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Biotech / Medical : Eli Lilly -- Ignore unavailable to you. Want to Upgrade?


To: Bull-like who wrote (326)9/9/1998 8:06:00 AM
From: Anthony Wong  Respond to of 642
 
[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




To: Bull-like who wrote (326)9/10/1998 8:09:00 AM
From: Anthony Wong  Respond to of 642
 
Novo's Prandin to Help Drugmaker Gain Ground in Diabetes Battle

Bloomberg News
September 10, 1998, 6:57 a.m. ET

Novo's Prandin to Help Drugmaker Gain Ground in Diabetes Battle

Barcelona, Sept. 10 (Bloomberg) -- Novo Nordisk A/S's
diabetes drug Prandin can help reduce patients' blood-sugar
levels alone or in combination with other drugs -- and unlike
other treatments, it's effective no matter how many meals
patients eat, new studies show.

Prandin, known as NovoNorm in Europe, showed it could reduce
blood-sugar levels to what doctors consider ''acceptable'' levels
in 83 percent of patients, regardless of whether they skipped
meals or ate four times a day. When patients took Prandin and a
generic drug called metform, 60 percent achieved ''good'' sugar
control, according to studies presented at this week's meeting of
the European Association for the Study of Diabetes.

Novo, the world's largest maker of diabetes treatments, is
counting on Prandin to extend its lead as competitors pile into a
market growing 15 percent a year. Novo and Eli Lilly & Co., the
market's No. 2 and like Novo a maker of the widely used treatment
insulin, must also widen their drug offerings as a new generation
of treatments threatens to reduce diabetics' need for insulin.

''Everyone is hedging their bets,'' by trying to rejuvenate
insulin and developing new pills that can defer the moment when
diabetics, who grow progressively less sensitive to oral
therapies, need to turn to insulin, said James Keeney, an analyst
with ABN Amro.

Diabetes, a chronic disorder characterized by the body's
inability to properly regulate glucose levels, is claiming more
victims as people lead more sedentary lifestyles and eat fattier
diets. Patients take the hormone insulin to help them process
glucose.

Room for Growth

''The market is poised for growth,'' said Keeney.

Indeed, the worldwide market for treatments of the most
common form of diabetes, estimated at $2.5 billion, will almost
triple in size by 2004 to an estimated $7 billion, according to
analysts at Societe Generale.

So far, analysts say Novo appears to be a step ahead of
Lilly because Prandin -- or NovoNorm -- is already sold in the
U.S. and received clearance for sales in the European Union last
month. It will be introduced in several European countries before
year-end, and analysts estimate it could soon generate annual
worldwide sales of $300 million to $400 million.


Investors appear to think the company's prospects are good,
too. Novo shares have risen 12 percent over the past month,
making the company one of the top 10 performers in the European-
wide Bloomberg 500 index of stocks.

The drug, known chemically as repaglinide, works by
stimulating the pancreas to produce insulin. It's designed to be
taken with meals so that it can keep glucose levels stable at
times when they vary the most.

The fast action may mean there is less chance of patients
having hypoglycemia, a condition of low blood sugar that can
occur when insulin-stimulating drugs push the body too far the
wrong way.

Rival Drug

Lilly's competing drug, pioglitazone, is still in the late
stages of clinical trials. If it reaches the market, though, it
could be an important addition to the anti-diabetes arsenal,
analysts say.

The Indianapolis-based drugmaker is working with Japan's
Takeda Chemical Industries on a product that may rival Warner-
Lambert Co.'s Rezulin, one of the fastest-growing diabetes drugs
in the U.S.

Early data suggests the Lilly drug could be as effective as
Rezulin without its liver-damaging side-effects, said Leonard
Yaffe, an analyst with NationsBanc Montgomery Securities.

In the meantime, Lilly is also moving on several fronts by
trying to give insulin a lift. The U.S. drugmaker, which
introduced the world's first insulin in 1922, will next year
bring in a new form of insulin that studies show is more
effective than existing treatments. It's also developed two new
insulin injection systems that could lure patients to its
products because they're easier to use than the competition's.

European studies of Lilly's new insulin, called HumalogMix
25, show it can reduce the peak level of glucose, or blood sugar,
that occurs in diabetics after meals by a third more than
existing treatments. Researchers in Barcelona also said the new
product is also easier to use because it can be injected shortly
before or after meals.

The new compound, to be introduced in Europe next year and
in the U.S. in 2000, will compete with Novo's Novolin and Lilly's
own Humulin. Novo controls 50 percent of the world's insulin
market, compared with Lilly's 45 percent.


Unlike insulin, the so-called oral treatments developed by
Novo, Lilly and others aim to treat Type II diabetes, the most
common form of the disorder, which typically develops later in
life as the pancreas does not produce an adequate supply of
insulin and muscle tissue becomes insensitive to the hormone.

Insulin is the chemical messenger the body normally makes to
regulate how glucose, or blood sugar, gets to cells. In the more
severe form of the disease, known as Type 1, the pancreas doesn't
produce insulin.

--Marthe Fourcade in Barcelona through the London newsroom (44



To: Bull-like who wrote (326)9/11/1998 10:21:00 AM
From: Anthony Wong  Read Replies (1) | Respond to of 642
 
Early Drug Treatment Can Curb Diabetes Complications (Update3)

Bloomberg News
September 11, 1998, 4:04 a.m. PT

Early Drug Treatment Can Curb Diabetes Complications (Update3)

(Adds analysts' comment in 11th-13th paragraphs, tightens
first paragraphs.)

Barcelona, Sept. 11 (Bloomberg) -- Life-threatening diabetes
complications such as heart and kidney problems can be greatly
reduced if doctors prescribe more drugs earlier to cut patients'
blood-sugar and blood-pressure levels, a new study shows.

The U.K. Prospective Diabetes Study, the longest study ever
conducted on the most common form of diabetes -- so-called Type
II -- found that by aggressively using available drugs, doctors
could prevent complications that many thought were inevitable.

The study could lead to increased prescriptions of diabetes
and hypertension drugs -- a benefit for companies such as
diabetes market leaders Novo Nordisk A/S and Eli Lilly & Co. and
Zeneca Group Plc, the maker of hypertension drugs used in the
study. Analysts estimate the worldwide market for Type II
diabetes treatments will triple to $7 billion by 2004, from an
estimated $2.5 billion last year.

''At present, diabetic complications are often regarded as
being a natural outcome of this chronic disease,'' said Robert
Turner, who teaches medicine at the University of Oxford and
directed the study. ''The study shows definitively that good
management does help prevent complications.''

The results of the 20-year study come as diabetes, a
disorder characterized by the body's inability to regulate blood-
sugar levels, claims more victims as the world's population ages,
eats fattier diets and leads a more sedentary life.

All Efforts Beneficial

The studies, conducted on more than 5,000 patients aged 25
to 65 and recently diagnosed with diabetes, showed any reduction
in blood-sugar and blood-pressure levels cuts the risk of heart
disease, kidney failure, vision problems and other complications
associated with the disease.

''It's the strongest evidence to date to show how important
it is to use available therapies,'' said James Anderson, a
research physician for Indianapolis-based Lilly, the world's No.
2 maker of diabetes treatments behind Novo of Denmark.

Doctors had previously observed that lower blood-sugar
levels were linked to fewer diabetes-related complications. Until
now, nobody had established that bringing down the level of sugar
in the blood would cut down on the occurrence of such diseases.

''Imagine you'd known for years that taller people were more
at risk of heart attacks,'' said David Matthews, who heads
clinical diabetes services at Oxford Hospital in the U.K. ''You'd
still need to establish that reducing their height would make
them less prone to heart attacks. That's in effect what this
study is showing.''

Drugs Safe

Researchers, who presented the data in the first part of a
two-day session at this week's meeting of the European
Association for the Study of Diabetes, also said the study found
few long-term adverse effects in treatments such as insulin, the
chemical messenger the body normally makes to regulate how blood
sugar gets to cells, which is sold by Lilly, Novo, and Hoechst
AG; sulfonylureas, a class of drugs that boosts the body's own
insulin secretion and includes Pfizer Inc.'s Glucotrol and
Hoechst's Amaryl; and metformin, a more recent kind of diabetes
treatment that inhibit glucose output from the liver, sold for
instance by Merck KGaA and Bristol-Myers Squibb Co. under the
name Glucophage.

''On balance, this has to be positive for drugmakers,'' said
Stewart Adkins, an analyst at Lehman Brothers in London.

Analysts cautioned, however, that the study only reinforces
what doctors already suspected and that many patients already
take a combination of drugs to cut the level of sugar in their
blood. They said while the research could point to increased
sales of insulin, the hormone is coming under pressure from a new
generation of oral diabetes treatments that weren't examined in
the study, and diabetics with few symptoms might be reluctant to
take insulin shots before meals -- regardless of their doctors'
recommendation.

''It's always easier to pop a pill than it is to inject
yourself,'' said Robin Campbell, an analyst at Paribas Capital
Markets in London.

Drugmakers Rejoice

Researchers, for their part, said their findings could
result in higher sales of insulin, which is currently used mostly
for Type I diabetics and in the late stages of Type II, when
patients' bodies produce almost no more insulin. Oral treatments
such as metformin, sulfonylureas or the newer generation of
glitazones work better in the early stages of the disease because
they either stimulate the body's insulin secretion, or its
sensitivity to existing insulin.

''More patients will probably take insulin than they used
to,'' said Turner of Oxford. ''And patients might be taking
three, four, or five kinds of tablets a day if they also have a
hypertension problem.''

That's good news for Novo, Lilly and others who've been
trying to win a bigger slice of the growing market for diabetic
treatments. The two drugmakers, as well as Glaxo Wellcome Plc,
Bristol-Myers, Hoechst, Roche Holding AG and SmithKline Beecham
Plc, helped fund the study along with government and charity
grants.

The study ''supports our current recommendations and
strategies regarding the treatment of type II diabetes,'' Lars
Rebien Soerensen, Novo executive vice president, said in a
prepared statement.

Different Strategies

Novo is counting on a key drug, Prandin, to extend its lead
as competitors push to enter the market and Lilly looks for ways
to rejuvenate insulin.

Prandin, or NovoNorm as it's known in Europe, works by
stimulating the pancreas to produce insulin. It's designed to be
taken with meals so that it can keep glucose levels stable at
times when they vary the most, and it's part of a growing market
for oral therapies used in patients before their bodies become
unable to produce insulin.

Lilly, for its part, is working with Japan's Takeda Chemical
Industries on a product that may rival Warner-Lambert Co.'s
Rezulin, one of the fastest-growing diabetes drugs in the U.S.
It's also moving trying to give insulin a lift. The U.S.
drugmaker will also next year introduce a new form of insulin
that studies show is more effective than existing treatments.

SmithKline and Novartis AG are among the other drugmakers
likely to benefit from this study because they make oral
treatments that work in combination and can be used with insulin.

--Marthe Fourcade in Barcelona and Theresa Waldrop in Zurich,



To: Bull-like who wrote (326)9/14/1998 8:46:00 AM
From: Anthony Wong  Read Replies (1) | Respond to of 642
 
Lilly, Merck Bone Drugs Widen Choice, Say Doctors (Update1)
Bloomberg News
September 14, 1998, 6:47 a.m. ET



(Adds share price reaction in 5th paragraph.)

Berlin, Sept. 14 (Bloomberg) -- Eli Lilly & Co.'s and
Merck & Co.'s new osteoporosis drugs may be more effective
than anticipated, studies released today showed, offering new
hope to women facing devastating age-related disorders.

While the new drugs aren't a panacea, doctors at the
European Congress of Osteoporosis conference said they're a
major advance in treating a condition that previously was
viewed not as a disease, but as a natural part of aging.

Lilly's Evista may eventually generate annual sales of
more than $1 billion, analyst say, while Merck's Fosamax
generated $532 million in 1997 and was the biggest-
selling osteoporosis-only drug in the U.S. Osteoporosis
affects some 200 million women, in a $2.8 billion market for
treatments, causing bones to become brittle and break easily.

''Osteoporosis is a major public health problem, yet many
people don't know what it is or how to treat it,'' said Mary
Fraser, executive director of the European Foundation for
Osteoporosis, a sponsor of the Berlin conference that
attracted some 4,000 doctors from all over the world.

Lilly shares traded in Switzerland rose as much as 2.75
francs, or 2.7 percent, to 106.25 francs ($74.30), while Merck
shares traded in France rose as much as 17 French francs, or
2.4 percent, to 737 French francs ($129).

Doctors predict that usage of the drugs -- which compete
with those of American Home Products Corp., Novartis AG and
others -- will rise as awareness grows that they can help
prevent hip and spinal fractures common in older women.

They are not without disadvantages, though. For continued
effectiveness, the new drugs will probably have to be taken
daily for decades, and they have undesirable side-effects.

Key Study

One key study, sponsored by Eli Lilly, the world's 10th-
biggest drugmaker, showed that Evista reduced the risk of spinal
fractures by about half in a two-year study involving 7,700 post-
menopausal women with osteoporosis, compared with patients who
took no drug.

In previous large trials, Evista was also shown to reduce
serum cholesterol levels, a risk factor for heart disease, and
reduce the new breast cancer cases by about half.

Evista ''in this large study looks favorable from several
points of view,'' said Steven R. Cummings, assistant dean of
research at the University of California, San Francisco, and a
lead researcher in the trial.

After hip fractures, which always land a patient in
hospital, spinal fractures have the biggest impact on
osteoporosis patients, causing severe pain, height loss and
back deformities. According to the National Osteoporosis
Foundation, about half the 1.5 million osteoporosis fractures
that occur each year in the U.S. are spinal. And often one
spinal fracture can lead to another.

With Evista, Eli Lilly hopes to build a bigger franchise
in a growing market for osteoporosis drugs, and compete
against common treatments like hormone replacement therapy
made by American Home Products and Novartis, as well as newer
bone-building drugs made by Merck, SmithKline Beecham Plc and
others.

Evista was approved in the last year in Europe and the
U.S. for prevention of osteoporosis, but the company is
looking to gain approval for the treatment of osteoporosis, a
much bigger market.

Fracture Risk

Women taking Evista also reported less of vaginal
bleeding and breast discomfort, which are common complaints in
hormone replacement therapy that is used by about nine million
women each year in the U.S. for treating post-menopausal
symptoms.

However, Evista wasn't shown to benefit patients by
reducing hip fractures, a drawback that may benefit Merck with
Fosamax, the only drug so far to be proven to cut the risk of
hip fracture in post-menopausal women.

Osteoporosis, which is thought to be caused by an
imbalance between bone-building cells and bone-destroying
cells, causes about 250,000 hip fractures a year in the U.S.,
with many suffering permanent disability requiring nursing
home care.

Merck, the world's biggest drugmaker, today released new
findings from the Fracture Intervention Trial, a 6,000 patient
trial, that showed that Fosamax cut the risk of hip fractures
by 56 percent among women who hadn't had a previous spinal
fracture. It also showed that Fosamax reduced the likelihood
of spinal fractures by 49 percent.

The new findings were part of a continuing clinical trial
for Fosamax. Previous results from the same trial showed that
Fosamax reduced the risk of hip fractures by 51 percent.

Doctors said whether to prescribe Fosamax, Evista or
other drugs to prevent or treat osteoporosis will depend on a
number of factors, including cost, risk of disease escalation
and side-effects.

Cost of Treatments

The University of California's Cummings said the cost of
the new treatments is a ''huge issue'' for health maintenance
organizations, because ''the odds are that this is something
she will have to take for decades.''

Evista and Fosamax each cost about $600 a year per
patient at the retail level, while older therapies like
hormone replacement therapy cost $300 a year or less, said
Cummings.

However, experts said the cost of prevention and
treatment is cheap compared to the cost of hospitalization. In
Britain, for instance, the cost of hospitalizations for hip
fractures is about 400 million pounds ($670 million) a year,
said John A. Kanis, a professor at the University of Sheffield
in England who treats osteoporosis patients.

While new drugs could dramatically cut those costs, Kanis
said the cost of a long-term drug treatment for osteoporosis
in patients who may already be on other medications is ''an
issue for people who have to pick up the bill.''

--Dane Hamilton in Berlin through the London newsroom (44-171)