An important example of "Precision Medicine" is crizotinib, which has advanced rapidly into Phase III trials. The novel compound targets the ALK gene mutation in certain advanced non-small cell lung cancer tumors. Pfizer expects to complete the U.S. submission of a New Drug Application for crizotinib in the first half of 2011.
Bosutinib is in Phase III trials in the U.S. for the treatment of chronic myelogenous leukemia.
Sutent has been approved in Europe for the treatment of pancreatic neuro-endocrine tumors.
Axitinib has demonstrated efficacy against metastatic renal cell carcinoma in Phase III trials.
Apixaban, an oral anticoagulant co-developed with Bristol-Myers Squibb, showed clear evidence of efficacy in a Phase III trial for atrial fibrillation. Meanwhile, it was submitted for approval in Europe for treating venous thromboembolism.
Taliglucerase alfa, a plant-based enzyme, has been submitted for approval in the U.S. and Europe for treating Gaucher's disease, a rare, inherited condition. With permission from regulatory authorities, the treatment, being developed in partnership with Protalix, is already being made available to people suffering from this genetic disease.
Pfizer brings unparalleled breadth of scientific capabilities to bear on urgent, unmet medical needs. We believe our leadership in drug design, biotherapeutics and vaccines, small molecules and discovery and development sciences—together with our extensive network of external collaborations—will help open a new era of biomedical research. We are driving a bold R&D strategy to deliver the next generation of medicines and vaccines that will matter most to the people we serve, year over year.
Like all of our peers, Pfizer faces challenges that will shape the future of R&D and the future of the industry. We are responding with a vigorous strategy to strengthen our innovative core, focusing on the delivery of our portfolio, the development of important new capabilities, and the anticipation and creation of the R&D ecosystem of the future, which will seek to deepen innovation networks connecting industry, academia and the public sector.
To strengthen the delivery of our portfolio, we are moving forward with renewed methods to drive medically differentiated products that are commercially relevant. We also are deepening our knowledge of pathogenic mechanisms to drive greater therapeutic impact.
To develop important new capabilities, we are pushing the boundaries of how drugs will look in the future, and we are creating totally novel platforms for open and external innovation.
To lead the R&D ecosystem of the future, we are aiming to fully deliver on the promise of "Precision Medicines" across multiple therapeutic areas—as well as highly interactive and networked R&D.
Expanded internal and external capabilities, a strong focus on "Precision Medicines," differentiated innovation and our commitment to thorough integration of science and business are designed to yield an important step change in productivity.
To accelerate these strategies, Pfizer has announced a series of measures to increase focus, expand externalization strategies and more strongly position the company for differentiated innovation.
We will concentrate on core research areas where we can deliver the greatest medical and commercial impact. These areas include neuroscience, cardiometabolic diseases, oncology, inflammation and immunology, and vaccines—all of which are augmented by the advantaged modalities delivered by our CovX and Rinat biotechnology units.
Specialized units will focus on pain and sensory disorders and on biosimilars. We will, furthermore, initiate external research programs in high-potential areas within Primary and Specialty Care. And in line with our disease-area strategy, our post-proof-of-concept portfolio will focus on high-priority disease areas and will include a mix of owned and partnered assets that together aims to improve our risk/return profile.
We are establishing industry-leading models for external collaboration that allow us to access the best science. We continue to establish strategic collaborations with industry and academia and look to expand the numbers and types of these collaborations. We joined with seven of New York City's top research universities and hospitals to expand Pfizer's Centers for Therapeutic Innovation (CTI) program. We have formed our first CTI partnership with the University of California, San Francisco and will co-locate Pfizer scientists there alongside their academic counterparts.
We will strengthen the fundamentals that drive differentiated innovation to deliver the medicines and vaccines that matter most. We are strengthening internal programs to drive disciplined decision-making and portfolio governance. Our R&D site network also will align more closely with key hubs for biomedical innovation, connecting our network more deeply with leading biomedical research institutions and providing us with more access to a deep talent base in science.
Pfizer scientists, along with our counterparts in many alliances and partnerships, are among the leaders in the global effort to incorporate innovative "Precision Medicine" strategies into all of our core and specialized research areas. "Precision Medicine" focuses on clusters of patients who share a genetic variation and thus would benefit from a specific therapeutic approach. For example, in oncology we are working on a variety of treatments—ranging from small molecule compounds to biologics to therapeutic vaccines—that target specific gene mutations in tumors.