Pipeline 2011: Launch Prospects
Pharma and biotech companies are hoping for a recovery in R&D productivity to replace aging blockbusters. But any rebound in new product approvals will have to wait until the research drought is over. It's as hard as ever to find agents near launch that might make a commercial impact.
That's not for a lack of effort. “[The pipeline] is chock full of phase III studies, but that's always been the case,” says Ben Weintraub, PhD, director of research, Wolters Kluwer inThought. “The question is, why haven't we had any blockbusters in the last few years?”
Reaching late-stage development—as all of these candidates have—is a good start. This report includes a number of important, novel therapies pegged by most analysts to reach blockbuster level—industry parlance for $1 billion in sales—and some wild cards worth watching.
Among the blue-chip launch prospects are two for treating patients with malignant melanoma: ipilimumab, the Bristol-Myers Squibb monoclonal antibody, and PLX 4032, the Roche/Plexxikon BRAF inhibitor. And much as Bayer's Nexavar, Pfizer's Sutent and Roche/Genentech's Avastin altered the outlook in renal cancer, Weintraub predicts these experimental agents will do the same for skin cancer.
Locks and long-shots
In the metabolic category, a new oral class of diabetes meds is gaining steam, the SGLT2 inhibitors. There's also an inhalable insulin, MannKind's Afrezza, that some say has an outside chance, if FDA concerns over lung safety can be assuaged. And don't count out obesity. Seeing as the agency rejected Arena's lorcaserin and Vivus' Qnexa weight-loss hopefuls in October, will Orexigen's Contrave have the right mix of safety and efficacy to satisfy regulators?
Another long-shot, but one with huge potential, hails from the cardiovascular area. With anacetrapib—a molecular cousin of Pfizer's failed torcetrapib—Merck hopes to realize the promise of the CETP inhibitor class in atherosclerosis.
Finally, two holdovers from last year's Pipeline Report, the hepatitis C therapies telaprevir and boceprevir, have analysts crowing. They say data released over the past year have narrowed differences between the two promising drugs, and that's good for patients. Standouts from the infectious disease, oncology, metabolic and cardiovascular areas are joined by those from rheumatology, plus a separate page with short lists covering respiratory, women's health, neurology and rare disease.
Top picks are based on consultation with Wolters Kluwer inThought, Adis R&D Insight and other experts. Since any close call is a mere bounce away from becoming a near miss, profilees include, in addition to the expected approval date, an inThought Approvability Index—a percentage to help readers gauge the likelihood of an FDA OK based on the agent's safety and efficacy through each phase of clinical development; anything above 50% has a good chance. Add in clinical trial results, analyst comment, revenue forecasts and extensive lists of other key products, and you get a pretty good overview of the late-stage biopharmaceutical drug pipeline.