer Provides Updates on R&D Pipeline, Discontinues 13 Drugs from Development