Lilly, Merck Bone Drugs Widen Choice, Say Doctors (Update1)
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) |