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Licensing Opportunities: Cancer Vaccines
Decision Resources, Inc., March 2010, Pages: 32
Is high-risk development of therapeutic cancer vaccines a good opportunity for pharmaceutical companies? In 2009, excitement built around several late-stage cancer vaccines that represent a new means to treat or prevent certain cancers. Efficacy has been disappointing for many vaccines, however, and the development of these vaccines is a high-risk endeavor. This risk is balanced by the prospective benefit of a new category of potential blockbusters that can help inhibit the progression of existing cancers, prevent recurrence of cancers, or destroy residual cancer cells not killed by prior treatments. Large and small pharmaceutical and biotech companies all look to one another as sources for needed licensing, partnering, and acquisition activities. To understand the landscape and dynamics of the cancer vaccine industry, we looked at different types of companies that are active in cancer vaccine development, analyzed their drug development and commercialization activities, and explored potential opportunities.
Questions Answered in This Report:
- Cancer vaccine development is high risk with high potential benefits. Is the high-risk development of therapeutic cancer vaccines a good opportunity for pharmaceutical companies? What will a cancer vaccines market look like?
- Cancer vaccines represent a new paradigm in the treatment of cancer. What do surveyed oncologists and urologists think about the prospects of cancer vaccines? What are their views on patient-specific versus off-the-shelf vaccines?
- Who are the major players and potential dealmakers in the cancer vaccine arena? Which smaller companies have cancer vaccines in development? Which Big Pharma and Midsize Pharma companies are already active in cancer vaccines and with which partners? Not all pharmaceutical companies are equipped to enter the cancer vaccine arena or to partner with a cancer vaccine company—why? What new financing vehicle was launched in 2009?
- The availability of appropriate regulatory guidelines has hindered cancer vaccine development and approval. What did the FDA recommend in its recent guidance document? What cancer vaccines are in late-stage development?
Scope:
- Cancer vaccines: therapeutic vaccines, prophylactic vaccines, vaccine technologies, immunomodulators, virally induced cancers, autologous vaccines, off-the-shelf vaccines, patient-specific vaccines, active cellular immunotherapy, peptide vaccines, anti-idiotype vaccines, antibody-targeted vaccines, fusion proteins, dendritic-cell-based vaccines, cancer stem cells, immune tolerance, immunosuppression, adjuvants.
- Dealmaking and financing: 15 cancer vaccine companies, partnering deals, mergers and acquisitions, financing, Cancer Immunotherapy Index Fund, shelf registration, Chapter 11 bankruptcy, first negotiation rights, potential Big Pharma and Midsize Pharma partners.
- Clinical development: good news and bad news in 2009, manufacturing considerations, findings presented at the American Society of Clinical Oncology meeting in 2009, primary end points, combination therapies, Phase III vaccine pipeline, overall response rate (ORR), progression-free survival (PFS), overall survival (OS), time to disease progression (TTP).
- Regulatory approval: draft guidance, 13 FDA recommendations, fast-track status, co-development pathway, associated diagnostic tests, special protocol assessment, conventional cancer trials, proof-of-concept studies, 3+3 drug escalation approach, accelerated titration approach, single-arm trials, randomized trials, superiority trials, equivalence/noninferiority trials, accelerated approval regulations.
- Primary data: Decision Resources’ Pharmaview and Onkos analyst insights; May 2009 survey on advanced cancer vaccines: 70 oncologists, 71 urologists, and 20 managed care organization pharmacy directors (MCO PDs); insights on Celldex Therapeutics/Pfizer’s CDX-110, biomarkers, reimbursement, diagnostic tests, Dendreon’s Provenge.
- Outlook: emerging market characteristics, likely blockbuster, convergence, a prudent caution.
Key Terms for This Report:
Adjuvant, Antibodies, Biomarker, Business development, Cancer vaccine, Convergence, Immunotherapy, Licensing, Partnering, Personalized medicine, Phase III failure, Provenge, Stem cell, Strategic planning, Targeted cancer therapy
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