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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.
Coalition promotes important acetaminophen dosing reminders
November 18th 2014It may come as a surprise that each year Americans catch approximately 1 billion colds, and the Centers for Disease Control and Prevention estimates that as many as 20% get the flu. This cold and flu season, 7 in 10 patients will reach for an over-the-counter (OTC) medicine to treat their coughs, stuffy noses, and sniffles. It’s an important time of the year to remind patients to double check their medicine labels so they don’t double up on medicines containing acetaminophen.
Support consumer access to specialty medications through value-based insurance design
June 30th 2014The driving force behind consumer cost-sharing provisions for specialty medications is the acquisition cost and not clinical value. This appears to be true for almost all public and private health plans, says a new report from researchers at the University of Michigan Center for Value-Based Insurance Design (V-BID Center) and the National Pharmaceutical Council (NPC).
Management of antipsychotic medication polypharmacy
June 13th 2013Within our healthcare-driven society, the increase in the identification and diagnosis of mental illnesses has led to a proportional increase in the prescribing of psychotropic medications. The prevalence of mental illnesses and subsequent treatment approaches may employ monotherapy as first-line treatment, but in many cases the use of combination of therapy can occur, leading to polypharmacy.1 Polypharmacy can be defined in several ways but it generally recognized as the use of multiple medications by one patient and the most common definition is the concurrent use of five more medications. The presence of polyharmacy has the potential to contribute to non-compliance, drug-drug interactions, medication errors, adverse events, or poor quality of life.
Medical innovation improves outcomes
June 12th 2013I have been diagnosed with stage 4 cancer of the pancreas, a disease that’s long been considered not just incurable, but almost impossible to treat-a recalcitrant disease that some practitioners feel has given oncology a bad name. I was told my life would be measured in weeks.
