Qualitative change, rather than the quantitative kind, marks this year's biopharmaceutical pipeline. There has been a shift in categories poised to yield near-term approvals. And while not the goldmine drug marketers were hoping for, analysts expect the 2010 R&D seam to yield some exciting launch prospects in the months and years ahead.
Oncology, a well of innovative approvals in years past, has run relatively dry. “In 2000-2001, we saw Avastin, Tarceva, Sutent, Nexavar, Gleevec—drugs that revolutionized the way we think about treating cancer,” notes Ben Weintraub, PhD, director of research, Wolters Kluwer inThought. “The second half of this decade is about using them properly.”
Another category making less noise is neurology, with scientists' search for an effective Alzheimer's disease treatment one of the lone highlights. In multiple sclerosis, oral therapy cladribine (Merck/Serono) is set to enter a self-injection and infusion market. Yet analysts see few potential game-changers among Parkinson's disease, schizophrenia, depression or pain candidates.A cardiovascular blockbuster?
The cardiovascular pipeline, on the other hand, contains a slew of provocative agents that could make a big impact. Indeed, the next blockbuster may be a clot-buster, with Johnson & Johnson and Bayer's Xarelto (rivaroxaban) anticoagulant shaping up to be physicians' best hope to replace warfarin. Then there are the upstarts. Patients with rare diseases are finally getting drugs specifically approved for them. According to a new analysis by the Tufts Center for the Study of Drug Development, the annual rate of new product approvals worldwide for neglected diseases increased from an average of 1.8 in 1975-99 to 2.6 in 2000-09. Vaccines and antiviral drugs have also seen a resurgence, with physicians talking about a possible cure for hepatitis C and a number of vaccines in the pipeline for ailments from flu to cancer and diabetes.
These drug-development dynamics are borne out in MM&M's Pipeline 2010. The report captures the latest trends, profiling 15 agents with a high probability of reaching market and bright commercial prospects. Surveying today's drug-development scene, the report highlights the rare disease and infectious disease categories, along with stalwarts cardiovascular, metabolic and rheumatology. A final category keeps readers updated on neurology, women's health, respiratory and oncology product candidates.
The top picks are based on Wolters Kluwer data. Each profiled drug includes a percentage called the inThought Approvability Index (IAI)—anything above 50% has a good chance—and, where available, a revenue forcecast. The IAI uses historical approval rates and detailed analysis of clinical trials to model the probability of approval. Each featured section of the pipeline also includes a box containing additional key products (from Wolters Kluwer data).