Sales of Wyeth's (WYE) new antidepressant Pristiq are nowhere
near the drug maker's 2006 peak annual forecast of more than $2
billion, due to fewer regulatory approvals than originally
expected, plus skepticism about its effectiveness. However, Wyeth
and future parent Pfizer Inc. (PFE) are betting expansion into new
markets and regulatory clearance for new uses will drive future
growth.
THE DRUG: Pristiq is a tablet taken once daily to treat major
depressive disorder. It is chemically derived from Wyeth's older,
best-selling antidepressant, Effexor, but Pristiq potentially has
patent protection lasting more than a decade beyond the expected
2010 loss of market exclusivity for Effexor. Approved by the U.S.
Food and Drug Administration in February 2008, Pristiq has a
wholesale list price of $3.57 per tablet, or about $107 for a
30-day supply.
THE OPPORTUNITY AND CHALLENGE: Antidepressants are the eighth
biggest drug category, totaling $20.3 billion in 2008 sales, says
prescription-data provider IMS Health. Wyeth hopes to tap an
additional market with Pristiq - relief of menopausal symptoms, for
which the drug is now in testing.
But Pristiq entered a crowded market with established brand-name
blockbusters Effexor and Eli Lilly & Co.'s (LLY) Cymbalta, plus
cheaper generic options. U.S. drug-benefit plans were initially
slow to provide favorable coverage for Pristiq, but Wyeth says that
has improved. Wyeth withdrew an application for European Union
regulatory approval of Pristiq in October because officials said
the drug seemed less effective than Effexor with no advantages in
terms of safety and tolerability. Wyeth still hopes to sell it in
Europe eventually.
PRISTIQ SALES: $115.8 million between its launch in the spring
of 2008 and through March 31. In comparison, Effexor, which went on
sale in the 1990s, had $2.7 billion in sales for 2008.
PRESCRIPTIONS: About 1.3% of all U.S. antidepressant
prescriptions written in the week ended May 22 were for Pristiq,
versus 9.1% for Effexor, 9.8% for Cymbalta and 16.8% for Lexapro
from Forest Laboratories Inc. (FRX), according to Deutsche
Bank.
THE MARKETING: Wyeth is running a television commercial
featuring a sluggish female wind-up doll to illustrate the effects
of depression. The doll perks up as the commercial progresses.
Also, Wyeth has launched a "Start Today" campaign offering to pay
for 50% of patients' out-of-pocket costs for the drug.
WHAT WYETH SAYS: "Pristiq continues to show steady progress in
product usage, patient and physician acceptance, and formulary
coverage as an antidepressant in the U.S. market...We remain
committed to developing Pristiq for menopausal symptom relief to
enable it to reach its full potential." - Joseph Mahady, senior
vice president, April 29.
WHAT ANALYSTS SAY: "WYE's new offering has only made very modest
inroads into the antidepressant market." - Deutsche Bank's Barbara
Ryan, June 1.
"Data from surveyed physicians suggest that Pristiq is weakly
differentiated from Effexor XR, with no single reason compelling
physicians to prescribe the former." - Decision Resources, May
report.
WHAT'S NEXT: Beginning July 1, Impax Laboratories Inc. (IPXL)
will help Wyeth promote Pristiq. A study testing Pristiq's efficacy
and safety in menopausal women is expected to be completed by the
end of this year; Wyeth plans to submit the data to the Food and
Drug Administration in 2010 in hopes of approval for that use.
-By Peter Loftus, Dow Jones Newswires; 215-656-8289;
peter.loftus@dowjones.com