Introduction:
Last Updated 10 August 2010
In the recent past,
depression presented drug developers with numerous lucrative market
opportunities because of its high and increasing prevalence and diagnosed and
drug-treated rates. However, the market for drugs used to treat unipolar
depressive disorders is expected to decline over the 2009-2019 study period
because of the patent expiries of major branded players, namely escitalopram
(Lundbeck’s Cipralex/Seroplex, Forest Laboratories’ Lexapro) and duloxetine
(Eli Lilly/Boehringer Ingelheim’s Cymbalta/Xeristar). Additionally, high
regulatory hurdles for approval, a large number of generic first-line
therapies, diminishing differentiation possibilities for emerging therapies,
and several late-stage failures plague the indication from a commercial
standpoint.
Despite the difficult market environment for emerging
antidepressants, developers are aggressively pursuing Phase III development for
at least three promising compounds. AstraZeneca/Targacept announced the
initiation of the Phase III Renaissance Program for its novel nicotinic
acetylcholine receptor antagonist, TC-5214. Additionally, Takeda and Lundbeck
have unveiled plans for five more Phase III studies of their mixed-action
serotonergic antidepressant, Lu-AA21004, and Forest has stated that it expects
to release the first Phase III data for its SNRI levomilnacipran during the
second half of 2010. We forecast that these key emerging therapies will begin
to recoup sales losses in the indication by 2014.
Questions Answered in This Report:
*
At the American Psychiatric Association meeting held in New
Orleans May 22-26, 2010, Clinical Data presented detailed data from its second
positive eight-week Phase III clinical trial of vilazodone, as well as the
results from a one-year Phase III safety study.
How do the results of these
studies impact our analysis of vilazodone’s therapeutic and sales potential in
depression, and what are experts’ opinions of this compound?
*
In June 2010, AstraZeneca
and Targacept provided details on the start of their comprehensive Phase III
development program for TC-5214 in patients failing to respond to first-line
treatment with an SSRI or SNRI.
Where is this emerging therapy expected to
fit in the treatment algorithm for depression, and how will it compete with
other adjunctive therapies?
*
In the first quarter of
2010, both GlaxoSmithKline and AstraZeneca announced plans to significantly cut
internal research and development programs in depression owing to economic
pressure.
Do experts believe there are any promising novel antidepressant
targets remaining, or is there too much risk involved in exploring molecules
with new mechanisms of action?
*
In the United States, there
are now three atypical antipsychotic products formally approved either as
adjunctive treatments to antidepressant therapy or as treatment for patients
failing to respond to standard antidepressant treatment.
How do experts feel
about the safety of adding these therapies to an antidepressant regimen? How
and when do physicians decide to prescribe these therapies to their depressed
patients?
*
Because the antidepressant market is extremely crowded and
genericized, developers growing difficulties in clinically differentiating
emerging therapies.
In what patient populations do developers believe there
is still market opportunity?Scope:
Markets covered: United States, France, Germany,
Italy, Spain, United Kingdom, Japan.
Primary research: 32 country-specific interviews with
primary care physicians and psychiatrists.
Epidemiology: Total unipolar depression population
(consisting of patients with major depressive disorder, minor depression, and
dysthymia); treatment-resistant depression (stages 1 and 2); major depressive
disorder comorbidity with chronic pain; major depressive disorder in patients
65 and older.
Emerging therapies: Phase II: 20 drugs; Phase III: 5
drugs; preregistration: 1 drug; registered: 1 drug. Coverage of 16 select
preclinical and Phase I products.
Market forecast features: This report features Decision
Resources’ first epidemiology-based market forecast to encompass the total
number of patients with unipolar depressive disorders, not just patients
suffering from major depressive disorder.