Pipeline drugs 2010, part 2

Key Points

As described in Part 1 (find full article in January 15, 2010 issue) Drug Topics' special pipeline 2010 coverage, the following months promise the appearance on the market of a diverse group of new drug therapies. Notable breakthroughs will include drugs for the treatment of Alzheimer's disease and cardiovascular disease, a number of new blood products, and a rise in vaccine development from various pharmaceutical companies.

Keep an eye out for new drug therapies to emerge to treat the conditions noted below.

Alzheimer's disease

Other agents undergoing phase 3 clinical trials include bapineuzumab (Wyeth), solanezumab (Lilly), dimebon (Pfizer), and LY450139 (Lilly).

In addition, agents with at least six different mechanisms of action are in the pipeline to treat Alzheimer's disease. Yet another approach, the Alzheimer's Disease Neuroimaging Initiative (ANDI), released in 2009, has the potential to redefine clinical development. Results from ANDI's longitudinal imaging trial indicate a correlation between low cerebrospinal fluid (CSF) biomarkers and the likelihood of progression from mild cognitive impairment (MCI) to Alzheimer's disease.

"The impact of the findings from this initiative is significant, indicating that physicians may have the potential to treat pre- or early-stage Alzheimer's patients with disease-modifying therapy," said Brian Kolling, PharmD, director of Pipeline and Trend Forecasting for Part D at Prescription Solutions, a subsidiary of the pharmacy benefit management company UnitedHealth Group of Minnetonka, Minnesota.

Cardiovascular diseases/blood-related products

Significant developments in this arena include two products: Rivaroxaban (Xarelto, Bayer/Johnson & Johnson) and dabigatran (Pradaxa, Boehringer Ingelheim). Healthcare providers today are seeking alternatives to warfarin that offer improved results without increased bleeding risks. These agents provide such benefits as both are once-daily oral agents and do not require coagulation monitoring.

Rivaroxaban is a potential blockbuster drug. This agent is an oral anticoagulant targeted to treat venous thromboembolism (VTE) and amyotrophic lateral sclerosis (ALS), and to prevent stroke. It is currently in phase 3 clinical trials.

"Rivaroxaban exhibited superiority to enoxaparin, an injectable, which has been the gold standard for post-op hip- and knee-replacement surgery in prophylaxis," said Kolling, a leading authority on pipeline drugs. He expects the drug to be expensive for consumers, compared to generic warfarin, for example, but "the clinical data appear to support its use in comparison to enoxaparin for that indication."

Dabigatran, which is also in phase 3, is indicated for the treatment of VTE and stroke prevention. It has also demonstrated lower bleeding rates than warfarin.

Additional products in the cardiovascular pipeline are rosuvastatin/fenofibric acid (Certriad, AstraZeneca/Abbott), darapladib (GlaxoSmithKline), ticagrelor (Brilinta/AZD6140, AstraZeneca), and SCH-530348 (Schering-Plough).

According to Kolling, no major changes are expected in the statin market through 2011. The cholesterol drug pipeline is "cloudy, given the success of statins," he said.

New antiplatelet and antithrombotic drugs could redefine treatment for several conditions; however, Kolling expects the hypertension market to slow after angiotensin receptor blocker (ARB) patents begin to expire later this year.

In a broad sense, the anticoagulant/antiplatelet category will be one to watch, according to Kolling.

"We saw prasugrel [Effient, Eli Lilly] come to market in mid-2009, and there are several drugs lined up behind it that will compete not only against clopidogrel but against enoxaparin, warfarin, and other forms of heparin."