Pfizer Unveils R&D Pipeline Update with Focus on Biologics

U.S. pharma major Pfizer has provided an update of its clinical programmes' pipeline, outlining the firms' therapeutic interests and insight into its future commercialisation portfolio. The company is looking at emphasis on three broad segments—biologics, vaccines, and high-priority growth areas. Further to that, the high-priority disease areas are indicated to be: oncology, pain, inflammation, Alzheimer's disease, psychoses, and diabetes. These therapeutic areas are also what the company has categorised as "Invest to Win" areas, noting their innovation and marketing opportunities.

The new pipeline has close to 600 drug programmes, with 500 attributed with special focus on high-priority disease areas. These defined growth areas are effectively leading to 70% of Pfizer's research projects and 75% of late-stage portfolio. The firm has set a target of five years to become a "top tier biotherapeutics" company, globally demonstrating a resolve to focus heavily on integrating Wyeth's research portfolio, particularly biologics. In all, six vaccines and 27 biologics in development now form part of the combined portfolio registering an almost 100% rise in the number of biologics and vaccines added since March, 2009.

In terms of therapeutic area coverage, the oncology segment has gained the most, with 30 compounds in developments in various indications. The Phase III table above has five drugs, with Torisel providing the momentum. The firm's successful oncology drug, Sutent (sunitinib), is currently seeking U.S. FDA approval as a treatment for pancreatic neuroendocrine tumours. The drug is already approved as treatment for advanced renal cell carcinoma and gastrointestinal stromal tumour after disease progression or intolerance to imatinib mesylate (brand name: Gleevec/Glivec).

Others to take note of include: 11 compounds in anti-inflammation, with tasocitinib in Phase III; 10 compounds in Alzheimer's disease; and 8 compounds in pain management led by tanezumab in osteoarthritis. Also noted is the potential for increasing portfolio in some disease areas, such as Women's Health, Gaucher's disease, and River Blindness, which demonstrates an emphasis on potential therapies in segments with unmet clinical need. The full pipeline is accessible here.

Outlook and Implications

The update on research and development (R&D) from Pfizer is largely along expected lines, with the inclusion of major compounds from Wyeth. This includes Prevenar-13, the successful pneumococcal disease vaccine franchise which is gaining acceptance in the paediatric segment. The other is bazedoxifene, the menopausal vasomotor symptoms therapy that has shown significant reduction in new vertebral fractures in post-menopausal women with osteoporosis in Phase III trials. While the drug did not receive full FDA approval in 2008, the new results could potentially bolster plans for securing a full approval shortly. The drug is already approved in Europe and sold under the brand name Conbriza. Bapineuzumab is another worthy contender that has complemented Pfizer's recent focus on the neurodegenerative market segment. The drug from Wyeth's portfolio is co-developed with Elan (Ireland) as a potential treatment for Alzheimer's disease. However, the late-stage clinical trial results in April 2009 forced the firms to decrease the highest dosage of bapineuzumab following efficacy studies in patients with mild-to-moderate Alzheimer's disease (see United States: 3 April 2009: Wyeth, Elan Drop Highest Dose in Bapineuzumab Drug Phase III Trials).

In terms of clinical development strategy, the focus is clearly on biologics and high-value therapeutic segments identified as future growth areas. It was no surprise that oncology and neurodegenerative segments were included, as Pfizer's traditional strengths created strong fundamentals. It is also in these high-value segments that the firm has also sought to increase collaborative alliances with other companies to boost its discovery pipeline. The strategy is to clearly balance between presence in high-value segments and areas identified with unmet clinical need which could also contribute to growth. These include presence in the Gaucher's disease segment, where Genzyme currently dominates, as well as the infectious diseases segment.

The new outline runs parallel to the firm's recently established structure following the acquisition of Wyeth. The new Pfizer has restructured its operational divisions into: Primary, Specialty, Established Products, Emerging Markets, and Oncology. The restructuring efforts reflect the need for optimising marketing and manufacturing operations since the acquisition. The R&D segment was also affected by the consolidation, which led to a reduction of global R&D square footage by 35%. Furthermore, activities are to be restricted to five main sites and nine specialised units.

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