The Pharmaceutical Pipeline: 2011 and Beyond

Atlanta—The number of drugs granted US Food and Drug Administration (FDA) approval decreased markedly in 2011 compared with other years. The FDA approval rate has slowed and the number of drugs under development has decreased, leading to a pattern of continued shrinkage. In a Contemporary Issues session at the AMCP meeting titled Scanning the Pharmaceutical Pipeline: What’s on the Horizon?, Brian Kolling, PharmD, senior director, pipeline & trend forecasting, Part D, Prescription Solutions by OptumRx, presented a review of 2011 drug approvals and an overview by therapeutic category of drugs in the pipeline. Dr. Kolling continued his presentation with a review of the pipeline by therapeutic category. Statins will maintain their dominance in the cardiovascular pipeline despite the growing number of generics available to treat high cholesterol, with new treatment pathways still years away, he noted. For hypertension, most classes are “mature” and there is little on the horizon, he said, adding that 2012 would be a significant year for angiotensin II receptor blocker generics. The number-1 growth pharmaceutical category will be in antiplatelets/anticoagulants, Dr. Kolling said, adding that savings from generics will be offset by new brands. There are few antiarrhythmic drugs in the pipeline, other than Multaq, which is currently in FDA review. Drugs in the cardiovascular pipeline include Eliquis (Bristol-Myers Squibb/Pfizer) for stroke prevention, Lixiana (Daiichi-Sankyo) for atrial fibrillation, lomitapide (Aegerion) for homozygous familial hypercholesterolemia, AMR101 (Amarin) for the treatment of elevated triglycerides and mixed dyslipidemia, MK-0524A (Merck) for treatment of primary hypercholesterolemia, and dalcetrapib (Roche) for the treatment of dyslipidemia. In the central nervous system medications, new therapies for depression are likely to be adjunctive, Dr. Kolling said. There will be significant patent expirations through 2012 in the antipsychotic class of medications, with the next wave of products expected in 2014-2015. For the treatment of migraines, there will be a shift to Botox for more complex cases, and there continues to be a market shift to tamper-resistant products for the treatment of chronic pain. Pipeline drugs related to the central nervous system include TC-5214 (Targacept/AstraZeneca) for major depressive disorder, levomilnacipran (Forest) for depression, cariprazine (Forest) for the treatment of schizophrenia and bipolar mania, Levadex (MAP/Allergan), dihydroergotamine by oral inhaler for the treatment of migraine headaches, and Remoxy (Pfizer) for the treatment of chronic pain. Dr. Kolling’s talking points related to drugs in the respiratory pipeline, including a continued focus on combination long-acting beta-agonist (LABA)/inhaled corticosteroid inhalers for the treatment of asthma. He added that there would be a “plethora of products for chronic obstructive pulmonary disease [COPD] hitting the market in 2011-2014,” with a focus on combination long-acting muscarinic antagonist (LAMA)/LABA inhalers. Dr. Kolling commented that there was “not much on the horizon” for the treatment of pulmonary hypertension, but added that in 2012 Revatio generics “could have off-label implications.” Drugs on the horizon for the treatment of respiratory diseases include Eklira (Almirall/Forest) for COPD, glycopyrronium (Novartis) for COPD, Relovair (GlaxoSmithKline) for COPD and asthma, and GSK573719/vilanterol (Theravance/GlaxoSmithKline), Spiriva (Boehringer Ingelheim), and QVA149 (Novartis), a combination LAMA/LABA for COPD. In his overview of drugs in the diabetes pipeline, Dr. Kolling said that oral agents were positioned for continued growth, there will be continued migration to rapid-acting analogs, with combination injections on the horizon, and Bydureon (Amylin) will test the level of enthusiasm for weekly dosing of glucagon-like peptide-1 (GLP-1). The final therapeutic class Dr. Kolling discussed was diabetes. Drugs in the pipeline for the treatment and management of diabetes include dapagliflozin (Bristol-Myers Squibb/AstraZeneca) to suppress glucose reabsorption and increase glucose excretion, Bydureon, a weekly GLP-1 analog, Degludec (Novo Nordisk), a long-acting basal insulin, and aleglitazar (Roche), for treatment of type 2 diabetes after a cardiovascular event. He concluded his presentation with a graph showing additional patent expirations in the next few years, including Boniva (March 2012), Revatio (September 2012), Aciphex (May 2013), Nexium (April 2014), and Actonel (June 2014).