The non-specialty pharmaceutical pipeline: What's on the horizon?

About half of the top non-specialty drugs will become generic within the next 5 years, therefore the trend is for pharmaceutical companies to search and "co-develop" agents rather than investing large amounts of dollars in "R&D."

Key Points

About half of the top non-specialty drugs will become generic within the next 5 years, therefore the trend is for pharmaceutical companies to search and "co-develop" agents rather than investing large amounts of dollars in "R&D."

The new R&D paradigm may result in: in-licensing of pipeline products later in development and leaving early development work to another "partner" company; and/or sharing the development risk with a similar-size company; and/or shifting to other emerging, markets such as in Mexico and China, to extend the "legacy" of current products after they are off-patent in the United States. These emerging markets have lower margins than the United States, but a much greater growth rate.

New generics include Aricept, Kadian, and Ambien CR. Potential new 2010 approvals include ticagrelor, saxagliption/metformin, ceftaroline, exogabine, and rosuvastatin/fenofibric acid (Certriad). Lurasidone and dabigatran were recently FDA approved. Some newer mechanism agents for potential cardiovascular indications in the pipeline include mipomersen, an antisense inhibitor of Apo-B 100, which is a once-weekly, subcutaneous injection for homozygous familial hypercholesterolemia (hoFH). There also may be 2 new cholesteryl ester transfer protein inhibitors for the treatment of hyperlipidemia-dalceptrapib and anacetrapib; they are in phase 3 clinical trials.

In the central nervous system category, 2 new antidepressants are on the horizon: vilazadone, an SSRI with 5-hydroxytryptamine 1A receptor partial agonist activity (PDUFA date: January 22, 2011); and targacept (TC-5214), a nicotinic acid channel blocker, currently in phase 3 trials (filing expected in 2012). A new antipsychotic, cariprazine, is being investigated, as well as one new mechanism, anti-migraine agent-telcagepant.

Respiratory agents include new phosphodiesterase-4 inhibitors, and new combinations of inhaled steroids and long-acting beta agonists, as well as the ultra long-acting, indacaterol, for asthma and COPD. New drugs in the diabetes pipeline are GLP-1 agents (LY2189265; lixisenatide; albiglutide), ultra-rapid-acting inhaled insulin (Afrezza; PDUFA date: December 29, 2010), and dapaglifozin, a sodium glucose co-transporter-2 inhibitor, the next new class to emerge. Pioglitazone is expected to become available as a generic in August 2012.