Recently, Pfizer (PFE) entered into a co-development agreement with Switzerland-based Debiopharm Group regarding pipeline candidate tremelimumab for the treatment of patients with melanoma. A biomarker will be used to identify those patients who are more likely to respond to the treatment. While Debiopharm will be responsible for conducting the phase III trial of tremelimumab, Pfizer will concentrate on the commercialization of the compound. Financial terms of the agreement have not been disclosed.
Pfizer’s tremelimumab is currently in a phase II clinical trial for the treatment of advanced melanoma. In April 2008, Pfizer had decided to discontinue a phase III trial for advanced melanoma after a review of interim data by a Data Safety Monitoring Board (DSMB). It was observed that the trial would not demonstrate superiority to standard chemotherapy. However, the analysis of data has helped identify the biomarker which can be used in patient selection for the forthcoming trial.
Melanoma is the deadliest form of skin cancer, affecting about 69,000 patients in the US each year and resulting in about 9,000 deaths. Globally, the number of melanoma cases is increasing faster than any other cancer.
Pfizer went through an extensive evaluation of all its products and potential drug candidates with an eye on areas where the company saw greater potential. Products and therapeutic areas which the company believes afford higher potential will be vigorously supported, while underperforming areas and products will be phased out. Pfizer is stopping discovery projects in dermatology, gastroenterology, heart disease, obesity and bone health. It is instead committing more resources to what it believes are higher growth opportunities like oncology, pain, inflammation, diabetes, Alzheimer’s and schizophrenia.
Pfizer is looking at strengthening its pipeline given the looming patent expiration of its top selling drug Lipitor, which is losing out to generic simvastatin (Zocor) as well as potentially superior branded products such as AstraZeneca’s (AZN) Crestor. Lipitor sales fell 2.2% in 2008 to $12.4 billion. Sales in third quarter 2009 fell 9.2% to $2.85 billion.
The weak economy appears to have accelerated a shift towards cheaper generic alternatives. We believe that the drug has peaked and sales will show a mid-to-high single digit decline until the patent expiration, slated for 2011.
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