As they pursue
home-runproducts, drugmakers also seek the pharmaceutical
equivalents of a baseball utility infielder -- a compound
that works on several diseases or conditions.
Few companies can produce sluggers like
Pfizer 's (NYSE: PFE) Lipitor, but they can
still field a decent lineup with drugs that can play several
positions and hit a lot of revenue singles and doubles. By
getting regulatory approval for several uses, a single
compound can be marketed in multiple ways, generating that
magical $1 billion "blockbuster" revenue home run.
Pfizer,
Wyeth (NYSE: WYE), and
Eli Lilly (NYSE: LLY) have pursued this
strategy with selective estrogen receptor modulators, or
SERMs, in women's health. They want to replicate the success
of Lilly's Evista, which still produces $1 billion a year,
but unfortunately, their success rate has been low.
They have SERMS to treat osteoporosis, invasive breast
cancer, vaginal atrophy, and/or post-menopausal symptoms.
However, SERMs have been hit with U.S. regulatory delays or
rejections and clinical trial disappointments, although some
recently won European Union support.
Bone drug blues
Lilly just
walked awayfrom the SERM arzoxifene, which had been
targeted for osteoporosis and invasive breast cancer.
Although arzoxifene met the main research goals in a
late-stage clinical trial, Lilly won't submit it to the Food
and Drug Administration. It cited the drug's side effects and
"currently available treatments, including Lilly's own
osteoporosis products." Probably not a bad call because, as
Fool contributor Brian Orelli pointed out, arzoxifene would
have had to compete in a crowded osteoporosis market filled
with non-SERM drugs such as Boniva from
GlaxoSmithKline (NYSE: GSK) and Roche.
Arzoxifene had been viewed as a successor to Evista, which
has been approved for both preventing and treating
osteoporosis and for reducing the risk of invasive breast
cancer in post-menopausal women.
The reason arzoxifene was important is that Evista faces a
patent challenge from
Teva Pharmaceutical Industries (Nasdaq:
TEVA). However, in April, Lilly won a temporary restraining
order from a federal court preventing Teva from selling a
generic until the case is resolved.
Long delays and rejections
The recent arzoxifene saga was brief compared to
Pfizer's long-running struggle with lasofoxifene. The FDA
rejected it in 2005 as a prevention of osteoporosis and again
early this year as a treatment for osteoporosis. It's also
been rejected for treating vaginal atrophy, according to
Ligand Pharmaceuticals (Nasdaq: LGND), which
partners Pfizer on the drug.
On the plus side, the
European Union endorsedthe drug in March for treating
osteoporosis in postmenopausal women with an increased risk
of bone fracture.
Ironically, Wyeth is partnered with Ligand on another SERM
called bazedoxifene. Wyeth filed prevention and treatment of
osteoporosis applications with the FDA in 2006 and 2007.
However, it has been requested to provide more information,
which it expects to do this year. Meanwhile, the EU has
recently permitted the sale of bazedoxifene as a treatment
for osteoporosis. Continued... |