[LLY MRK Novartis] Lilly's New Drug to Heat Up Battle for Bone
Market: Spotlight
Bloomberg News
September 9, 1998, 6:13 a.m. ET
Lilly's New Drug to Heat Up Battle for Bone Market: Spotlight
Berlin, Sept. 9 (Bloomberg) -- The battle for the $2.8
billion market for osteoporosis treatments will likely heat up
this weekend as Eli Lilly & Co. unveils evidence that its new
treatment for the bone-thinning disease may leapfrog rival
drugs from Merck & Co. and American Home Products Corp.
Lilly, the world's 10th biggest drugmaker, is pitting its
new hormone treatment Evista against both the standard drug
for the age-related illness -- American Home's blockbuster
Premarin -- and also against Fosamax, the bone-building drug
that was Merck & Co.'s fastest-growing pharmaceutical last
year. Lilly aims to show that Evista has the qualities of both
Premarin and Fosamax, a huge potential marketing advantage.
The U.S. drugmakers, along with European rivals including
SmithKline Beecham Plc, Novartis AG and Hoechst AG, are
battling for what could become one of the most lucrative
niches in the $244 billion industry. The osteoporosis market
is expected to double by 2005 as the number of elderly people
rises and new drugs are approved. Some 20 million people in
the U.S. alone are affected by the disease, mostly women.
''It will be interesting to get indications on how these
various types of therapies fit together,'' said Ian Smith, an
analyst at Lehman Brothers. ''We need to know which patients
should get which therapy.''
Estrogen Treatment
Osteoporosis has for years been treated with limited
results with estrogen, a bone and skin-strengthening hormone
that falls in women after menopause, and Premarin has been the
best-selling hormone replacement therapy, generating $1
billion in 1997 sales. Calcium and vitamin D supplements are
also commonly prescribed.
The 1995 approval of Fosamax changed all that. Unlike
Premarin, the Merck drug was found to actually build bone mass
in post-menopausal osteoporosis patients. Sales of Fosamax
took off, reaching $532 million in 1997 sales, an 89 percent
rise from 1996. It also fueled development of other similar
drugs called bisphosphonates by Hoechst, Roche Holding AG and
others.
Now its Lilly's turn to make its mark with Evista, a drug
many analysts predict could sell more than $1 billion a year
at peak sales. Evista is the first of a class of new hormone
drugs called selective estrogen receptor modulators, or serms,
and it reflects a different approach to treating osteoporosis.
SmithKline Beecham Plc, Pfizer Inc. and others are racing
to develop similar high-tech estrogens, while other companies
are looking at osteoporosis drugs called parathyroid hormones
or synthetic versions of the hormone calcitonin.
They will likely find a ready market for treating the
disease, which causes bones to become brittle and break
easily. Each year, such fractures cost some $14 billion to
treat, according to Merck.
Patient groups hail the new focus by drugmakers in a
market that has historically been one of the slowest growing
in the pharmaceuticals industry. And drug company executives
are aiming to make sure they know more about the drugs at a
conference next week in Germany.
''I believe the more choice there is, the better,'' said
Mary Frazier, executive director of the European Foundation
for Osteoporosis, one sponsor of the European Congress on
Osteoporosis, starting in Berlin on Friday. ''The ultimate
test is to show that the drugs stop bone fractures.''
Lilly's Turn
At the Berlin gathering of more than 3,000 doctors and
researchers, Lilly will have a chance to counter a Merck study
last year which showed that Fosamax cut non-spinal bone
fractures by almost half over a one-year period.
Lilly plans to release two-year data in a study of some
7,700 post-menopausal women that's expected to show Evista
reduced new spinal fractures by around 50 percent. Analysts
say they anticipate a strong showing for the drug.
''We are probably going to get more good news,'' said
Jeffrey Kraws, an analyst with Everen Securities. ''There is
no reason why this drug would not be continuing its trend of
strong efficacy.''
A positive presentation is important for Indianapolis-
based Lilly. The company faces patent loss early next decade
for Prozac, the blockbuster antidepressant that made up a
third of its 1997 sales of $7.9 billion.
Evista is now approved for use in the prevention of
osteoporosis, while Fosamax is approved both for the
prevention and treatment of the disease. Lilly aims to show
that the drug not only prevents the disease, but can increase
bone mass like Fosamax.
Evista may also have another major advantage. Tests have
shown that it reduces the rate of breast cancer and heart
attacks in women, a major marketing advantage over
osteoporosis-only drugs. Earlier studies showed that Evista
reduced by more than 50 percent the incidence of newly
diagnosed breast cancer, Lilly said.
''That's what they need for a big product,'' said Rick
Drake, a money manager with Duff & Phelps Investment
Management, which holds about $120 million worth of Lilly
shares. ''For them to get all those, it's probably going to
take a few years.''
Other Competitors
Competitors have no plans to let Lilly grab the whole
spotlight at the conference, however. Swiss drugmakers Roche
and Novartis will both present data on their new drugs,
although neither said the data from earlier studies is
completely new.
Roche, Europe's fifth-biggest drugmaker, will discuss
ibandronate, a bisphosphonate like Fosamax that Roche claims
is more palatable to patients since it can be taken with one
injection every three months. Fosamax, by contrast, must be
taken on an empty stomach each day, usually in the morning.
''You can expect it to have a reasonable turnover,'' said
Roche spokesman Roland Haefeli of ibandronate, which was
developed by Boehringer Mannheim GmbH, the German company
Roche bought for about $7 billion this year.
Haefeli said ibandronate is the only injected drug in the
class of bisphosphonates, which he called ''a major
advantage.'' Roche predicts bisphosphonates like ibandronate
and Fosamax will grab half the market for osteoporosis drugs
in 2000.
Novartis, the world's third-biggest drugmaker, will
discuss the benefits of Miacalcic, an injected or nasal spray
drug used to treat pain in osteoporosis. Miacalcic is
Novartis' tenth-biggest selling drug, generating 224 million
Swiss francs ($158 million) in sales in the first half of
1998, a 26 percent rise.
Novartis Product
Novartis spokesman Felix Raeber said his company will
present four-year data from a study expected to last five
years aimed at demonstrating the analgesic properties of
Miacalcic, which is a synthetic salmon calcitonin. Miacalcic
is the second biggest prescribed drug for osteoporosis in the
U.S. after Fosamax, according to IMS Health, a market research
firm.
Hoechst, Germany's third-largest drugs and chemicals
maker, plans to discuss Actonel, also a bisphosphonate which
is now in final stage clinical trials with Procter & Gamble
Co. The drug is approved for Paget's disease, but the company
said it will present major new data mostly at later
conferences.
Other companies expected to be make news at the
conference are Cortecs Plc, which is developing an oral salmon
calcitonin, and Akzo Nobel NV, which will present new data on
its drug Livial for post-menopausal women. Germany's Merck
KGaA is due to discuss its calcium product Ostram.
--Dane Hamilton in the London newsroom (44-171) 330-7727 with
quote.bloomberg.com
|
