Mental illness R&D reaches record level

July 20, 2010 – 2:06 pm by Michael Christel

Offering further proof of the lucrative appeal of mental health drugs despite the continuing minefield for researchers, there are a record 313 new drugs in development to treat conditions ranging from Alzheimer’s disease and depression to schizophrenia and addictive disorders, according to a new report by the Pharmaceutical Researchers and Manufacturers of America.

All the candidates are either in clinical trials or awaiting review by FDA, PhRMA says. Products targeting Alzheimer’s disease and other dementias represent the largest portion of activity, with 90 drugs in development. There are 11 products in Phase III clinical trials for Alzheimer’s disease, according to the study, which breaks down all 313 drugs by condition and provides contact information for each compound.

Information on these drugs can also be found in the June issue of R&D Directions, the magazine’s 15^th annual listing of all medicines in U.S. development, or in global development programs that involve the United States. Echoing the activity shown in PhRMA’s report, a search of our database reveals that there are more than 150 life sciences companies working in the central nervous system field.

According to PhRMA, treatments for depression make up the second busiest pipeline among mental illnesses, with 71 products being tested. Rounding up the top six most active areas are schizophrenia, with 54 drugs in development; anxiety disorders, with 38; and addictive disorders, such as alcohol or drug dependence, and eating disorders, with 33 apiece.

Other potential medicines are targeting attention-deficit/hyperactivity disorder, autism, personality disorders, premenstrual disorders, and sleep disorders.

The prevalence of mental illness continues to drive R&D efforts, even with the hit-and-miss history of treatments for some of these conditions. As this article notes, mental health drugs offer substantial profit opportunity, even as long development timelines, huge expense, and past failures continue to saddle the prospects that these medicines will indeed pay off for patients.

Despite the repeated setbacks, much of big pharma hasn’t shied away, as evidenced by the recent launch of a data-sharing program centered on pooling data from failed Alzheimer’s and Parkinson’s disease trials, giving researchers access to information on 4,000-plus patients.

According to figures cited by PhRMA, an estimated 300 million people worldwide – including 60 million Americans – struggle with mental health problems. The National Institute of Mental Health reports that 26.2% of Americans ages 18 and older – about one in four adults – suffer from a diagnosable mental disorder in a given year. NIMH says mental illness, including suicide, accounts for more than 15% of the burden of disease in established market economies, which is more than the disease burden caused by all cancers.

The Alzheimer’s Association recently released a new report contending that in the absence of disease-modifying treatments, the cumulative costs of care for people with Alzheimer’s disease from 2010 to 2050 will exceed an astronomical $20 trillion.

The report explores two treatment scenarios that could help decrease that burden significantly. The first one is finding a drug breakthrough that delays the onset of Alzheimer’s by five years — similar to the effect of anti-cholesterol drugs on preventing heart disease. The Alzheimer’s Association says that would result in an immediate and long-lasting reduction in the number of Americans with the condition and the cost of their care.

A treatment that delays onset by five years and begins to show its effect in 2015 would decrease the total number of Americans age 65 and older with Alzheimer’s from 5.6 million to 4 million in 2020, according to the report.

The second scenario is establishing a marketed treatment that slows disease progression, much like advances achieved in HIV/AIDS and several cancers. The Alzheimer’s Association says this would result in far fewer people in 2050 with the disease in the severe stage when care demands and costs are greatest.

Assuming such a breakthrough occurs in 2015, the report says by 2020, the number of people age 65 and older with Alzheimer’s disease in the severe stage would drop from 2.4 million to 1.1 million. In 2050, that number would decline from an expected 6.5 million to 1.2 million.

Industry pursuits to curb Alzheimer’s prevalence have grabbed the headlines of late. Helped by potential new guidance for Alzheimer’s diagnosis aimed at detecting the disease even before memory problems set in, Bristol-Myers Squibb is testing a drug designed to attack the disease earlier (see stories here and here). Also, Lilly recently discussed its pair of late-stage beta amyloid blockers, saying the company’s early use of biomarkers provides hope that the products will be effective.

Tags: Alzheimer's disease, clinical trials, mental illness, PhRMA